A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Sponsor: Pfizer

PF-06700841
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CLINICAL PROTOCOL 
A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, 
MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND
SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC 
LUPUS ERYTHEMATOSUS (SLE)
Study intervention Number:
PF-06700841
Study intervention Name:
Brepocitinib 
United States (US) Investigational 
New Drug (IND) Number:
123650
European Clinical Trials Database 
(EudraCT) Number:
2018-004175-12
Protocol Number:
B7931028
Phase:
Phase 2b
Sponsor Legal Address:
Pfizer Inc.
66 Hudson Boulevard East
New York, NY 10001
Short Title: A Phase 2b multicenter dose ranging study to evaluate efficacy and 
safety of PF-06700841 in systemic lupus erythematosus
This document and accompanying materials contain confidential information belonging to Pfizer.  Except as 
otherwise agreed to in writing, by accepting or reviewing these documents, you agree to hold this 
information in confidence and not copy or disclose it to others (except where required by applicable law) or 
use it for unauthorized purposes.  In the event of any actual or suspected breach of this obligation, Pfizer 
must be promptly notified.
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Protocol Amendment Summary of Changes Table
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Non-substantial Modification(s)
Amendment 8 
15 June 2023
The driver for B7931028 Protocol Amendment 8
is to modify the key secondary endpoint of ‘time 
to first severe SLE flare’
 
 
‘ Time to first severe SLE flare’ will remain 
as a secondary endpoint, just not the ‘key’ 
secondary endpoint and the data will be
summarized as a secondary endpoint.   The 
estimands for the associated endpoints have been 
updated to reflect these changes.  E2, has been
updated to align with the revised ‘Key’ secondary 
endpoint of ‘BICLA response at Week 52’ as was 
E7, the estimand for 'time to first severe SLE 
flare’.  
Section 1.1 Synopsis, the table of Objectives and 
Estimands have been updated to reflect the change 
of key secondary endpoint to ‘BICLA response at 
Week 52’. These changes have also been made 
throughout the OBJECTIVES, ESTIMANDS 
AND ENDPOINTS table in Section 3.  Language 
has been added to Section 4.2 to describe the 
BICLA endpoint and the justification of its use.  
Language has been added to Section 9.1.1 
Estimands to indicate that details regarding 
sensitivity analyses of the primary endpoint may
be provided in the SAP. In Section 9.1.2 
Hypotheses and Decision Rules, changes have 
been made throughout to replace time to first 
severe flare with BICLA response at Week 52 in 
the statistical hierarchy.  The estimand for BICLA 
response at Week 52 is now described in Section 
9.4.3.1, in place of the estimand which had 
previously described the analysis of time to first 
severe flare; the analysis of this endpoint will be 
performed in a manner which is entirely consistent 
with the primary analysis of the primary endpoint, 
SRI-4 response at Week 52.  Subsequently, the 
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planned analysis for time to first severe flare is 
now described in Section 9.4.3.2.
Rationale: The assumptions about the
severe SLE flare rate in this study 
population have not been observed and 
thus the time to first severe flare endpoint 
would be substantially underpowered.
Section 6.3.1 Allocation of Study Intervention has 
been updated to remove the following sentence, 
“Allocation to Study Intervention, In the event of a
Quality Assurance audit, the auditor(s) will be
allowed access to unblinded study intervention 
records at the site(s) to verify that 
randomization/dispensing has been done 
accurately”.  
Rationale: This sentence was removed 
because the study was not set-up to allow 
study sites to have unblinded study 
intervention records.  Therefore, the auditor 
would not have the ability to verify the 
accuracy of randomization and dispensing 
of study intervention as proposed in this 
sentence.
Additionally, changes have been made throughout 
to ensure consistency of the protocol with the 
SAP.  Typographical changes, and changes for 
grammar, have been made as they have been 
identified throughout the protocol and will not be 
summarized here.
Rationale: Additional clarity regarding 
planned sensitivity analyses is provided.
Section 9.1.2 Hypotheses and Decision Rules,
Language has been added to indicate that any 
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future changes to the family-wise error control 
procedure would be detailed in the SAP.
Rationale: This language is used to indicate 
how any additional changes to the 
statistical hierarchy will be addressed.
Section 9.2 Sample Size Determination has been 
updated with power calculations for both the 
primary endpoint, SRI-4 response at Week 52, and 
the key secondary endpoint, BICLA response at 
Week 52 in a manner which is now consistent with 
the planned primary analyses of these endpoints.  
Rationale: Previously, the power 
calculations conducted and described in 
this section incorporated a 25% dropout 
rate even though these participants are 
counted as non-responders by the primary 
estimand.  The calculations are now 
consistent with the estimand. This section 
is also updated to reflect the change in the 
key secondary endpoint.
Amendment 7
06 June 2022
The overall rationale for B7931028 Protocol 
Amendment 7 is to decrease the sample size for 
the study from 448 participants to 350 participants, 
and to allow eligibility of participants with latent 
TB (positive quantiferon gold tests) who agree to 
receiving treatment with INH and Vitamin B6.
This amendment also includes the administrative 
changes made in Protocol Amendment 5 
(requested during the EU Voluntary 
Harmonization Procedure (VHP) review of 
Amendment 4, countries submitting their initial 
clinical trial application with Amendment 5 (Italy 
and Argentina), and to any country requiring new 
protocol amendments to be submitted (Taiwan); 
and Protocol Amendment 6 (China only 
amendment) to be globally implemented. 
Furthermore, this change will allow specific safety 
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monitoring to be put into place to allow 
participants with latent TB (not active TB) to be 
eligible for the study provided the protocol 
inclusion/exclusion criteria can be met.  
Section 1.1 Synopsis, Section 3.0 Objectives, 
estimands and ENDPOINTS and Section 9.5 
Interim Analysis –The Interim Analysis was 
updated to now read, “An Interim analysis may be 
conducted when sufficient number of participants 
completes Week 52 visits and before the interim 
analysis is instigated, the details of the objectives, 
decision criteria, dissemination plan and method of 
maintaining the study blind per Pfizer’s SOPs will 
be documented and approved in the E-DMC 
charter. In addition, the analysis details must be 
documented and approved in an interim analysis 
plan (IAP).”
Rationale: Since the sample size was 
modified from 448 to 350, there are already 
more than 50% subjects of the subjects that 
have completed Week 24 therefore, including 
a ‘sufficient amount of participants’ allows 
for the participants that meet the interim
analysis requirements to all be included. In 
addition, the timepoint was updated from 
Week 24 to Week 52 to provide a more 
robust dataset.
Section 1.1 Synopsis, Section 9.2 Sample Size 
Calculation - The Sample size has been modified
from approximately 448 to approximately 350.
Rationale: reduction of sample size to 
350 patients provides at least 80% power for 
the primary endpoint and will allow more 
timely completion of this study.
Section 1.3, Schedule of Activities, Section 8.2.1.2 
Chest X-ray was added to the Week 56 visit, for 
subjects entering the study with latent TB. If a 
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subject is diagnosed with latent TB at Week 24 
visit and follows the protocol requirements, a chest 
X-ray will be conducted at the Week 24 visit. The
Schedule of Activities footnotes were reordered.
Rationale: The Schedule of Activities was 
updated to collect the specific items required 
at each visit and to reorder the footnotes in 
chronological order.
Section 2.2.2, Clinical Overview was updated to 
align the clinical trial data in this section with the 
latest version of IB. 
Section 2.2.2, Table 1 -Summary of Clinical 
Studies for Brepocitinib was replaced with 
Table 14 from the latest version of the 
PF-06700841 IB to ensure absolute alignment 
between the 2 documents. 
Section 5.2, Exclusion Criterion #27, Zostavax®
was added as an example of a live herpes zoster 
virus vaccination that is prohibited in the study.
Section 5.2, Exclusion Criterion #28, ‘serological’ 
was removed from the HIV criteria to broaden the 
HIV testing methodology. 
Section 5.2, Exclusion Criterion #32 and 
Section 8.2.6, Tuberculosis (TB) Screening and 
Monitoring: If a prospective participant is being 
treated for latent TB or is diagnosed during 
screening with latent TB and agrees to be treated –
the requirements for a prospective participant to be 
eligible for the study were clarified.
Rationale: To allow participants who have 
been diagnosed with latent TB and are 
currently receiving latent TB treatment or 
who are were diagnosed during screening and 
initiated latent TB treatment to be eligible for 
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the study. This scenario was not included in 
the previous versions of the protocol.
Section 5.2, Exclusion Criterion #35, If the total 
bilirubin is ≥1.5 times the ULN, the subject may 
be eligible for the study if they have a history of 
Gilbert’s syndrome and if their direct bilirubin was 
< ULN.
Rationale: Participants with known Gilbert’s 
syndrome have normal liver function despite 
elevated total bilirubin levels and do not need 
to be excluded from participation on the basis 
of the elevated bilirubin level.
Sections 5.1, 5.3.1 and Appendix 10.4.1, Male 
participants are not required to use barrier 
contraception to minimize partner exposure to 
brepocitinib.
Rationale: Based on calculated exposures in 
semen, Brepocitinib concentrations are 
predicted to have a safety margin ≥100 in 
male participants, and therefore female 
partners are not at teratogenicity/fetotoxicity 
risk. This was updated in the IB (version 7.0, 
dated November 2021).
Section 6.1.1, Administration, Section 6.4, Study 
Intervention Compliance and Section 7.1.1, 
Temporary Discontinuation, the duration of study 
intervention interruption permitted was updated to
14 days.  The updated text reads, “Participants 
interrupting study intervention for more than 
14 days, should be discussed with the sponsor for 
possible withdrawal from the study.”
Rationale: To allow text alignment of study 
intervention interruptions. 
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Section 6.4, Study Intervention Compliance, was 
updated to include the upper bounds of the 
compliance range (>120%). 
Rationale: Both the upper and lower bounds 
of the study intervention should be included 
in the protocol to provide the comprehensive 
compliance situation. If compliance is 
outside these limits, Pfizer clinical should be 
contacted as soon as possible to determine if 
the participant should discontinue study 
medication due to non-compliance and if any 
additional safety assessments are needed.
Section 9.3, Populations for Analysis, the ‘full 
analysis set’ was updated to read, “All participants 
randomly assigned to study intervention and 
received at least one dose of study intervention. 
Participants will be analyzed according to the 
product they were randomized.” Previously the 
description was “All participants randomly 
assigned to study intervention regardless of 
whether they have taken study intervention”. 
Participants will be analyzed according to the 
product they were randomized.
Rationale: This change was made to 
accurately define the full analysis set 
population.
Appendix 10.13, List of Prohibited and Permitted 
Medications was updated to reflect accurate 
information on the following medications (updated 
text is bolded below):
!
Anti-malarials: Provided pre-existing dose 
is stable for at least 12 weeks and 
treatment not started/or stopped within 
12 weeks of Day 1.
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Throughout the protocol, the laboratory test, 
Coombs direct was updated to read, ‘direct 
Coombs’.
Rationale: This change was made to provide 
the accurate name of this laboratory test.
Minor typographical errors and omissions were 
corrected.
Amendment 6
28 September 
2021
Protocol Amendment 6 is only for use in China.  If 
there is a global amendment in the future for this
study, the changes in Amendment 6 will be 
implemented into the global amendment.
The overall rationale for B7931028 protocol 
amendment 6 is to address the Quantiferon gold 
test results which are not negative.  The 
amendment will allow specific safety monitoring 
to be put into place to allow participants with 
latent TB (not active TB) to be eligible for the 
B7931028 study provided the protocol criteria can 
be met.  China is having the biggest impact on 
enrolling participants into the study because of this 
eligibility criteria; however, once the next global 
protocol amendment is required, this language will 
be added as well.
Section 1.1. Synopsis, Overall Design; 
Intervention Groups and Duration Design; Section 
1.2, Schema; Schedule of Activities, Footnote ‘g’; 
Section 4.1 Study Design (twice); Section 5.2, 
Exclusion Criteria #32; Section 8, Study 
Assessments and Procedures, Screening - the 
screening period was increased from 5 weeks or 
35-days to 7 weeks or 49 days.  
Rationale: These additional requirements 
would take additional time; therefore 2 weeks 
were added to the screening period.  In 
addition, the following processes around TB 
testing and diagnosis of latent TB were added 
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to the protocol.  Subjects diagnosed with 
latent TB were not previous permitted into the 
study; however, other investigation products 
with similar mechanisms of action permit 
subject with latent TB to be entered into their 
studies, but they also have processes to follow 
to monitor participant safety.
Section 5.2, Exclusion Criteria #12: The following 
sentence was added to this exclusion criteria, 
“Prior Splenectomy is prohibited”.
Rationale: Splenectomy is associated with an 
increased risk of infection; therefore, it is 
prohibited from this study. 
Section 5.2, Exclusion Criteria #32 and 
Section 8.2.6,  Tuberculosis (TB) Screening and 
Monitoring: Latent TB – Requirements for a 
prospective participant to be eligible for the study 
if the subject is diagnosed with latent TB (ie, visit 
to the infectious disease/pulmonary specialist for 
further investigation and agreement the participant 
can enroll into the study, only medication to treat 
latent TB permitted in the study is INH and 
Vitamin B6 therapy) was added to the protocol as 
it was not permitted in previous protocol versions.
The main additions to Monitoring of TB on-study:
!
Week 24, if participant tests TB positive or TB 
indeterminant, they must discontinue study 
medication immediately, be seen the 
pulmonary/infectious disease specialist, once 
active TB is ruled out, then if the subject start 
INH and B6 latent TB treatment, they must be 
on that treatment at least 2-weeks prior to 
re-starting study medication.
!
Week 56, language to encourage the 
investigator to continue to follow-up with the 
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subject as appropriate after the conclusion of 
the study. 
Rationale: To allow prospective participants 
in the study to have the possibility of being 
eligible for the study (by having IGRA retest 
done, and the other protocol requirements 
completed by Day 1); whereas this was not 
permitted in the previous versions of the 
protocol.
 
 
 
  
 
 
Section 5.2, Exclusion Criteria #24 and 
Appendix 13, Prohibited and Permitted 
Medications: The following exclusion criteria was 
added to ensure subjects on any of the bone
marrow stimulants to improve cell counts is 
discontinued 12 weeks prior to Screening/Day 1.  
Rationale: In this study, a prospective 
participant was taking this medication.  The 
team felt this was not an appropriate 
medication to be taken while participating in 
an investigational study due to unknown 
potential safety concerns.  This exclusion 
criteria was added to avoid this situation in the 
future.
Section 2.3 Benefit/Risk Assessments and 
Appendix 13 Permitted and Prohibited 
Concomitant Medications-In Section 2.3, the 
phrase ‘inhibitors or’ was removed.  The list of 
prohibited CYP3A inhibitors were also removed 
from Appendix 13.
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Rationale: To allow CYP3A inhibitors to be 
taken before and during the study, in order to 
align with the Brepocitinib IB dated 
September 2020.
Appendix 15 Columbia Suicide Severity Rating 
Scale-The appendix was modified to align with 
Section 8.2.10, Suicidal Ideation and Behavior 
Risk Monitoring.
Rationale: To avoid mishandling of 
participant safety data.  
Amendment 5
28 April 2021
Summary of Changes in Amendment 4: 
Page 7; Appendix 14 Oral Corticosteroids, 
Systemic Equivalencies – will now include the 
following guidance: has been corrected to 
‘Appendix 13 List of Prohibited and Permitted 
Concomitant Medications – will now include the 
following guidance:’
‘Rationale: This change adds the washout times to 
Appendix 14 to be consistent with the text in 
Section 5.2 Exclusion Criteria, #14’ has been 
corrected to: ‘Rationale: This change adds the 
washout times to Appendix 13 to be consistent 
with the text in Section 5.2 Exclusion Criteria, 
#14’
Appendix 13 List of Prohibited and Permitted 
Concomitant Medications: 
Within the section on Topical, Permitted, Low 
potency topical steroids the following text 
“[class 6 (mild, such as desonide) or class 7 (least 
potent, such as hydrocortisone)]” has been added 
for completeness.
In the row on Lower potency [opioid analgesics] 
the ‘£’ symbols before the doses of Tramadol, 
Hydrocodone and Codeine were corrected to ‘≤’.
Amendment 4
02 March 2021
The driver for the initiation of protocol 
amendment 4 (PA4) was the FDA feedback from 
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the March 2020 Type C meeting.  In the March 
2020 Type C meeting, the FDA suggested to 
Pfizer statistical considerations for the protocol 
that have been implemented and the FDA 
suggested to Pfizer to consider anchoring the 
Facit-fatigue data changes in the study that were 
statistically significant in comparison to what the 
patient felt was clinically significant. 
!
Section 1.1. Synopsis, Objectives and 
endpoints table, Section 3.0 Objectives, 
Estimands and Endpoints, Section 9.1 
Estimands and Statistical Hypotheses and 
Section 9.4 Statistical Analysis were 
updated to reflect the feedback from the 
FDA Type C meeting. 
Primary endpoint edited for clarity and 
secondary endpoint criteria sub-divided in to 
“key secondary” and “other secondary”.
Analysis of the Primary Endpoint – Revised 
the primary analysis from a logistic regression 
model to the Cochran-Mantel-Haenszel (CMH) 
approach.  Both approaches should produce 
similar results, but the former approach may be 
subject to convergence issue in some 
occasions.
Updated all estimands with the five attributes 
to align with the finalized ICH9(R1) Estimands 
and Sensitivity Analysis Guidance.  The five 
attributes are: Treatment, Population, Variable, 
Intercurrent events, and Population level 
summary. 
Updated the intercurrent events to make them 
specific.  Removed the missing data from the 
Estimand statement per regulatory authority 
(FDA) comments on the Statistical Analysis 
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Plan (SAP) and updated relevant estimand 
descriptions in the synopsis.
Incorporated new PRO scales into the 
secondary endpoints.
Updated the estimands for the FACIT-F and 
LupusQoL into a hypothetical estimand. 
 
 
 
 
The following modifications were made to PA4 as 
a result of the PF-06700841 Investigational 
Brochure (IB).  The following changes were added 
and/or modified to the overview of the MoA and 
the safety profile of the product:
!
Section 2.2.2. Clinical Overview
Added study C2501007, an ongoing study in 
hidradenitis suppurativa.
!
Updated Table 1, Clinical Development 
Plan – the studies listed in this table were 
updated to reflect the updated information 
as well as the format of this table to be 
aligned with the September 2020 IB.
!
Section 2.3. Benefit/Risk Assessment -The 
following paragraph was added to the 
benefit/risk section of the protocol to be 
consistent with the language in the updated 
IB: 
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“In the brepocitinib development program, 
there have been thromboembolic events 
reported in ongoing blinded clinical studies, 
where relationship to treatment is uncertain.  
Suspected thromboembolic events will be 
subject to review by an external blinded 
adjudication committee.  In this study, 
B7931028, participants with any history of 
pulmonary embolisms (unless these were 
caused by known antiphospholipid syndrome 
will be excluded from the protocol unless the 
participant has been adequately 
anticoagulated), exclusion criteria #5 and #6 
have more detailed information”. 
The following modifications from the 21Jan2020 
PACL were incorporated into PA4: 
!
Section 1.3 Schedule of Activities (SoA) 
footnote “s”, Screening – will now state: 
SLE diagnosis using either the ACR SLE 
classification or SLICC criteria.  Only one is to 
be used to perform the assessment; American 
College of Rheumatology Systemic Lupus 
Erythematosus Classification or Systemic 
Lupus International Collaborating Clinics 
Criteria. 
Rationale: This clarification will better align 
the (SoA footnote “s”) with Section 5.1 
Inclusion Criterion #3.
!
Section 5.2 Exclusion Criteria #20 – will 
now state: 
Participation in any studies with kinase 
inhibitors, other than JAK inhibitors such as 
those mentioned in #19 within 12 weeks of 
Day 1. 
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Rationale: The current text states #18 and 
represents a carry-over from Amendment 2.  In 
Amendment 3, 1 exclusion criteria (#7) was 
split in to 2 separate criteria, which should 
have been addressed in Exclusion Criteria #20 
by renumbering exclusion criteria #18 to 
exclusion criteria #19.  This error in the criteria 
numbering has been corrected.
!
Section 5.2 Exclusion Criteria #31 – will 
now state: 
Chest radiograph taken at screening with 
changes suggestive of active TB infection, or 
previous inactive TB, general infections, heart 
failure or malignancy unless previously 
performed and documented within 12 weeks 
prior to Day 1. 
Rationale: The addition of the new text will 
make exclusion criterion #31 consistent with 
Section 8.2.2.1 Chest X-Ray. 
!
Section 8.2.3 Vital Signs – will now state: 
Participants should refrain from smoking (or 
use any tobacco products) or ingesting caffeine 
during the 30 minutes prior to the 
measurements.
Rationale: Per Amendment 3, Section 5.2 
Exclusion Criteria, Other Exclusionary Criteria 
#38, “Participants who are currently vaping or 
using e-cigarettes” was added as a new 
exclusion criterion; the reference to e-cigarettes 
was erroneously NOT removed from Section 
8.2.3 – this has now been corrected.
!
Various Sections – the listed typographical 
errors, which were introduced in 
Amendment 3, are corrected as follows:
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!
Section 1.1, Adjudication Committees, 
Section 3 Objectives, Estimands and 
Endpoints and Section 9.5.2 Adjudication 
Committees: thromboemblic was updated 
to thromboembolic.
!
Section 2.2.2, Clinical Overview-excertion 
as updated to excretion.
!
Table 1- mcirotracer was updated to 
microtracer; Peroid was updated to Period 
and unlabled was updated to unlabeled.
!
Section 3, Objectives, Estimands and 
Endpoints immunoimpressive was updated 
to immunosuppressive.
!
Section 3 and 9.5.2, Adjudication 
Committees- Malignacy was updated to 
Malignancy.
!
Section 5.1, Inclusion Criteria-
monontherapy was updated to 
monotherapy. 
!
Section 5.2, Exclusion Criteria-
aematologic was updated to hematologic.
!
Section 10.12, Appendix 12- Comombs 
hmolytic was updated to Coombs 
haemolytic.
!
Appendix 9, Systemic Lupus International 
Collaborating Clinics (SLICC) Criteria 
(Immunological Criteria #4) – will now 
state: 4. Antiphospholipid antibody.
Rationale: Deleted text was not removed 
previously.
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!
Appendix 13 List of Prohibited and 
Permitted Concomitant Medications was 
updated to reflect accurate information:
Stable dose is defined as no new therapy or 
change in standard-of-care therapies as above 
within 12 weeks of Day 1 for 
immunosuppressives or within 2 weeks of 
Day 1 for corticosteroids (inserted after title of 
appendix). 
Rationale: This change will add a definition of 
stable dose to Appendix 13 for consistency 
with the definition of stable dose in Section 5.1 
Inclusion Criteria, #5.
!
Appendix 13, List of Prohibited and 
Permitted Concomitant Medications – will 
now include the following guidance: 
Oral or parenteral (IV or IM) corticosteroids at 
doses <40 mg per day of prednisone (or 
equivalent) within 8 weeks of Day 1. 
Intra-articular corticosteroids or hyaluronic 
acid >4 weeks of Day 1. 
Topical corticosteroids, other than stable doses 
of class 6 (mild, such as desonide) or class 7 
(least potent, such as hydrocortisone), 
>4 weeks of Day 1. 
<20 mg/day of prednisone or equivalent or 
have adjusted the dose of corticosteroids within 
2 weeks of Day 1.
Rationale: This change adds the washout times 
to Appendix 13 to be consistent with the text in 
Section 5.2 Exclusion Criteria, #14.
!
The following changes were implemented 
into PA4 from the PACL dated 04Feb2020:
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An incorrect daily dose of chloroquine of 
2.3 mg/kg/day was stated in the protocol; the 
maximum dose of chloroquine has been 
corrected to now be 250 mg/day to align with the 
standard maintenance dose used in practice for 
the treatment of SLE.
!
Modifications from the 03Aug2020 PACL 
were incorporated into PA4 were:
Removal of Complement (Total) CH50 
measurement from the protocol in the 
following sections: 
Section 1.3 Schedule of Activities – footnote 
“n”.
Section 3 Objectives Estimands and Endpoints. 
Section 8.8.4 Standard Complement Levels. 
Section 10.2 Appendix 2. 
Section 10.11 Appendix 11. 
Rationale: The central laboratory changed the 
kit for the CH50 assay during the study.  No 
correlation could be achieved between the 
previous and new assays; therefore, it is not 
possible to compare the measurements between 
the previous and the new assay. 
The following changes were additional changes 
that incorporated into PA4:
!
Section 1.3 Schedule of Activities:
!
Weight was added to all visits in order to 
support BILAG scores which required the 
weight to be taken at every visit.
!
In order to better understand why 
investigators are not tapering steroids and 
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to remind investigators to taper the 
participant steroids, a new steroid tapering 
CRF was implemented to capture data for 
SLE Tapering Steroids as well as the 
reasons for not tapering steroids.
!
In order to provide support for the SLE 
activity on the assessments, the following 
data will now be collected on the brief PE 
CRF: general appearance, heart, lungs, 
skin, musculoskeletal and any other patient 
reported symptoms.
!
 
 
 
!
Footnotes have been amended accordingly 
to support changes outlined.  
Section 4.1 Overall Design: 
!
Updated to include additional guidance to 
the sites to encourage randomized 
participants to remain in the study at least 
through to the end of the double-blind 
period to complete safety and efficacy 
assessments.
Section 4.2. Scientific Rationale for Study Design-
This section was updated to provide accurate 
information in the protocol: 
!
State the screening SLEDAI total score 
used for stratification from randomization 
was adjudicated.
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!
Remove the “attempt to taper” to “should 
taper” to emphasize tapering is not 
optional.  
Section 5.1. Inclusion Criteria: 
!
Inclusion #2: The following sentence was 
added to this inclusion criteria, “All 
participants should be willing to remain in 
the study to the end of the double-blind 
period for safety and efficacy 
assessments.” to emphasize, subjects in the 
study need to understand the study 
requirements for participating.
!
Inclusion #5: The following sentence was 
added to Inclusion 5 to allow for a 
minimum baseline dose of corticosteroids, 
“If receiving antimalarials in combination 
with corticosteroids, the minimum dose of 
corticosteroids permitted as part of this 
combination is 5 mg prednisone daily or an 
equivalent dose.”
!
Inclusion #6: This inclusion criteria was 
updated to provide further clarity of the 
required inclusion for SLE disease activity 
at screening and baseline. 
Section 5.2. Exclusion Criteria: 
!
Exclusion #1: This exclusion criteria was 
updated to provide more detailed 
information on renal exclusion in order to 
provide further clarity.
!
Exclusion #2: ‘Active’ was added in front 
of psychosis to clarify psychosis is at the 
time of the subject entering the study or 
60 days prior to Day 1.
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!
Exclusion #3: This is the cancer exclusion 
criteria and the timepoint of ‘within 5 years 
of screening’ was added back into the 
exclusion criteria along with a statement 
that requires a note from the treating 
physician stating they are aware that their 
patient may participant in this study.  
Lastly, language added that Pfizer can 
determine if the subject should be excluded 
from the study for safety concerns based on 
their history of cancer.
!
Exclusion #5: Language added to provide 
further guidance to this exclusion criteria: 
“Any history of antiphospholipid syndrome 
associated with prior obstetrical loss with 
no prior thrombosis in women that does not 
require anticoagulation.”
!
Exclusion #6: Language was added to 
provide further clarity of the process when 
Central ECG Review findings are reported 
as ‘old MI’. 
!
Exclusion #13: The following text in bold 
was added to this exclusion criteria to 
provide further clarity.  Participation in 
other interventional studies within 
12 weeks or 5 half-lives, if known, 
whichever is longer, prior to study entry 
and/or during study participation.  
Participation in any observational studies 
during study participation which would 
require a participant to provide any 
study specific information including but 
not limited to the following: sponsor 
name of the study in which they are 
participating, the name of the study 
intervention, the indication being 
studied.  
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!
Exclusion #14: The addition of brief 
fluctuations in the dose prior to Day 1 were 
added to allow minor changes in the steroid 
at the beginning of the study.
!
Exclusion #17: The timeframe for the 
discontinuation of topical creams and 
ointments to be discontinued prior to Day 1 
was updated from 12 weeks to 4 weeks to 
implement accurate requirements.
!
Exclusion #20: Combined exclusion 
criteria #20 with exclusion criteria #21 
(now exclusion #20) to eliminate 
redundancy.  The exclusion criteria #20 
now reads, “Treatment with any non 
biologic investigational drug(s) including 
non-JAK kinase inhibitors, within 12
weeks of Day 1 or within 5 half-lives, if 
known, whichever is longer, and/or during 
study participation.
!
Exclusion #29: The following sentence was 
added to this exclusion criteria to allow for 
CT and MRI’s to be collected in the study 
instead of chest radiograph, “(If the 
Investigator identifies a different diagnostic 
imaging study such as computed 
tomography [CT] or magnetic resonance 
imaging [MRI] with pre-approval from 
Pfizer clinical)”.
!
Exclusion #31: First Bullet in this section 
was updated to provide more specific 
information on the IGRA preferred test, 
QFT-G and due to participants receiving 
corticosteroids or immunosuppressants 
having a false negative test.  Therefore, the 
Mantoux ppd skin test is not an acceptable 
in this study.
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!
Exclusion #31: Bullet for Chest X-ray –
Last bullet in this section was updated to 
provide more clarity of the expectations 
that, Chest radiograph taken at screening 
with changes suggestive of active or prior 
active or latent TB infection, other active 
or chronic pulmonary infections, heart 
disease, malignancy or other chronic, 
progressive pulmonary disease, unless 
previously performed and documented 
within 12 weeks prior to Day 1.
!
Exclusion #33, First bullet was updated 
from “Total immunoglobulins” to “IgG”. 
Section 5.2.1. Screening: 
!
For randomization of stratification, both 
the screening (not the baseline visit)
SLEDAI score and the anti-dsDNA to 
reflect the actual data which are available.  
Section 5.3.2 Surgery: 
!
Study intervention discontinuation from 
28 days to 2 days was updated to allow for 
the appropriate amount of time for 
discontinuation prior to surgery. 
Section 5.3.3. Meals and Dietary Restrictions: 
!
The following sentence was added to this 
section for further clarity 
“Diabetics who are taking antidiabetic 
medications or participants who cannot 
reasonably tolerate an 8-12 hour fast should 
not eat immediately prior to the visit as far 
as possible.” 
Section 5.3.4 Other Requirements: 
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!
The last bullet in this section provides 
information that all participants who are 
randomized should be encouraged to 
remain in the study through to the end of 
the double-blind period for safety and 
efficacy assessments, whether or not they 
continue to receive study intervention or 
are switched to non-protocol treatment; this 
is in order to reduce missing data as much 
as possible.  
Section 5.4. Screen Failures: 
!
HIV test was added to this section (CXR 
and IGRA are already contained in this 
section) as it too does not need to be 
reobtained if the HIV test was already 
obtained within the protocol defined time 
period (12 weeks).
Section 6.4. Study Intervention Compliance: 
!
To provide more guidance to the site when 
a subject discontinues study intervention, 
the following sentence was added, 
“Subjects who are non-compliant with 
scheduled study visits or with study 
intervention should still be encouraged to 
return for all scheduled study visits.”
Section 6.5.2.1. Treatment Failures: 
!
This section is not a required section in the 
protocol template.  Therefore, this section 
was removed from the protocol and will be 
located in the SAP.  
Section 6.5.1.1. Use of Corticosteroids and 
Tapering Guidelines: 
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!
Concise guidance on when to taper and 
when not to taper corticosteroids were 
updated for clarity.  
!
New information which allows slight 
fluctuations of corticosteroids during 
Weeks 2-12 was added.
Section 8. Study Assessments and Procedures, 
Screening: 
!
For consistency purposes, participants who 
are screen failures may be rescreened one 
time in the study, the re-screening visit 
must occur at least ≥2 weeks (previously, 
the time between screen failure 
determination and re-screening was ≥1 
month).  The re-screen time period of 2 
weeks or once month was inconsistent in 
the protocol and the study team felt that 
re-screening within at least 2 weeks was 
ample time for re-screening.  For instance, 
if there was a lab result that was 
exclusionary, within 2 weeks, it is possible 
the result would not be exclusionary.
Section 8.1.9. Joint Assessment (28 Swollen and 
Tender/Painful Joint Counts): 
!
In this section, the joints of the ankles and 
feet were added to the 28 swollen and/or 
painful joints as these joints are 
representative to the SLE subjects.  The 
following joints are examined along with 
the 28 joint count: temporomandibular 
joints, sternoclavicular joints, 
acromioclavicular joints, hip, ankle joints, 
transverse tarsal joints, 
metatarsophalangeal (MTP) joints (MTP 1, 
2, 3, 4 and 5), interphalangeal joint 1 (foot) 
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Section 8.1.12. Patient Reported Outcome 
Measures (PROs): 
!
 
 
 
 
 
Section 8.2.1.2. Chest X-Ray: 
!
For consistency purposes, this section was 
updated to include:
A chest CT or MRI may be obtained in 
place of the chest x-ray, PA and lateral 
view, only with advance permission of 
Pfizer (please note, this is not 
recommended for the screening 
assessment).
Section 8.2.5. Hepatitis Screening and Monitoring: 
!
For accuracy, the follow bullet was 
modified:
Participants who have negative HBsAg, 
positive HBcAb and positive HBsAb, 
whether or not they have received prior 
HBV vaccination, and participants who 
have negative HBsAg, negative HBcAb 
and positive HBsAb without 
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documentation of prior HBV vaccination 
are required to undergo HBV cDNA testing 
monthly.
Section 8.2.6.1 Interferon Gamma Release Assay 
(IGRA) Tuberculin Test: 
!
To clarify the IGRA TB test preferred is 
the QUANTIFERON® Gold Test and the 
central laboratory is the preferred testing 
facility; however, it is allowed for a locally 
approved IGRA to be used per local 
guidelines.
!
To provide rationale to support the 
statement “The IGRA test is required since 
the Mantoux test skin test (tuberculin, 
purified protein derivative [PPD] skin test) 
may have false negative results in patients 
taking immunosuppression or 
corticosteroids”.
Section 9.1.2. Hypotheses and Decision Rules: 
!
For consistency purposes, this section was 
updated to implement rewording of the 
treatment comparisons testings into 
one-sided hypothesis statements which 
were updated in other sections of the 
protocol per the FDA feedback.
Section 10. Appendices: 
Section 10.13. Appendix 13: List of Prohibited and 
Permitted Concomitant Medications: 
!
Added text to allow fluctuation in brief 
changes of permitted medications.
!
Updated the ‘Oral prednisone or 
equivalent’ row for accuracy purposes.
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!
Prednisone up to 20 mg/day (or equivalent) 
provided dose is stable for at least two weeks 
prior to Day 1 and corticosteroids were started 
at least 8 weeks prior to Day 1.  If a participant 
is receiving antimalarials in combination with 
corticosteroids as background medication 
without an immunosuppressant, the minimum 
dose of corticosteroids allowed at baseline is 
5 mg/day prednisone or equivalent.
!
Corticosteroids are permitted as clinically 
indicated for hypersensitivity reactions, 
insect bites or asthmatic exacerbations (up 
to 125 mg IV hydrocortisone or oral 
methylprednisolone dose pack with top 
dose of oral methylprednisolone 24 mg [or 
prednisone 30 mg or oral equivalent]) up to 
Week 12 and between Weeks 24 and 40.
!
Participants with active disease at baseline 
can receive the increased dose of 
corticosteroids as early as Day 1, up to the 
Week 4 visit and then the dose should be 
tapered back to the preceding dose.  The 
maximum additional dose allowed is 10 
mg/day prednisone equivalence above the 
Day 1 dose level, for a maximum of 
14 days after which the previous dose must 
be resumed.
!
Antimalarials permitted row now read as 
follows, “Substitution of one antimalarial 
medication for another may be permitted 
for safety related issues after discussion 
with the sponsor.
!
High Potency opioids: Clarification that 
high opioids are prohibited for at home use 
by the participant was added to Appendix 
13, List of Prohibited and Permitted 
Concomitant Medications.
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!
Low Potency opioids-Oxycodone is a high 
potency opioid and therefore removed from 
the low potency opioid section of 
Appendix 13.
!
Updated the list of ‘moderate and strong 
CYP3A inducers prohibited information 
was updated to provide clarity that these 
medications as they are prohibited during 
treatment and within 12 weeks of Day 1.
!
CNIs (cyclosporine, tacrolimus, 
picrolimus, or voclosporin): 
!
No systemic calcineurin inhibitors within 
12 weeks of Day 1.
!
Optic; optic topical preparations (eye 
drops) are permitted on study. 
!
Topical creams and ointments must be 
discontinued within 4 weeks of Day 1. 
!
Other minor updates and edits for 
completion.
Section 10.17 – Appendix 17 Guidelines for 
Participant Safety Monitoring and 
Discontinuation: 
The following clarifications were updated in this 
section:
!
For participants requiring a laboratory 
re-test between visits but not able to return 
to the site, the investigator must document 
this information in the subject source 
documents.
!
Pfizer Clinical can waive the re-test 
requirement if the principal investigator 
first discusses this situation with Pfizer 
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Clinical and if the participant is known to 
have intermittent abnormal labs.
!
When subjects discontinue study 
intervention, but continue in the study (do 
not withdraw consent) and later become a 
lost to follow-up participant, the process 
required by the site before declaring the 
participant to be a true lost to follow-up 
participant has been further detailed.
!
Updated second to last bullet to define that 
all participants whom experience a 
thromboembolic event must discontinue 
study intervention.
!
Other updates were included to provide 
further clarifications to safety monitoring 
and discontinuation. 
Global Changes made throughout the document 
include:
!
Updated the words, “subject” and “patient” 
to “participant” throughout the protocol, 
with the following exception, discussions 
of patient reported outcomes (PROs), 
statistical analysis and/or previous SLE 
patient data.  Participant reflects the 
terminology used in the current protocol 
template. 
!
The words, “investigational product” and 
“study drug” have been updated to “study 
intervention” as this is the terminology in
the current protocol template.
!
Screening disease activity and anti-dsDNA 
is used to stratify randomization into the 
study and not the baseline disease activity 
and anti-dsDNA; therefore, the protocol 
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was updated to reflect the correct 
information. 
!
For accuracy purposes, the reference to the 
SLE Flare CRF was updated to modified-
SELENA-SLEDAI Flare Index (mSSFI).
!
Most references to completion of the CRFs 
was updated and instructions to reference 
the CRF completion guidelines was added.  
Key Updates made to PA4 dated 02 March 2021 
(PA4 Second Update)
!
Section 1.2: Schema – Schema must show 
entirety of the text in the text boxes.
!
 
 
 
 
!
Section 2.3 - Benefit Risk: This section 
was updated to reflect that participants who 
are screened for this study and whom have 
a history of thromboembolic events will be 
excluded from this study.
!
Section 5.1: Inclusion Criteria
Inclusion #2- For further clarification, the 
following phrase was added to the text that 
describes that participants should return 
back to the study site monthly once they 
discontinue study intervention, “whether or 
not study intervention was discontinued”.
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Inclusion #5, NOTE: The following text 
was added to the protocol, “brief 
fluctuations in therapy for toxicity are 
permitted (eg, holding a dose (≤7 days) or 
temporary reduction in corticosteroids of 
less than 3 mg/day.”
Inclusion Criteria #6, b, the following text 
in bold font was added for completeness, 
“On the day of randomization, a minimum 
of 3 joints that are both swollen and tender 
is required if SLEDAI Arthritis is 
marked PRESENT.” 
At the end of Inclusion #6, the following 
Note was added back into protocol: 
“Note: Data from the SLICC, SLEDAI and 
BILAG evaluations will be reviewed by the 
Sponsor and/or the Sponsor-selected 
independent reviewer(s).  For participants 
to receive their first administration of study 
agent, approval must be received by the 
Sponsor and/or Sponsor-selected 
independent reviewers” was removed 
inadvertently on a previous draft of the 
protocol; therefore, in this version of the 
protocol, the Note was added back into the 
protocol.
!
Section 5.2: Exclusion Criteria
Exclusion #5, NOTE: The following NOTE 
was inadvertently removed from the 
previous Protocol draft version and has 
been added back into the protocol: “Note:
Any participant being treated for 
antiphospholipid syndrome or 
anticardiolipin antibodies must be 
adequately anticoagulated according to 
current local guidelines.  Sites should make 
every effort to obtain a medical history of 
at least 3 years duration to document that 
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there have been no thrombotic events or an 
obstetrical history of repeat fetal losses.  In 
the absence of this medical history 
information, a hematology consult may be 
required if antiphospholipid screening tests 
are positive.”
Exclusion #10, The following language 
was added for clarity.  Participants that 
have had gastric bypass surgery are not 
permitted in this study; participants that 
have had the gastric sleeve procedure are 
permitted in the study.
Exclusion #26 – The following herpes 
zoster vaccine was added to the protocol as 
it is permitted in the study, “the 
recombinant adjuvant herpes zoster vaccine 
(Shingrix®, GSK) is permitted prior to and 
on study.
Exclusion #31- The following text was for 
completeness, “active infection, previous 
inactive TB infection, heart failure, 
suspected malignancy or any other 
clinically significant findings unless 
previously performed and documented 
within 12 weeks prior to Day 1.  
!
Section 8.2.5 - Hepatitis Screening and 
Monitoring
In the first bullet of this section, “unless 
previously vaccinated” was removed as it 
was incorrect.
 
 
 
 
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!
Section 8.2.1.2: Chest X-Ray-For 
completeness, "or other approved 
diagnostic tests (ie, CT scan with or 
without contrast or MRI)."
!
Section 8.2.3-Vital Signs: The last sentence 
of this section was updated to be consistent 
with the SLE assessment requirements 
which requires oral temperatures to be 
collected (oral thermometers were used to 
validate these instruments).
!
Section 8.2.8 Clinical Safety Laboratory 
Tests.  The following guidance was added 
to the third paragraph of this section.  “All 
laboratory tests with values considered 
clinically significantly abnormal during 
participation in the study or within 28 days 
after the last dose of study intervention 
should be repeated at the central lab until 
the values return to normal or baseline or 
are no longer considered clinically 
significant by the investigator or medical 
monitor.”
!
Section 10.2, Table 5 - This table was 
re-organized slightly and the 3 laboratory 
were added: cystatin, eGFR cystatin, eGFR 
creatinine.  
!
Footnote “a” was removed causing 
all the other footnotes to move up one 
letter.
!
Section 10.13 Appendix 13- List of 
Prohibited and Permitted Concomitant 
Medications: Updated for accuracy with in 
the various sections of the protocol.  Added 
the medication colchicine to this appendix.  
This medication must not exceed 
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0.6 mg BID for at least 8 weeks prior to 
Day 1 and throughout the study.  
!
Miscellaneous formatting and 
typographical errors were modified.
Amendment 3
31 Oct 2019
Section 1.1. Synopsis
Objectives and endpoint table: 
!
Primary estimand edited for clarity and 
secondary endpoint criteria sub-divided in 
to “key secondary” and “other secondary”.
!
Health related quality of life estimands and 
endpoint were incorrectly outlined as “total 
domain score”. These have been updated to 
“individual domain scores”.
!
Added details of all planned adjudication 
committees. 
!
Clarified the role of the eDMC. 
!
Statistical methods updated to include 
assessment of dose groups and rejective 
closed testing procedures. 
Section 1.3. Schedule of activities
!
Footnote x added to specify that direct 
coombs should only be sent to a local 
laboratory only if the investigator suspects 
a clinically significant hemolytic anemia 
that will be scored on the BILAG and 
added to Appendix 12.
!
eGFR cystatin added at all visits
!
Urine microscopic exam added at all visits.
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!
ECG assessment added at Week 2 so as to 
assess cardiac function in combination with 
detailed PK assessments
!
 
!
SLICC criteria added to make the SOA 
assessments consistent with the Inclusion 
Criteria.
!
MMF language updated removing the 
criteria for assessment to be performed at 
12 hrs ± 30 mins. Participants are instead 
asked to refrain from taking a dose 
immediately prior to clinic visits where 
MMF levels are assessed.
!
Photographs are to be taken at US sites 
only; this has been made an optional 
assessment. 
!
Abbreviations and footnotes have been 
amended accordingly to support changes 
outlined. 
Section 2.2.2., Table 1. Updated to include all 
completed/ongoing studies and to align with 
updates made in the latest version of the 
Investigator Brochure.
Section 2.2.2.2. Clinical studies have been updated 
consistent with changes noted in IB.
Section 2.2.2.3 updated to include draft results 
from definitive QTc study to support adding an 
ECG at week 2 and changes in Appendix 13 and 
stopping rules in Appendix 17 
Section 2.3. Benefit Risk. Updated to include 
potential risk identified from the formal QT study 
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(B7931019) and to include more detailed risk 
language around thromboembolic events. 
Section 3. Objectives and estimands 
!
Added additional clarifications on the 
primary endpoint estimand.
 
 
!
Added details of all planned adjudication 
committees. 
!
Clarified the role of the eDMC. 
Section 4.1. Overall design
!
MMF language updated removing the 
criteria for assessment to be performed at 
12 hrs ± 30 mins. Participants are instead 
asked to refrain from taking a dose 
immediately prior to clinic visits where 
MMF levels are assessed.
Section 5.1. Inclusion criteria
Inclusion #5: Language updated to provide greater 
clarity around and specify permitted background 
therapy and all permitted combinations. 
Inclusion #6: To increase the baseline disease 
activity SLEDAI 2K ≥6 has been updated to 
≥8 with a clinical score of ≥6 and clarification of 
BILAG disease activity criteria added” to the note 
in SOC.
Inclusion #7. Updated to include a BMI criteria of 
<40, to prevent participants enrolling with 
significant co-morbidities and to allow accurate 
assessment of joint counts. 
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Section 5.2. Exclusion criteria.
Please note that due to the deletion of some criteria 
in this amendment all references in this section to 
specific a exclusion number refers to the numbers 
as it will appear in the final version of this 
document.   
!
Exclusion #1. The unit is incorrect and has 
been updated from mg/g to the correct unit 
of mg/mg.
!
Exclusion #3. Removed 5 year time frame 
for cancers prior to study entry such that 
current cancer or any history of cancer, 
other than the exceptions outlined, will be 
exclusionary. A requirement has also been 
added that if a participant has a cancer that 
has been treated and deemed cured, there 
must be documented evidence of the same 
from their oncologist or appropriate 
specialist.  
!
Exclusion #5. Thrombosis exclusion has 
been broadened and exclusionary period 
increased from 6 to 12 months in response 
to potential risk outlined in the Investigator 
Brochure. 
!
Exclusion #6. Added specific exclusion 
relating to pulmonary artery hypertension.  
!
Exclusion #7/8. Split and clarification that 
participants with confounding autoimmune 
disorders are not eligible added.
!
Exclusion #10. Exclusion criteria removed 
as duplicate of a later exclusion criteria. 
!
Exclusion #13. The exclusionary period 
has been increased from 4 to 12 Weeks for 
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participants taking part in other 
interventional studies. 
!
Exclusion #14. Dose of prednisolone or 
equivalent has been updated from 
≥20 mg/day to >20 mg/day to align with all 
other protocol references. 
!
Exclusion #16. Added reference to 6-
mercaptopurine to align with all other 
protocol sections. 
!
Exclusion #17. Added sulfasalazine 
exclusion to prevent enrolment of subject 
with co-morbidities such as rheumatoid 
arthritis and Crohns disease. 
!
Exclusion #19. Updated language to “Any 
prior treatment….”
!
Exclusion #20. Clarification added 
regarding prohibited prior Jak inhibitors.
!
Exclusion #21. The exclusionary period 
has been increased from 4 to 12 weeks 
prior to Day 1 for non-biologic 
investigation drugs to align with all other 
protocol sections. 
!
Exclusion #22. The exclusionary period for 
exposure to live vaccine has been increased 
from 6 to 8 weeks prior to Day 1. 
!
Exclusion #23. 
!
Exclusion #30. Removed reference to CT 
and MRI which are being removed as 
alternate imaging modalities to monitor for 
tuberculosis. 
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!
Exclusion #31. Clarified language to 
include any chronic infection and added 
specific reference to herpes simplex.  
!
Exclusion #32 and all other relevant 
sections of the protocol. Removed 
preference for TB testing via T-spot as not 
available at the central lab. 
!
Exclusion #34. Removed duplicate 
language around UPCR. 
!
Exclusion #38 Added an exclusion for 
participant who are currently vaping. 
Section 5.3.3. Use of e-cigarettes or vaping is 
prohibited in new participants due to severe 
adverse events associated with this form of 
tobacco/nicotine use.
Section 5.4. Clarifications for rescreening added.
Section 6.5.1.1. Use of corticosteroids and tapering 
guidelines. Language simplified such that 
maximum additional dose is 10 mg/day above 
Day 1 dose level and for a maximum of 14 days.
Section 6.5.2.2. Management of severe flare and/or 
worsening of disease. Language updated to clarify 
that participants should where possible remain in 
the study after discontinuation of study 
intervention, unless they also withdraw consent. 
They should, where possible, complete withdrawal 
procedures. 
Section 6.5.3. Rescue Medication. This section has 
been removed as use of additional therapies has 
been addressed in prior sections. 
Section 7.1. Updated to refer to Appendix 17 
defined reasons for mandated discontinuation of 
study drug.
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Section 8.1.6. Systemic Lupus International 
Collaborating Clinics. Appendix 9 is incorrectly 
referenced, updated to the correct reference to 
Appendix 10.
Section 8.1.8. Photography. Made optional and 
restricted to participants with a CLASI-A score 
≥10 at baseline.
Section 8.1.11.2. Lupus QoL. Reference to “final 
score” updated to “ individual domain score”. 
Section 8.1.11.4. Administrative correction to 
PRO score name.
 
 
 
Section 8.2.1.2. Chest x-ray. Reference to CT and 
MRI removed as these will no longer be used as 
alternate imaging modalities. 
Section 8.2.4 ECG. Wording clarified around 
which measurements will be single or triplicate 
readings and the use of central read. 
Section 8.2.5 Hepatitis screening and monitoring. 
The exclusion criteria and ongoing monitoring on 
study have been updated to provide clearer 
guidance to sites. 
Section 8.2.6.1. Interferon Gamma Release Assay 
(IGRA) Tuberculin Test. Language removed for 
participants who are positive for IGRA but are 
perceived at low risk of infection by PI. All 
positive tests will now be exclusionary. 
Section 8.2.7. Monitoring for infections. Parenteral 
antimicrobial updated to intravenous so as to only 
define the most severe infections. 
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Section 8.2.8. Clarification for handling of direct 
Coombs test.
 
.
Section 8.8.5. Coombs Direct Test. Updated to 
clearly outline that testing is only required if 
participant has evidence of hemolytic anemia. 
 
 
 
 
  
 
 
 
Section 9.1.1. Updated to be consistent with the 
clarifications made for the primary endpoint 
estimand in Section 3.
Section 9.1.2. Hypothesis and decision rules and 
Section 12 References.
Rationale: a new section added to predefine a 
sequentially rejective testing procedure for both 
the primary and the key secondary endpoints in 
order to control the family-wise type-I error rate. 
An associated reference added in the Reference 
section. 
Section 9.2. Sample size determination & 
Section 9.4.2. Analysis of Primary Endpoint. 
Updated to reflect the simulation results based on 
the sequentially rejective multiple testing 
procedure.
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Section 9.4.3.2. Added the analysis method for the 
LupusQoL endpoint. 
Section 9.5.1. Clarified the eDMC’s role in the 
interim analysis.
Section 9.5.2. Adjudication Committees. Updated 
to add the details of all planned adjudication 
committees. 
Appendix 2. Table 5. Laboratory Testing
!
!
Clarified requirements from complement 
assays
!
 
 
Appendix 4: Contraceptive Guidelines, Section 
10.4.4. To remove the need for a country specific 
amendment the highly effective contraceptive 
methods that are user dependent, which are not 
approved in Japan have been highlighted. 
Appendix 7: ECG Findings of Potential Clinical 
Concern. QTcF criteria updated to 500 ms 
(absolute) to align with all other protocol 
references. 
Appendix 10: Systemic Lupus International 
Collaborating Clinics (SLICC)/American College 
of Rheumatology (ACR) Damage Index for SLE 
and Section 12 References. Reference incorrect, 
updated with the correct reference. 
Appendix 12: Footnote clarifying use of direct 
Coombs.
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Appendix 13: List of Prohibited and Permitted 
Concomitant Medications. 
!
Change in dose of permitted 
methylprednisolone for treatment of 
hypersensitivity
!
Immunosuppressive or immunomodulatory 
agents
!
6-mercaptopurine and maximum permitted 
dose added.
!
Required period for stable dose updated 
from 30 days to 4 weeks to align with all 
other protocol references. 
Sulfasalazine added as a prohibited drug. 
Thymopetidum added as a prohibited drug.
Herbal Medicine restriction added
A list of common medications known to prolong 
the QT interval have been added. 
Appendix 17: Guidelines for Participant Safety 
Monitoring and Discontinuation.
!
Stopping rules added for decrease in eGFR 
cystatin and for increases in UPCr
!
Discontinuation criteria added around QT 
prolongation, eGFR, uPCR and thrombosis 
events to align with potential risks outlined 
in the Investigator Brochure. 
Where required typographical errors have been 
corrected.  All new abbreviations have been 
added/removed from Appendix 23 as required.
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Amendment 2
11 June 2019
Title page: United States (US) Investigational New 
Drug (IND) Number: The IND number is incorrect 
and has been updated to 123650. 
Section 1.3 Schedule of Activities: Complete and 
Brief Physical Examination incorrectly referenced 
footnote “c”, this has been corrected to footnote 
“d”
Section 1.3 Schedule of Activities: modified
SELENA-SLEDAI SLE flare index. The flare 
index measures changes since the last visit. As 
such measurements at screening and Baseline Day 
1 are not required and have been removed.  
Section 5.1: Inclusion criteria #5, updated to 
remove reference to failed therapy and to include 
leflunomide and mizoribine.
Section 5.2: Exclusion criteria #16, updated to 
include leflunomide and mizoribine.
Section 6.5.1.1, Paragraph #5: Start of steroid 
taper window updated to Week 2 to make it 
consistent throughout the protocol
Section 6.5.2.1, bullet #6, IM clarified as IM 
corticosteroids. 
Section 6.5.2.2, paragraph 1. Duplicate text 
referencing the use of rescue medication has been 
removed. 
Section 7.2 Patient discontinuation/ withdrawal 
from study: The following wording was removed 
so as to clarify participants right to withdraw: 
Participants should be questioned regarding their 
reason for withdrawal.
Section 7.2 Withdrawal of consent: Wording 
regarding the need for participants to notify the 
investigator in writing of the decision to withdraw 
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consent removed so as to clarify participants right 
to withdraw.
Section 8.1.9 Joint Assessments. Reference to 
medical marijuana removed and reference to 
narcotics replaced with lower potency opioid 
analgesics to make it consistent with Appendix 13. 
Section 8.2.3 Vital Signs, Paragraph 6, reference 
to tympanic assessment of body temperature 
removed as assessment instruments for SLE 
require an oral temperature. 
Section 8.2.4 Electrocardiograms. Paragraph 2, 
duplicate language has been removed. 
 
 
 
 
 
 
 
 
 
 
 
Section 9.5.1 Data Monitoring Committee. The 
section has been updated to outline that the 
external data monitoring committee (E-DMC) is a 
sponsor independent committee.
Appendix 2, Table 4: References to Pneumococcal 
and tetanus antibodies have been removed as these 
are not assessed in this protocol. 
Section 10.4.4, Appendix 4: Contraceptive 
Methods. Section heading re-instated as missing 
from prior version. Only highly effective methods 
are permitted per protocol as such the following 
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contraceptive methods defined as “effective 
methods” have been removed. 
!
Progestogen-only oral hormonal 
contraception where inhibition of ovulation 
is not the primary mode of action.
!
Male or female condom with or without 
spermicide.
!
Cervical cap, diaphragm, or sponge with 
spermicide.
!
A combination of male condom with either 
cervical cap, diaphragm, or sponge with 
spermicide (double-barrier methods).
10.13, Appendix 13. Section referencing 
Thalidomide, lenalidomide, dapsone, 
adrenocorticotropic hormone (ACTH) by injection 
has been updated to remove incorrect wording and 
outline exclusion criteria prior to and during 
treatment and in the follow-up phase. 
10.13 Appendix 13. CYP3A inhibitors (including 
drinks/foods): Updated to clarify these are 
permitted in the Follow-up period after a minimum 
of 48 hours (approximately 5 half-lives) following 
last dose of study intervention.
Amendment 1
04 Feb 2019
Section 1.3 Schedule of Events:  The CLASI and 
28 joint count will be performed at all scheduled 
visits including follow up (Visit 18).  These 
additional assessments have been added to 
facilitate the adjudication of the primary endpoint 
assessments (BILAG, SLEDAI and Physician’s 
Global Assessment) by an external adjudication 
committee. 
Section 10 Supporting Documentation and 
Operational Considerations.  Patient reported 
outcome exemplars have been removed from the 
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amended protocol (formerly Appendices 22 to 28).  
Reference to these appendices in the body of the 
protocol have also been removed and replaced 
with reference to a separate PRO manual.
Schedule of Activities. Visit day has been added to 
provide clarity on overall visit window. 
Footnote “q” of SOA and Section 6.5.1.2. 
Reference to the use of a daily diary have been 
removed. The text has been updated to outline that 
corticosteroid use will now be recorded in the 
participant’s CRF. 
Section 3 and Section 8.1.4. 
 
  
Exclusion 12: Whilst this exclusion outlines that 
suicidal ideation is exclusionary, a reference to 
Section 8.2.10 has been added so that exclusion 
criteria at screening and discontinuation criteria 
are made explicit. 
Exclusion 32 and Table 4: Quantiferon GOLD 
plus has been added as an option to the TB testing. 
The appropriate abbreviation has also been added 
to Appendix 23 (Abbreviations).
Section 6.1.1. Last sentence has been removed as 
this vaccine coadministered with 13vPnC does not 
apply to this protocol.
Section 6.3.1: Reference to Third Party has been 
removed as there is no requirement for third party 
blinding in this study.
Section 8.3.1: The active reporting period for 
adverse event collection was incorrectly stated as 
through and including a minimum of 30 calendar 
days. This has been corrected to 28 calendar days. 
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Section 10.1.6., Paragraph 8: The retention period 
for records pertaining to study conduct was 
missing. A 15 year retention period has been 
added.   
Section 10.1.7: Missing reference. The reference to 
study completion guidelines has now been added. 
Appendix 19 and References: The references 
outlined for the modified SELENA-SLEDAI Flare 
Index are incorrect. These sections have been 
updated with the correct reference. 
General: The following typographical and 
formatting errors have been corrected;
Section 1.1 Synopsis: Statistical Methods and 
Section 9.1.1.
!
“non responder” has been updated to “a 
non-responder”
Section 2: Introduction. 
!
“with IC50 of….”  has been updated to 
“with IC50 values of….”
Section 8.1.8 Photography
!
“Photograph” corrected to “Photography”
The last sentence in the second paragraph reading 
“These photographs will be reviewed as part of the 
participants eligibility criteria review by the 
sponsor and/or a consultant prior to 
randomization.” is removed as photographs are not 
part of study eligibility criteria
Appendix 8: 1997 Update on the 1982 Revised 
American College of Rheumatology (ACR) 
Criteria for the Classification of SLE
!
Bullets 10 and 11 formatting has been 
corrected
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Appendix 10: Systemic Lupus International 
Collaborating Clinics (SLICC)/American College 
of Rheumatology (ACR) Damage Index for SLE
!
Renal section formatting has been 
corrected
Appendix 13: List of Prohibited and Permitted 
Concomitant Medications
!
The typographical error “nvestigation” has 
been removed from Section 11.  
Original 
protocol
12 Dec 2018
Not applicable (N/A)
This amendment incorporates all revisions to date, including amendments made at the 
request of country health authorities and institutional review boards (IRBs)/ethics committees 
(ECs). 
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TABLE OF CONTENTS
LIST OF TABLES...................................................................................................................59
LIST OF FIGURES .................................................................................................................59
1. PROTOCOL SUMMARY...................................................................................................60
1.1. Synopsis ..................................................................................................................60
1.2. Schema ....................................................................................................................65
1.3. Schedule of Activities .............................................................................................66
2. INTRODUCTION ...............................................................................................................74
2.1. Study Rationale .......................................................................................................74
2.2. Background .............................................................................................................74
2.2.1. Nonclinical overview..................................................................................75
2.2.2. Clinical Overview.......................................................................................76
2.2.2.1. Safety Overview........................................................................87
2.2.2.2. Summary of PF-06700841 Pharmacokinetics in human...........88
2.2.2.3. Assessment of PF-06700841 Effect on QT...............................89
2.3. Benefit/Risk Assessment.........................................................................................89
3. OBJECTIVES, ESTIMANDS AND ENDPOINTS ............................................................90
4. STUDY DESIGN.................................................................................................................99
4.1. Overall Design.........................................................................................................99
4.2. Scientific Rationale for Study Design.....................................................................99
4.3. Justification for Doses...........................................................................................102
4.4. End of Study Definition ........................................................................................103
5. STUDY POPULATION....................................................................................................103
5.1. Inclusion Criteria...................................................................................................103
5.2. Exclusion Criteria..................................................................................................106
5.2.1. Randomization Criteria.............................................................................116
5.3. Lifestyle Considerations........................................................................................116
5.3.1. Contraception............................................................................................116
5.3.2. Surgery......................................................................................................116
5.3.3. Meals and Dietary Restrictions.................................................................117
5.3.4. Other Requirements..................................................................................117
5.4. Screen Failures ......................................................................................................117
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6. STUDY INTERVENTION................................................................................................118
6.1. Study Intervention(s) Administered......................................................................118
6.1.1. Administration..........................................................................................118
6.2. Preparation/Handling/Storage/Accountability ......................................................119
6.2.1. Preparation and Dispensing......................................................................120
6.3. Measures to Minimize Bias: Randomization and Blinding...................................120
6.3.1. Allocation to Study Intervention ..............................................................120
6.3.2. Breaking the Blind....................................................................................120
6.4. Study Intervention Compliance.............................................................................121
6.5. Concomitant Therapy............................................................................................121
6.5.1. Corticosteroids..........................................................................................122
6.5.1.1. Use of Corticosteroids and Tapering Guidelines ....................122
6.5.1.2. Record of Corticosteroids........................................................123
6.5.1.3. Management of Severe Flare and/or Worsening of 
Disease.............................................................................................123
6.6. Dose Modification.................................................................................................124
6.7. Intervention After the End of the Study................................................................124
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL.........................................................................124
7.1. Discontinuation of Study Intervention ..................................................................124
7.1.1. Temporary Discontinuation......................................................................124
7.1.2. Rechallenge...............................................................................................124
7.2. Participant Discontinuation/Withdrawal From the Study.....................................124
7.3. Lost to Follow-up..................................................................................................125
8. STUDY ASSESSMENTS AND PROCEDURES.............................................................126
8.1. Efficacy Assessments............................................................................................128
8.1.1. Rater Qualifications..................................................................................128
8.1.2. American College of Rheumatology (ACR) Criteria for the 
Classification of SLE.....................................................................................128
8.1.3. Systemic Lupus International Collaborating Clinics (SLICC) criteria.....129
8.1.4. Systemic Lupus Erythematosus Responder Index (SRI)-4 ......................129
8.1.4.1. Systemic Lupus Erythematosus Disease Activity 
Index -2000 (SLEDAI-2K)..............................................................129
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8.1.4.2. British Isles Lupus Assessment Group (BILAG) 2004...........130
8.1.4.3. Physician Global Assessment (PhGA)....................................130
8.1.5. modified SELENA-SLEDAI Flare Index (mSSFI) ..................................131
8.1.6. British Isles Lupus Assessment Group Based Composite Lupus 
Assessment (BICLA).....................................................................................131
8.1.7. Systemic Lupus International Collaborating Clinics 
(SLICC)/American College of Rheumatology (ACR) Damage Index for 
SLE ................................................................................................................132
8.1.8. Cutaneous Lupus Erythematosus Disease Area and Severity Index 
(CLASI) .........................................................................................................132
8.1.9. Photography..............................................................................................132
8.1.10. Joint Assessment (28 Swollen and Tender/Painful Joint Counts)..........133
8.1.11. Lupus Low Disease Activity Score (LLDAS)........................................134
8.1.12. Patient Reported Outcome Measures (PROs).........................................134
8.1.12.1. Functional Assessment of Chronic Illness 
Therapy-Fatigue (FACIT-F) Version 4...........................................134
8.1.12.2. Lupus Quality of Life (LupusQoL) Questionnaire................134
8.1.12.3. Pain Intensity.........................................................................135
8.1.12.4. The Short Form (36) Health Survey (SF-36) Version 2, 
Standard...........................................................................................135
8.1.12.5. European Quality of Life-5 Dimensions-5 Level Version 
(EQ-5D-5L) .....................................................................................135
8.1.12.6. Patient’s Global Assessment (PtGA) ....................................135
8.1.12.7. Patient Global Impression of Severity-Lupus (PGIS-L).......135
8.1.12.8. Patient Global Impression of Severity-Fatigue (PGIS-F) .....135
8.1.12.9. Patient Global Impression of Change (PGI-C) .....................136
8.1.12.10. Health Care Resource Use (HCRU)....................................136
8.2. Safety Assessments ...............................................................................................136
8.2.1. Assessments at Screening Only................................................................136
8.2.1.1. Medical History.......................................................................136
8.2.1.2. Chest X-Ray............................................................................136
8.2.2. Physical Examinations..............................................................................137
8.2.3. Vital Signs ................................................................................................137
8.2.4. Electrocardiograms...................................................................................138
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8.2.5. Hepatitis Screening and Monitoring.........................................................138
8.2.6. Tuberculosis (TB) Screening and Monitoring..........................................139
8.2.6.1. Interferon Gamma Release Assay (IGRA) Tuberculin Test ...139
8.2.6.2. Additional Measures for Tuberculosis (TB) Monitoring ........141
8.2.7. Monitoring for Infections .........................................................................144
8.2.7.1. Suspected Herpetiform Rash...................................................144
8.2.8. Clinical Safety Laboratory Assessments ..................................................145
8.2.9. Serum Creatinine, Serum Cystatin C and Estimated Glomerular 
Filtration Rate (eGFR)...................................................................................145
8.2.10. Suicidal Ideation and Behavior Risk Monitoring ...................................146
8.2.11. Pregnancy Testing ..................................................................................146
8.3. Adverse Events and Serious Adverse Events........................................................146
8.3.1. Disease-Related Events and/or Disease-Related Outcomes Not 
Qualifying as AEs or SAEs............................................................................147
8.3.2. Time Period and Frequency for Collecting AE and SAE Information.....147
8.3.2.1. Reporting SAEs to Pfizer Safety.............................................147
8.3.2.2. Recording Nonserious AEs and SAEs on the CRF.................148
8.3.3. Method of Detecting AEs and SAEs ........................................................148
8.3.4. Follow-up of AEs and SAEs.....................................................................148
8.3.5. Regulatory Reporting Requirements for SAEs.........................................148
8.3.6. Exposure During Pregnancy or Breastfeeding, and Occupational 
Exposure ........................................................................................................149
8.3.6.1. Exposure During Pregnancy....................................................149
8.3.6.2. Exposure During Breastfeeding ..............................................149
8.3.6.3. Occupational Exposure ...........................................................149
8.3.7. Cardiovascular and Death Events.............................................................149
8.3.8. Adverse Events of Special Interest...........................................................150
8.3.8.1. Lack of Efficacy......................................................................150
8.3.9. Medication Errors .....................................................................................150
8.4. Treatment of Overdose..........................................................................................151
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9. STATISTICAL CONSIDERATIONS ..............................................................................155
9.1. Estimands and Statistical Hypotheses...................................................................155
9.1.1. Estimands..................................................................................................155
9.1.2. Hypotheses and Decision Rules................................................................156
9.2. Sample Size Determination...................................................................................158
9.3. Populations for Analysis .......................................................................................158
9.4. Statistical Analyses ...............................................................................................159
9.4.1. Efficacy Analyses .....................................................................................159
9.4.2. Analysis of the Primary Endpoint.............................................................159
9.4.3. Analysis of Secondary Endpoints.............................................................160
9.4.3.1. Analysis of Key Secondary Endpoint .....................................160
9.4.3.2. Analysis of Other Secondary Endpoints .................................160
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9.4.6. Safety Analysis .........................................................................................161
9.4.7. Adverse Events.........................................................................................162
9.4.8. Electrocardiogram.....................................................................................162
9.5. Interim Analysis ....................................................................................................162
9.5.1. Data Monitoring Committee.....................................................................162
9.5.2. Adjudication Committees.........................................................................163
10. SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS........................................................................................................164
10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations.............164
10.1.1. Regulatory and Ethical Considerations ..................................................164
10.1.1.1. Reporting of Safety Issues and Serious Breaches of the 
Protocol or ICH GCP.......................................................................164
10.1.2. Financial Disclosure ...............................................................................165
10.1.3. Informed Consent Process ......................................................................165
10.1.4. Data Protection .......................................................................................166
10.1.5. Dissemination of Clinical Study Data ....................................................166
10.1.6. Data Quality Assurance ..........................................................................167
10.1.7. Source Documents..................................................................................169
10.1.8. Study and Site Closure............................................................................169
10.1.9. Publication Policy...................................................................................169
10.1.10. Sponsor’s Qualified Medical Personnel ...............................................170
10.2. Appendix 2: Clinical Laboratory Tests ...............................................................171
10.3. Appendix 3: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-up, and Reporting ....................................................................173
10.3.1. Definition of AE .....................................................................................173
10.3.2. Definition of SAE...................................................................................174
10.3.3. Recording/Reporting and Follow-up of AEs and/or SAEs.....................175
10.3.4. Reporting of SAEs..................................................................................178
10.4. Appendix 4: Contraceptive Guidance and Collection of Pregnancy 
Information..............................................................................................................180
10.4.1. Male Participants ....................................................................................180
10.4.2. Female Participant Reproductive Inclusion Criteria...............................180
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10.4.3. Woman of Childbearing Potential (WOCBP) ........................................180
10.4.4. Contraception Methods...........................................................................181
10.6. Appendix 6: Liver Safety: Suggested Actions and Follow-up Assessments ......185
10.7. Appendix 7: ECG Findings of Potential Clinical Concern .................................187
10.8. Appendix 8: 1997 Update on the 1982 Revised American College of 
Rheumatology (ACR) Criteria for the Classification of SLE .................................189
10.9. Appendix 9: Systemic Lupus International Collaborating Clinics (SLICC) 
criteria......................................................................................................................190
10.10. Appendix 10: Systemic Lupus International Collaborating Clinics 
(SLICC)/American College of Rheumatology (ACR) Damage Index for SLE......191
10.11. Appendix 11: Systemic Lupus Erythematosus Disease Activity 
Index-2000 (SLEDAI-2K).......................................................................................193
10.12. Appendix 12: British Isles Lupus Assessment Group Index (BILAG)-2004 ...195
10.13. Appendix 13: List of Prohibited and Permitted Concomitant Medications......196
10.14. Appendix 14: Oral Corticosteroids, Systemic Equivalencies ...........................202
10.15. Appendix 15: Columbia Suicide Severity Rating Scale (CSSRS)....................203
10.16. Appendix 16: Select Laboratory Values from the Common Terminology 
Criteria for Adverse Events (CTCAE) v4.03 ..........................................................208
10.17. Appendix 17: Guidelines for Participant Safety Monitoring and 
Discontinuation........................................................................................................212
10.17.1. Safety Monitoring.................................................................................212
10.17.2. Permanent Discontinuation of Study Intervention ...............................212
10.18. Appendix 18: Physician Global Assessment (PhGA).......................................215
10.19. Appendix 19: modified SELENA-SLEDAI Flare Index (mSSFI)....................216
10.20. Appendix 20: Cutaneous Lupus Erythematosus Disease Area and Severity 
Index (CLASI).........................................................................................................217
10.21. Appendix 21: Joint Assessment (28-Count)......................................................218
10.22. Appendix 22: eGFR Calculations .....................................................................219
10.23. Appendix 23: Abbreviations .............................................................................220
11. REFERENCES ................................................................................................................225
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LIST OF TABLES
Table 1.
Summary of Clinical Studies for Brepocitinib .........................................77
Table 2.
Treatment Group.......................................................................................99
Table 4.
Families of Hypotheses...........................................................................156
Table 5.
Laboratory Tests .....................................................................................171
LIST OF FIGURES
Figure 1.
Testing Procedure ...................................................................................158
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1. PROTOCOL SUMMARY 
1.1. Synopsis
Rationale:
This is the first study of PF-06700841(brepocitinib) in participants with moderate to severe 
active, generalized Systemic Lupus Erythematosus (SLE) that have inadequate response to 
standard of care.  The purpose of the study is to determine the safety and efficacy of 
PF-06700841 in SLE.  The patient population selected for this study is participants who have 
active SLE (excluding active central nervous system [CNS] lupus or renal lupus with 
proteinuria (UPCr >3.0 mg/mg) and/or estimated glomerular filtration rate [eGFR] 
<50 mL/min/1.73 m2) that usually require an increased level of immunosuppression.  Such 
participants with SLE are currently being managed with multiple medications, including 
antimalarial drugs, immunosuppressives and corticosteroids.  All these medications will be 
allowed as standard of care background treatment during the study.  As study intervention 
will be adjunct therapy to participant’s standard of care, no participants will receive placebo 
alone.
Objectives and Endpoints:
Objectives
Endpoints:
Estimands
Primary:
Primary:
Primary:
!
To evaluate the efficacy 
of 3 QD dose levels of 
PF-06700841 compared 
to placebo in participants 
with active SLE.
!
Proportion of participants 
achieving the Systemic Lupus 
Erythematosus Responder Index 
(SRI) change of 4 (SRI-4) at 
Week 52.
E1: This composite estimand is defined 
as a population average treatment 
difference between PF-06700841 and 
placebo in the proportion of participants 
with active SLE who achieved the 
binary SRI-4 endpoint at Week 52 and 
did not discontinue treatment prior to 
Week 52.
Key Secondary:
Key Secondary:
Key Secondary:
!
To evaluate the efficacy 
of 3 QD dose levels of 
PF-06700841 compared 
to placebo in participants 
with active SLE.
!
Proportion of participants 
achieving the British Isles 
Lupus Assessment Group-
Based Composite Lupus 
Assessment (BICLA) at 
Week 52.
d between PF-06700841 and placebo in 
the proportion of participants with 
active SLE who achieved the binary 
BICLA endpoint at Week 52 and did 
not discontinue treatment prior to Week 
52.
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Objectives
Endpoints:
Estimands
!
Other Secondary:
!
Other Secondary:
Other Secondary:
!
To assess attainment of 
low disease activity state 
of 3 QD dose levels of 
PF-06700841 compared 
to placebo in participants 
with active SLE.
!
Proportion of participants 
achieving the Lupus Low 
Disease Activity State (LLDAS) 
at Week 52.
E3: This composite estimand is defined 
as a population average treatment 
difference between PF-06700841 and 
placebo in the proportion of participants 
with active SLE who achieved a 
LLDAS at Week 52 and did not 
discontinue treatment prior to Week 52.
!
To compare the 
corticosteroid use 
(prednisone or 
equivalent) in 
PF-06700841 treated 
participants relative to 
placebo.
!
Proportion of participants 
achieving a reduction in 
prednisone (or equivalent) dose 
to ≤7.5 mg/day at Week 52 and 
sustained for 12 weeks prior to 
Week 52, in the subset of 
participants on prednisone 
>7.5 mg/day (or equivalent) at 
baseline.
There is no defined estimand for this 
endpoint.
!
To evaluate the efficacy 
of PF-06700841 
compared to placebo in 
participants with active 
SLE and with sustained 
reduction of oral 
corticosteroids.
!
Proportion of participants 
achieving SRI-4 response with 
dose of prednisone (or 
equivalent) reduced to 
≤7.5 mg/day and sustained for 
12 weeks at Week 52.
E4: This composite estimand is defined 
as a population average treatment 
difference between PF-06700841 and 
placebo in the proportion of participants 
who achieved the binary SRI-4 endpoint 
with sustained prednisone dose 
reduction to ≤7.5 mg/day (or equivalent)
for 12 weeks at Week 52 and did not 
discontinue treatment prior to Week 52. 
!
To evaluate the 
Cutaneous Lupus 
Erythematosus Disease 
Area and Severity Index 
activity (CLASI-A) score 
in the subset of 
participants with baseline 
CLASI-A score ≥10 in 
PF-06700841 treated 
participants relative to 
placebo.
!
Proportion of Participants with 
Cutaneous Lupus 
Erythematosus Disease Area 
and Severity Index (CLASI-A) 
Total Activity Score ≥10 at 
Baseline with ≥50% Reduction 
in CLASI-A Total Activity 
Score at Week 52.
There is no defined estimand for this 
endpoint.
!
To evaluate the effect on 
fatigue of PF-06700841 
treated participants 
relative to placebo.
!
Change from baseline in the 
total scores of Functional 
Assessment of Chronic Illness 
Therapy-Fatigue (FACIT-F) at 
Week 52.
E5: This hypothetical estimand is 
defined as a population average 
treatment difference between 
PF-06700841 and placebo in the 
FACIT-F score at Week 52 as if none of 
the specified intercurrent events have 
occurred.
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Objectives
Endpoints:
Estimands
!
To evaluate the effect on 
health-related quality of 
life of PF-06700841 
treated participants 
relative to placebo.
!
Change from baseline in the 
individual domain scores of the 
Lupus Quality of Life 
(LupusQoL) at Week 52.
E6: This hypothetical estimand is 
defined as a population average 
treatment difference between 
PF-06700841 and placebo in the 
LupusQoL individual domain scores at 
Week 52 as if none of the specified 
intercurrent events have occurred.
!
To assess time to first 
severe flare in 
PF-06700841 treated 
participants relative to 
placebo.
!
Time to first severe flare as 
measured by the modified 
Safety of Estrogen in Lupus: 
National Assessment 
(SELENA)-Systemic Lupus 
Erythematosus Disease Activity 
Index (SLEDAI) Flare Index 
(m-SSFI).
E7: This estimand is defined as a 
population average treatment hazard 
ratio between PF-06700841 and placebo
for the occurrence of the first severe 
flare event.
!
To evaluate the safety 
and tolerability of 
PF06700841 dose levels 
versus placebo.
!
Incidence of treatment-
emergent adverse events (AEs).
!
Incidence of serious AEs 
(SAEs) and AEs leading to 
discontinuation.
!
The incidence of clinically 
significant abnormalities in vital 
signs and ECGs.
!
The incidence of clinically 
significant abnormalities in 
clinical laboratory values. 
There is no defined estimand for these 
endpoints and they will be analyzed 
using Pfizer data standards as 
applicable.
Overall Design:
This is a Phase 2b, double-blind, randomized, placebo controlled, parallel design, 
multicenter, dose ranging study to assess the efficacy and safety of PF-06700841 in 
participants with active, moderate to severe generalized SLE.  After an up to a 7-week 
screening period, eligible participants will be randomized in a 1:2:2:2 ratio such that 
participants will receive either 1 of three PF-06700841 once a day (QD) dose levels (15 mg, 
30 mg and 45 mg) or placebo every day for 52 weeks.  
Number of Participants
Approximately 350 randomized participants (100 participants per treatment group except 
50 participants for the PF-06700841 15 mg QD dose group) will participate in this study at 
approximately 185 investigative sites worldwide.  Randomization will be stratified by 
screening disease severity and anti-dsDNA status.  The purpose of the stratified 
randomization is to achieve balanced treatment groups in these stratification factors.
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Intervention Groups and Duration
For this study, the study intervention is PF-06700841.  Blinded PF-06700841 and its matched 
placebo will be provided as tablets for oral administration.  Participants will participate in 
this study for approximately 63 weeks.  This includes up to a 7-week screening period, the 
52-week treatment period, and the 4-week follow-up period. 
Data Monitoring Committee
This study will use an independent external data monitoring committee (E-DMC).  The 
E-DMC will be responsible for ongoing monitoring of the safety of participants in the study.
This E-DMC will make recommendations with regard to continuing, stopping or altering the 
trial to a Sponsor Management Committee throughout the study. If an interim analysis is 
performed, the interim analysis results will also be provided to the E-DMC for review.
Adjudication Committees
This study will also use separate blinded adjudication committees consisting of independent 
external experts who will be responsible for the ongoing review of the following efficacy and 
safety endpoints:
1. BILAG, SLEDAI-2K and associated data.  
2. Severe Flare.
3. Cardiovascular and thromboembolic events.
4. Malignancy.
5. Opportunistic infections.
Statistical Methods:
The primary estimand for the primary endpoint of Systemic Lupus Erythematosus Responder 
Index (SRI-4) response at Week 52 will be the population average treatment difference 
between PF-06700841 and placebo in the proportion of participants with active SLE who 
achieved SRI-4 endpoint at Week 52 and did not discontinue study intervention before 
Week 52. SRI-4 response is a composite endpoint where a responder must meet criteria in 
the assessment of SLEDAI-2K, BILAG and PhGA. Data post intercurrent events will be 
censored and any participant who experienced these intercurrent events will be considered as 
a non-responder at Week 52.  The population-level summary will be the differences in the 
proportions of SRI-4 responder at Week 52 between each treatment dose arm of 
PF-06700841 and the placebo arm. For the primary endpoint, a treatment policy estimand 
will also be included in the SAP as a secondary estimand to estimate the treatment difference 
in the SRI-4 response rate at Week 52 regardless of occurrence of any intercurrent events 
prior to Week 52.
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Each of the three dose groups of PF-06700841 will be compared with the placebo group for 
both the primary endpoint of SRI-4 response at Week 52 and the key secondary endpoint of 
BICLA response at Week 52 in 6 hypotheses.  In order to control the overall family-wise 
type-I error rate, a sequentially rejective closed testing procedure is defined.
The primary endpoint is the proportion of SRI-4 responders at Week 52 and the primary 
analysis of this endpoint will be based on the Cochran-Mantel-Haenszel (CMH) approach 
adjusting for stratification factors.  The hypothesis testing of this endpoint will be based on 
the p-values for pairwise treatment comparisons between each dose group of PF-06700841 
and the placebo group. Treatment difference in the proportion of responders for the active 
treatment compared to the placebo will be estimated based on the CMH approach. These 
estimates will be reported with 95% confidence intervals and one-sided p-values.
The key secondary endpoint is the proportion of BICLA responders at Week 52 and the 
primary analysis of this endpoint will be conducted in the manner described above for the 
primary endpoint using the CMH approach adjusting for stratification factors.  The 
hypothesis testing of this endpoint will be based on the p-values for pairwise treatment 
comparisons between each dose group of PF-06700841 and the placebo group.  Treatment 
difference in the proportion of responders for the active treatment compared to the placebo 
will be estimated based on the CMH approach.  These estimates will be reported with 95% 
confidence intervals and one-sided p-values.
An Interim analysis may be conducted when sufficient number of participants completes 
Week 52 visits and before the interim analysis is instigated, the details of the objectives, 
decision criteria, dissemination plan and method of maintaining the study blind per Pfizer’s 
SOPs will be documented and approved in the E-DMC charter.  In addition, the analysis 
details must be documented and approved in an interim analysis plan (IAP).
Further details of analyses in safety and efficacy will be specified in the statistical analysis 
plan. 
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1.2. Schema
Steroid 
increase 
allowed
Flexible 
steroid 
tapering 
allowed
W2-W12
Flexible steroid
tapering allowed
W24-W40
No 
change 
in steroid 
W12-W24
No change 
in steroid 
W40-W52
Primary Endpoint
SRI-4 @ Week 52  
PF-06700841 15 mg QD (n=50)
PF-06700841 30 mg QD (n=100)
PF-06700841 45 mg QD (n=100)
Placebo (n=100)
Screening =
≤7 Weeks 
(≤49 days) 
Follow-Up =
4 Weeks
Treatment Period = 52 Weeks
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1.3. Schedule of Activities
A table provides an overview of the protocol visits and procedures.  Refer to the STUDY ASSESSMENTS AND PROCEDURES
section of the protocol for detailed information on each procedure and assessment required for compliance with the protocol. The 
investigator may schedule visits (unplanned visits) in addition to those listed in the Schedule of Activities table, in order to conduct 
evaluations or assessments required to protect the well-being of the participant.
Protocol Activity
Screening
Treatment Period
Follow-
up 
Period
Participant 
withdrawal or
EWb
Post-EW
Study Identifier 
(Study Visit)
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
Visit Day/Weeka
Days 
-49 to -1
Baseline 
Day 1
Wk 2
Day 15
Wk 4
Day 29
Wk 6
Day 43
Wk 8
Day 57
Wk 12
Day 85
Wk 16
Day 
113
Wk 20
Day 
141
Wk 24
Day
169
Wk 28
Day
197
Wk 32
Day 
225
Wk 36
Day 
253
Wk 40
Day 
281
Wk 44
Day 
309
Wk 48
Day 
337
Wk 52 
Day 
365/
EOT
Week 56
/Day 
393 EOS
N/A
EW
+4 Weeks 
28 days
Visit Window
None
None
±3 Days based
on Day 1 Visit
±7 Days based on Day 1 Visit
±3 Days 
based on 
Day 1 
Visit
N/A
EW 
+4 Weeks 
(±3 Days)
Enrollment 
Procedures
Informed consent
X
Inclusion/exclusion 
criteria
X
X
Demographics, 
medical history, 
SLE history, and 
smoking history
X
Prior SLE and 
non-SLE medications 
check
X
X
Medical Procedures
Vital signs (BP, HR 
[pulse], respirations 
and temperature)c
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Weightc
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Heightc
X
Complete physical 
examinationd
X
X
X
X
Brief physical 
examinationd
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
ECG (12-lead)f
X
X
X
X
X
X
X
X
X
X
Chest x-raye,bb
X
X
X
X
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Protocol Activity
Screening
Treatment Period
Follow-
up 
Period
Participant 
withdrawal or
EWb
Post-EW
Study Identifier 
(Study Visit)
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
Visit Day/Weeka
Days 
-49 to -1
Baseline 
Day 1
Wk 2
Day 15
Wk 4
Day 29
Wk 6
Day 43
Wk 8
Day 57
Wk 12
Day 85
Wk 16
Day 
113
Wk 20
Day 
141
Wk 24
Day
169
Wk 28
Day
197
Wk 32
Day 
225
Wk 36
Day 
253
Wk 40
Day 
281
Wk 44
Day 
309
Wk 48
Day 
337
Wk 52 
Day 
365/
EOT
Week 56
/Day 
393 EOS
N/A
EW
+4 Weeks 
28 days
Laboratory Safety 
Assessments
Blood chemistry, 
hematology, 
urinalysisg
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Cystatin-based 
eGFRh
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Lipid profile panel 
(fasting)g
X
X
X
X
X
X
X
X
Spot urine (Upr:Ucr)i
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Serum FSH 
(WONCBP only)
X
Serum ∀-hCGj
X
Urine ∀-hCG 
(conducted at site)j
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Urine microscopic 
examg
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
HBsAg, HBcAb, and 
HCVAb (Hep B and 
Hep C reflex testing)k
X
HBV DNA to assess 
reactivation in high 
risk participantsk
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
HIV testing (per local 
regulations)l
X
TB testing (IGRA)m
X
X
X
X
 
 
 
 
 
 
 
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Protocol Activity
Screening
Treatment Period
Follow-
up 
Period
Participant 
withdrawal or
EWb
Post-EW
Study Identifier 
(Study Visit)
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
Visit Day/Weeka
Days 
-49 to -1
Baseline 
Day 1
Wk 2
Day 15
Wk 4
Day 29
Wk 6
Day 43
Wk 8
Day 57
Wk 12
Day 85
Wk 16
Day 
113
Wk 20
Day 
141
Wk 24
Day
169
Wk 28
Day
197
Wk 32
Day 
225
Wk 36
Day 
253
Wk 40
Day 
281
Wk 44
Day 
309
Wk 48
Day 
337
Wk 52 
Day 
365/
EOT
Week 56
/Day 
393 EOS
N/A
EW
+4 Weeks 
28 days
 
 
 
 
 
 
 
 
 
 
Trial Treatment 
Procedures
IRT Registration
X
Randomization (after 
all screening 
procedures are 
completed/reviewed)
X
Study Intervention 
dispensing
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Study Intervention 
administrations
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Study Intervention 
accountability
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Safety Assessments
SLE Steroid Tapering
X
X
X
X
X
X
X
X
X
Concomitant 
corticosteroidst
#
#
#
#
#
#
#
#
#
#
#
#
#
#
#
#
#
#
#
#
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Protocol Activity
Screening
Treatment Period
Follow-
up 
Period
Participant 
withdrawal or
EWb
Post-EW
Study Identifier 
(Study Visit)
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
Visit Day/Weeka
Days 
-49 to -1
Baseline 
Day 1
Wk 2
Day 15
Wk 4
Day 29
Wk 6
Day 43
Wk 8
Day 57
Wk 12
Day 85
Wk 16
Day 
113
Wk 20
Day 
141
Wk 24
Day
169
Wk 28
Day
197
Wk 32
Day 
225
Wk 36
Day 
253
Wk 40
Day 
281
Wk 44
Day 
309
Wk 48
Day 
337
Wk 52 
Day 
365/
EOT
Week 56
/Day 
393 EOS
N/A
EW
+4 Weeks 
28 days
Other concomitant 
medications & 
non-drug treatments
#
#
#
#
#
#
#
#
#
#
#
#
#
#
#
#
#
#
#
#
Serious and 
non-serious AE 
monitoring
#
#
#
#
#
#
#
#
#
#
#
#
#
#
#
#
#
#
#
#
Contraception checku
#
#
#
#
#
#
#
#
#
#
#
#
#
#
#
#
#
#
#
#
Monitoring for 
Infections (skin swab 
for herpetiform rash, 
if suspected) 
#
#
#
#
#
#
#
#
#
#
#
#
#
#
#
#
#
#
#
#
Clinical Assessments
SLE diagnosis using 
either the ACR SLE 
classification or 
SLICC criteriav
X
BILAG history
X
Joint Assessment 
(28 tender/painful 
and swollen joint 
counts)
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
SLEDAI-2K
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
BILAG 2004
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Physician Global 
Assessment (PhGA)
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
modified 
SELENA-SLEDAI 
SLE flare index
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
SLICC/ACR damage 
index for SLE
X
X
X
CLASI
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Photography, if 
applicablew
X
X
X
X
X
C-SSRSx
X
X
Patient Reported 
Outcomes
FACIT-F
X
X
X
X
X
X
X
X
X
X
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Protocol Activity
Screening
Treatment Period
Follow-
up 
Period
Participant 
withdrawal or
EWb
Post-EW
Study Identifier 
(Study Visit)
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
Visit Day/Weeka
Days 
-49 to -1
Baseline 
Day 1
Wk 2
Day 15
Wk 4
Day 29
Wk 6
Day 43
Wk 8
Day 57
Wk 12
Day 85
Wk 16
Day 
113
Wk 20
Day 
141
Wk 24
Day
169
Wk 28
Day
197
Wk 32
Day 
225
Wk 36
Day 
253
Wk 40
Day 
281
Wk 44
Day 
309
Wk 48
Day 
337
Wk 52 
Day 
365/
EOT
Week 56
/Day 
393 EOS
N/A
EW
+4 Weeks 
28 days
Lupus QoL
X
X
X
X
X
X
X
X
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: #= ongoing/continuous event; ACR = American College of Rheumatology; AE = adverse event;
; 
anti-dsDNA = anti-double-stranded deoxyribonucleic acid; ∀-hCG = beta-human chorionic gonadotropin; BILAG = British Isles Lupus Assessment Group; 
; BP = blood pressure; CLASI = Cutaneous Lupus Erythematosus Disease Area and Severity Index; CLASI-A = CLASI 
activity score; CRF = Case Report Form; C-SSRS = Columbia-Suicide Severity Rating Scale; DNA = deoxyribonucleic acid; EC = ethics committee; 
ECG = electrocardiogram; eGFR = estimated glomerular filtration rate; 
; EOS = end of study; EOT = end of treatment; 
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Protocol Activity
Screening
Treatment Period
Follow-
up 
Period
Participant 
withdrawal or
EWb
Post-EW
Study Identifier 
(Study Visit)
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
Visit Day/Weeka
Days 
-49 to -1
Baseline 
Day 1
Wk 2
Day 15
Wk 4
Day 29
Wk 6
Day 43
Wk 8
Day 57
Wk 12
Day 85
Wk 16
Day 
113
Wk 20
Day 
141
Wk 24
Day
169
Wk 28
Day
197
Wk 32
Day 
225
Wk 36
Day 
253
Wk 40
Day 
281
Wk 44
Day 
309
Wk 48
Day 
337
Wk 52 
Day 
365/
EOT
Week 56
/Day 
393 EOS
N/A
EW
+4 Weeks 
28 days
n; EW = Early Withdrawal; FACIT-F = Functional Assessment of Chronic Illness 
Therapy-Fatigue; FSH = follicle stimulating hormone; HBV = hepatitis B virus; HEENT = head, eyes, ears, nose and throat; Hep B = Hepatitis B; 
HBcAb = hepatitis B core antibody; HBsAg = hepatitis B surface antigen; HCV = hepatitis C virus; HCVAb = hepatitis C virus antibody; Hep C = Hepatitis C; 
HIV = human immunodeficiency virus; HR = heart rate; 
 
 IGRA = interferon gamma release assay; IP = study intervention; IRT = interactive response technology; 
modified SELENA-SLEDAI SLE Flare Index = Safety of Estrogen in Lupus:  National Assessment-Systemic Lupus Erythematosus Disease Activity Index SLE 
Flare Index; 
; PBMC = peripheral blood mononuclear cells; PhGA = Physician Global Assessment; 
; 
; RNA = ribonucleic acid;
; SLE = Systemic 
Lupus Erythematosus; SLEDAI-2K = Systemic Lupus Erythematosus Disease Activity Index-2000; SLICC/ACR Damage Index for SLE = Systemic Lupus 
International Collaborating Clinics/American College of Rheumatology Damage Index for SLE; TB = tuberculosis; Upr:Ucr = urine protein to urine creatinine 
ratio; WOCBP = women of childbearing potential; WONCBP = women of non-childbearing potential.
a.
Day relative to start of study treatment (Day 1).
b.
Please reference the B7931028 case report form completion guidelines to identify the appropriate CRFs to complete for any participant who discontinue
study intervention early and/or prematurely withdraws from the study.
c.
Vital Signs include blood pressure, pulse rate, respirations and temperature measured after approximately 5 minutes of rest.  Weight and height will be
measured without shoes.  Since all clinical assessments were validated using oral temperatures, it is important to take oral temperatures ONLY on study;
oral thermometers will be supplied by the Sponsor if requested.
d.
A complete physical examination will include, at a minimum, head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, and
gastrointestinal, musculoskeletal, and neurological systems. A brief physical, examination will include, at a minimum, assessments of general appearance,
the heart, lungs, skin, musculoskeletal and participant-reported symptoms. Findings on the physical exam should support disease activity manifestations
scored in SLEDAI, BILAG, CLASI and joint count.
e.
Chest x-ray or other appropriate diagnostic imaging (ie, CT Scan with or without contrast or an MRI) may be performed up to 12 weeks prior to Day 1.  All 
official reading must be located in the source documentation. Refer to Section 8.2.6.
f.
A single ECG measurement will be collected at all scheduled visits except at baseline on Day 1 where ECG will be collected in triplicate approximately 2-4 
minutes apart.  At Week 2 visit, an ECG will be collected approximately 3 hours after dosing at the study site.
g.
Samples for central laboratory evaluations (ie, hematology, blood chemistry, urinalysis, dipstick and microscopic) when performed for the lipid profile
panel (total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides) must be collected after a minimum fast of 8 hours prior to the visit.  Diabetics
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Protocol Activity
Screening
Treatment Period
Follow-
up 
Period
Participant 
withdrawal or
EWb
Post-EW
Study Identifier 
(Study Visit)
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
Visit Day/Weeka
Days 
-49 to -1
Baseline 
Day 1
Wk 2
Day 15
Wk 4
Day 29
Wk 6
Day 43
Wk 8
Day 57
Wk 12
Day 85
Wk 16
Day 
113
Wk 20
Day 
141
Wk 24
Day
169
Wk 28
Day
197
Wk 32
Day 
225
Wk 36
Day 
253
Wk 40
Day 
281
Wk 44
Day 
309
Wk 48
Day 
337
Wk 52 
Day 
365/
EOT
Week 56
/Day 
393 EOS
N/A
EW
+4 Weeks 
28 days
who are taking antidiabetic medications or participants who cannot reasonably tolerate an 8-12 hour fast should not eat immediately prior to the visit as far 
as possible.  Laboratory tests may be repeated once during the 7-week screening period; the last value will be used to determine participant eligibility.  
h.
Cystatin-C based estimated glomerular filtration rate (eGFR) to be calculated by the central laboratory at all time points (with the exception of the Week 56 
Visit).
i.
Random spot urine samples will be collected after the first morning void.
j.
Serum/urine pregnancy tests for WOCBP; serum pregnancy test must be performed at screening for all WOCBP as defined in the eligibility criteria urine 
pregnancy test must be performed at Day 1 for all WOCBP prior to dosing with study intervention and at all subsequent visits.  
k.
Reflex-testing (if necessary) consists of: participants at screening who are HBsAg negative but HBcAb positive will be reflex-tested for HBV DNA and, if 
HBV DNA is negative, may enroll; if HBV DNA is positive, they will be screen-failed.  To assess for reactivations of HepB monthly, high risk participants 
are defined as follows: 1) HBsAg negative, HBcAb negative, HBsAb positive without documentation of prior HBV vaccination, 2) HBsAg negative, 
HBcAb positive, HBsAb positive whether or not they have received prior HBV vaccination.  
l.
Confirmation and documentation of negative HIV test result within 12 weeks prior to screening is acceptable.
m.
Documented TB testing (IGRA) performed within 12 weeks prior to Study Day 1 is acceptable.  Test results should be available in the source document.  In 
this study therefore, a Mantoux skin test is not acceptable and an IGRA must be performed.  An initial IGRA should be performed at the central laboratory 
so that at least one set of results will be available in the Pfizer database.  If another test is required, it may be performed locally, and a T-SPOT® TB test (if 
available) would be preferred to another QuantiFERON® test.  
n.
Standard complement level measurements will include but are not limited to C3 and C4.
o.
Direct Coombs should only be performed at a local lab and only if the investigator suspects a clinically significant hemolytic anemia is present that will be 
scored on the BILAG. 
 
 
 
 
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Protocol Activity
Screening
Treatment Period
Follow-
up 
Period
Participant 
withdrawal or
EWb
Post-EW
Study Identifier 
(Study Visit)
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
Visit Day/Weeka
Days 
-49 to -1
Baseline 
Day 1
Wk 2
Day 15
Wk 4
Day 29
Wk 6
Day 43
Wk 8
Day 57
Wk 12
Day 85
Wk 16
Day 
113
Wk 20
Day 
141
Wk 24
Day
169
Wk 28
Day
197
Wk 32
Day 
225
Wk 36
Day 
253
Wk 40
Day 
281
Wk 44
Day 
309
Wk 48
Day 
337
Wk 52 
Day 
365/
EOT
Week 56
/Day 
393 EOS
N/A
EW
+4 Weeks 
28 days
s.
On study visit days during the treatment period, participants should be instructed to refrain from dosing at home, and are instructed to take the study 
intervention at the investigator site.
t.
A detailed history of corticosteroid use will be collected.  Participants may receive a prescribed oral daily dose of prednisone (or equivalent see 
Appendix 14).  The investigator/site staff will review the participant’s corticosteroid usage and record in the CRF at each study visit.
u.
WOCBP should have their method of contraception recorded in their source documentation.
v.
SLE diagnosis using either the American College of Rheumatology Systemic Lupus Erythematosus Classification or Systemic Lupus International 
Collaborating Clinics Criteria.
w.
US sites only (optional).
x.
Participants who have recent or active suicidal ideation or behaviors will be excluded from study entry or after Day 1, would be discontinued from 
treatment and referred to a mental health professional for appropriate evaluation and treatment.
 
  
bb.
Participants that enter the study with latent TB or develop newly positive QFT-G results during the study may be required to have additional chest X-Ray 
or chest CT at Weeks 24 and/or 56 (or End of study Visit).  Refer to Section 8.2.6.
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2. INTRODUCTION
PF-06700841(brepocitinib) is a potent tyrosine kinase (TYK)2/Janus kinase (JAK)1 inhibitor 
that is highly selective over the other human kinases and is being developed for the treatment 
of participants with active Systemic Lupus Erythematosus (SLE).
PF-06700841 is an orally bioavailable small molecule with a good selectivity profile over the 
other human kinases including JAK2 and JAK3.  PF-06700841 inhibited the in vitro
activities of TYK2, JAK1, JAK2 and JAK3 with IC50 values of 22.7, 16.8 nM, 76.6 nM and 
6490 nM, respectively.  PF-06700841 is capable of inhibiting the cytokines with signaling 
pathways mediated by JAK1 and/or TYK2, including type I IFNs, IL-6, IL-12, IL-15, IL-21, 
IL-22, IL-23, and IFN∃.  Many of these cytokines are involved in the pathogenesis of SLE. 
The inhibition of TYK2 and JAK1 will lead to modulation of multiple cytokines which play 
a critical role in the pathogenesis of SLE, including Type 1 interferons (IFN%,∀; 
JAK1/TYK2 dependent), IFN∃(JAK1/JAK2 dependent), IL-6 (JAK1/JAK2/TYK2 
dependent), and IL-21(JAK1/JAK3 dependent).  In addition, IL-6 and IL-21 play a critical 
role in the development of Th17 cells and production of their signature cytokine IL-17, 
which has a critical role in a variety of autoimmune diseases including SLE.1  Thus, key 
signaling molecules TYK2 and JAK1 are attractive therapeutic targets for diseases associated 
with widely dysregulated immune functions, such as SLE.
2.1. Study Rationale 
This is the first study of PF-06700841 in participants with active, generalized SLE that have 
inadequate response to standard of care.  The purpose of the study is to determine the safety 
and efficacy of PF-06700841 in SLE.  The patient population selected for this study is 
participants who have active SLE (excluding active central nervous system [CNS] lupus or 
renal lupus with proteinuria (UPCr >3.0 mg/mg) and/or estimated glomerular filtration rate 
[eGFR] <50 mL/min/1.73 m2) that usually require an increased level of immunosuppression.  
Such participants with SLE are currently being managed with multiple medications, 
including anti-malarial drugs, immunosuppressives and corticosteroids.  All these 
medications will be allowed as standard of care background treatment during the study.  As 
study intervention will be adjunct therapy to participant’s standard of care, no participants 
will receive placebo alone.
2.2. Background
Systemic Lupus Erythematosus (SLE) is a chronic inflammatory disease of unknown 
etiology, which can affect the skin, joints, kidneys, lungs, nervous system, serous membranes 
and/or other organs of the body.  Immunologic abnormalities, especially the production of 
 are a prominent feature of the disease.2  The clinical course of 
SLE is variable and characterized by periods of remissions and relapses.  Women, especially 
in their childbearing years, are affected more frequently than men.3  SLE is more prevalent in 
certain racial and ethnic groups such as blacks (of African descent), Asians, and Hispanics.4  
The prevalence of lupus ranges from approximately 40 cases per 100,000 persons among 
Northern Europeans to more than 200 per 100,000 persons among blacks.5  Although the 
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quality of care and survival of SLE patients have improved in the past two decades, further 
improvement depends on the availability of more effective and safer treatment modalities. 
The treatment of SLE can be individualized and depends on symptom manifestations, organ 
involvement, and disease severity.6,7  Antimalarials, low dose corticosteroids, and 
nonsteroidal anti-inflammatory drugs (NSAIDs) are used in the treatment of mild symptoms 
such as arthralgias and cutaneous manifestations.  High dose corticosteroids and cytotoxic 
agents are used in more severe disease.  Immunosuppressive agents such as 
cyclophosphamide, tacrolimus and rituximab are used depending on the severity and various 
organ systems involved.  Development of novel therapies for SLE has been relatively slow 
partly because of the variability of the disease and partly because the disease is often 
responsive to corticosteroids and conventional immunosuppressive agents. 
Prior to 2011, only 3 drugs were approved by the United States Food and Drug 
Administration (US FDA) for the treatment of SLE:  corticosteroids, hydroxychloroquine 
(Plaquenil) and low-dose aspirin.  These therapies are not ideal in terms of efficacy and 
toxicities.  In March 2011, the US FDA approved belimumab (Benlysta) for treatment of 
SLE, and several months later in July 2011, the European Commission granted marketing 
authorisation for Benlysta valid throughout the European Union.8,9  However, the magnitude 
of the clinical benefit of belimumab seems modest and the drug is indicated for treatment of 
patients with active SLE as a combination therapy with conventional modalities.  
Management of refractory lupus manifestations, minimization of treatment-related 
complications and prevention of disease flares and cumulative damage remain unsatisfactory.  
Therefore, there is an unmet need for the development of safer and more effective therapies 
that can induce a long-lasting remission in SLE. 
SLE is characterized by broad dysregulation of the immune system that involves T and 
B cells, dendritic cells, and macrophages.  The hallmark of the disease is the production of 
 and the formation of immune complexes causing organ damage by 
deposition in the tissues.  Pro-inflammatory cytokines play an important and diverse role in 
the pathogenesis of SLE, and their imbalance determines disease activity and severity.
Many key cytokines implicated in the pathogenesis of SLE are dependent on activation of 
Janus kinases (JAKs) for intracellular signaling.10 The JAK family of cytoplasmic protein 
tyrosine kinases mediates the signalling of several pro-inflammatory cytokines, such as type I 
(JAK1/TYK2) and type II (JAK1/JAK2) interferons, IL-6 (JAK1/JAK2/TYK2), and IL-12 
and IL-23 (JAK2/TYK2). PF-06700841 is an orally administered selective and reversible 
inhibitor of JAK1 and TYK2.11
2.2.1. Nonclinical overview
No adverse findings were observed in oral repeat-dose toxicity studies with PF-06700841 in 
rats and monkeys up to 6 and 9 months in duration, respectively.  PF-06700841-related, 
non-adverse, target organs identified include the immune and hematolymphopoietic systems 
(thymus, spleen, lymph nodes, and bone marrow), cardiovascular system (blood pressure, 
heart rate, corrected QT wave interval [QTc]), gastrointestinal tract (body weight and weight 
gain effects), and adrenal gland (vacuolation).  The findings in the thymus, spleen, lymph 
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nodes, and bone marrow are consistent with the pharmacological activity of PF-06700841.  
The no observed adverse effect level (NOAELs) in the 6-and 9-month toxicity studies were 
45 mg/kg/day in rats (unbound maximum concentration (Cmax) of 8280 ng/mL and area under 
the curve at 24 hours (AUC24) of 69,700 ng•h/mL) and 20 mg/kg/day in monkeys (unbound 
Cmax of 2260 ng/mL and AUC24 of 10,700 ng•h/mL).  Adverse findings in the central nervous 
system (decreased activity, mortality, prostration, convulsions) were observed at high 
systemic exposures in pregnant, but not in non-pregnant rabbits. 
In oral embryo-fetal development studies in rats and rabbits, adverse PF-06700841-related 
developmental effects occurred (lower embryo-fetal viability and mean fetal body weights, 
fetal skeletal malformations, external malformations).  The developmental NOAEL in rabbits 
was 1 mg/kg/day (unbound Cmax of 174 ng/mL and AUC24 of 608 ng•h/mL). 
The developmental NOAEL in rats was not established and is <2 mg/kg/day (unbound Cmax
of 482 ng/mL and AUC24 of 2240 ng•h/mL), the lowest dose tested.  No effects on female 
reproductive organs, as assessed by histopathologic examination, were noted in either the rat 
or monkey repeat-dose toxicity studies.  PF-06700841 is not mutagenic in bacterial reverse 
mutation assays.  Although PF-06700841 was positive for micronuclei formation in vitro 
(through an aneugenic mechanism), it did not induce micronuclei in vivo in rats at 
55 mg/kg/day (unbound Cmax = 7730 ng/mL and AUC24 = 88,300 ng•h/mL), the highest dose 
tested in the 1-month oral toxicity study. 
Further details of the nonclinical safety program are provided in the current PF-06700841 
Investigator’s Brochure. 
2.2.2. Clinical Overview
To date, the clinical development program for the oral tablet formulation of PF-06700841 
comprises Phase 1 studies in adult healthy Western participants (B7931001; single ascending 
dose [SAD] and multiple ascending dose [MAD] study) and Japanese participants 
(B7931009; placebo controlled multidose study), an adsorption, distribution, metabolism and
excretion study (B7931014), a formal QT study (B7931019) and Phase 1 and 2 studies in 
participants with chronic plaque psoriasis (B7931001, B7931004), alopecia areata 
(B7931005), ulcerative colitis (B7981005), Crohn’s disease (B7981007), psoriatic arthritis 
(B7931030), and vitiligo (B7981019) and hidradenitis suppurative (C2501007).  The studies 
conducted to date described in this section have all used oral administration of PF-06700841.
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Table 1.
Summary of Clinical Studies for Brepocitinib
Study 
Number
Study Design
Treatment Groups/Dose and Regimen
Number of 
Participants 
Enrolled/Completed
Treatment 
Duration
Status
Oral Administration
Phase 1 Study
B7931001a
This was a Phase 1, within 
cohort, randomized, double 
blind, third-party open, 
placebo-controlled, single- and 
multiple dose escalation, parallel 
group study to evaluate the 
safety, tolerability, PK and 
pharmacodynamics of 
brepocitinib in healthy 
participants and participants 
with plaque psoriasis and 
bioavailability of a tablet 
formulation relative to 
suspension formulation and the 
effect of food on a tablet 
formulation of brepocitinib.
SAD in HV: 1, 3, 10, 30, 100, and 200 mg 
single dose of brepocitinib or placebo
MAD in HV: 10, 30, 100, or 175 mg QD, or 
50 mg BID of brepocitinib or placebo
Multiple doses in psoriasis participants:  
30 mg QD or 100 mg QD of brepocitinib or 
placebo (QD)
Bioavailability in HV: 100 mg Tablet 
(Fasted) or 100 mg Oral Solution/ 
Suspension (Fasted) or 100 mg Tablet (Fed)
SAD: 54 participants 
enrolled (41 active 
and 13 placebo)/51 
completed (39 active 
and 12 placebo)
MAD: 37 
participants enrolled 
(26 active and 11 
placebo)/33 
completed (22 active 
and 11 placebo)
Psoriasis: 30 
participants enrolled 
(21 active and 9 
placebo)/17 
completed (10 active 
and 7 placebo)
BA: 12 participants 
enrolled and 
completed
(12 active)
SAD: single 
dose
MAD: 
10 days
Psoriasis: 
28 days
BA: single 
dose
Completed
Completed
Completed
Completed
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Table 1.
Summary of Clinical Studies for Brepocitinib
Study 
Number
Study Design
Treatment Groups/Dose and Regimen
Number of 
Participants 
Enrolled/Completed
Treatment 
Duration
Status
Total 96 participants 
enrolled and 
84 completed
B7931009
This was a Phase 1, randomized, 
double-blind, third-party open, 
placebo-controlled study to 
evaluate the safety, tolerability, 
and PK after multiple oral doses 
of brepocitinib in healthy 
Japanese participants.
100 mg QD of brepocitinib or placebo
8 HVs (6 active and 
2 placebo)
10 days
Completed
B7931010
This is an open-label, single 
dose, 2-period, 2-sequence 
crossover study in healthy 
volunteers to characterize 
brepocitinib PK profile and 
relative bioavailability following 
single oral dose formulation of 
IR tablets and MR tablets.
Sequence 1: a single oral dose of 30 mg 
brepocitinib IR tablets to a single oral dose 
of 30 mg brepocitinib MR tablets
Sequence 2: a single oral dose of 30 mg 
brepocitinib MR tablets to a single oral dose 
of 30 mg brepocitinib IR tablets
8 participants 
enrolled and 
completed
Single doses
Completed
B7931014
This is a Phase 1, open label, 
non-randomized, 2 period, fixed 
sequence study to investigate the 
absorption, distribution, 
metabolism and excretion of 
[14C PF 06700841] and to assess 
the absolute bioavailability and 
fraction of brepocitinib in 
healthy male participants using a 
14C microtracer approach.
Period A: an oral dose of 60 mg brepocitinib
containing 300 nCi 14C-brepocitinib; 
Period B: an oral dose of 60 mg unlabeled 
brepocitinib followed by an IV dose of 30 μg 
14C labeled brepocitinib (300 nCi)
6 enrolled and 
completed
Single doses
Completed
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Table 1.
Summary of Clinical Studies for Brepocitinib
Study 
Number
Study Design
Treatment Groups/Dose and Regimen
Number of 
Participants 
Enrolled/Completed
Treatment 
Duration
Status
B7931018
This was a Phase 1, randomized, 
2 way crossover, multiple-dose, 
open label study of the effect of 
brepocitinib on single dose 
combination OC PKs in healthy 
female participants.
Treatment A: Single dose of combination 
OC in the form of 1 PORTIA (EE and LN) 
or equivalent oral tablet, containing 
EE 30 μg and LN 150 μg
Treatment B: Single dose of combination OC 
in the form of 1 PORTIA (EE and LN) or 
equivalent oral tablet, containing of EE 30 
μg and LN 150 μg on the morning of Day 10 
following 9 days of brepocitinib dosed at 
60 mg PO QD. Dosing with brepocitinib at 
60 mg PO QD continued through until 
Day 13.
18 enrolled/17 
completed
Multiple dose
Completed
B7931019
This is a Phase 1, 6-sequence, 
3-period, participant- and 
investigator blinded and 
sponsor-open, crossover study in 
healthy volunteers to evaluate 
the brepocitinib effect on QTc 
interval.  Each participant 
randomized will receive 
placebo, brepocitinib 200 mg 
and moxifloxacin (open label) in 
one of the 6 sequences.  
Moxifloxacin is positive control 
to demonstrate the study 
sensitivity and brepocitinib
effect on QTc will be assessed 
by concentration-QT analysis.
Sequence 1: single dose of brepocitinib 
200 mg to placebo to moxifloxacin 400 mg
Sequence 2: single dose of brepocitinib 
200 mg to moxifloxacin 400 mg to placebo
Sequence 3: placebo to brepocitinib 200 mg 
to moxifloxacin 400 mg
Sequence 4: placebo to moxifloxacin 400 mg 
to brepocitinib 200 mg
Sequence 5: moxifloxacin 400 mg to 
brepocitinib 200 mg to placebo
Sequence 6: moxifloxacin 400 mg
to placebo to brepocitinib 200 mg
33 enrolled
32 completed
Single doses
Completed
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Table 1.
Summary of Clinical Studies for Brepocitinib
Study 
Number
Study Design
Treatment Groups/Dose and Regimen
Number of 
Participants 
Enrolled/Completed
Treatment 
Duration
Status
B7931033
This is a phase 1, open-label, 
fixed-sequence, 2-period study 
to investigate the effect of 
multiple oral doses of 
itraconazole on a single oral 
dose of brepocitinib PK in 
healthy volunteers.
Period 1: a single oral dose of 30 mg 
brepocitinib tablets
Period 2: Itraconazole 200 mg once daily on 
Days 1-7 with a single oral dose of 30 mg 
brepocitinib tablets administered 
approximately 1 hour after itraconazole 
dosing on Day 4.
12 enrolled and 
completed
Single doses 
Completed
B7931048
This is a phase 1, non-
randomized, open label, single 
dose study to evaluate the 
pharmacokinetics, safety and 
tolerability of brepocitinib in 
participants with renal 
impairment and in healthy 
participants with normal renal 
function
A single oral dose of 30 mg brepocitinib
tablets
Part 1:
Severe renal 
impairment (8 
enrolled /8 
completed)
Normal renal 
function (8 enrolled 
/8 completed)
Part 2:
Mild renal 
impairment (7 
enrolled /8 planned)
Moderate renal 
impairment (7 
enrolled /8 planned)
(as of 16 Feb 2022)
Single dose
Ongoing
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Table 1.
Summary of Clinical Studies for Brepocitinib
Study 
Number
Study Design
Treatment Groups/Dose and Regimen
Number of 
Participants 
Enrolled/Completed
Treatment 
Duration
Status
B7931058
This was a Phase 1, open-label 
study in healthy participants to 
investigate the PK of 
brepocitinib following single 
oral administration of modified 
release formulations under fed 
and fasted conditions in Part A 
and a randomized, double-blind, 
sponsor-open, placebo 
controlled study to evaluate 
safety, tolerability, and PK of 
brepocitinib following multiple 
oral administration of modified 
release formulation under fasted 
condition in Part B
Part A: 60 mg IR tables or MR capsules
Part B: 30 mg, 60 mg, 120 mg tablets
Part A: 12 healthy 
participants
Part B: 24 healthy 
participants
Part A: 
Single dose
Part B: 
Multiple dose
Completed
Phase 2 Study
B7931004
This was a Phase 2a, 
randomized, double-blind, 
placebo-controlled study to 
evaluate safety and efficacy of 
brepocitinib in participants with 
moderate to severe plaque 
psoriasis.  The study consisted 
of 4 weeks of induction and 
8 weeks of maintenance therapy 
periods.
brepocitinib:
60 mg QD to 30 mg QD
60 mg QD to 10 mg QD
60 mg QD to 100 mg QW
60 mg QD to placebo
30 mg QD;
Or placebo
212 enrolled (189 
active and 23 
placebo)
12 weeks
Completed
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Table 1.
Summary of Clinical Studies for Brepocitinib
Study 
Number
Study Design
Treatment Groups/Dose and Regimen
Number of 
Participants 
Enrolled/Completed
Treatment 
Duration
Status
B7931005b
This is a Phase 2a randomized, 
double-blind, placebo-
controlled, multicenter study 
with two extension periods to 
evaluate the efficacy and safety 
profile of ritlecitinib and 
brepocitinib in participants with 
moderate to severe AA.  This 
includes a 24-week treatment 
period, a 4-week drug holiday 
(#1), an up to 12 month SBE 
period, a 4-week drug holiday 
(#2), and a 6-month CO Open 
Label Extension Period.
brepocitinib: 60 mg QD in 4-week induction 
and 30 mg QD in 20-week maintenance or 
placebo
142 enrolled (47 on 
active brepocitinib
and 47 on placebo) 
/115 completed (36 
on active brepocitinib
and 34 on placebo)
In extension 1, 
96 participants 
entered SBE period, 
32 received 
brepocitinib and 
25 completed the 
study.
In extension 2, 
23 participants 
entered CO 
Extension Period and 
5 participants 
received brepocitinib.
24 weeks in 
the original 
treatment 
period; 24 
weeks in 
extension 1; 
24 weeks in 
extension 2. 
Completed
B7981005b
This is a Phase 2b, double-blind, 
randomized, placebo-controlled, 
parallel group, dose ranging 
study of oral ritlecitinib and 
brepocitinib as induction and 
chronic therapy in participants 
with moderate to severe 
ulcerative colitis.  The study has 
8-weeks of double-blind and 
placebo-controlled induction 
treatment period followed by a 
Induction treatment period:
brepocitinib 60 mg QD, 30 mg QD, and 
10 mg QD or placebo
Chronic treatment period:
brepocitinib 30 mg QD
144 enrolled 
(142 treated)
32 weeks
Completed
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Table 1.
Summary of Clinical Studies for Brepocitinib
Study 
Number
Study Design
Treatment Groups/Dose and Regimen
Number of 
Participants 
Enrolled/Completed
Treatment 
Duration
Status
24-week of chronic active 
treatment period.
B7981007b
This is a Phase 2a, double-blind, 
randomized, placebo-controlled, 
parallel group study to evaluate 
the efficacy and safety of oral 
ritlecitinib and brepocitinib as 
induction and open label 
extension treatment in 
participants with moderate to 
severe Crohn’s disease.  The 
study has a 12-week of induction 
treatment period followed by a 
52-week open label active 
treatment period.
Induction treatment period: 
brepocitinib 60 mg QD or placebo
Extended open label treatment period:
brepocitinib 30 mg QD
223 enrolled/ 255 
planned/58 
completed (as of 
04 Feb 2022)
64 weeks
Ongoing
B7931028
This is a randomized, placebo-
controlled, double-blinded study 
to evaluate the efficacy and 
safety of 3 doses of brepocitinib
compared to placebo in patients
with active systemic lupus 
erythematosus receiving 
concomitant standard of care 
therapy.
brepocitinib 15 mg/day oral
brepocitinib 30 mg/day oral
brepocitinib 45 mg/day oral
Placebo
325 enrolled
(350 planned) and 
180 completed (as of 
02 May 2022)
52 weeks
Ongoing
B7931030
This is a Phase 2b, randomized, 
double-blind, placebo-
controlled, dose-range, parallel 
group study of brepocitinib to 
evaluate the efficacy of 
brepocitinib at 16 weeks and to 
evaluate the safety and efficacy 
brepocitinib 60 mg QD, 30 mg QD, and 
10 mg QD or placebo
219 enrolled 
218 treated
203 completed 
Week 16
168 completed 
Week 52
60 mg and 
30 mg QD 36 
or 52 weeks, 
10 mg QD 
16 weeks
Completed
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Table 1.
Summary of Clinical Studies for Brepocitinib
Study 
Number
Study Design
Treatment Groups/Dose and Regimen
Number of 
Participants 
Enrolled/Completed
Treatment 
Duration
Status
up to 1 year in participants with 
active psoriatic arthritis.
B7981019b
This is a phase 2b randomized, 
double-blind, 
placebo-controlled, multicenter, 
dose-ranging study to evaluate 
the efficacy and safety profile of 
ritlecitinib with a partially 
blinded Extension Period to 
evaluate the efficacy and safety 
of ritlecitinib and brepocitinib in 
participants with active 
non-segmental vitiligo.  The 
study has a 4-week induction, 
20-week maintenance with 
ritlecitinib.  After the 4-week of 
drug holiday, participants may 
receive brepocitinib during 
extended treatment period.
During Extension Period:
brepocitinib 60 mg QD (4 weeks) to 30 mg 
QD (16 weeks)
Extension Group 1: 
55 enrolled and 
47 completed
20 weeks
Completed
C2501007
This is an ongoing Phase 2a, 
multicenter, randomized, double 
blind placebo-controlled, 16-
week study evaluating the safety 
and efficacy of IRAK4 inhibitor 
PF-06650833, TYK2/JAK1 
inhibitor brepocitinib, Tyk2 
inhibitor PF-06826647 in adult 
with moderate to severe 
hidradenitis suppurativa.
PF-06650833 400 mg QD (16 weeks)
brepocitinib 45 mg QD (16 weeks)
PF-06826647 400 mg QD (16 weeks)
52 enrolled and 
52 completed (as of 
16 February 2022)
16 weeks
Ongoing
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Table 1.
Summary of Clinical Studies for Brepocitinib
Study 
Number
Study Design
Treatment Groups/Dose and Regimen
Number of 
Participants 
Enrolled/Completed
Treatment 
Duration
Status
Topical Administration
Phase 1 Study
B7931029
This is a Phase 1, single center, 
randomized, vehicle and white 
petrolatum-controlled, evaluator 
blinded study to assess the skin 
irritation potential with a range 
of concentrations of brepocitinib
cream including vehicle and 
empty patch with white 
petrolatum under occlusive 
conditions in adult Japanese 
healthy participants.
brepocitinib cream 0% [vehicle], 0.1%, 
0.3%, 1%, 3%, and empty patch with white 
petrolatum) were applied in all participants.
20 enrolled /20 
completed
48 hrs 
(2 days)
Completed
Phase 2 Study
B7931022
This is a Phase 2b, randomized, 
double blind, vehicle controlled, 
parallel group, dose ranging 
study to assess the efficacy, 
safety, tolerability and 
pharmacokinetics of brepocitinib 
cream applied once or twice 
daily for 6 weeks in participants 
with mild to moderate atopic 
dermatitis.
brepocitinib (topical)
0.1% QD
0.3% QD, BID
1% QD, BID
3% QD
Vehicle QD, BID
292 enrolled and 240 
completed
6 weeks
Completed 
B7931023
This is a Phase 2b, randomized, 
double blind, vehicle controlled, 
parallel group, dose ranging 
study to assess efficacy, safety, 
tolerability and 
pharmacokinetics of brepocitinib 
brepocitinib (topical)
0.1% QD
0.3% QD, BID
1% QD, BID
3% QD, BID
Vehicle QD, BID
344 enrolled/treated
258 completed). 
12 weeks
Completed
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Table 1.
Summary of Clinical Studies for Brepocitinib
Study 
Number
Study Design
Treatment Groups/Dose and Regimen
Number of 
Participants 
Enrolled/Completed
Treatment 
Duration
Status
topical cream applied QD or 
BID for 12 weeks in participants 
with mild to moderate chronic 
plaque psoriasis
AA = Alopecia areata; BID = Twice daily; CD = Crohn’s disease; CO = Cross Over; HV = Healthy volunteers; IV = Intravenous; IR = Immediate release; MAD = multiple 
ascending dose; MR = Modified release; PK = Pharmacokinetic; PsO = Psoriasis; QD = Once daily; QTc = Interval corrected for heart rate; QW = Once weekly; SAD = Single 
ascending dose; SBE = Single blind extension; UC = Ulcerative colitis.
a.
Participants who completed the 100 mg SAD and 100 mg MAD periods continued in the 50 mg BID period and received either placebo or brepocitinib twice daily 
according to original treatment assignment when randomized into the 100 mg SAD period.
b.
Platform study that assessed efficacy and safety of ritlecitinib and a second investigational agent (brepocitinib) separately.  Ritlecitinib is an orally bioavailable small 
molecule that irreversibly inhibits JAK3 and TEC family of kinases.
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2.2.2.1. Safety Overview
Overall, PF-06700841 was generally safe and well tolerated in all clinical trials to date.  
There were no clinically meaningful findings in vital signs, electrocardiograms (ECG), 
suicidal behavior or ideation, or potential Hy’s Law cases reported during these studies. 
Refer to the current Investigator’s Brochure (IB) for more details on the clinical safety 
information with PF-06700841.
2.2.2.1.1. Phase 1 Studies (B7931001 and B7931009)
The most commonly reported all causality treatment-emergent adverse events (TEAEs) 
across active healthy participants were serum creatinine increased (reported in 2 participants 
during the SAD period and 11 participants during the MAD period) without any changes in 
Cystatin C measured renal function.  Neutropenia was reported in four participants during the 
MAD period, most of them were mild in severity except one with moderate, and none of 
them reached <500/mm3 during the study.  The most frequently observed laboratory 
abnormalities in healthy participants were elevated low density lipoprotein (LDL) and serum 
creatinine.  There were no deaths or serious adverse events (SAEs) reported in the Phase 1 
studies.  One psoriasis participant receiving 100 mg QD of Study intervention (IP) in 
B7931001 experienced an adverse event of herpes zoster during the follow up period, after 
completing 28-day treatment. 
2.2.2.1.2. Phase 2 Studies (B7931004 and B7931005)
A total of 189 psoriasis participants out of 212 enrolled in B7931004 were exposed to at least 
1 dose of PF-06700841 during the study.  The proportion of participants with all-causality 
TEAEs was comparable across all treatment arms but numerically higher in the active 
treatment arms (64.0% to 76.7%) than the placebo group (56.5%).  The majority of 
participants in all treatment arms experienced mild or moderate all-causality TEAEs, and 
only 5.2% experienced severe all-causality TEAEs. 
Overall, there were no dose dependent increases in the all-causality TEAEs.  Most TEAEs in 
the Infection and Infestation class were mild to moderate except one participant who had two 
serious infections after taking a single dose of 60 mg PF-06700841 on Day 1.  One 
participant in the 30 mg QD to 100 mg once a week (QW) group had squamous cell 
carcinoma of skin reported on Day 2 of treatment.  One participant in the 30 to 10 mg group 
was confirmed to be pregnant after in the study 42 days and discontinued from the study with 
obstetrical ultrasound demonstrating fetal cleft lip.
Decreased reticulocytes, hemoglobin, and neutrophils were observed in the participants on 
active treatment during 4-week induction phase and returned toward baseline level during 
8-week maintenance phase.  Increases in serum creatinine from baseline were observed in all 
active treatment arms with no association of change in cystatin C based renal function 
measurement.  Other commonly reported laboratory abnormalities were elevation of low 
density lipid (LDL) with no clinical meaningful changes in LDL/HDL ratio.  There were no 
clinically meaningful changes from baseline observed in creatine kinase (CK) during the 
study.  CK levels >10 × upper limit of normal (ULN) were observed in two participants 
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without adverse event.  One moderate adverse event (AE) of CK-myoglobin increase was 
reported by one participant in the 30 to 10 mg QD group during the induction period, which 
was considered to be related to the IP by the investigator.  No participant was discontinued 
from the study due to CK elevation.
In the study B7931005, 47 alopecia areata participants were exposed to at least one dose of 
PF-06700841.  The most commonly reported TEAEs in the active treatment arm was in the 
Infections and Infestations system organ class (SOC) (51.1% in the IP vs 40.4% in the 
placebo).  Other TEAEs were Gastrointestinal Disorders (23.4% in the IP vs 25.5% in the 
placebo).  Most of those TEAEs were mild.  There were two participants receiving 
PF-06700841 that experienced rhabdomyolysis after strenuously exercising during the study, 
which were not considered to be related to the IP by investigator assessment.  Three 
participants experienced mild decreases in neutrophils, one participant had a mild reduction 
in platelets, and one participant a mild reduction in lymphocytes.
Please refer to the Investigator’s Brochure for safety and efficacy findings in other 
brepocitinib Phase 1 and 2 studies.
2.2.2.2. Summary of PF-06700841 Pharmacokinetics in human
In Study B7931001, following single oral doses of 1 mg to 200 mg under fasted conditions, 
PF-06700841 was absorbed rapidly with median time to maximum (Tmax) of 1 hour or less.  
Mean terminal half-life (t½) ranged from 3.8 to 7.5 hours.  In general, both the area under the 
plasma concentration time curve from time 0 extrapolated to infinity (AUCinf) and maximum 
plasma concentration (Cmax) appeared to increase proportionally with dose from 1 mg to 
100 mg.  Increases from 100 mg to 200 mg appear more than dose proportional, especially 
for AUCinf.
On Day 10 of multiple dose administration, PF-06700841 was absorbed rapidly with median 
Tmax of 1 to 1.5 hours or less across the entire range of doses, from a total daily dose of 
10 mg up to 175 mg.  Following attainment of Cmax, the disposition of PF-06700841 was 
similar with that observed following single dose administration.  Mean terminal half-life (t½) 
ranged from 4.9 to 10.7 hours.  Both area under the concentration time curve from time 0 to 
time& (AUCt) and Cmax generally appeared to increase proportionally with dose from 10 mg 
to 100 mg QD, with a trend towards greater than proportional increase from 100 mg to 
175 mg QD.  Accumulations, following once daily dosing, ranged from 1.1 to 1.4 for AUCt
and 0.8 to 1.1 for Cmax.  The urinary recovery of unchanged (Ae&%) PF-06700841 on Day 10 
across all doses ranged from 8.9% to 15.5%.  Following multiple dose administration of 
PF-06700841 to participants with psoriasis for 28 days, the overall exposure observed was 
comparable to that in healthy participants at same dose level.
Refer to the current Investigators Brochure (IB) for more details on the PF-06700841 PK in 
humans.
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2.2.2.3. Assessment of PF-06700841 Effect on QT 
A formal QT study (B7931019) was recently completed.  As the clinical study report (CSR) 
preparation is in progress, the results are considered draft and potentially subject to change. 
Following a single dose of 200 mg PF-06700841, the maximum placebo-corrected QTcF 
change from baseline was observed at 3 hours post-dose with mean of 14.6 ms and 
90% confidence interval (CI) of (12.4, 16.8 ms).  Despite QTc increase seen, no clinically 
significant findings in ECG including QTc change from baseline >60 msec and QTc absolute 
value >500 msec were observed.  As pre-defined in the protocol, concentration-QTcF (CQT) 
analysis was used to determine PF-06700841 effects on QT prolongation at relevant clinical 
exposures.  The results from the CQT analysis suggested that the relationship between 
PF-06700841 concentration and QTcF change from baseline was most adequately described 
by an Emax model, in which the maximum QTcF change (Emax) was estimated to be 15.7 ms 
(90% CI: 13.2, 18.2 ms).  The QTcF increase observed at a dose of 200 mg PF-06700841 
appeared to reach maximum effect.  Based on the model prediction, the mean change in 
QTcF at steady-state Cmax of a 45 mg QD dose was 7.7 ms (90% CI: 6.5, 9.1 ms), which 
suggested that no positive QT effect is expected at PF-06700841 therapeutic doses up to 
45 mg QD as the upper bound of two-sided 90% CI is <10 ms.36  At PF-06700841 60 mg 
QD, the highest clinical dose being tested in Phase 2 studies, the mean QTcF increase at Cmax
was expected to be 8.8 ms (90%CI: 7.7, 10.2 ms) with the upper bound of 90% CI slightly 
exceeding 10 ms.  
Refer to the current Investigator’s Brochure (IB) for more details on the QT study design and 
results.
2.3. Benefit/Risk Assessment
PF-06700841, a TYK2/JAK1 inhibitor, is expected to offer therapeutic benefit in the 
treatment of SLE.  Indeed, compared with other JAK inhibitors, inhibition of IL-12 and 
IL-23 signaling mediated by TYK2 inhibitory activity may provide a new and improved 
therapeutic benefit.  Study participants could benefit from the potential achievement of 
disease control, improvement of signs and symptoms, as well as improvements in quality of 
life.
Based on the current clinical and nonclinical experience with brepocitinib and other 
information from other approved oral JAK inhibitors (eg, Xeljanz® (tofacitinib), Jakafi®
(ruxolitinib), Olumiant® (baricitinib), and Rinvoq® (upadacitinib), the potential risks for 
brepocitinib include: (1) viral reactivation; (2) serious infection and opportunistic infections; 
(3) malignancy and lymphoproliferative disorders; (4) hematological abnormalities and other 
alterations in laboratory parameters: decreased neutrophil counts, change in lymphocyte 
counts, decreased hemoglobin level, decreased platelet counts, and elevation of hepatic 
transaminases; (5) alterations in the lipid profile; (6) increases in serum creatinine; 
(7) increases in creatine phosphokinase; (8) QT prolongation, (9) bone changes for oral route 
of administration in the administration in the <12 years of age group; (10) vaccinations: and 
(11) thromboembolism.
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In the brepocitinib development program, there have been thromboembolic events reported in 
ongoing blinded clinical studies, where relationship to treatment is uncertain. Suspected 
thromboembolic events will be subject to review by an external blinded adjudication 
committee. In this study, B7931028, participants with any history of a pulmonary embolisms 
(unless these were caused by known antiphospholipid syndrome will be excluded from the 
protocol unless the participant has been adequately anticoagulated), exclusion criteria #5 and 
#6 have more detailed information. 
Based on in vitro data, and the clinical DDI study of brepocitinib with itraconazole, moderate 
and strong cytochrome P450 3A (CYP3A) inducers, strong P-glycoprotein (P-gp) inhibitors, 
P-gp substrates and substrates of OCT2/MATE with a narrow therapeutic index, will be 
prohibited during oral PF-06700841 treatment periods in ongoing Phase 2 studies to 
minimize any potential significant drug interaction.  Detailed information about in vitro 
assessments on drug metabolism, enzyme phenotype and drug-drug interaction can be found 
in the investigator’s brochure.
In conclusion, the sponsor considers that the available information from the nonclinical and 
clinical studies completed to date with PF-06700841 provide a favorable benefit-risk profile 
and support its continued investigation as a potential treatment for SLE.  
More detailed information about the known and expected benefits and risks and reasonably 
expected adverse events (AEs) of PF-06700841 may be found in the current IB, which is the 
single reference safety document (SRSD) for this study. 
3. OBJECTIVES, ESTIMANDS AND ENDPOINTS 
Objectives:
Endpoints:
Estimands:
Primary:
Primary:
Primary:
!
To evaluate the efficacy of 
3 QD dose levels of 
PF-06700841 compared to 
placebo in participants with 
active SLE.
!
Proportion of participants 
achieving the Systemic Lupus 
Erythematosus Responder Index 
(SRI) change of 4 (SRI-4) at 
Week 52.
E1: This composite estimand is 
defined as a population average 
treatment difference between 
PF-06700841 and placebo in the 
proportion of participants with 
active SLE who achieved the binary 
SRI-4 endpoint at Week 52 and did 
not discontinue treatment prior to 
Week 52.
Treatment: PF-06700841, Placebo.
Population: Participants with active 
SLE as defined by 
inclusion/exclusion criteria.
Variable: SRI-4 at Week 52. A 
study participant will be considered 
as a non-responder for the visit of 
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Objectives:
Endpoints:
Estimands:
interest after the occurrence of an 
intercurrent event. 
Intercurrent Events: Treatment 
discontinuation prior to Week 52 
visit.  Data post intercurrent events 
will be censored.
Population level summary: 
treatment difference between 
PF-06700841 and placebo in 
proportions of responders using the 
composite endpoint. 
Key Secondary:
Key Secondary:
Key Secondary:
!
To evaluate the efficacy of 
3 QD dose levels of PF-
06700841 compared to 
placebo in participants with 
active SLE.
! Proportion of participants 
achieving the British Isles 
Lupus Assessment Group-
Based Composite Lupus 
Assessment (BICLA) at 
Week 52.
E2: This composite estimand is 
defined as a population average 
treatment difference between 
PF-06700841 and placebo in the 
proportion of participants with 
active SLE who achieved the binary 
BICLA endpoint at Week 52 and 
did not discontinue treatment prior 
to Week 52.
Treatment: PF-06700841, Placebo.
Population: Participants with active 
SLE as defined by 
inclusion/exclusion criteria.
Variable: BICLA at Week 52.  A 
study participant will be considered 
as a non-responder for the visit of 
interest after the occurrence of an 
intercurrent event. 
Intercurrent Events: Treatment 
discontinuation prior to Week 52 
visit.  Data post intercurrent events 
will be censored.
Population level summary: 
treatment difference between 
PF-06700841 and placebo in 
proportions of responders using the 
composite endpoint.
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Objectives:
Endpoints:
Estimands:
Other Secondary:
Other Secondary:
Other Secondary:
!
To assess attainment of low 
disease activity state of 
3 QD dose levels of 
PF06700841 compared to 
placebo in participants with 
active SLE.
!
Proportion of participants 
achieving the Lupus Low 
Disease Activity State (LLDAS) 
at Week 52.
E3: This composite estimand is 
defined as a population average 
treatment difference between 
PF-06700841 and placebo in the 
proportion of participants with 
active SLE achieving LLDAS at 
Week 52 and did not discontinue 
treatment prior to Week 52.
Treatment: PF-06700841, Placebo.
Population: Participants with active 
SLE as defined by 
inclusion/exclusion criteria.
Variable: LLDAS at Week 52.  A 
study participant will be considered 
as a non-responder for the visit of 
interest after the occurrence of an 
intercurrent event.
Intercurrent Events: Treatment 
discontinuations prior to Week 52 
visit. Data post intercurrent events 
will be censored. 
Population level summary: 
Treatment difference between 
PF06700841 and placebo in 
proportions of responders using the 
composite endpoint.
!
To compare the 
corticosteroid use 
(prednisone or equivalent) 
in PF-06700841 treated 
participants relative to 
placebo.
!
Proportion of participants 
achieving a reduction in 
prednisone (or equivalent) dose 
to ≤7.5 mg/day at Week 52 and 
sustained for 12 weeks prior to 
Week 52, in the subset of 
participants on prednisone >7.5 
mg/day (or equivalent) at 
baseline.
There is no defined estimand for 
this endpoint.
!
To evaluate the efficacy of 
PF-06700841 compared to 
placebo in participants with 
active SLE and with 
sustained reduction of oral 
corticosteroids.
!
Proportion of participants 
achieving SRI-4 response with 
dose of prednisone (or 
equivalent) reduced to ≤7.5 
mg/day and sustained for 
12 weeks at Week 24 and Week 
52, in the subset of participants 
E4: This composite estimand is 
defined as a population average 
treatment difference between 
PF-06700841 and placebo in the 
proportion of participants who 
achieved the binary SRI-4 endpoint 
with sustained prednisone dose 
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Objectives:
Endpoints:
Estimands:
with prednisone dose >7.5 
mg/day (or equivalent) at 
baseline.
reduction to ≤7.5 mg/day (or 
equivalent) for 12 weeks at 
Week 24 and Week 52, and did not 
discontinue treatment prior to 
Week 52, in the subset of 
participants with prednisone dose 
>7.5 mg/day (or equivalent) at 
baseline.
Treatment: PF-06700841, Placebo.
Population: Participants with active 
SLE as defined by 
inclusion/exclusion criteria and 
with prednisone dose >7.5 mg/day 
(or equivalent) at baseline.
Variable: SRI-4 at Week 52 with 
sustained prednisone dose 
reduction ≤7.5 mg/day (or 
equivalent) for 12 weeks at 
Week 24 and Week 52.
Intercurrent Events: treatment 
discontinuations prior to Week 52 
visit. Data post intercurrent events 
will be censored. 
Population level summary: 
treatment difference between 
PF-06700841 and placebo in 
proportions of responders using the 
composite endpoint.
!
To evaluate the Cutaneous 
Lupus Erythematosus 
Disease Area and Severity 
Index activity (CLASI-A) 
score in the subset of 
participants with baseline 
CLASI-A score ≥10 in 
PF06700841 treated 
participants relative to 
placebo.
!
Proportion of Participants with 
Cutaneous Lupus Erythematosus 
Disease Area and Severity Index 
(CLASI-A) Total Activity Score 
≥10 at Baseline with ≥50% 
Reduction in CLASI-A Total 
Activity Score
There is no defined estimand for 
this endpoint.
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Objectives:
Endpoints:
Estimands:
!
To evaluate the effect on 
fatigue of PF-06700841 
treated participants relative 
to placebo.
!
Change from baseline in the total 
scores of Functional Assessment 
of Chronic Illness Therapy-
Fatigue (FACIT-F) at Week 52.
E5: This hypothetical estimand is 
defined as a population average 
treatment difference between
PF-06700841 and placebo in the 
FACIT-F score at Week 52 as if 
none of the specified intercurrent 
events have occurred.
Treatment: PF-06700841, Placebo.
Population: Participants with active 
SLE as defined by 
inclusion/exclusion criteria.
Variable: Change from baseline in 
total scores FACIT-F at Week 52.
Intercurrent Events:  Treatment 
discontinuations prior to Week 52 
visit.  Data post intercurrent events 
will be censored.
Population level summary: The 
mean difference between each 
PF-06700841 group and placebo in 
the change from baseline in 
FACIT-F score at Week 52.
!
To evaluate the effect on 
health-related quality of 
life of PF-06700841 treated 
participants relative to 
placebo.
!
Change from baseline in the 
individual domain scores of the 
Lupus Quality of Life 
(LupusQoL) at Week 52.
E6: This hypothetical estimand is 
defined as a population average 
treatment difference versus placebo 
in the LupusQoL individual 
domain scores at Week 52 as if 
none of the specified intercurrent 
events have occurred.
Treatment: PF-06700841, Placebo.
Population: Participants with active 
SLE as defined by 
inclusion/exclusion criteria.
Variable: change from baseline in 
the individual domain scores of 
LupusQoL at Week 52.
Intercurrent Events: Treatment 
discontinuations prior to Week 52 
visit.  Data post intercurrent events 
will be censored.
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Objectives:
Endpoints:
Estimands:
Population level summary: The 
mean difference between each 
PF06700841 arm and placebo arm 
in the change from baseline in 
LupusQoL individual domain 
scores at Week 52.
!
To assess time to first 
severe flare in 
PF-06700841 treated 
participants relative to 
placebo.
!
Time to first severe flare as 
measured by the modified Safety 
of Estrogen in Lupus: National 
Assessment 
(SELENA)-Systemic Lupus 
Erythematosus Disease Activity 
Index (SLEDAI) Flare Index 
(m-SSFI).
E7: This estimand is defined as a 
population average treatment 
hazard ratio between PF-06700841 
and placebo, based on the Cox PH 
model, for the occurrence of the 
first severe flare event. However, 
the p-values will be derived using 
the log-rank test per protocol.
Treatment: PF-06700841, Placebo.
Population: Participants with active 
SLE as defined by 
inclusion/exclusion criteria.
Variable: Time to first severe flare 
measured by modified SELENA-
SLEDAI Flare Index.
Intercurrent Events: Treatment 
discontinuations prior to Week 52 
visit.  
Population level summary:
Treatment differences between PF-
06700841 doses and placebo in the 
hazard ratio of first severe flare 
occurrence.
!
To evaluate the safety and 
tolerability of PF06700841 
dose levels versus placebo.
!
Incidence of treatment-emergent 
adverse events (AEs).
!
Incidence of serious AEs (SAEs) 
and AEs leading to 
discontinuation.
!
The incidence of clinically 
significant abnormalities in vital 
signs and ECGs.
!
The incidence of clinically 
significant abnormalities in 
clinical laboratory values.
There is no defined estimand for 
these endpoints and they will be 
analyzed using Pfizer data 
standards as applicable.
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Objectives:
Endpoints:
Estimands:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Objectives:
Endpoints:
Estimands:
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Objectives:
Endpoints:
Estimands:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
This study will use separate blinded adjudication committees consisting of independent 
external experts who will be responsible for the ongoing review and adjudication of the 
following efficacy and safety endpoints: 
1. BILAG, SLEDAI and associated data.
2. Severe Flare.
3. Cardiovascular and thromboembolic events.
4. Malignancy.
5. Opportunistic infections.
In addition, a separate external data monitoring committee (E-DMC) will conduct unblinded 
reviews of all safety data on a regular basis throughout the duration of the trial (see the Data 
Monitoring Committee section). This E-DMC will make recommendations with regard to 
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continuing, stopping or altering the trial to a Sponsor Management Committee throughout the 
study. 
4. STUDY DESIGN
4.1. Overall Design
This is a Phase 2b, double-blind, randomized, placebo controlled, parallel design, 
multicenter, dose-ranging study to assess the efficacy and safety of PF-06700841 in 
participants with active, moderate to severe generalized SLE.  After a 7-week screening 
period, eligible participants will be randomly assigned to one of the four treatment groups 
(A-D in Table 2) in a 1:2:2:2 ratio such that participants will receive either 1 of three 
PF-06700841 QD dose levels (15 mg, 30 mg and 45 mg) or placebo every day for 52 weeks. 
All participants who are randomized should be encouraged to remain in the study to at least 
the end of the double-blind period to complete safety and efficacy assessments in order to 
reduce missing data as much as possible.  It is expected that the only reasons for which a 
participant will withdraw from the study will be for withdrawal of consent or lost to 
follow-up.
Approximately 350 randomized participants (100 participants per treatment group except 
50 participants for the PF-06700841 15 mg QD dose group) will participate in this study at 
approximately 185 investigative sites worldwide.  Randomization will be stratified by 
screening disease severity (SLEDAI-2K total adjudicated score) and anti-dsDNA status.  The 
purpose of the stratified randomization is to achieve balanced treatment groups in these 
stratification factors.  
Table 2.
Treatment Group
Treatment Group
Treatment Group Description
Participant Size
A
PF-06700841 15 mg QD
50
B
PF-06700841 30 mg QD
100
C
PF-06700841 45 mg QD 
100
D
Placebo
100
For this study, the study intervention is PF-06700841.  Blinded PF-06700841 and its matched 
placebo will be provided as tablets for oral administration.  Participants will participate in 
this study for approximately up to 63 weeks.  This includes up to a 7-week screening period, 
a 52-week treatment period, and a 4-week follow-up period. 
4.2. Scientific Rationale for Study Design
The primary endpoint of the study is the proportion of participants achieving Systemic Lupus 
Erythematosus Responder Index (SRI)-4 at Week 52.  The SRI is a disease activity index 
developed for use in systemic lupus erythematosus (SLE) clinical trials in collaboration with 
the FDA.  It detects both improvement and worsening in the same and different organ 
systems, and it was validated in a long term clinical trial and is compatible with regulatory 
guidance from both the European Medicines Agency (EMA) and FDA.  The SRI is a 
composite score utilizing the SLEDAI to assess improvement, the BILAG to assess 
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significant worsening or flares, and the physician global assessment (PhGA) to assess 
whether or not there has been any significant deterioration in the participant’s overall 
condition.  The 4-point improvement in the SRI has been shown to be a clinically meaningful 
change in large, randomized control studies.12  Therefore, the SRI-4 was chosen for the 
primary efficacy assessment in this study.  Based on published data 52 weeks of treatment is 
appropriate to establish efficacy of a new compound in SLE. 
The key secondary endpoint of the study is the proportion of participants achieving BICLA 
response at Week 52.  BICLA is a composite endpoint requiring  that the following criteria 
are met: improvement in the BILAG-2004 score (improvement in all BILAG-2004 grade A 
scores at study entry to grades B, C, or D at follow-up; improvement in all BILAG-2004 
grade B scores at study entry to grades C or D at follow-up); no worsening in the BILAG-
2004 score (no new BILAG-2004 grade A scores; no more than 1 new BILAG-2004 grade B 
score); no increase compared to baseline in the SLEDAI-2K total score; no worsening 
compared to baseline (10-mm increase on a 100-mm visual analog scale) in the physician’s 
global assessment of disease activity; and no disallowed prohibited changes in concomitant 
medications (corticosteroids, immunomodulators or antimalarials). BICLA was developed as 
an alternative method to the SRI-4 of detecting clinical activity in SLE and has been used to 
support the approval of anifrolumab as well as being used in other SLE investigational 
programs. 13 Compared to the SRI-4 which demonstrated improvement in disease activity as 
an absence of activity in an organ system, BICLA requires a decrease in disease activity in an 
affected organ system but also requires that all organ systems that are affected have 
demonstrated improvement. Additionally SRI considers  disease activity to be reduced based 
on normalization of serological markers (
) while BICLA ( 
based on BILAG scoring) does not consider reduction in serologic markers as evidence of 
improvement. 
In prior versions of this protocol, time to severe flare had been proposed as a major 
secondary endpoint, however Pfizer considers that it is scientifically justified to change the 
key secondary endpoint to BICLA in this study for 3 reasons. First, in prior versions of this 
protocol, the incidence of severe flare in a moderate to severe lupus population was 
considered to be 25% per year. This flare rate is an overestimation of what has been seen in 
multiple SLE studies conducted in patients with moderate to severe disease, where the severe 
flare rate generally approximates 5-10% annually. Based on this information, the major 
secondary endpoint of severe flare was estimated to be underpowered. Second, although 
there is fairly good concordance between SRI and BICLA, there is occasionally a difference 
in the reduction in disease activity assessed by these methods within the same study, as 
illustrated by the discrepancy observed in the 2 anifrolumab phase 2 studies. Elevating 
BICLA to a secondary endpoint recognizes the importance of looking for consistency 
between both outcome measures in the current trial. Finally, BICLA response, similar to SRI 
response, has been shown to correlated with general improvement in patient physical and 
mental health, demonstrating that BICLA response is clinically meaningful to both patients 
and health care providers. 14
The presence of dsDNA antibodies is associated with a higher likelihood of developing renal 
involvement and is predictive of overall disease flare. Stratification by dsDNA (±) is to 
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ensure that participants who have a higher risk of developing renal disease or who are 
actively flaring at the time of study entry are evenly distributed cross treatment arms. 
Adjudicated screening SLEDAI-2K scores differentiate participants by disease activity at the 
time of study entry.  In some studies, participants with higher disease activity at study entry 
were more likely to demonstrate a benefit from a study intervention and more likely to have 
adverse events than participants with lower baseline disease activity.  Stratification by 
adjudicated screening SLEDAI scores is to limit the possible confounding effects of disease 
activity on efficacy and safety outcomes. 
It is desirable to have participants treated with corticosteroids (CS) on a dose as low as 
possible to minimize side effects/long term damage associated with administration of CS.  A 
low dose of CS has been associated with a lower risk of sustaining long-term damage, hence 
the specification that participants should be tapered to a dose ≤7.5 mg/day of prednisone (or 
equivalent).
Approximately 350 participants will be enrolled in the study with 100 participants per 
treatment group with the exception of the PF-06700841 15 mg QD dose group, which will 
enroll approximately 50 participants.  Based on evidence from other studies, the 15 mg dose 
does not inhibit inflammatory cytokine effects to the same extent as the proposed 30 mg and 
45 mg doses and is likely to be a subtherapeutic dose.  Because SLE is a severe debilitating 
disease and participants with unabated disease activity may accrue end-organ damage over 
time, it is decided to reduce the number of participants for the 15 mg QD dose arm. 
It is estimated that 5 to 10% of study participants may be taking concomitant mycophenolate 
mofetil (MMF) at study entry.  Target trough levels for therapeutic effect and levels at which 
risk of adverse effects of MMF are more likely to occur have been characterized and 
therapeutic drug monitoring to ascertain exposures within the defined target ranges can be 
obtained easily at central laboratories.13  Glucuronidation is the primary metabolic pathway 
for MMF.  Corticosteroids are potent inducers of the glucuronidation pathway.  Therefore, as 
participants taper corticosteroids, the rate of MMF metabolism may decrease and MMF 
levels may rise by as much as 30-35%.16  Since participants in this study are required to taper 
corticosteroids (when appropriate), measurement of the active metabolite of MMF, 
mycophenolic acid (MPA), prior to and following corticosteroid tapering will be evaluated in 
this study. 
Trough levels of MMF will be measured at Day 1 and Week 40 at the central laboratory.  
The participant should refrain from taking their MMF dose immediately prior to these clinic 
visits and record the time of their last MMF dose.  Should participants develop adverse 
events suggestive of high MMF levels (decreases in cellular blood counts, serious infections) 
additional safety monitoring of MPA levels may be requested. 
 
 
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4.3. Justification for Doses
This Phase 2b, dose-ranging study will assess three PF-06700841 doses (15 mg, 30 mg and 
45 mg) administered once a day (QD) for 52 weeks in comparison to placebo. 
Doses selected for this Phase 2 study are based on the safety and efficacy observed to date 
with PF-06700841 in healthy participants (B7931001) and participants with active psoriasis 
(B7931001 and B7931004) and alopecia areata (B7931005).  The overall safety profile to 
date with PF-06700841 has been acceptable with doses up to 60 mg QD for 4 weeks and 
30 mg QD for up to 20 weeks in completed studies.  Ongoing studies in inflammatory bowel 
disease (IBD) are assessing the 60 mg QD dose for up to 12 weeks, and an extended period at 
30 mg QD for up to 52 weeks.  The highest dose level selected for this study is 45 mg QD, 
lower than the top dose of 60 mg in the ongoing Phase 2 studies in IBD to reduce any 
potential safety risk, particularly associated with a population of SLE participants compared 
to the other populations currently being assessed in Phase 2.  SLE participants are known to 
have a greater overall risk for severe infections due to underlying immune defects as well as 
to the common use of immunosuppressants, including corticosteroids.
Based on the preliminary population PK analysis with combined data from studies B7931001 
in healthy participants and B7931004 in participants with moderate to severe psoriasis, the 
expected median steady state exposures (AUC24) following 15, 30 and 45 mg QD are 677, 
1360 and 2030 ng.h/mL, respectively in a patient population.  As a result, the exposure of 
PF-06700841 (AUC24) at 45 mg QD in this study are expected to be 56x and 8.6x below the 
AUC24 at the no observed adverse effect levels (NOAELs) observed in the 6-month rat (45 
mg/kg/day) and 9-month monkey (20 mg/kg/day) studies, respectively.  The pharmacological 
activity of PF-06700841 was assessed by reduction of high sensitivity C-reactive protein 
(hsCRP) in participants with moderate to severe psoriasis (B7931004).  In study B7931004, 
the median reduction (percent change from baseline) of hsCRP observed at week 4 were 
approximately 61% and 76% with PF-06700841 30 and 60 mg QD treatment, respectively.  
Study B7931004 also showed that PF-06700841 reached maximal effect on hsCRP within 
approximately 2 weeks after start of treatment and remained constant throughout the 12-week 
treatment period.  Previous studies suggested that the baseline levels of hsCRP in participants 
with moderate to severe psoriasis and active SLE were comparable (median of ~2.9 mg/dL in 
both participant populations).  As a result, the median hsCRP reduction with PF-06700841 
45 mg daily dose up to 52 weeks would expect to be between 61% to 76% in participants 
with active SLE in the current study. 
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Based on the preliminary exposure response analysis with Psoriasis Area and Severity Index 
(PASI) in participants with moderate to severe psoriasis in B7931004, PF-06700841 15 mg is 
estimated to provide a limited therapeutic effect in psoriasis compared to the 30 or 60 mg 
dose levels.  A dose of 15 mg is included in this study to support characterization of the 
minimum effect of PF-06700841 treatment in participants with active SLE. 
4.4. End of Study Definition
A participant is considered to have completed the study if he/she has completed all periods of 
the study including the last visit.
The end of the study is defined as the date of the last visit of the last participant in the trial 
globally.
5. STUDY POPULATION
This study can fulfill its objectives only if appropriate participants are enrolled.  The 
following eligibility criteria are designed to select participants for whom participation in the 
study is considered appropriate.  All relevant medical and nonmedical conditions should be 
taken into consideration when deciding whether a particular participant is suitable for this 
protocol. 
Prospective approval of protocol deviations to recruitment and enrollment criteria, also 
known as protocol waivers or exemptions, is not permitted.
5.1. Inclusion Criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
Age and Sex:
1. Male or female participants between the ages of 18 (or the minimum country-specific 
age of consent if >18) and 75 years, inclusive, at the time of signing the informed 
consent document (ICD).  
!
Refer to Appendix 4 for reproductive and contraceptive criteria for male and
female participants.
Type of Participant and Disease Characteristics:
2. Participants who are willing and able to comply with all scheduled visits, treatment 
plan, laboratory tests, lifestyle considerations, and other study procedures.  All 
participants should be willing to remain in the study to the end of the double-blind 
period for safety and efficacy assessments, whether or not study intervention is 
discontinued. 
3. Have a clinical diagnosis of SLE according to the 1997 update on the 1982 revised 
American College of Rheumatology (ACR) Criteria for the Classification of SLE see 
Appendix 8 OR meet at least 4 of the 2012 Systemic Lupus International 
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Collaborating Clinics (SLICC) classification criteria see Appendix 9, including at 
least 1 clinical criterion and 1 immunologic criterion, at least 6 months prior to dosing 
of study agent.
4. Have serologically positive SLE at the screening visit based on 1 of the following test 
results from the central laboratory during the screening period:
!
ANA titer ≥1:80, or 
!
Positive anti-dsDNA.  
Note: The ANA and/or anti-double-stranded DNA (anti-dsDNA) measurement 
may be repeated once at the central laboratory within approximately 2 weeks of 
the initial value, and the value resulting from repeat testing may be accepted for 
enrollment eligibility if it meets the eligibility criterion.
5. All participants must be currently receiving EITHER a stable dose of an 
immunosuppressant [methotrexate (MTX), azathioprine (AZA)/6-mercaptopurine 
(6-MP), leflunomide, mizoribine, mycophenolate/mycophenolic acid (MMF)] with or 
without antimalarials and/or corticosteroids, OR anti-malarials (hydroxychloroquine 
or chloroquine) in combination with corticosteroids. Antimalarial or steroid 
monotherapy is not permitted.  If receiving antimalarials in combination with 
corticosteroids, the minimum dose of corticosteroids permitted as part of this 
combination is 5 mg prednisone daily or an equivalent dose and steroids must have 
been started at least 8 weeks prior to Day 1. Participants may not be receiving 
combinations of 2 or more immunosuppressants. 
Note: Stable dose is defined as no new therapy or change in standard-of-care 
therapies as above within 12 weeks of Day 1 for immunosuppressives or within 
2 weeks of Day 1 for corticosteroids, however brief fluctuations in therapy for 
toxicity are permitted (eg, holding a dose (≤7 days) or temporary reduction in 
corticosteroids of less than 3 mg/day. See Appendix 13 for allowable stable doses. 
6. Have active disease defined as:
!
SLEDAI-2K score of ≥8 points at screening and at randomization, and “Clinical” 
SLEDAI-2K score of ≥6 points at both screening and at randomization. 
!
NOTE: "Clinical" SLEDAI-2K score (See Appendix 11) is the SLEDAI-2K score 
without the inclusion of points attributable to any urine or laboratory results 
including immunologic measures. 
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a.
For inclusion in the study, the Clinical SLEDAI-2K calculation for entry will 
exclude points for:
1. Lupus Headache, 
2. Skin disease involving Cutaneous Lupus Erythematosus Disease Area and 
Severity Index (CLASI) Activity Erythema scores <2,
3. Arthritis scores must involve a minimum of 3 joints, both swollen and 
tender,
4. Mucosal ulcers which may have occurred within the previous 30 days but 
are not noted on exam and CLASI at the time of screening.
b. On the day of randomization, a minimum of 3 joints that are both swollen and 
tender is required if SLEDAI Arthritis is marked PRESENT.  The site should 
check the joint exam prior to randomization to ensure there are ≥3 joints that 
are both tender and swollen to avoid a protocol deviation.
c.
For SCREENING and ONSTUDY visits, SLEDAI arthritis SHOULD be 
scored per the glossary definitions if there are ≥2 joints with both swelling and 
tenderness noted on the joint assessment.  However, the 4 points due to 
arthritis will not be counted towards the total and clinical SLEDAI-2K scores 
required for eligibility unless ≥3 joints are both swollen and tender are 
present. The adjudicators will review the joint exam to determine if there are 
enough swollen and tender joints present at screening to meet eligibility.  
Similarly, the SLEDAI rash, alopecia and mucosal ulcers SHOULD be scored 
if present as per usual SLEDAI glossary, at all visits (even if the CLASI score 
is not ≥2). The adjudicators will review the CLASI at screening to determine 
if the patient has enough mucocutaneous disease activity for eligibility.
!
AND
BILAG Level A disease in ≥1 organ system (except renal or central nervous system 
[CNS]) or BILAG B disease in ≥2 organ systems if no level A disease is present at 
screening.  At least one A or one B level body system grade must be in the 
Mucocutaneous or Musculoskeletal systems. 
a.
For eligibility at screening and at randomization, a Mucocutaneous B due to 
BILAG #6, mild skin eruption, must have a CLASI erythema activity score 
of >=2.  
b. For eligibility at screening and at randomization, a Musculoskeletal B due to #42, 
moderate arthritis, must have ≥3 swollen, tender joints and a qualifying 
Musculoskeletal A score due to #41, severe arthritis, must show ≥6 tender, 
swollen joints on the screening joint count. (see Appendix 12).  
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c.
For SCREENING and ONSTUDY visits, BILAG moderate arthritis SHOULD be 
scored per the usual BILAG convention if ≥1 joint with swelling and tenderness is 
present on the joint assessment, (BILAG is scored for arthritis but patient does not 
meet qualifying screening activity required for musculoskeletal BILAG B if 
<3 swollen tender joints are present).  The adjudicators will review the joint exam 
to determine if there are enough swollen and tender joints present at screening to 
meet eligibility. Similarly, BILAG mucocutaneous scoring should be done as per 
usual BILAG convention at all visits, but the adjudicators with review CLASI 
scoring to ensure there is enough mucocutaneous activity at screening for 
eligibility.
Note: Data from the SLICC, SLEDAI and BILAG evaluations will be reviewed 
by the Sponsor and/or the Sponsor-selected independent reviewer(s).  For 
participants to receive their first administration of study agent, approval must be 
received by the Sponsor and/or Sponsor-selected independent reviewers.
Weight:
7. Participants weighing greater than 35 kg and less than 130 kg and with a BMI of <40.
Informed Consent:
8. Capable of giving signed informed consent as described in Appendix 1, which 
includes compliance with the requirements and restrictions listed in the ICD and in 
this protocol.
5.2. Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions
1. Active, severe lupus nephritis (World Health Organization Class III, IV) that requires 
or may require treatment with cytotoxic agents or high-dose CS are excluded. 
Participants with prior, controlled, renal disease that has been treated with an ACE or 
ARB inhibitor and immunosuppressive therapy (cyclophosphamide or mycophenolate 
mofetil) with serum creatinine ≤2× upper limit of normal (ULN) and either residual 
proteinuria up to ≤3 g/day or a urine protein/creatinine ratio (UPCR) of ≤3 mg/mg or 
339 mg/mmol are allowed if prior treatment has been demonstrated. Control of renal 
disease must be documented with at least 2 measurements of proteinuria or UPCR 
over the past 6 months. Participants with pure Type V membranous nephropathy 
must be biopsy confirmed if immunosuppressive therapy was not administered.
Pfizer clinical and adjudicators will make the final decision regarding this exclusion 
criteria. If at all possible, biopsy results confirming the diagnosis should be available 
in the participant chart.
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Note: The lab measurements related to lupus nephritis may be repeated once within 
approximately 2 weeks of the initial values, and the values resulting from repeat 
testing may be accepted for enrollment eligibility if they meet the eligibility criteria.
2. Have severe active central nervous system (CNS) lupus (eg, BILAG A neurological 
disease and/or active, poorly controlled seizure disorder, acute confusional state, 
myelitis, stroke or stroke syndrome, cerebellar ataxia or dementia related to SLE, 
active psychosis, organic brain syndrome, cerebrovascular accident [CVA], cerebritis 
or CNS vasculitis) requiring therapeutic intervention within 60 days of Day 1.  
Participants with BILAG B level neurologic disease are not excluded as long as they 
meet all other qualifying criteria for the study. 
3. Have cancer or a history of cancer within 5 years of screening (other than adequately 
resected cutaneous basal cell, squamous cell carcinoma, or carcinoma in situ of the 
uterine cervix with no evidence of recurrence within the previous 3 years).  If a 
participant is followed for a history of cancer that is considered to be treated and 
cured, a note from the oncologist or specialist following the participant for recurrence 
noting they are aware of and agree with potential participation should be available in 
the source document.  Potential participants who have an unacceptably high risk of 
tumor recurrence may be rejected by the Sponsor or their delegate.  Additionally, the 
participant is required to comply with recommended follow up testing with their 
specialist of record while participating in the study.
4. Have a history of a major organ transplant (eg, heart, lung, kidney, liver) or 
hematopoietic stem cell/marrow transplant or total lymphoid irradiation. 
5. The following is exclusionary; 
!
Any history of thrombosis (venous or arterial) or cerebrovascular ischemic event 
(stroke or transient ischemic attack [TIA]) within the last 6 months. 
!
A history of an ischemic cerebrovascular event (stroke, TIA) within the past 
12 months unless these were caused by known antiphospholipid syndrome and the 
participant has been adequately anticoagulated (and will continue on 
anticoagulation per guidelines) according to current guidelines for at least 
6 months without a recurrence of any thrombotic event.
!
Any history of a pulmonary embolus, unless these were caused by known 
antiphospholipid syndrome and the participant has been adequately anticoagulated 
(and will continue on anticoagulation per guidelines) according to current 
guidelines for at least 6 months without a recurrence of any thrombotic event.
Note: Any participant being treated for antiphospholipid syndrome or 
anticardiolipin antibodies must be adequately anticoagulated according to current 
local guidelines.  Women with a history of antiphospholipid syndrome with prior 
obstetrical loss but with no prior thrombosis do not require anticoagulation for 
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eligibility.  Sites should make every effort to obtain a medical history of at least 3 
years duration to document that there have been no thrombotic events or an 
obstetrical history of repeat fetal losses.  In the absence of this medical history 
information, a hematology consult may be required if antiphospholipid screening 
tests are positive.
6. Have acute coronary syndrome (eg, myocardial infarction, unstable angina pectoris), 
known pulmonary arterial hypertension or any history of significant cerebrovascular 
disease within 24 weeks of screening. If a previous MI (recorded on the ECG report 
as an ‘old MI’) of indeterminate age is present on the ECG and there is no known 
cardiac history, a cardiology consult may be requested.
7. Have preexisting demyelinating disorder such as multiple sclerosis, or other severe 
neurological deficits.
8. Have any autoimmune or inflammatory disease with mucocutaneous, 
musculoskeletal, renal, CNS, hematologic, or vascular manifestations that would 
interfere with interpretation of test results or clinical assessments.  This would include 
but is not limited to rheumatoid arthritis, ‘rhupus’, overlap syndromes, 
psoriasis/psoriatic arthritis, eczema, inflammatory bowel disease, any other vasculitis 
such as ANCA vasculitis, mixed connective tissue disease.  A decision about the 
suitability of the participant for enrollment will be made by the independent disease 
activity adjudicators.
9. A history of additional risk factors for torsade de pointes (TdP) (eg, heart failure 
[New York Heart Association status of class III or IV], hypokalemia, family history 
of Long QT Syndrome).
10. A participant with any condition possibly affecting oral drug absorption, 
eg, gastrectomy, clinically significant diabetic gastroenteropathy, or certain types of 
bariatric surgery such as gastric bypass.  Procedures such as gastric banding or gastric 
sleeve procedure without a bypass surgery, that simply divide the stomach into 
separate chambers, are NOT exclusionary.
11. Have active fibromyalgia/myofascial/chronic pain that, in the investigator’s opinion, 
would make it difficult to appropriately assess SLE activity for the purposes of this 
study.
12. Other acute or chronic medical or psychiatric condition including recent (within the 
past year) or active suicidal ideation (defined in Section 8.2.10) or behavior or 
laboratory abnormality that may increase the risk associated with study participation 
or study intervention administration or may interfere with the interpretation of study 
results and, in the judgment of the investigator or sponsor, would make the participant 
inappropriate for entry into this study.  Prior splenectomy is prohibited.
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Prior/Concurrent Clinical Study Experience:
13. Participation in other interventional studies within 12 weeks or 5 half-lives, if known, 
whichever is longer, prior to study entry and/or during study participation.  
Participation in any observational studies during study participation which would 
require a participant to provide any study specific information including but not 
limited to the following: sponsor name of the study in which they are participating, 
the name of the study intervention, the indication being studied. 
Note any investigational or experimental therapy or procedure for SLE must be 
discontinued for at least 12 weeks prior to Day 1. 
Prior/Concomitant Therapy.
Please refer to Appendix 13: List of Prohibited and Permitted Concomitant Medications. 
14. The following use of corticosteroids is exclusionary;  
!
Receiving >20 mg/ day of prednisone or equivalent (see Appendix 14) or have 
adjusted the dose of corticosteroids (with the exception of brief fluctuations; see 
Inclusion Criteria #5) within 2 weeks of Day 1.
!
Have received oral or parenteral [intravenous (IV) or intramuscular (IM)] 
corticosteroids at doses >40-mg per day of prednisone (or equivalent see 
Appendix 14) within 8 weeks of Day 1, or are anticipated to require parenteral 
injection of corticosteroids during the study.
!
Have had a joint injected with intra-articular corticosteroids or hyaluronic acid 
within 4 weeks of Day 1.
!
Have received topical corticosteroids, (except for, corticosteroids that are 
inactivated by first- pass in the liver [for example mometasone, fluticasone, 
budesonide or beclomethasone]) other than stable doses of class 6 (mild, such as 
desonide) or class 7 (least potent, such as hydrocortisone), within 4 weeks of 
Day 1.
15. Have started or stopped treatment or adjusted the dose of antimalarials within 
12 weeks of Day 1. 
16. Have started or stopped treatment with an accepted standard of care 
immunosuppressant (azathioprine/6-mercaptopurine, methotrexate, leflunomide, 
mizoribine or mycophenolate) within 12 weeks of Day 1. The dose of 
immunosuppressants should be as stable as possible within 12 weeks of Day 1 and 
should only be changed for toxicity documented in the source document. No changes 
in the dose of immunosuppressants are acceptable within 4 weeks of Day 1. Please 
see Appendix 13 for acceptable doses.
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17. Additional immunomodulatory drug exclusions see Appendix 13 for details:
!
No systemic calcineurin inhibitors within 12 weeks of Day 1. Topical creams and 
ointments must be discontinued within 4 weeks of Day 1.  Optic calcineurin 
(eye drops) are permitted on study. 
!
No cyclophosphamide or chlorambucil use within 24 weeks of Day 1.
!
No anti-tumor necrosis factor (anti-TNF) inhibitors (adalimumab, etanercept, 
infliximab, certolizumab, golimumab), anakinra or belimumab within 12 weeks of 
Day 1.
!
No tocilizumab, ustekinumab, or abatacept within 24 weeks of Day 1.
!
No rituximab, or investigational B cell targeted therapies within 24 weeks of 
Day 1.
!
No investigational or approved biologic therapies within 12 weeks of Day 1.
!
No history of hydroxyurea treatment.
!
No history of prior treatment with any lymphoid depleting therapy (Campath, 
anti-CD3, Lemtrada, alemtuzumab, total lymphoid irradiation).
!
No sulfasalazine within 12 weeks of Day 1.
18. Have received plasmapheresis within 12 weeks of screening or intravenous 
immunoglobulin (IVIg) within 24 weeks of screening.
19. Any prior treatment with an approved or investigational JAK inhibitor (ie, tofacitinib, 
baricitinib, filgotinib, upadacitinib) 
20. Treatment with any non-biologic investigational drug(s) including non-JAK kinase 
inhibitors, within 12 weeks of Day 1 or within 5 half-lives, if known, whichever is 
longer, and/or during study participation.
21. Has been exposed to a live vaccine within 8 weeks of Day 1 or are expected to 
need/receive a live vaccine during the course of the study (with the exception of 
herpes zoster vaccination- refer to EC #27 below). Participants should not have 
received a Bacillus Calmette-Guérin (BCG) vaccination within 52 weeks of 
randomization.
22. Use of concomitant medications known to prolong the QT interval (see
Appendix 13). 
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Please note that Appendix 13 does not provide an exhaustive list of such medications.  
If you have concerns that a concomitant medication may present a risk of QT 
prolongation please discuss this directly with the Pfizer Clinical Team.  
23. Require concomitant treatment with prohibited concomitant medications (see 
Appendix 13).  
24. Use of filgrastim, pegfilgrastim, erythropoietin or other bone marrow stimulants to 
improve cell counts within 12-weeks of screening.
Infection
25. Active bacterial, viral, fungal, mycobacterial or other infections (including but not 
limited to tuberculosis [TB] and atypical mycobacterial disease, allergic aspergillosis 
or cavitary lung lesions or granulomatous disease on chest x-ray).  History of 
recurrent bacterial, viral, fungal, mycobacterial or other infections (including but not 
limited to TB and atypical mycobacterial disease, granulomatous disease on chest 
x-ray) that would substantially increase the risk to the participant if he or she 
participates in the study. 
26. Have a history of any lymphoproliferative disorder such as Epstein-Barr virus (EBV) 
related lymphoproliferative disorder, history of lymphoma, leukemia, or signs and 
symptoms suggestive of lymphoproliferative disease, including lymphadenopathy or 
splenomegaly (other than primarily due to SLE).
27. Have a history (single episode) of disseminated herpes zoster or disseminated herpes 
simplex, or recurrent (more than 1 episode within last 5 years) localized, dermatomal 
herpes zoster.
Note: All participants who have not received the herpes zoster vaccine at screening 
will be encouraged (per local guidelines) to do so prior to randomization; vaccination 
must occur >4 weeks prior to randomization and start of study intervention.  
Participants will be excluded if they were exposed to live herpes zoster vaccination
(Zostavax®, Merck) within 4 weeks of planned randomization; the recombinant 
adjuvant herpes zoster vaccine (Shingrix®, GSK) is permitted prior to and on study.
28. Known history of human immunodeficiency virus (HIV) based on documented 
history with positive test, or positive HIV test at screening. 
Note: a documented negative HIV test within 12 weeks prior to screening is 
acceptable and does not need to be repeated. 
29. Have evidence of clinically significant active or latent infection of hepatitis B or 
hepatitis C based on screening tests (see Section 8.2.5). 
30. Have clinically relevant finding on a chest radiograph (or other diagnostic imaging 
study such as computed tomography [CT] or magnetic resonance imaging [MRI]with 
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pre-approval from Pfizer Clinical) such as the presence of TB, general infection, heart 
failure or malignancy.  Findings due to SLE activity do not require the participant to 
be excluded.
31. Have required management of acute or chronic infections as follows:
!
Currently on any suppressive therapy for any chronic infection (such as 
pneumocystis, cytomegalovirus [CMV], and atypical mycobacteria, herpes 
simplex) that, in the opinion of the investigator and sponsor, would place the 
participant at risk for reactivation.  Participants receiving prophylactic therapy for 
prior outbreaks of herpes simplex virus may be enrolled with the expectation that 
this treatment will continue for the duration of the study. Participants who have no 
prior pneumocystis carinii infections may be allowed to enroll if they are 
receiving prophylaxis for pneumocystis if they obtain permission from Pfizer 
Clinical.
!
Hospitalization for treatment of serious infections within 60 days of Day 1.
!
Use of IV or IM antibacterials, antivirals, antifungals, or anti-parasitic agents 
within 60 days of Day 1.  Substitution of IM agents for oral agents because of 
gastrointestinal (GI) intolerance may be acceptable, as long as it does not 
otherwise meet the criteria for a serious infection (requires hospitalization or use
of other IV antibiotics). 
!
Use of oral antibiotics to treat an active infection within 14 days of Day 1.
32. Have evidence of untreated or inadequately treated latent Mycobacterium 
tuberculosis (TB) infection as evidenced by any of the following:
a.
Currently have active TB
b. Have a past history of active TB.
c.
Have history of latent TB and completed latent TB treatment prior to screening.
If a participant has been diagnosed with latent TB prior to screening and is currently 
receiving treatment for latent TB during the screening period, the participant may be 
eligible for the study ONLY if the participant is seen by a pulmonary or infectious 
disease consultant and confirmed to have no findings of active TB AND if the 
consultant agrees that the participant’s latent TB can be adequately treated with INH 
and B6.  The consultant will need to check the incidence of multidrug resistant TB 
locally to ensure that INH and B6 treatment is in the participant's best interest if the 
participant randomizes into the study. Documentation of when the participant’s
treatment began and how latent TB was diagnosed must be available in the source 
document.  These participants should be discussed with Pfizer clinical prior to
screening. The participant must agree to complete a course of INH and B6 during the 
study.
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An interferon gamma release assay (IGRA) test performed at or within the 12 weeks 
prior to Day 1 is required; a negative test or immediate commencement of treatment 
for latent TB with INH/vitamin B6 is also required for eligibility.  The following are 
acceptable IGRA assays: 
!
T-SPOT® TB test;
!
QuantiFERON® - TB Gold In-Tube test (QFT-GIT);
!
QuantiFERON® - TB Gold test (QFT-G);
!
QuantiFERON® - TB Gold Plus test (QFT-G Plus).
NOTE: A Mantoux skin test is not an acceptable test in this study and an IGRA must 
be performed.  An initial IGRA should be performed at the central laboratory so that 
at least one set of results will be available in the Pfizer database. If another test is 
required, it may be performed locally, and a T-SPOT® TB test (if available) would be 
preferred to another QuantiFERON® test.
If the results of the IGRA are: 
!
Negative, enrollment may proceed.
!
Indeterminate, the test must be repeated; a different IGRA test should performed 
(eg, T-SPOT®, if available) for the repeat test. If the repeat IGRA test result is: 
!
Indeterminant, participants may be enrolled after consultation with an 
infectious disease and/or pulmonary specialist indicating active TB is not 
present, the English translation of the specialist report must be provided to the 
Sponsor and the Sponsor must agree with enrollment. 
!
Positive: the participant must be seen by an infectious disease and/or pulmonary 
specialist who will review any radiographic and diagnostic studies (including
chest CT scan, chest x-rays or chest MRIs), the interferon gamma release assay 
results, participant history, and any other pertinent information to determine 
whether the participant has latent or active TB, or any other active, chronic or 
latent disease in the chest including infection other than TB,  malignancy or other 
clinically significant cardiovascular and/or pulmonary disease;
If the infectious disease and/or pulmonary specialist diagnoses:
!
Active TB or other active or uncontrolled clinically significant pulmonary 
disease, the participant is not eligible.
!
Latent TB, the infectious disease and/or pulmonary specialist will recommend a 
treatment for latent TB aligned with the participant’s best interest and local 
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standard of care. The local incidence of multi-drug resistant TB should be 
considered in determining how the participant is treated. 
!
Once the infectious disease and/or pulmonary specialist report has been 
obtained, the sponsor must receive an English translation of the specialist 
report and the local incidence rate of multi-drug resistant TB for review. If the 
specialist recommends INH and vitamin B6 therapy as adequate treatment for 
latent TB for the prospective participant, the participant must agree to 
continue therapy during the study to completion of the course of treatment for 
latent TB per the local guidelines. If the participant agrees and is compliant, 
the participant may be eligible for the study if all other eligibility criteria are 
met.
!
The only therapy acceptable for on-study treatment of latent TB is isoniazid 
(INH) plus vitamin B6.
Diagnostic Assessments:
33. Have a Chest radiograph (ie, chest x-ray or other appropriate diagnostic imaging such 
as computed tomography or MRI) taken at screening with changes suggestive of any 
active infection, prior untreated TB, heart failure, suspected malignancy, or any other 
clinically significant disease in the chest. A CT scan or chest x-ray performed within 
12 weeks of expected randomization may be used.
If a chest CT shows any abnormalities (nodules, infiltrates, scarring, stranding, etc), 
these must be documented to be stable compared to a prior chest radiograph obtained 
at least 12 months previously. 
34. Screening 12 lead electrocardiogram (ECG) that demonstrates clinically significant 
abnormalities requiring treatment (eg, acute myocardial infarction, serious tachy or 
bradyarrhythmias) or that are indicative of serious underlying heart disease 
(eg, cardiomyopathy, major congenital heart disease, low voltage in all leads, Wolff 
Parkinson White syndrome) and other clinically relevant abnormalities which may 
affect participant safety or interpretation of study results.  Specifically, participant 
with screening Fredericia corrected QT interval (QTcF) >450 milliseconds (msec) 
should be excluded.  If QTcF exceeds 450 msec, the ECG should be repeated two 
more times and the average of the three QTcF should be used to determine the 
participant eligibility.
35. Participants with ANY of the following abnormalities in clinical laboratory tests at 
Screening, as assessed by the study specific laboratory and confirmed by a single 
repeat, if deemed necessary: 
!
IgG levels below lower limits of normal;
!
Hemoglobin <9 g/dL (<90 g/L); 
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!
Absolute neutrophil count (ANC) <1.2 x 109/L (<1200 mm3); 
!
Absolute lymphocyte count (ALC) of <0.75 x 109/L (<750/mm3); Note: 
Participants may be enrolled with an ALC <0.75 x 109/L but ≥0.5 x 109/L if the 
ALC is considered by the investigator to be a result of the underlying SLE disease 
or concomitant medications;
!
Platelet count <75 x 109/L (<75,000/mm3); 
!
Serum cystatin C-based estimated glomerular filtration rate (eGFR) 
<50 mL/min/1.73 m2 based on the age appropriate calculation; 
!
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values 
≥2 times the ULN; 
!
Total bilirubin ≥1.5 times the ULN; participants with a history of Gilbert's 
syndrome may have a direct bilirubin measured and would be eligible for this 
study provided the direct bilirubin is < ULN; 
!
Creatine kinase (CK) >3 times the ULN and positive urine myoglobin.
Note: Screening laboratory tests with abnormal results may be repeated once to 
confirm abnormal results within the 7-week screening period.  If results return to 
normal within the 7-week screening period, the participant may enter the study.
Other Exclusionary Criteria: 
36. Investigator site staff members directly involved in the conduct of the study and their 
family members, site staff members otherwise supervised by the investigator, or 
Pfizer employees, including their family members, directly involved in the conduct of 
the study. 
37. Have a history of severe allergic or anaphylactoid reaction to kinase inhibitors.
38. Have had significant trauma or major surgery or blood transfusion within 4 weeks of 
screening, or scheduled to occur during the study, excluding diagnostic surgery.
39. History of alcohol or drug abuse in investigator’s opinion unless in full remission for 
greater than 12 months prior to first dose of study intervention.
40. Participants who are currently vaping or using e-cigarettes. 
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5.2.1. Randomization Criteria 
Participants enrolled in the study will be randomly assigned to a treatment group provided 
they have satisfied all of the participant eligibility criteria.  Participants in this study will be 
stratified based on two factors:
!
Screening disease severity (Adjudicated total SLEDAI-2K score <10 versus ≥10).
 
The use of stratification is to facilitate the investigation of the potential impact (if any) of the 
two stratification factors on efficacy including the participants screening disease severity 
(SLEDAI score <10 versus ≥10).  A computer-generated randomization schedule will be 
used to assign participants to the treatment groups using an interactive response technology 
(IRT) system. 
5.3. Lifestyle Considerations
5.3.1. Contraception
Participants must understand that they should avoid becoming pregnant during this study.  
The investigator or his or her designee, in consultation with the participant, will confirm that 
the participant has selected a protocol permitted method of contraception from the permitted 
list of contraception methods (see Appendix 4) and will confirm that the participant has been 
instructed in its consistent and correct use.  The method of contraception used by the 
participant should be provided in the source document. At all visits, the investigator or 
designee will inform the participant of the need to use highly effective contraception 
consistently and correctly and document the conversation and the participant’s affirmation in 
the participant’s chart (participants need to affirm their consistent and correct use of at least 
1 of the selected methods of contraception).  In addition, the investigator or designee will 
instruct the participant to call immediately if the selected contraception method is 
discontinued or if pregnancy is known or suspected in the participant or partner.
5.3.2. Surgery
During the study, no elective surgery should occur without first consulting with the sponsor.  
Preferably, elective surgery should occur before the study or be delayed until participation in 
the study is completed. 
The sponsor should be notified if a participant requires surgery (including dental surgery) 
during the study to determine whether the participant should discontinue from the study 
and/or discontinue the study intervention prior to the surgical procedure.  In general, planned 
surgical procedures should not be performed unless the study intervention has been 
discontinued for at least 2 days (unless otherwise advised by the sponsor).  In addition, the 
sponsor should be notified as soon as possible if a participant undergoes a surgical procedure 
without first informing the study staff.
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5.3.3. Meals and Dietary Restrictions
Participants should refrain from all food and liquids (water and medications are permitted) 
for a minimum fast of 8 hours prior to the designated study visit days when a lipid profile 
panel is scheduled (see Schedule of Activities).  Fasting is not required for safety laboratory 
tests or PK sampling when a lipid profile panel is not being performed. 
Diabetics who are taking antidiabetic medications or participants who cannot reasonably 
tolerate an 8-12 hour fast should not eat immediately prior to the visit as far as possible.
In addition, it is recommended that participants not smoke (or use any tobacco products) or 
ingest caffeine on study visit days during the 30 minutes prior to blood pressure (BP) and 
heart rate (pulse) measurements. 
5.3.4. Other Requirements
In order to participate in the study, participants must be made aware of the following lifestyle
guidelines and restrictions that apply during and after the study period.  Details of these 
lifestyle guidelines are provided in the sections as noted. 
!
Agree to avoid strenuous exercise on the day of a scheduled study visit and maintain 
adequate hydration, if possible.
!
If enrolled with latent TB, must agree to remain compliant with INH and vitamin B6 
therapy to completion of a course of latent TB treatment.
!
On study visit days, take prescribed permitted concomitant medication, as needed, 
prior to the study visit, if it can be administered with water only.
!
Must agree to avoid prolonged exposure to the sun and avoid use of tanning booths or 
other ultraviolet light sources during the study.
!
Contact the study site investigator if there are any changes or additions to 
concomitant medications.
!
All participants who are randomized should be encouraged to remain in the study 
through to the end of the double-blind period for safety and efficacy assessments, 
whether or not they continue to receive study intervention or are switched to 
non-protocol treatment; this is in order to reduce missing data as much as possible.  It 
is expected that the only reasons for which a participant will withdraw from the study 
will be for withdrawal of consent or lost to follow-up. This was specifically 
requested by a regulatory authority to minimize missing data in participants who 
prematurely discontinue study intervention.
5.4. Screen Failures
Screen failures are defined as participants who consent to participate in the clinical study but 
are not subsequently entered in the study.  A minimal set of screen failure information is 
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required to ensure transparent reporting of screen failure participants to meet the 
Consolidated Standards of Reporting Trials (CONSORT) publishing requirements and to 
respond to queries from regulatory authorities.  Minimal information includes demography, 
screen failure details, eligibility criteria, and any serious adverse event (SAE).
Participants who do not meet the eligibility criteria (screen failure was determined) may be 
re-screened once at a later date (must be at least ≥2 weeks after screening failure is 
determined to initiate any re-screening procedures).  Any participant who is re-screened must 
be re-consented and receive a new participant number.  All activities required for the 
screening visit must be repeated with the exception of CXR, IGRA and HIV test which do 
not need to be reobtained if they have been obtained within the protocol defined time period 
(12 weeks). 
6. STUDY INTERVENTION
Study intervention is defined as any investigational intervention(s), marketed product(s), 
placebo, or medical device(s) intended to be administered to a study participant according to 
the study protocol.
For the purposes of this protocol, the term study intervention may be used synonymously 
with study intervention.
6.1. Study Intervention(s) Administered
Blinded PF-06700841 tablets and matching placebo will be provided as tablets for oral 
administration.  The PF-06700841, 5 mg and 25 mg tablets and their matching placebos will 
be supplied in blisters and labeled according to local regulatory requirements.
6.1.1. Administration
Study intervention will be self-administered by oral administration.  Participants will 
swallow the study intervention whole, and will not manipulate or chew the study intervention 
prior to swallowing. 
Participants will be encouraged to take the study intervention in the morning after breakfast 
whenever possible; however, the study intervention may be taken with or without food.  On 
study visit days during the treatment period, participants should be instructed to refrain from 
dosing at home, and are instructed to take the study intervention at the investigator site.  On 
study visit days requiring a scheduled lipid panel evaluation, participants should refrain from 
all food and liquids (water and medications are permitted) for a minimum fast of 8 hours 
prior to the study visit.
Participants interrupting study intervention for more than 14 days should be discussed with 
the sponsor for possible withdrawal from the study.
Any temporary hold on dosing of the study intervention during the study should be recorded 
in the case report form (CRF). 
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6.2. Preparation/Handling/Storage/Accountability
1. The investigator or designee must confirm appropriate temperature conditions have 
been maintained during transit for all study interventions received and any 
discrepancies are reported and resolved before use of the study intervention, as 
applicable for temperature-monitored shipments. 
2. Only participants enrolled in the study may receive study intervention and only 
authorized site staff may supply or administer study intervention.  All study 
interventions must be stored in a secure, environmentally controlled, and monitored 
(manual or automated recording) area in accordance with the labeled storage 
conditions with access limited to the investigator and authorized site staff.  At a 
minimum, daily minimum and maximum temperatures for all site storage locations 
must be documented and available upon request.  Data for nonworking days must 
indicate the minimum and maximum temperature since previously documented for all 
site storage locations upon return to business.
3. The investigator, institution, or the head of the medical institution (where applicable) 
is responsible for study intervention accountability, reconciliation, and record 
maintenance (ie, receipt, reconciliation, and final disposition records).  All study 
interventions will be accounted for using a study intervention accountability 
form/record.  
4. Further guidance and information for the final disposition of unused study 
interventions are provided in the IP manual.
5. Any storage conditions stated in the SRSD will be superseded by the storage 
conditions stated on the product label. 
6. Study interventions should be stored in their original containers and in accordance 
with the labels. 
7. Site staff will instruct participants on the proper storage requirements for take-home 
study intervention. 
8. Any excursions from the study intervention label storage conditions should be 
reported to Pfizer upon discovery along with any actions taken.  The site should 
actively pursue options for returning the study intervention to the storage conditions 
described in the labeling, as soon as possible.  Once an excursion is identified, the 
study intervention must be quarantined and not used until Pfizer provides permission 
to use the study intervention.  It will not be considered a protocol deviation if Pfizer 
approves the use of the study intervention after the temperature excursion. Use of the 
study intervention prior to Pfizer approval will be considered a protocol deviation. 
Specific details regarding the definition of an excursion and information the site 
should report for each excursion will be provided to the site in the IP manual. 
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9. The sponsor or designee will provide guidance on the destruction of unused study 
intervention (eg, at the site).  If destruction is authorized to take place at the 
investigator site, the investigator must ensure that the materials are destroyed in 
compliance with applicable environmental regulations, institutional policy, and any 
special instructions provided by Pfizer, and all destruction must be adequately 
documented.
Additional details about accountability, storage, destruction, and excursion reporting can be 
found in the IP manual.
6.2.1. Preparation and Dispensing
The study intervention will be dispensed using an IRT drug management system at each visit 
from Visit 2 to Visit 16.  A qualified staff member will dispense the study intervention via 
unique container numbers in the blister cards provided, in quantities appropriate for the study 
visit schedule.  The participant/caregiver should be instructed to maintain the product in the 
blister cards provided throughout the course of dosing and return the blister cards to the site 
at the next study visit.
6.3. Measures to Minimize Bias: Randomization and Blinding
6.3.1. Allocation to Study Intervention
Allocation of participants to treatment groups will proceed through the use of an interactive 
response technology (IRT) system (interactive web-based response [IWR]).  The site 
personnel (study coordinator or specified designee) will be required to enter or select 
information including but not limited to the user’s identification (ID) and password, the 
protocol number, and the participant number.  The site personnel will then be provided with a 
treatment assignment, randomization number, and dispensable unit (DU) or container number 
when study intervention is being supplied via the IRT system.  The IRT system will provide 
a confirmation report containing the participant number, randomization number, and DU or 
container number assigned.  The confirmation report must be stored in the site’s files. 
Study intervention will be dispensed at the study visits summarized in the Schedule of 
Activities. 
Returned study intervention must not be redispensed to the participants.
The study-specific IRT reference manual and IP manual will provide the contact information 
and further details on the use of the IRT system.
Participants will be assigned to receive study intervention according to randomization 
scheme.  Investigators will remain blinded to each participant’s assigned study intervention 
throughout the course of the study.  
6.3.2. Breaking the Blind
The IRT will be programmed with blind-breaking instructions.  In case of an emergency, the 
investigator has the sole responsibility for determining if unblinding of a participant’s 
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treatment assignment is warranted.  Participant safety must always be the first consideration 
in making such a determination.  If the investigator decides that unblinding is warranted, the 
investigator should make every effort to contact the sponsor prior to unblinding a 
participant’s treatment assignment unless this could delay further management of the 
participant.  If a participant’s treatment assignment is unblinded, the sponsor must be notified 
within 24 hours after breaking the blind.  The date and reason that the blind was broken must 
be recorded in the source documentation and case report form (CRF)/data collection tool 
(DCT).
The study-specific IRT reference manual and IP manual will provide the contact information 
and further details on the use of the IRT system.
6.4. Study Intervention Compliance
Study intervention will be self-administered by oral administration.  Participant compliance 
will be monitored by the appropriately designated study staff by the accounting of unused 
study intervention returned by the participant at study visits. 
Participants will be directed to bring blister cards with any remaining study intervention to 
study visits for review.  Compliance with expected consumption of dispensed study 
intervention will be assessed by comparing the expected number of doses to be taken to the 
number of doses returned (tablet count) during any given time period.  Compliance will be 
documented on the CRF and in the source records. 
If compliance is <80%, or >120%, the investigator or designee will counsel the participant 
and ensure steps are taken to improve compliance. If compliance is outside these limits,
Pfizer clinical should be contacted as soon as possible to determine if the participant should 
discontinue study medication due to non-compliance and if any additional safety assessments 
are needed. Participants interrupting study intervention for more than 14 days, should be 
discussed with the sponsor for possible withdrawal from the study.
The investigator has the discretion to withdraw any participant from the study for reasons of 
non-compliance with the dosing regimen.  Participants who are non-compliant with 
scheduled study visits or with study intervention should still be encouraged to return for all 
scheduled study visits.  Inventory control of all study intervention must be rigorously 
maintained throughout the duration of the study until all study intervention has been 
accounted for and/or returned to the sponsor (or appointed agent).  Any discrepancies noted 
between drug dispensing records and drug inventory must be reported to the sponsor.
6.5. Concomitant Therapy
Prohibited drugs must be discontinued according to protocol guidelines; a list of prohibited 
drugs with specific discontinuation recommendations is listed in Appendix 13. 
Participants taking certain medications for SLE, and deriving inadequate benefit from them, 
may enter the study after a sufficient washout period for that medication.  All biologic 
disease modifying anti-rheumatic drugs (DMARDs) are prohibited.  Non-biologic DMARDs 
other than those listed in Appendix 13 are prohibited.  
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6.5.1. Corticosteroids
6.5.1.1. Use of Corticosteroids and Tapering Guidelines
Participants are allowed to receive a stable dose of oral corticosteroids at study entry as 
described in Section 4 and over the treatment period as described below.  A detailed history 
of corticosteroid use will be collected at screening.  
Participants may be given supplemental (ie, in addition to the stable dose) oral corticosteroids 
at baseline through Week 4 to control SLE disease activity.  The maximum additional dose 
allowed is 10 mg per day above the Day 1 dose level, for a maximum of 14 days after which 
the previous dose must be resumed.  
A single intramuscular IM dose of methylprednisolone (Depo-Medrol) 60 mg (or equivalent 
see Appendix 14) administered as 1 injection can be substituted for the oral corticosteroid 
allowed increase described above through Week 4 to control SLE disease activity.  The 
baseline oral corticosteroid dose must not be modified in participants who receive IM 
corticosteroids. 
To minimize potential long term side effects (including infection risk), PIs are required to 
decrease corticosteroids to the lowest safely tolerated dose when appropriate.  The tapering 
goal for prednisone (or equivalent see Appendix 14) is 7.5 mg per day or less by the end of 
the two tapering windows (Week 12 and Week 40), however the corticosteroid tapering 
schedule is flexible and at the discretion of individual PIs based on participants’ clinical signs 
and symptoms.  Corticosteroid tapering is allowed only during Weeks 2-12 and 
Weeks 24-40. 
The decision to initiate or intensify corticosteroid therapy should be carefully considered by 
the investigator, and depends on various factors, including the severity of the participants’ 
symptoms and type of organ involvement.  However, an important outcome in this study will 
be whether or not PF-06700841 permits tapering of corticosteroid use beyond tapering 
achieved with background therapy alone. In order to maximize the ability to detect a 
difference in corticosteroid use across arms in this study, beginning at Week 2 and 
continuing through Week 12, and again during Weeks 24-40, steroid tapering to an oral 
corticosteroid (OCS) dose of ≤7.5 mg/day is required in all participants when appropriate. 
The following guidance must be adhered to for steroid tapering:
1. Do not need to taper steroids if the participant has new, worsening, still active SLE 
disease activity and meets any of the below criteria:
!
SLEDAI-2K activity which is worsened compared to baseline in major organ 
systems (renal, CNS, cardiopulmonary, vasculitis, fever, thrombocytopenia, or 
haemolytic anaemia, or gastrointestinal activity).
!
BILAG – any new BILAG A or B.
!
Moderate to severe skin disease as reflected by a CLASI activity score of ≥10.
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2. Steroids MUST be tapered if the participating meets the following criteria:
!
The total SLEDAI score decreases by 4 points from baseline; AND
!
There is no new BILAG A or B.
3. Participants that do not meet the criteria in one or two of the scenarios above, must 
attempt to taper at the investigator's discretion.
For participants who have tapered during Weeks 2-12 and Weeks 24-40, the dose may be 
increased once during each of the 2 taper windows to a maximum dose of 20 mg/day 
(prednisone equivalent see Appendix 14) for a maximum of 14 days, after which the previous 
dose must be resumed.  
Between Weeks 12-24, steroid doses should remain as stable as possible.  No change in 
steroid dosing, either up or down, is allowed between Week 40-Week 52. In addition, any 
time prior to Week 28, if the dose of oral corticosteroids exceeds 30 mg/day, this should be 
discussed with the medical monitor and may result in discontinuation of study intervention.
6.5.1.2. Record of Corticosteroids 
Participants will be required to follow the corticosteroid dosing guidelines during the 
treatment period of the study.  The investigator/site staff will review the participants 
corticosteroid use at each study visit and record in the participant’s CRF.  It is recommended 
that corticosteroids be tapered as quickly as clinically feasible.  No change in steroid dosing 
is allowed between Weeks 12-24 and Weeks 40-52.  For concomitant use of corticosteroids 
for hypersensitivity reactions, insect bites or asthmatic exacerbations see Appendix 13. 
In addition, the intake of oral corticosteroids taken by the participants during the study will 
be captured on a separate CRF.  The CRF page will capture the name of the corticosteroid 
taken, indication for use, total daily dose, route of administration, and start date and stop 
dates of administration.
6.5.1.3. Management of Severe Flare and/or Worsening of Disease 
During the treatment period, those participants who experience a severe flare requiring new 
or increased doses of immunosuppressants (including new or increased doses of 
corticosteroids beyond that outlined in Appendix 13: List of Prohibited and Permitted 
Concomitant Medications) or hospitalization, or worsening of disease requiring new or 
increased doses of immunosuppressants or hospitalization, will be discontinued from 
treatment, and will receive no further study intervention. 
In addition, those participants who require oral corticosteroid doses greater than 15 mg/day 
prednisone (or equivalent see Appendix 14) at or after the Week 28 visit will be discontinued 
from treatment at that time point, other than those participants undergoing tapering and who 
receive the allowed single increase in corticosteroids (Section 6.5.1.1).  
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All participants who prematurely discontinue study intervention are encouraged to maintain 
consent and continue on with the study through Week 56 to minimize missing data.  
Participants who are not willing to remain on study should undergo early withdrawal 
procedures outlined in the Schedule of Activities. 
6.6. Dose Modification 
Not applicable.
6.7. Intervention After the End of the Study
No intervention will be provided to study participants at the end of the study.
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL
7.1. Discontinuation of Study Intervention
For participant withdrawal/early withdrawal procedures (including post-withdrawal visit 
procedures) see Schedule of Activities and Section 8.
In order to minimize missing data, health authorities have requested that all participants that 
discontinue study intervention early, should continue with all scheduled study visits unless 
they withdraw consent.
For Guidelines for Monitoring and Discontinuations refer to Appendix 17.
Note that discontinuation of study intervention does not represent withdrawal from the study.
7.1.1. Temporary Discontinuation
Participants interrupting study intervention for more than 14 days, should be discussed with 
the sponsor for possible withdrawal from the study.
7.1.2. Rechallenge
Not applicable.
7.2. Participant Discontinuation/Withdrawal From the Study 
A participant may withdraw from the study at any time at his/her own request, or may be 
withdrawn at any time at the discretion of the investigator for safety, behavioral, compliance, 
or administrative reasons.
At the time of discontinuing from the study, Schedule of Activities for assessments and for 
any further evaluations that need to be completed. 
All participants who prematurely discontinue study intervention based on criteria outlined in 
the protocol are encouraged to maintain consent and continue on with the study through 
Week 56. Participants who are not willing to remain on study should undergo early 
withdrawal procedures outlined in the Schedule of Activities. 
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The early discontinuation visit applies only to participants who are randomized and then are 
prematurely withdrawn from the study.  The participant will be permanently discontinued 
both from the study intervention and from the study at that time.
If a participant withdraws from the study, he/she may request destruction of any remaining 
samples, but data already generated from the samples will continue to be available, and may 
be used to protect the integrity of existing analyses.  The investigator must document any 
such requests in the site study records.
If the participant withdraws from the study and also withdraws consent (see below) for 
disclosure of future information, no further evaluations should be performed and no 
additional data should be collected.  The sponsor may retain and continue to use any data 
collected before such withdrawal of consent.
When a participant withdraws from the study because of an SAE, the SAE must be recorded 
on the CRF and reported on the Clinical Trial (CT) SAE Report.
Lack of completion of all or any of the withdrawal/early termination procedures will not be 
viewed as protocol deviations so long as the participant’s safety was preserved.
Withdrawal of Consent: 
Participants who request to discontinue receipt of study intervention will remain in the study 
throughout Week 56 and must continue to be followed for protocol-specified follow-up 
procedures.  The only exception to this is when a participant specifically withdraws consent 
for any further contact with him or her or persons previously authorized by the participant to 
provide this information.  The withdrawal of consent should be explained in detail in the 
medical records by the investigator, as to whether the withdrawal is only from further receipt 
of study intervention or also from study procedures and/or posttreatment study follow-up, 
and entered on the appropriate CRF page.  In the event that vital status (whether the 
participant is alive or dead) is being measured, publicly available information should be used 
to determine vital status only as appropriately directed in accordance with local law.
7.3. Lost to Follow-up 
A participant will be considered lost to follow-up if he or she repeatedly fails to return for 
scheduled visits and is unable to be contacted by the study site.
The following actions must be taken if a participant fails to return to the clinic for a required 
study visit:
!
The site must attempt to contact the participant and reschedule the missed visit as 
soon as possible and counsel the participant on the importance of maintaining the 
assigned visit schedule and ascertain whether or not the participant wishes to and/or 
should continue in the study;
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!
Before a participant is deemed lost to follow-up, the investigator or designee must 
make every effort to regain contact with the participant (where possible, 3 telephone 
calls and, if necessary, a certified letter to the participant’s last known mailing 
address or local equivalent methods).  These contact attempts should be documented 
in the participant’s medical record;
!
Should the participant continue to be unreachable, he/she will be considered to have 
withdrawn from the study. 
Discontinuation of specific sites or of the study as a whole is handled as part of Appendix 1.
8. STUDY ASSESSMENTS AND PROCEDURES
The investigator (or an appropriate delegate at the investigator site) must obtain a signed and 
dated ICD before performing any study-specific procedures.  
Study procedures and their timing are summarized in the Schedule of Activities. Protocol
waivers or exemptions are not allowed.
Immediate safety concerns should be discussed with the sponsor immediately upon 
occurrence or awareness to determine if the participant should continue or discontinue study 
intervention.
Adherence to the study design requirements, including those specified in the Schedule of 
Activities, is essential and required for study conduct.
All screening evaluations must be completed and reviewed to confirm that potential 
participants meet all eligibility criteria.  The investigator will maintain a screening log to 
record details of all participants screened and to confirm eligibility or record reasons for 
screening failure, as applicable.
Procedures conducted as part of the participant’s routine clinical management (eg, blood 
count) and obtained before signing of the ICD may be utilized for screening or baseline 
purposes provided the procedures met the protocol-specified criteria and were performed 
within the time frame defined in the Schedule of Activities.
Every effort should be made to ensure that protocol-required tests and procedures are 
completed as described.  However, it is anticipated that from time to time there may be 
circumstances outside the control of the investigator that may make it unfeasible to perform 
the test.  In these cases, the investigator must take all steps necessary to ensure the safety and 
well-being of the participant.  When a protocol-required test cannot be performed, the 
investigator will document the reason for the missed test and any corrective and preventive 
actions that he or she has taken to ensure that required processes are adhered to as soon as 
possible.  The study team must be informed of these incidents in a timely manner.
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For samples being collected and shipped, detailed collection, processing, storage, and 
shipment instructions and contact information will be provided to the investigator site prior 
to initiation of the study.
The total blood sampling volume for individual participants during the treatment period is 
approximately 470 mL.  The actual collection times of blood sampling may change.  
Additional blood samples may be taken for safety assessments at times specified by Pfizer, 
provided the total volume taken during the study does not exceed 550 mL during any period 
of 60 consecutive days.
Screening 
For screening procedures, see Schedule of Activities.
Participants will be screened within 49 days prior to administration of the initial dose of 
study intervention in order to confirm that they meet the participant eligibility criteria for the 
study.  The investigator (or appropriate delegate at the investigator site) will obtain informed 
consent from each participant in accordance with the procedures described in Appendix 1. 
Screening visits may occur over multiple visits to achieve all of the required testing.
Screening laboratory tests with abnormal results may be repeated once to confirm abnormal 
results.  The last value will be used to determine eligibility.  If results return to normal within 
the 7-week screening period, the participant may enter the study. 
Participants who do not meet the eligibility criteria (screen failure was determined) may be 
re-screened once at a later date (which must be at least ≥2 weeks after screen failure was 
determined to initiate any re-screening procedures).  Participants who are pregnant at the 
time of their initial screening visit may not be rescreened.  Any participant who is 
re-screened must be re-consented and receive a new participant number.  All activities 
required for the screening visit must be repeated. Participants are not permitted to rescreen if 
they have any of the following positive laboratory results: Hepatitis B surface antigen, 
Hepatitis B cDNA, Hepatitis C antibody, HIV screen or an IGRA.
Participant eligibility will be reviewed and confirmed by the sponsor and/or a consultant to 
the sponsor.  Sites will be required to submit appropriate documentation of participants 
deemed to be eligible to review and approve.  Participants cannot be randomized into the 
study until eligibility is confirmed.
Treatment Period 
For treatment period procedures, see Schedule of Activities.
 
 
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Follow-up Period/End of Study 
For follow-up period and end of study procedures see Schedule of Activities section.
Follow-up contact will be completed at least 28 calendar days, and up to 34 calendar days 
after the last dose of the study intervention to capture any potential adverse events 
Appendix 3 and to confirm appropriate contraception usage see Appendix 4. 
8.1. Efficacy Assessments
8.1.1. Rater Qualifications
For specific rating assessments, only qualified raters will be allowed to evaluate and/or rate 
participants in this study.  The minimum qualifications a rater must meet for each study 
rating assessment will be outlined in the Rater Assessment Manual provided to each 
participating site.  The level of experience with the target population (or equivalent), specific 
scale experience, and certification required (if applicable) will be listed and used to 
determine whether a rater is approved for a given assessment.  Proposed raters who do not 
meet specific criteria but who may be qualified based on unique circumstances may be 
individually reviewed by the study clinical team to determine whether or not a waiver may be 
issued.  The rater must become certified to perform selected study assessments before he or 
she can participate in the conduct of the study.  For specifically defined assessments, rater 
training and standardization exercises may be conducted, and written and signed 
documentation will be provided by the site for each rater’s certification.  In return, each site 
will be provided written and signed documentation outlining each rater’s certification for 
specific study assessments.  Recertification may be required at periodic intervals during the 
study.  The raters who administer specific study assessments will be documented in a 
centralized location and all site staff who administer ratings will be verified in the site study 
documentation during the conduct of the study.
8.1.2. American College of Rheumatology (ACR) Criteria for the Classification of SLE
Eligibility for the study will be evaluated according to the 1997 update on the 1982 revised 
American College of Rheumatology (ACR) Criteria for the Classification of SLE see 
Appendix 8 or by the Systemic Lupus International Collatoring Clinics (SLICC) see 
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Appendix 9.  These criteria require that participants have met at least 4 of the 11 criteria 
either simultaneously or in succession to be classified as having SLE.17
8.1.3. Systemic Lupus International Collaborating Clinics (SLICC) criteria 
The SLICC criteria for SLE classification requires: 1) Fulfillment of at least four criteria, 
with at least one clinical criterion AND one immunologic criterion OR 2) Lupus nephritis as 
the sole clinical criterion in the presence of ANA or anti-dsDNA antibodies. 
8.1.4. Systemic Lupus Erythematosus Responder Index (SRI)-4
The primary objective of this study is to evaluate the efficacy of three PF-06700841 QD dose 
levels (15 mg, 30 mg and 45 mg) relative to placebo in participants with active SLE using the 
Systemic Lupus Erythematosus Responder Index (SRI) at 52 weeks.  The primary endpoint 
of this study is the SRI-4 response rate at Week 52.  The components of this composite 
endpoint are the Systemic Lupus Erythematosus Disease Activity Index-2000 
(SLEDAI-2K),18 the British Isles Lupus Assessment Group (BILAG) 2004,19 and the 
Physician’s Global Assessment (PhGA). 
The endpoint is designed to assure that if improvements occur, they are not accompanied by 
clinically-relevant worsening.  The SRI-4 requires demonstration of improvement in disease 
activity as measured by at least a 4-point reduction in SLEDAI-2K score as the first step in 
identifying a responder.  Since the SLEDAI-2K 4-point improvement threshold is based on a 
published threshold for clinical meaningfulness, and because reduction in the score generally 
requires normalization of a manifestation, not just improvement, an SRI-4 response is also 
considered clinically meaningful.  Once achieving at least, a 4-point reduction in the 
SLEDAI-2K, a participant must also show no worsening of disease as measured by BILAG 
and PhGA to be considered a responder.  If either tool shows worsening, the participant is not 
considered a responder, despite an improvement in the SLEDAI-2K.  All 3 of the 
components are needed to be scored as a responder for purposes of the analysis. 
In order to be classified as a responder, participants meet all of the following criteria 
compared with baseline:
!
≥4 point reduction in the SLEDAI-2K score, and
!
No new BILAG A organ domain score or 2 new BILAG B organ domain scores, and
!
No worsening (<0.3 point increase) in PhGA score.
8.1.4.1. Systemic Lupus Erythematosus Disease Activity Index -2000 (SLEDAI-2K)
The SRI-4 uses the SLEDAI-2K (see Appendix 11) as a rigorous assessment of the 
improvement in a participants disease activity.18
The SLEDAI-2K contains 24 individual manifestations which will be scored by the 
investigator as either present or absent at the time of the visit or within the preceding 30 days 
of the visit.  Each manifestation must be related to lupus; 16 are clinical items and 8 are 
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based on laboratory results.  The manifestations can also be grouped into 9 organ systems for 
analysis (CNS, vascular, renal, musculoskeletal, cardiovascular and respiratory, 
mucocutaneous, immunologic, constitutional and hematologic).  Scores are weighted from 
1 to 8 points, based on the seriousness of the manifestation. 
For the purposes of completing the SLEDAI at Weeks 2 and 6
 
 from the baseline and 
Week 4 visits should be used respectively.
8.1.4.2. British Isles Lupus Assessment Group (BILAG) 2004
The BILAG 2004 index see Appendix 12 is an assessment of the extent and severity of 
disease activity in individual organ systems.19  It is an effective tool to detect worsening in a 
specific organ system because it is responsive to worsening severity of disease manifestations 
as well as the onset of new disease manifestations in specific organ domains.  Only features 
attributable to SLE disease activity are recorded and not due to damage, infection, 
thrombosis (in absence of inflammatory process) or other conditions. 
The BILAG 2004 contains 97 lupus related manifestations given a score of either new, 
worse, same, improving, or not present.  The assessment refers to manifestations occurring in 
the last 4 weeks compared with the previous 4 weeks.  Multiple manifestations and 
laboratory test (as applicable) are then combined into 9 organ domains (constitutional, 
mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, GI, ophthalmic, renal 
and hematological).  BILAG scoring is based on the “intention to treatment” paradigm.  Each 
organ domain is given a score from A to E depending on the SLE clinical manifestations.  An 
“A” score represents an increase in disease activity sufficient to normally require 
intensification of therapy with steroids or immunosuppressants.  A “B” score represents 
moderate, reversible manifestations requiring antimalarials, NSAIDs, or low dose steroids.  
A “C” score reflects mild, stable disease.  A “D” score indicates no current disease activity in 
a previously affected organ system.  An “E” score indicates the organ system has never been 
involved. 
8.1.4.3. Physician Global Assessment (PhGA)
The Physician Global Assessment (PhGA) is a measure of worsening in the participants 
general health status rather than the disease activity in a specific organ (see Appendix 18).  
The investigator will mark a visual analog scale answering the question “Evaluate the 
participants lupus activity since the last visit using the visual analog scale” indicating the 
participants overall disease activity at a particular visit.  The investigator’s response will be 
recorded using a visual analog scale (VAS) by placing a mark on the scale between 0 (none), 
1 (mild), 2 (moderate), and 3 (severe). 
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Evaluate the participants lupus activity since the last visit using the VAS:
Place a vertical mark (|) across the line in the position that best describes your response.
[Note: Scale will be 100 mm in length]
8.1.5. modified SELENA-SLEDAI Flare Index (mSSFI)
The secondary objective is to assess the severe flare rate in PF-06700841 treated participants 
relative to placebo.  The corresponding key secondary endpoint of this study is the time to 
first severe flare as measured by the modified SELENA-SLEDAI SLE Flare Index (SFI);20
(see Appendix 19).  This index categorizes SLE flares as either “mild or moderate” or 
“severe” based on 6 variables:  change in SLEDAI-2K score from most recent assessment to 
current, change in signs or symptoms of disease activity, change in prednisone (or equivalent 
see Appendix 14) dose, use of new medication for disease activity or hospitalization, change 
in PhGA score, or hospitalization for SLE activity (severe flare only). 
The modified SELENA-SLEDAI Flare Index (mSSFI) requires that a participant who has a
SLEDAI score >12 is considered as having a severe flare only if they have one other 
component present.  This modification was made because participants entering the trial with 
high disease activity (ie, ≥11) could too easily trigger a severe flare by minor increases in 
SLEDAI score. 
Lupus flares will also be assessed using an experimental version of the modified 
SELENA-SLEDAI Flare Index (mSSFI), which eliminates medication criteria from the 
modified SELENA-SLEDAI SFI.21
 
  All severe 
SLE flares will be reviewed by a blinded central adjudication committee as discussed in 
Section 9.5.2.
8.1.6. British Isles Lupus Assessment Group Based Composite Lupus Assessment 
(BICLA)
An additional endpoint that will be evaluated in this study is the responder rate according to a 
composite endpoint, British Isles Lupus Assessment Group-Based Composite Lupus 
Assessment (BICLA) that includes the BILAG-2004, SLEDAI-2K, and PhGA of disease 
activity.  The BILAG-2004 index was selected as the central score on the basis of its 
comprehensiveness, ability to capture partial improvement, and the clinical relevance of its 
scoring system. 
0
None
1
Mild
2
Moderate
3
Severe
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In order to be classified as a responder, participants must meet all of the following criteria 
compared with baseline:
!
BILAG-2004 improvement (all A scores at baseline improved to B/C/D and all 
B scores improved to C or D), and
!
No worsening in disease activity (no new BILAG-2004 A scores or ≤1 new B score), 
and
!
No worsening of total SLEDAI-2K score, and
!
No significant deterioration (<10% worsening) in analogue PhGA.
8.1.7. Systemic Lupus International Collaborating Clinics (SLICC)/American College 
of Rheumatology (ACR) Damage Index for SLE
The Systemic Lupus International Collaborating Clinics (SLICC)/ACR Damage Index for 
SLE records damage occurring in participants with SLE regardless of the cause (see 
Appendix 10).  The damage index does not include hematologic items such as cytopenias, 
since these can be a waxing and waning phenomena; other manifestations need to have been 
present for at least 6 months.  It has been found to be well-defined and reliable for measuring 
organ damage.  The SLICC/ACR damage index is useful both as a descriptor for participants 
included in studies, as well as an outcome measure for therapeutic trials and prognosis.23
8.1.8. Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)
The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI; see 
Appendix 20) was designed to convert subjective elements of disease severity into objective 
data by means of a scoring system.24  This validated index has separate scores for activity 
and damage so that it is possible to monitor the course of the disease over time and in 
response to therapy.  The CLASI activity (CLASI-A) score is based upon degree of 
erythema, scale, mucous membrane lesions, and non-scarring alopecia.  Increased weight is 
assigned to the face and neck, relative to other less frequently involved parts of the body.
8.1.9. Photography
Photography will only be performed at sites in the United States and is an optional procedure. 
For participants with a CLASI-A score ≥10 at baseline, clinical photographs of the area of 
active skin involvement should be obtained at baseline, Week 12, Week 24, Week 52, where 
possible (and, if applicable, at participant withdrawal or early withdrawal visit) as per 
Schedule of Activities.  Areas photographed should be recorded in study documents so that 
the same areas will be photographed at the designated time points as per the Schedule of 
Activities.  Additional photographs may also be taken at the investigator’s discretion.  
All photographs will be de-identified and will be used for purposes of this study only, they 
may also be used in external disclosures. 
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Photographic services will be provided through a central photography lab selected by the 
sponsor.  Cameras and detailed procedures to assure consistency including photograph 
specifications (lighting, camera settings, etc) will be provided separately in a central 
photography lab instruction manual provided by vendor.  Training will be provided to the 
sites by the vendor in order to standardize the photographs.
On the day of photography, participants are requested to avoid applying ointments onto their 
skin prior to the visit. 
8.1.10. Joint Assessment (28 Swollen and Tender/Painful Joint Counts)
The joint assessment for this study will consist of the swollen joint count (SJC; see 
Appendix 21) and the tender/painful joint count (TJC) and will be carried out on 28 joints: 
the shoulders, elbows, wrists (radiocarpal, carpal, and carpometacarpal bones were 
considered as a single unit), metacarpophalangeal (MCP) joints (MCP 1, 2, 3, 4, and 5), 
thumb interphalangeal joint, proximal interphalangeal (PIP) joints (PIP 2, 3, 4, and 5), along 
with the following joints: temporomandibular joints, sternoclavicular joints, 
acromioclavicular joints, hip, ankle joints, transverse tarsal joints, metatarsophalangeal 
(MTP) joints (MTP 1, 2, 3, 4 and 5),  interphalangeal joint 1 (foot) and proximal 
interphalangeal (PIP) joints of the foot (PIP 2, 3, 4 and 5) and the knees.  Artificial and 
ankylosed joints will be excluded from the assessments.
Participants taking maintenance or as needed (PRN) NSAIDS/analgesics, or lower potency 
opioid should not take a dose of these medications within 12 hours prior to the joint 
assessment visits in order to allow a true assessment of the joint swelling and tenderness to 
be conducted.
Swelling and tenderness will be graded on a 2-point scale as described in Table 3.  Joint 
count is recorded on the CRF as follows for this study: right tender joint, left tender joint and 
right swelling joint, left swelling joint.
Table 3.
Joint Swelling and Tenderness Grades
Grade
Swelling Response
Tenderness Response
0
Not swollen
Not tender
1
Detectable synovial thickening with or 
without loss of bony contours, or bulging 
synovial proliferation with or without cystic 
characteristics
Positive response to questioning (tender), 
spontaneous response elicited (tender and winced), or 
withdrawal by participant on examination (tender, 
winced, and withdrew)
Every effort should be made to ensure each participant is evaluated by the same assessor 
during all study visits.  In addition, every effort should be made to assess all 28 joints (in 
addition to the joints in the ankles and feet) at baseline since joints missing at baseline will 
not be included in the analysis throughout the study. 
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The joint assessment should be performed without the knowledge of Patient Reported 
Outcomes measures.  A sample diagram and scoring sheet can be found in Appendix 21.
8.1.11. Lupus Low Disease Activity Score (LLDAS)
LLDAS is defined as (1) SLE disease activity index (SLEDAI-2K ≤4, with no activity in 
major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, fever) and 
no haemolytic anaemia or gastrointestinal activity; (2) no new lupus disease activity 
compared with the previous assessment; (3) a Safety of Estogens in Lupus Erythematosus 
National Assessment (SELENA)-SLEDAI physician global assessment (scale 0-3) ≤1; (4) a 
current prednisolone (or equivalent) dose ≤7.5 mg/ daily; and (5) well tolerated standard 
maintenance doses of immunosuppressive drugs and approved biological agents.22
8.1.12. Patient Reported Outcome Measures (PROs)
Participants must complete all patient reported outcome (PRO) questionnaires before any 
other assessments per the schedule of assessments.  All PROs should be completed in the 
following order, 
 
 
 
 
 The amount of time required for a participant to complete the PRO questionnaires 
is approximately 20-30 minutes (depending on the visit and associated PROs).  Upon 
completion of PROs by the participant, site staff must review forms for completeness.
8.1.12.1. Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) 
Version 4
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) version 4 scale is 
a patient completed questionnaire consisting of 13 items that assess fatigue each measured on 
a 4‐point Likert scale over the past 7 days.25,26,27  Instrument scoring yields a range from 
0 to 52, with higher scores representing less fatigue.  The FACIT-F has been validated for 
use SLE and has demonstrated good internal consistency, clinical sensitivity, and a high 
correlation with the SF 36 vitality domain.  A copy of the FACIT-F version 4 questionnaire 
can be found in the PRO manual. 
8.1.12.2. Lupus Quality of Life (LupusQoL) Questionnaire
The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE-specific 
concepts of SLE as reported by patients .31  It consists of 34 items in 8 different domains: 
physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, 
and burden to others measured over a 5-point Likert response (0-4) over the past 4 weeks.  
To facilitate analysis and result interpretation, the individual domain scores are transformed 
from 0 to 100 scale wherein higher scores indicate better quality of life (QoL).  A copy of the 
LupusQoL questionnaire can be found in the PRO manual. 
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8.1.12.3. Pain Intensity
Participants will assess their overall pain rating, joint pain at its worst and pain at its worst in 
the past 7 days on a 11-point NRS; ‘0’ indicates no pain and ‘10’ is pain as bad as it could be. 
Higher scores suggest worse pain intensity (see the PRO manual for details).   
8.1.12.4. The Short Form (36) Health Survey (SF-36) Version 2, Standard 
The 36-Item Short Form Health Survey version 2 standard version  (SF36v2) is a validated 
generic health status measure which measures concepts of health related quality of life 
(HRQoL) over the past 4 weeks.28,29,30  It measures 8 general health domains: physical 
function, role physical, bodily pain, general health, vitality, social functioning, role 
emotional, and mental health.  These domains can be summarized as physical component 
summary (PCS) and mental component summary (MCS).  Higher scores on this 
questionnaire indicate a better QoL.  A copy of the SF-36v2, standard questionnaire can be 
found in the PRO manual. 
8.1.12.5. European Quality of Life-5 Dimensions-5 Level Version (EQ-5D-5L) 
The EuroQoL 5 Dimensions (EQ-5D-5L) is a validated, standardized, generic instrument 
used to measure health states and utilities in various disease areas.  The measure contains 
5 items that cover mobility, self-care, usual activities, pain/discomfort, and 
anxiety/depression, as well as a visual analogue scale.32,33  Scores from the 5 domains maybe 
used to calculate a single index value, also known as a utility score.  
There is also one visual analogue scale (VAS) item which records the respondent’s self-rated 
health where the endpoints are labelled ‘Best imaginable health state’ and ‘Worst imaginable 
health state’.  A copy of the EQ-5D-5L questionnaire can be found in the PRO manual. 
8.1.12.6. Patient’s Global Assessment (PtGA)
The PtGA is an overall assessment of impact of SLE on a participant’s health. Participants 
will rate their overall health as a result of SLE in the past 4 weeks on a 11-point Numeric 
Rating Scale with a score range of 0 (Very well) to 10 (very poorly). Lower scores on the 
scale suggest better health. A copy of the PtGA can be found in the PRO manual. 
8.1.12.7. Patient Global Impression of Severity-Lupus (PGIS-L)
The PGIS-L is the participant’s overall of assessment of severity of their SLE on a 5-point 
Likert scale ranging from ‘None’ to ‘Very Severe’ over the past 7 days. Higher scores on the 
scale suggest greater severity. This questionnaire is only collected for participants enrolled 
after protocol amendment 4 or 5 has been approved. 
8.1.12.8. Patient Global Impression of Severity-Fatigue (PGIS-F)
The PGIS-F is the participant’s overall of assessment of severity of their fatigue on a 5-point 
Likert scale ranging from ‘None’ to ‘Very Severe’ over the past 7 days.  Higher scores on the 
scale suggest worse fatigue. This questionnaire is only collected for participants enrolled 
after protocol amendment 4 or 5 has been approved.
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8.1.12.9. Patient Global Impression of Change (PGI-C)
The PGI-C is the participant’s overall assessment of change in their SLE since the start of the 
study intervention. Participants will evaluate this change on a 5-point Likert scale ranging 
from ‘Much better’ to ‘Much worse’. Higher scores on the scale suggest worsening of their 
SLE.  This questionnaire is only collected for participants enrolled after protocol amendment 
4 or 5 has been approved.
8.1.12.10. Health Care Resource Use (HCRU)
Participants utilization of the health care system outside of the clinical trial will be assessed 
using the Health Care Resource Use (HCRU) questionnaire.  Questions will be asked to 
gauge any physician and specialist visits as hospitalization and emergency room visits 
stratified by those which are SLE related or not.  The questionnaire is to be completed by the 
patient.  A copy of the HCRU can be found in the PRO manual. 
8.2. Safety Assessments
Planned time points for all safety assessments are provided in the Schedule of Activities.  
Unscheduled clinical laboratory measurements may be obtained at any time during the study 
to assess any perceived safety concerns.
8.2.1. Assessments at Screening Only
8.2.1.1. Medical History
Complete medical history, SLE disease history (including disease duration, extent of disease, 
and prior treatments), cardiovascular disease history, venous thromboembolic event history 
and smoking history will be collected at Screening. 
8.2.1.2. Chest X-Ray
Chest radiograph (posterior-anterior and lateral views are recommended, however, local 
guidelines should be followed) or other approved diagnostic test (ie, CT scan with or without 
contrast or MRI) with no evidence of current, active TB or previous inactive TB, general 
infections, heart failure, malignancy, or other clinically significant findings in the chest taken 
at screening or within 12 weeks prior to Study Day 1 and read by a qualified radiologist.  
Documentation of the official reading must be located and available in the source 
documentation. A chest CT or MRI may be obtained in place of the chest x-ray, PA and 
lateral view, only with advance permission of Pfizer. If a chest CT or MRI shows any 
abnormalities (nodules, infiltrates, scarring, stranding, etc), these must be documented to be 
stable compared to a prior chest radiograph or MRI obtained at least 12 months previously.
Participants who entered the study with latent TB or who test positive for QFT-G during the 
study may have a chest x-ray (posterior-anterior and lateral views are recommended, 
however, local guidelines should be followed) or other approved diagnostic test (ie, CT scan 
with or without contrast or MRI) done at Weeks 24 and/or 56 of the study to monitor for 
active TB.  If there is any evidence of active disease on the chest radiograph, study 
intervention must be stopped immediately (unless study intervention has already been 
stopped) and Pfizer Clinical should be notified.  
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8.2.2. Physical Examinations
A complete physical examination will include, at a minimum, head, ears, eyes, nose, mouth, 
skin, heart and lung examinations, lymph nodes, and gastrointestinal, musculoskeletal, and 
neurological systems. 
A brief physical examination will include, at a minimum, assessments of general appearance, 
heart, lungs, skin, musculoskeletal and any other patient and participant-reported symptoms. 
Physical examinations may be conducted by a physician, trained physician's assistant, or 
nurse practitioner as acceptable according to local regulation. 
Height and weight will also be measured and recorded as per the Schedule of Activities. For 
measuring weight, a scale with appropriate range and resolution is used and must be placed 
on a stable, flat surface.  Participants must remove shoes, bulky layers of clothing, and 
jackets so that only light clothing remains.  They must also remove the contents of their 
pockets and remain still during measurement of weight. 
8.2.3. Vital Signs
Vital signs (blood pressure, pulse rate, respirations and temperature) will be measured after 
5 minutes of rest as indicated in the Schedule of Activities. 
Blood pressure (BP) will be measured using a standard calibrated blood pressure measuring 
device.  A BP device that uses multiple cuff sizes for the participant based on the arm 
circumference is required.  The arm circumference at the midpoint of the length of the upper 
arm should be measured to determine the appropriate cuff size in accordance with the 
specifications of the BP measuring device.  The properly sized and calibrated blood pressure 
cuff will be used to measure blood pressure each time.  The use of an automated device for 
measuring BP and pulse rate is acceptable, although, when done manually, pulse rate will be 
measured in the brachial/radial artery for at least 30 seconds. 
Participants should be seated in a chair, back supported, and arms bared (free of restrictions 
such as rolled-up sleeves, etc) and supported at the level of the heart.  Measurements should 
be taken on the same arm (preferably the non-dominant arm) at each visit throughout the 
study after 5 minutes of rest and recorded to the nearest mm Hg.  Participants should refrain 
from smoking (or use any tobacco products) or ingesting caffeine during the 30 minutes prior 
to the measurements. 
When the timing of BP and pulse rate measurements coincides with a blood collection or
other study procedure, BP and pulse rate should be obtained first.
Since all clinical assessments were validated using oral temperatures, it is important to 
ONLY take oral temperatures on study; oral thermometers will be supplied by the Sponsor if 
requested.
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8.2.4. Electrocardiograms
Standard 12-Lead ECGs should be collected at times specified in the Schedule of Activities
section of this protocol using the study specific ECG machine that automatically calculates 
the heart rate and measures PR, QT, and QTc intervals and QRS complex.  All scheduled 
ECGs should be performed after the participant has rested quietly for at least 10 minutes in a 
supine position and prior to any blood collections. 
A single ECG measurement will be collected at all scheduled visits except at baseline on 
Day 1 where ECG will be collected in triplicate approximately 2-4 minutes apart.  At Week 2 
visit, an ECG will be collected approximately 3 hours after dosing at the study site.  The 
Day 1 ECG values (average of the triplicate measures) will serve as each participant’s
baseline values. If Day 1 ECG is missing, then screening ECG will serve as baseline value.
To ensure safety of the participants, a qualified individual (investigator or sub-investigator) 
at the investigator site will make comparisons to baseline measurements.  ECG data will be 
submitted to a central laboratory for measurement.  The final ECG report from the central 
laboratory should be maintained in the participant’s source documentation and be the final 
interpretation of the ECG recording.  Any clinically significant changes from the baseline 
Day 1 ECG may potentially be AEs (Appendix 7) and should be evaluated further, as 
clinically warranted. 
In some cases, it may be appropriate to repeat abnormal ECGs to rule out improper lead 
placement as contributing to the ECG abnormality.  It is important that leads be placed in the 
same positions each time in order to achieve precise ECG recordings.  If a machine-read QTc 
value is prolonged, as defined above, repeat measurements may not be necessary if a 
qualified medical provider’s interpretation determines that the QTc values are in the 
acceptable range.
ECG values of potential clinical concern are listed in Appendix 7.
8.2.5. Hepatitis Screening and Monitoring
During the study screening period, all participants will be screened for hepatitis B surface 
antigen (HBsAg), hepatitis surface antibody (HBsAb) and hepatitis B core antibody 
(HBcAb). 
!
Participants who are HBsAg positive will be excluded.
!
Participants who have negative HBsAg, positive HBcAb, and negative HBsAb will 
be excluded. 
!
Participants who have negative HBsAg, negative HBcAb and positive HBsAb and 
provide a documentation of prior HBV vaccination are eligible for the study and will 
not require HBV DNA monitoring during the study. 
!
Participants who have negative HBsAg, positive HBcAb and positive HBsAb, 
whether or not they have received prior HBV vaccination, and participants who have 
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negative HBsAg, negative HBcAb and positive HBsAb without documentation of 
prior HBV vaccination are required to undergo HBV cDNA testing monthly.
!
Participants will be excluded with detectable HBV DNA. 
In addition, all participants will be screened for hepatitis C virus antibody (HCV Ab) during 
the study screening period.  Participants who are positive for HCV Ab will be reflex-tested 
for hepatitis C virus ribonucleic acid (HCV RNA) and, if HCV RNA is positive, they will be 
screen-failed.
If hepatitis B reactivation has been confirmed during the study based upon the above 
evaluations, the participant should not receive further doses of the study intervention.  
Investigators should consider such as event as medically important and report the event as an 
SAE in accordance with the process described in Appendix 3.
8.2.6. Tuberculosis (TB) Screening and Monitoring
8.2.6.1. Interferon Gamma Release Assay (IGRA) Tuberculin Test
Participants should be screened for TB using an interferon gamma release assay (IGRA) and 
it is preferable that a QuantiFERON® gold test be obtained and sent to the central laboratory, 
although it is acceptable for a locally approved IGRA to be used per local guidelines.  IGRA 
will be tested during screening or within 12 weeks prior to Day 1.  The following are 
acceptable IGRA assays:  T-SPOT® TB test, QuantiFERON®-TB Gold In-Tube test 
(QFT-GIT), QuantiFERON®-TB Gold test (QFT-G) or QuantiFERON®-TB Gold Plus test 
(QFT-G Plus).  Site personnel should follow the processing and analyses steps based on the 
assay chosen.  Ensure incubation steps are followed as appropriate.  Documentation of IGRA 
product used and the test result must be in the participants source documentation.
A Mantoux skin test is not an acceptable test in this study and an IGRA test must be 
performed.  An initial IGRA should be performed at the central laboratory so that at least one 
set of results will be available in the Pfizer database.  If another test is required, it may be 
performed locally, and a T-SPOT® TB test (if available) would be preferred than another 
QuantiFERON® test.
Procedure for Indeterminate or Positive interferon gamma release assay tests at 
screening
!
Indeterminate interferon gammas release assay: Participants with indeterminate 
IGRA results should have a different IGRA test obtained (eg, T-SPOT® instead of 
QuantiFERON®-TB Gold In-Tube test (QFT-GIT), QuantiFERON®-TB Gold test 
(QFT-G) or QuantiFERON®-TB Gold Plus test (QFT-G Plus) and must be seen by an 
infectious disease and/or pulmonary specialist who should recommend the 
appropriate repeat IGRA test, review all pertinent information and determine whether 
the risk of latent or active infection is low (ie, participant would be acceptable for 
immunosuppressant treatment without additional treatment). A copy of the specialist 
report stating that they do not think the participant has active or latent TB should be 
translated into English and provided to the Sponsor.
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!
Positive interferon gamma release assay: If the results of the initial and/or repeat 
test are positive, the participant must be seen by an infectious disease and/or 
pulmonary specialist. The infectious disease and/or pulmonary specialist will review 
the chest radiography (ie. chest x-rays, CT scan, etc.) along with all TB testing results 
and review any other pertinent information to determine whether the participant has 
latent or active TB, or any other active, chronic or latent pulmonary infection or 
malignancy or other clinically significant pulmonary disease.  Participants with 
indeterminate IGRA results should have a different IGRA test obtained (eg, T-SPOT®
instead of QuantiFERON®-TB Gold In-Tube test (QFT-GIT), QuantiFERON®-TB 
Gold test (QFT-G) or QuantiFERON®-TB Gold Plus test (QFT-G Plus); the 
consultant should recommend the appropriate repeat IGRA test.
Infectious disease and/or pulmonary specialist consultation
1. If the pulmonary specialist diagnoses latent TB during the screening period, the 
pulmonary specialist will recommend a treatment for latent TB aligned with the 
participant’s best interest and local standard of care.  The local incidence of multidrug 
resistant TB should be considered in determining how the participant is treated. Once 
the infectious disease and/or pulmonary specialist report has been obtained, the 
following must occur:
!
Report is translated into English and the local incidence rate of multi-drug 
resistant TB in the participant’s home area must be provided to the sponsor for 
review. 
!
If INH and vitamin B6 therapy are considered by the infectious disease and/or 
pulmonary specialist to be adequate treatment for latent TB for the 
prospective participant, the participant must agree to continue therapy during 
the study to complete the course of treatment for latent TB.  If the participant 
agrees with this plan and the site monitors for compliance with this regimen 
on study, the participant may be eligible for randomization if they meet all 
other inclusion requirements and none of the exclusion criteria.  The 
prospective participant agreement to take INH and B6 during the study and 
confirmation the site will track the subject’s compliance appropriately should 
also be provided to the Sponsor.
!
Following review of specialist report, incidence of multidrug resistant TB and 
participants acceptance of required treatment for latent TB, the participant may be 
eligible for the study if all other eligibility criteria are met.  The only therapy 
acceptable for on-study treatment of latent TB is a 9-month course of INH plus 
vitamin B6.
!
For participants who enter the study with latent TB on INH and vitamin B6, a 
follow up chest CT will be required at Week 56.  
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2. If a participant has been diagnosed with latent TB prior to screening, they must be 
seen by a pulmonary or infectious disease consultant who will review all radiographic 
studies and the participant’s history to ensure that the patient does not have active TB. 
The consultant should also consider whether there is a high incidence of multi-drug 
resistant TB in the participant’s region. 
!
The consultant’s report is translated into English and the local incidence rate of 
multi-drug resistant TB in the participant’s home area must be provided to the 
sponsor for review. 
!
If the participant has begun treatment for latent TB with therapy other than INH 
and B6, the consultant and participant must agree that changing to INH and B6 is 
in the participant’s best interest.  The only therapy acceptable for on-study 
treatment of latent TB is the equivalent of a 9-month course of INH plus 
vitamin B6. Adjustment of the treatment period or acceptance of treatments other 
than INH and B6 prior to screening should be discussed with Pfizer Clinical and 
may take into account the duration and type of therapy that has been documented 
prior to screening.
!
If the participant agrees with this treatment plan and the site monitors for 
compliance with this regimen on study, the participant may be eligible for 
randomization if they meet all other inclusion requirements and none of the 
exclusion criteria.  The prospective participant agreement to take INH and 
B6 during the study and confirmation the site will track the participant’s 
compliance appropriately should also be provided to the Sponsor.
!
For participants who enter the study with latent TB on INH and vitamin B6, a 
follow-up chest CT will be required at Week 56.  
Refer to lab manual for any additional processing information and shipping instructions.
8.2.6.2. Additional Measures for Tuberculosis (TB) Monitoring
In addition to the tuberculosis (TB) screening already in place, additional testing for TB has 
been added at the Week 24 visit and at the Week 56 visit/end of study visit (and if applicable, 
at participant withdrawal/early withdrawal visit) to monitor for new cases of TB during the 
course of the study.  The following measures have been included in this protocol to ensure 
the continued safety of participants and to further mitigate the risk of Mycobacterium 
tuberculosis infection:
!
Participants should be carefully monitored throughout the study for signs and 
symptoms of TB, such as chest pain, difficulty breathing, wheezing, fever, cough, 
excessive sweating (especially at night), lymphadenopathy, hepatosplenomegaly, new 
fatigue, anorexia or new unplanned weight loss.  Participants with these symptoms 
should be carefully evaluated to determine if these symptoms are due to SLE, TB, or 
other unrelated cause.  Referrals to infectious disease and/or pulmonology specialists 
should be considered on an individual basis.  The sponsor should be immediately 
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notified and may evaluate these cases in consultation with infectious disease and/or 
pulmonology specialists.
Procedure for Indeterminate or Positive interferon gamma release assay tests at 
Week 24 and/or Week 56:
!
Indeterminate interferon gamma release assay: At both Week 24 and 56 the test 
should be repeated.  The IGRA assay to be utilized for the repeat test should be a 
different assay than the first test (eg, T-SPOT®).  
!
Participants who have an IGRA test result at Week 24 or Week 56 that is 
indeterminate should be seen by an infectious disease and/or pulmonary specialist 
who should determine whether the risk of TB infection is low (ie, it would be 
acceptable for the participant to remain in the study and continue 
immunosuppressant treatment without additional action).  A report from the 
infectious disease and/or pulmonary specialist should be available in the source 
document.  If the specialist determines that the risk of TB infection is low, the 
participant may remain in the study as per the Schedule of Activities.  If the 
consultant determines that the risk of TB infection is not low, the 
recommendations of the consultant to determine whether active or latent TB 
infection is present should be followed and the final determination of the 
participants status and results of any other diagnostic testing reported to the 
Sponsor.
!
Positive interferon gamma release assay: At both Week 24 and 56 the test should 
be repeated.  The IGRA assay to be utilized for the repeat test should be a different 
assay than the first (eg, T-SPOT®). The participant should be thoroughly evaluated to 
exclude active TB.  The sponsor should be notified as soon as possible. These 
participants should have study drug dosing interrupted immediately until details have 
been discussed with the sponsor and it has been determined whether the participant
has active or latent TB. Evaluations should include, and may not be limited to:
!
Participant information to include at a minimum the following: 
!
Close contact with someone with active TB (home, work, school, etc).
!
Work at a job that has an increased risk of acquiring TB (for example a 
healthcare or nursing home worker).
!
Physical examination.
!
Check for symptoms (fever, cough, weight loss).
!
Consultation with an infectious disease and/or pulmonary specialist should be 
obtained as soon as possible to determine whether the participant has active or 
latent TB. Radiographic studies required for diagnosis should be obtained as 
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per the recommendation of the consultant. The subject should stop study 
intervention immediately until the pulmonary specialist is able to confirm if 
the participant has latent or active TB.
!
At Week 24, if the infectious disease and/or pulmonary specialist determines that 
the participant has active TB, the participant must discontinue study intervention
permanently and should follow the infectious disease and/or pulmonary specialist
recommendation for treatment. Sites should be aware that in many regions, new 
active or latent TB is a reportable disease and may require reporting to the local 
public health office. Investigators should consider such an event as medically 
important and report the event as an SAE in accordance with the process 
described in Appendix 3.
!
At Week 24, if the infectious disease and/or pulmonary specialist determines that 
the participant has latent TB, the consultant should determine if INH and Vitamin 
B6 would be adequate therapy for latent TB.  If the specialist agrees that INH and 
Vitamin B6 treatment is adequate treatment for latent TB, the participant agrees to 
start INH and B6 treatment and to comply with the treatment during the study, the 
participant should start INH and vitamin B6 treatment immediately, interrupt 
study intervention for 14 days and obtain blood chemistry assessments to 
include at a minimum ALT, AST, and bilirubin prior to re-starting study 
intervention.
!
The participant may restart study drug after these laboratory assessments have 
been determined to be in the normal range. 
!
For any clinically significant laboratory results, Investigators should consider 
such an event as medically important and report the event as an SAE in 
accordance with the process described in Appendix 3.  
!
The Sponsor strongly recommends that the participants who develop latent TB 
on study, should receive a 9-month course of INH and B6, INH and B6 
therapy following the completion of study participation is at the discretion of 
the investigator.
!
The participant is required to have an additional chest X-ray or chest CT at 
Week 56.
!
Participants that enter the study with latent TB or develop newly positive QFT-G 
results during the study may be required to have additional chest X-ray or chest CT at 
Weeks 24 and/or 56.  
!
At Week 56, if the consultant determines that the participant has active or latent TB, 
the participant should follow the infectious disease and/or pulmonary specialist
recommendation for treatment. Sites should be aware that in many regions, new 
active or latent TB is a reportable disease and may require reporting to the local 
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public health office. Investigators should consider such an event as medically 
important and report the event as an SAE in accordance with the process described in 
Appendix 3.
!
If treatment with high dose corticosteroids (oral doses ≥60 mg/day prednisone [or 
equivalent see Appendix 14] or pulse IV doses) is required to treat a documented 
severe lupus flare, or intercurrent medical condition, the participant should be 
evaluated for TB as soon as clinically feasible and preferably before starting the high 
dose corticosteroid treatment.  In areas of high background TB prevalence, it is 
recommended that the evaluation be repeated following corticosteroid taper.
8.2.7. Monitoring for Infections
Participants will be monitored for development of any infection (viral, bacterial, and fungal).  
Infections will be classified as either treated or non-treated infections.  All treated infections 
occurring during the study require identification of the causative organism, if feasible, 
whether by culture, antigen assay, serology, etc. (as appropriate) and the results (eg, any 
identified organisms or absence of growth) recorded in the CRF.
Treated infections are infections that:
!
Require antimicrobial therapy by any route of administration or; 
!
Require any surgical intervention (eg, incision and drainage).
Treated infections will be further classified as serious or non-serious.  Serious infections are 
treated infections that:
!
Require intravenous antimicrobial therapy or; 
!
Required hospitalization for treatment or; 
!
Meet other criteria that require the infection to be classified as a SAE.
A participant who experiences a serious infection should be discontinued from treatment.  A 
serious infection should be reported as a SAE and should be listed as the reason for 
discontinuation in the CRF.  All serious infections occurring during the study should undergo 
appropriate laboratory investigations, including culture, and the results (eg, any identified 
organisms or absence of growth) be recorded in the CRF.
For participants who experience non-serious infections that require a temporary hold on 
dosing of the study intervention during the study see Section 6.1.1.  Consultation with the 
sponsor is available.
8.2.7.1. Suspected Herpetiform Rash 
For any occurrence of a suspected herpetiform rash (eg, herpes simplex and herpes zoster), 
specimens for viral deoxyribonucleic acid (DNA) analysis will be obtained: A swab of the 
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affected area should be collected for confirmation; a blood sample for viral surveillance will 
be collected for the analysis of viral load.  Details for these collections will be provided in the 
laboratory manual.
8.2.8. Clinical Safety Laboratory Assessments
See Appendix 2 for the list of clinical safety laboratory tests to be performed and the 
Schedule of Activities for the timing and frequency.  The direct Coombs test sent to a local 
laboratory should only be obtained if the investigator suspects that a clinically significant 
hemolytic anemia is present that will be reflected in a BILAG score for hemolytic anemia.
The investigator must review the laboratory report, document this review, and record any 
clinically relevant changes occurring during the study in the AE section of the CRF.  
Clinically significant abnormal laboratory findings are those which are not associated with 
the underlying disease, unless judged by the investigator to be more severe than expected for 
the participant's condition.
All laboratory tests with values considered clinically significantly abnormal during 
participation in the study or within 28 days after the last dose of study intervention should be 
repeated at the central lab until the values return to normal or baseline or are no longer 
considered clinically significant by the investigator or medical monitor.
If such values do not return to normal/baseline within a period of time judged reasonable by 
the investigator, the etiology should be identified and the sponsor notified.
All protocol-required laboratory assessments, as defined in Appendix 2, must be conducted 
in accordance with the laboratory manual and the Schedule of Activities.
If laboratory values from non-protocol-specified laboratory assessments performed at the 
institution’s local laboratory require a change in participant management or are considered 
clinically significant by the investigator (eg, SAE or AE or dose modification), then the 
results must be recorded in the CRF.
8.2.9. Serum Creatinine, Serum Cystatin C and Estimated Glomerular Filtration Rate 
(eGFR)
Serum creatinine will be measured as part of serum chemistry at times specified in the 
Schedule of Activities section of the protocol.  Creatinine elevations above the upper limit of 
normal (ULN) will be followed until resolution or return to baseline values.  Serum 
creatinine based eGFR will be calculated.  Serum cystatin C will be measured and cystatin C 
based eGFR will be calculated at corresponding times per Schedule of Activities. 
The eGFR will be calculated using the 2 sets of equations developed by the Chronic Kidney 
Disease Epidemiology Collaboration (CKD-EPI), which utilize serum creatinine (SCr) and 
serum cystatin C (S Cystatin C) respectively (see Appendix 22). 
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8.2.10. Suicidal Ideation and Behavior Risk Monitoring 
The Columbia-Suicide Severity Rating Scale (C-SSRS; Appendix 15) will be used to assess 
suicidal ideation and behavior.  The C-SSRS is a validated tool to evaluate suicidal ideation 
and behavior.34
At the screening visit (baseline), if there are “yes” answers on items 4 and/or 5 in the past 
year, or on any question in the suicidal behavior section of the C-SSRS in the past 5 years, 
the participant will be excluded from the study. 
At Week 24 visit the Since Last Visit version of the C-SSRS should be utilized.  The Since 
Last Visit version refers to the participants experience since their last visit. If there are “yes” 
answers on items 4 and/or 5 or on any suicidal behavior question of the C-SSRS, the 
participant will be discontinued from treatment and referred to a mental health professional 
for appropriate evaluation and treatment.  If the participant cannot be seen by a mental health 
professional within 24 hours, then the participant should be sent to a local emergency room 
for psychiatric assessment.
8.2.11. Pregnancy Testing
Pregnancy tests may be urine or serum tests, but must have a sensitivity of at least 
25 mIU/mL.  Pregnancy tests will be performed in women of child bearing potential 
(WOCBP) at the times listed in the Schedule of Activities.  Following a negative pregnancy 
test result at screening, appropriate contraception must be commenced and a negative 
pregnancy test result will be required at Day 1 prior to dosing and then prior to the 
participant’s receiving the study treatment at all subsequent visits.  Pregnancy tests will also 
be done whenever 1 menstrual cycle is missed during the active treatment period (or when 
potential pregnancy is otherwise suspected) and at the end of the study.  Pregnancy tests may 
also be repeated if requested by institutional review boards (IRBs)/ethics committees (ECs) 
or if required by local regulations.  If a urine test cannot be confirmed as negative (eg, an 
ambiguous result), a serum pregnancy test is required.  In such cases, the participant must be 
excluded if the serum pregnancy result is positive.
8.3. Adverse Events and Serious Adverse Events
The definitions of an AE and an SAE can be found in Appendix 3. 
AEs will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or 
the participant's legally authorized representative).
The investigator and any qualified designees are responsible for detecting, documenting, and 
recording events that meet the definition of an AE or SAE and remain responsible to pursue 
and obtain adequate information both to determine the outcome and to assess whether it 
meets the criteria for classification as an SAE or that caused the participant to discontinue the 
study (see Section 7).
In addition, the investigator may be requested by Pfizer Safety to obtain specific follow-up 
information in an expedited fashion.
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8.3.1. Disease-Related Events and/or Disease-Related Outcomes Not Qualifying as AEs 
or SAEs
Not applicable.
8.3.2. Time Period and Frequency for Collecting AE and SAE Information
The time period for actively eliciting and collecting AEs and SAEs (“active collection 
period”) for each participant begins from the time the participant provides informed consent, 
which is obtained before the participant’s participation in the study (ie, before undergoing 
any study-related procedure and/or receiving study intervention), through and including a 
minimum of 28 calendar days, except as indicated below, after the last administration of the 
study intervention.
For participants who are screen failures, the active collection period ends when screen failure 
status is determined.
If the participant withdraws from the study and also withdraws consent for the collection of 
future information, the active collection period ends when consent is withdrawn.
If a participant definitively discontinues or temporarily discontinues study intervention 
because of an AE or SAE, the AE or SAE must be recorded on the CRF and the SAE 
reported using the CT SAE Report Form.
Follow-up by the investigator continues throughout and after the active collection period and 
until the event or its sequelae resolve or stabilize at a level acceptable to the investigator.
Investigators are not obligated to actively seek AEs or SAEs after conclusion of the study 
participation.  However, if the investigator learns of any SAE, including a death, at any time 
after a participant has been discharged from the study, and he/she considers the event to be 
reasonably related to the study intervention or study participation, the investigator must 
promptly report the SAE to Pfizer using the CT SAE Report Form.
8.3.2.1. Reporting SAEs to Pfizer Safety
All SAEs occurring in a participant during the active collection period are reported to Pfizer 
Safety on the CT SAE Report Form immediately and under no circumstance should this 
exceed 24 hours, as indicated in Appendix 3.  The investigator will submit any updated SAE 
data to the sponsor within 24 hours of it being available.
SAEs occurring in a participant after the active collection period has ended are reported to 
Pfizer Safety if the investigator becomes aware of them; at a minimum, all SAEs that the 
investigator believes have at least a reasonable possibility of being related to study 
intervention must be reported to Pfizer Safety.
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8.3.2.2. Recording Nonserious AEs and SAEs on the CRF
All nonserious AEs and SAEs occurring in a participant during the active collection period, 
which begins after obtaining informed consent as described in Section 8.3.1, will be recorded 
on the AE section of the CRF.  
The investigator is to record on the CRF all directly observed and all spontaneously reported 
AEs and SAEs reported by the participant.
8.3.3. Method of Detecting AEs and SAEs
The method of recording, evaluating, and assessing causality of AEs and SAEs and the 
procedures for completing and transmitting SAE reports are provided in Appendix 3.
Care will be taken not to introduce bias when detecting AEs and/or SAEs.  Open-ended and 
nonleading verbal questioning of the participant is the preferred method to inquire about 
AE occurrences.
8.3.4. Follow-up of AEs and SAEs
After the initial AE/SAE report, the investigator is required to proactively follow each 
participant at subsequent visits/contacts.  For each event, the investigator must pursue and 
obtain adequate information until resolution, stabilization, the event is otherwise explained, 
or the participant is lost to follow-up (as defined in Section 7.3).
In general, follow-up information will include a description of the event in sufficient detail to 
allow for a complete medical assessment of the case and independent determination of 
possible causality.  Any information relevant to the event, such as concomitant medications 
and illnesses, must be provided.  In the case of a participant death, a summary of available 
autopsy findings must be submitted as soon as possible to Pfizer Safety. 
Further information on follow-up procedures is given in Appendix 3.
8.3.5. Regulatory Reporting Requirements for SAEs
Prompt notification by the investigator to the sponsor of an SAE is essential so that legal 
obligations and ethical responsibilities towards the safety of participants and the safety of a
study intervention under clinical investigation are met.
The sponsor has a legal responsibility to notify both the local regulatory authority and other 
regulatory agencies about the safety of a study intervention under clinical investigation.  The 
sponsor will comply with country-specific regulatory requirements relating to safety 
reporting to the regulatory authority, institutional review boards (IRBs)/ethics committees 
(ECs), and investigators.
Investigator safety reports must be prepared for suspected unexpected serious adverse 
reactions (SUSARs) according to local regulatory requirements and sponsor policy and 
forwarded to investigators as necessary.
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An investigator who receives an investigator safety report describing an SAE or other 
specific safety information (eg, summary or listing of SAEs) from the sponsor will review 
and then file it along with the investigator’s brochure and will notify the IRB/EC, if 
appropriate according to local requirements.
8.3.6. Exposure During Pregnancy or Breastfeeding, and Occupational Exposure
Exposure to the study intervention under study during pregnancy or breastfeeding and 
occupational exposure are reportable to Pfizer Safety within 24 hours of investigator 
awareness.
8.3.6.1. Exposure During Pregnancy
Details of all pregnancies in female participants and, if indicated, female partners of male 
participants will be collected after the start of study intervention and until 30 days after the 
last dose.
If a pregnancy is reported, the investigator should inform the sponsor within 24 hours of 
learning of the pregnancy and should follow the procedures outlined in Appendix 4.
Abnormal pregnancy outcomes (eg, spontaneous abortion, fetal death, stillbirth, congenital 
anomalies, ectopic pregnancy) are considered SAEs.
8.3.6.2. Exposure During Breastfeeding
Scenarios of exposure during breastfeeding must be reported, irrespective of the presence of 
an associated SAE, to Pfizer Safety within 24 hours of the investigator’s awareness, using the 
CT SAE Report Form.  An exposure during breastfeeding report is not created when a Pfizer 
drug specifically approved for use in breastfeeding women (eg, vitamins) is administered in 
accord with authorized use.  However, if the infant experiences an SAE associated with such
a drug’s administration, the SAE is reported together with the exposure during breastfeeding.
8.3.6.3. Occupational Exposure
An occupational exposure occurs when, during the performance of job duties, a person 
(whether a healthcare professional or otherwise) gets in unplanned direct contact with the 
product, which may or may not lead to the occurrence of an AE.
An occupational exposure is reported to Pfizer Safety within 24 hours of the investigator’s 
awareness, using the CT SAE Report Form, regardless of whether there is an associated 
SAE.  Since the information does not pertain to a participant enrolled in the study, the 
information is not recorded on a CRF; however, a copy of the completed CT SAE Report 
Form is maintained in the investigator site file.
8.3.7. Cardiovascular and Death Events
Cardiovascular events will be reviewed as part of the regular safety review by the eDMC (see 
Section 9.5.1).
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8.3.8. Adverse Events of Special Interest
Not Applicable.
8.3.8.1. Lack of Efficacy
“Lack of efficacy” or “failure of expected pharmacological action” per se will not be reported 
as an AE or SAE.  Such instances will be captured in the efficacy assessments. However, the 
signs, symptoms, and/or clinical sequelae resulting from lack of efficacy will be reported as 
an AE or SAE if they fulfill the definition of an AE or SAE.
8.3.9. Medication Errors
Medication errors may result from the administration or consumption of the study 
intervention by the wrong participant, or at the wrong time, or at the wrong dosage strength. 
Exposures to the study intervention under study may occur in clinical trial settings, such as 
medication errors.
Safety Event
Recorded on the CRF
Reported on the CT SAE Report 
Form to Pfizer Safety Within 
24 Hours of Awareness
Medication errors 
All (regardless of whether 
associated with an AE)
Only if associated with an SAE
Medication errors include:
!
Medication errors involving participant exposure to the study intervention;
!
Potential medication errors or uses outside of what is foreseen in the protocol that do 
or do not involve the study participant.
Such medication errors occurring to a study participant are to be captured on the medication 
error page of the CRF, which is a specific version of the AE page.
In the event of a medication dosing error, the sponsor should be notified immediately.
Whether or not the medication error is accompanied by an AE, as determined by the 
investigator, the medication error is recorded on the medication error page of the CRF and, if 
applicable, any associated AE(s), serious and nonserious, are recorded on an AE page of the 
CRF.
Medication errors should be reported to Pfizer Safety within 24 hours on a CT SAE Report 
Form only when associated with an SAE.
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8.4. Treatment of Overdose
For this study, any dose of study intervention greater than that prescribed for the participant 
within a 24-hour time period will be considered an overdose.
Sponsor does not recommend specific treatment for an overdose.  
In the event of an overdose, the investigator/treating physician should:
1. Contact the medical monitor within 24 hours.
2. Closely monitor the participant for any AEs/SAEs and laboratory abnormalities until 
study intervention can no longer be detected systemically (at least 10 days).
3. Obtain a blood sample for pharmacokinetic (PK) analysis within 2 days from the date 
of the last dose of study intervention if requested by the medical monitor (determined 
on a case-by-case basis).
4. Document the quantity of the excess dose as well as the duration of the overdose in 
the CRF.
5. Overdose is reportable to Safety only when associated with an SAE.
Decisions regarding dose interruptions or modifications will be made by the investigator in 
consultation with the medical monitor based on the clinical evaluation of the participant.
 
 
 
 
 
 
 
 
 
 
 
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9. STATISTICAL CONSIDERATIONS
Detailed methodology for summary and statistical analyses of the data collected in this study 
is outlined here and further detailed in a statistical analysis plan (SAP), which will be 
maintained by the sponsor.  The SAP may modify what is outlined in the protocol where 
appropriate; however, any major modifications of the primary endpoint definitions or their 
analyses will also be reflected in a protocol amendment.
9.1. Estimands and Statistical Hypotheses
9.1.1. Estimands
The primary estimand for the primary endpoint of Systemic Lupus Erythematosus Responder 
Index (SRI-4) response at Week 52 will be the population average treatment difference 
between PF-06700841 and placebo in the proportion of participants with active SLE who 
achieved the SRI-4 endpoint at Week 52 and did not discontinue study intervention prior to 
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Week 52. SRI-4 response is a composite endpoint where a responder must meet criteria in 
the assessment of SLEDAI-2K, BILAG and PhGA. Data post intercurrent events will be 
censored and any participant who experienced these intercurrent events will be considered as 
a non-responder at Week 52. The population-level summary will be the differences in the 
proportions of SRI-4 responders at Week 52 between each treatment dose arm of 
PF-06700841 and the placebo arm. For the primary endpoint, a treatment policy estimand 
will also be included in the SAP as a secondary estimand to estimate the treatment difference 
in the SRI-4 response rate at Week 52 regardless of occurrence of any intercurrent events 
prior to Week 52.  Additional sensitivity analyses involving the primary endpoint may be 
specified within the SAP.
Estimands are also defined corresponding to secondary objectives.  In general, population 
will consist of participants with active SLE as defined by inclusion/exclusion criteria except 
those estimands for a subgroup of participants.  Intercurrent events for secondary binary and 
continuous endpoints are defined similar to those events for the primary endpoint. For each 
binary endpoint, the main estimand is similarly defined as a composite estimand and any 
participant who experienced the specified intercurrent events will be considered as a 
non--responder; for each continuous endpoint the main estimand will be a hypothetical 
estimand and only data collected prior to the occurrence of intercurrent events will be 
included for analyses. Treatment policy estimand may be defined in the SAP for selected 
secondary endpoints. 
Participants who had data missing due to COVID-19 or Russia-Ukraine conflict at Week 52 
visit will be removed from analysis for that visit (eg, not included into numerator and 
denominator in the calculation of proportion of responders at the visit where the data are 
missing due to COVID-19 or Russia-Ukraine conflict). 
9.1.2. Hypotheses and Decision Rules
Each of the 3 dose groups of the PF-06700841 will be compared with the placebo group for 
both the primary endpoint of SRI-4 response at Week 52 and the key secondary endpoint of 
the BICLA response at Week 52 in 6 hypotheses.  Two families (FA and FB) of hypotheses 
are formed from these 6 hypotheses (Table 4).  In order to control the overall family-wise 
type-I error rate, a sequentially rejective closed testing procedure is defined.  The family FA 
serves as the gatekeeper before testing hypotheses in the family FB.  The hypotheses in the 
family FB will not be formally tested unless all null hypotheses in the family FA are rejected.  
Additional details, including any future changes regarding the multiplicity control of the 
primary and key secondary endpoints at the overall family-wise type-I error rate of one-sided 
0.025, will be handled within the SAP.
Table 4.
Families of Hypotheses 
Notation
Hypotheses
Family of 
Hypotheses
HvP1
H0: SRI-4 response rates at Week 52 are the same between the PF-06700841 
45 mg dose group and the placebo group  
FA
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Table 4.
Families of Hypotheses 
Notation
Hypotheses
Family of 
Hypotheses
H1: The SRI-4 response rate at Week 52 for the PF-06700841 45 mg dose 
group is greater than the SRI-4 response rate for the placebo group
HvP2
H0: BICLA response rates at Week 52 are the same between the PF-
06700841 45 mg dose group and the placebo group  
H1: The BICLA response rate at Week 52 for the PF-06700841 45 mg dose 
group is greater than the BICLA response rate for the placebo group
FA
MvP1
H0: SRI-4 response rates at Week 52 are the same between the PF-06700841 
30 mg dose group and the placebo group 
H1: The SRI-4 response rate at Week 52 for the PF-06700841 30 mg dose 
group is greater than the SRI-4 response rate for the placebo group
FA
MvP2
H0: BICLA response rates at Week 52 are the same between the PF-
06700841 30 mg dose group and the placebo group  
H1: The BICLA response rate at Week 52 for the PF-06700841 30 mg dose 
group is greater than the BICLA response rate for the placebo group
FA
LvP1
H0: SRI-4 response rates at Week 52 are the same between the PF-06700841 
15 mg dose group and the placebo group  
H1: The SRI-4 response rate at Week 52 for PF-06700841 15 mg dose group 
is greater than the SRI-4 response rate for the placebo group
FB
LvP2
H0: BICLA response rates at Week 52 are the same between the PF-
06700841 15 mg dose group and the placebo group  
H1: The BICLA response rate at Week 52 for the PF-06700841 15 mg dose 
group is greater than the BICLA response rate for the placebo group
FB
It follows from Bretz, et al. (2009)38 that the multiple testing procedure is shown in a 
graphical presentation (Figure 1).  The initial significance levels are equally assigned to two 
hypotheses (HvP1 and MvP1).  The transition matrix is 
∋∋
∋
∋
∋
∋
∋
∋
(
)
∗∗
∗
∗
∗
∗
∗
∗
+
,
−
−
.
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0
0
1
0
0
5.0
0
0
5.0
0
0
1
0
0
0
0
0
5.0
5.0
0
/
/
/
/
G
,
where the order of the six hypotheses is (HvP1, HvP2, MvP1, MvP2, LvP1, LvP2).  The ε is 
an infinitesimally small weight for the gatekeeping strategy.  Since the regularity condition is 
met for the transition matrix, this testing procedure is a closed testing procedure and controls 
the family-wise type-I error rate for the multiple testing of both primary and the key 
secondary endpoints.  
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Figure 1.
Testing Procedure
9.2. Sample Size Determination
The study randomized 350 participants in a 1:2:2:2 allocation ratio in the order of PF-
06700841 15 mg, 30 mg, and 45 mg, and placebo arms. The primary endpoint of this study 
is the proportion of participants achieving SRI-4 response at Week 52. Using a Cochran-
Maentel-Haenszel test, a placebo SRI-4 response rate of 40% at Week 52 and the true effect 
of treatment with PF-06700841 45 mg on SRI-4 response rate of 65% at Week 52, an overall 
type-I family-wise error %=0.025 (one-sided), and N=95 evaluable participants in both arms
to account for potential loss of participants impacted by either the COVID-19 or Russia-
Ukraine crises, we expect to have at least 88% power to reject the null hypothesis in 
HvP1. Using the same parameters and assuming a placebo BICLA response rate of 30% at 
Week 52 and the true effect of treatment with PF-06700841 45 mg on BICLA response rate 
of 47.5% at Week 52, we expect to have at least 58% power to reject the null hypothesis in 
HvP2. The calculation on sample size for key secondary endpoint assume primary endpoint 
hypotheses that were higher up in the testing hierarchy in Figure 1 were tested and rejected
9.3. Populations for Analysis
For purposes of analysis, the following populations are defined:
Population
Description
Safety Analysis Set
All participants randomly assigned to study intervention and 
who take at least one dose of study intervention.  Participants 
will be analyzed according to the product they actually 
received.
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Defined Population for 
Analysis
Description
Full Analysis Set
All participants randomly assigned to study intervention and 
received at least one dose of study intervention. Participants 
will be analyzed according to the product they were 
randomized.
 
 
9.4. Statistical Analyses
The SAP will be developed and finalized before database lock and will describe the 
participant populations to be included in the analyses, and procedures for accounting for 
missing, unused, and spurious data.  This section is a summary of the planned statistical 
analyses of the primary and secondary endpoints.
9.4.1. Efficacy Analyses
Continuous variables will be summarized by N, mean, median, standard deviation, minimum 
and maximum.  Categorical variables will be summarized by count and percent of 
participants in each group.  All summaries will be split by treatment group.  Efficacy data 
will be listed, tabulated and summarized graphically, as appropriate.  Model assumptions will 
be tested using appropriate statistical or graphical techniques.  
 
If statistical hypothesis testing is performed, tests will be conducted at the %=0.025 
(one-sided) level.  Analysis results will include the estimated effect and 95% confidence 
intervals.  
The primary population of interest for efficacy analysis is the Full Analysis Set (FAS) which 
will include all randomized participants who have received at least 1 dose of study 
intervention.  Additional analysis populations may be defined in the SAP.
The final analyses will be performed when all participants complete Week 52.  
Further details of analyses in efficacy will be specified in the statistical analysis plan. 
9.4.2. Analysis of the Primary Endpoint
The primary endpoint is the proportion of SRI-4 responders at Week 52 and the primary 
analysis of this endpoint will be based on the Cochran-Mantel-Haenszel (CMH) approach 
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adjusting for stratification factors. The hypothesis testing of this endpoint will be based on 
the p-values for pairwise treatment between each dose group of PF-06700841 and the 
placebo group.  Treatment difference in the proportion of responders for the active treatment 
groups compared to the placebo will be estimated based on the CMH approach.  These 
estimates will be reported with 95% confidence intervals and one-sided p-values. A 
supplementary analysis using a generalized linear marginal model for repeated measures 
(GLMMRM) will be performed for the longitudinal SRI-4 endpoint data. This model will 
include treatment, visit, treatment by visit interaction as fixed effects.  A common AR(1) 
variance-covariance matrix for all treatment groups will be used to model the variability 
among longitudinal observations within a participant.  If there are any concerns with model 
convergence, covariance structures of compound symmetry will be attempted. Unlike the 
non-responder imputation for missing data in the primary analysis, missing at random is 
assumed for missing data in the GLMMRM analysis. Details will be provided in the SAP.  
 
9.4.3. Analysis of Secondary Endpoints
9.4.3.1. Analysis of Key Secondary Endpoint
The key secondary endpoint is the proportion of BICLA responders at Week 52 and the 
primary analysis of this endpoint will be conducted in the manner described above for the 
primary endpoint using the CMH approach adjusting for stratification factors.  The 
hypothesis testing of this endpoint will be based on the p-values for pairwise treatment 
comparisons between each dose group of PF-06700841 and the placebo group.  Treatment 
difference in the proportion of responders for the active treatment compared to the placebo 
will be estimated based on the CMH approach.  These estimates will be reported with 95% 
confidence intervals and one-sided p-values.
9.4.3.2. Analysis of Other Secondary Endpoints
The proportion of participants achieving LLDAS, oral corticosteroid reductions, and SRI-4 
response with sustained reduction of oral corticosteroids will be estimated using similar 
methods for the SRI-4 responder analysis.
A linear mixed model will be used to analyze the continuous longitudinal response of 
CLASI-A, FACIT-F and LupusQoL.  This linear mixed model will include fixed effects for 
treatment, week, treatment by week interaction, and the stratification factors.  Other 
covariates may be included in the analysis if deemed appropriate.  Participant variable will be 
modeled as a random effect with an unstructured covariance.  Further details regarding 
imputation methods for missing data and any sensitivity analyses will be provided in the 
SAP.
Occurrence of severe flares will be analyzed as a time to event endpoint.  Time to first severe 
flare will be tested to compare treatment groups with placebo based on a log-rank test with 
estimates from the Kaplan-Meier product-limit method.  The corresponding Kaplan-Meier 
plot will also be used to visualize differences in the incidence of flares over time.  The hazard 
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ratio will be estimated using a Cox regression model. The stratification variables will be 
included as covariates when there is no convergence issue.
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
9.4.6. Safety Analysis
The safety analysis will include all participants who have received at least one dose of study 
drug or placebo.  Safety data will be presented in tabular and/or graphical format and 
summarized descriptively, where appropriate.  All safety endpoints will be listed and 
summarized in accordance with Pfizer Data Standards.  Categorical outcomes (eg, AEs) will 
be summarized by participant counts and percentage.  Continuous outcome (eg, BP, heart 
rate, ECG intervals, etc) will be summarized using N, mean, median, standard deviation, etc.  
Laboratory data, ECG intervals and vital signs crossing the thresholds of clinical concern will 
be tabulated according to sponsor Data Standards.  Participant listings will be produced for 
these safety endpoints accordingly.
Data relevant to the assessment of suicidality will be mapped to the Columbia-Classification 
Algorithm of Suicide Assessment (C-CASA) codes.  Baseline 
 C-SSRS data 
(mapped to C-CASA scores) will be summarized descriptively by treatment group at baseline 
 
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Details of the safety analyses will be included in the SAP.
9.4.7. Adverse Events
The safety analyses will be carried out in the safety population and detailed analyses will be 
described in the SAP. 
 
  There will be no adjustment for multiple comparisons or stratification factor in 
the analyses unless specified.
Nominal p-values (Tier 1 events only) and 95% confidence intervals (Tier 1 and Tier 2 
events) will be provided for between treatment differences in the percentage of participants 
with events.  Reporting p-values and confidence intervals will follow Pfizer standard practice 
in the 3-tier approach.
9.4.8. Electrocardiogram
Changes from baseline for the ECG parameters of heart rate, QT interval, QTc interval, PR 
interval, and QRS complex will be summarized by treatment and time.
The number (%) of participants with maximum postdose QTc values and maximum increases 
from baseline in the following categories will be tabulated by treatment: 
Safety QTc Assessment
Degree of Prolongation
Mild (msec)
Moderate (msec)
Severe (msec)
Absolute value
>450-480
>480-500
>500
Increase from baseline
30-60
>60
In addition, the number of participants with uncorrected QT values >500 msec will be 
summarized.
9.5. Interim Analysis 
An Interim analysis may be conducted when sufficient number of participants completes 
Week 52 visits and before the interim analysis is instigated, the details of the objectives, 
decision criteria, dissemination plan and method of maintaining the study blind per Pfizer’s 
SOPs will be documented and approved in the E-DMC charter.  In addition, the analysis 
details must be documented and approved in an interim analysis plan (IAP).
9.5.1. Data Monitoring Committee
This study will use an independent external data monitoring committee (E-DMC).  The 
E-DMC will be responsible for ongoing monitoring of safety of participants in the study 
according to the charter. 
This E-DMC will make recommendations with regard to continuing, stopping or altering the 
trial to a Sponsor Management Committee throughout the study. If an interim analysis is 
performed, the interim analysis results will also be provided to the E-DMC for review, 
stopping or altering the trial to a Sponsor Management Committee throughout the study. 
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Additional information can be obtained in the E-DMC charter.
9.5.2. Adjudication Committees
This study will also use separate blinded adjudication commitees consisting of independent 
external experts who will be responsible for the ongoing review of the following efficacy and 
safety endpoints:
1. BILAG, SLEDAI and associated data.  
2. Severe Flare.
3. Cardiovascular and thromboembolic events.
4. Malignancy.
5. Opportunistic infections.
The results of the adjudication committees’ decisions will be databased and be used for the 
statistical analyses of these endpoints.  The details of these analyses will be described in the 
SAP.  
Specific details on this process and additional information can be obtained in the adjudication 
committee charters.
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10. SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS
10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations
10.1.1. Regulatory and Ethical Considerations
This study will be conducted in accordance with the protocol and with the following:
!
Consensus ethical principles derived from international guidelines including the 
Declaration of Helsinki and Council for International Organizations of Medical 
Sciences (CIOMS) International Ethical Guidelines;
!
Applicable International Council for Harmonisation (ICH) Good Clinical Practice 
(GCP) guidelines;
!
Applicable laws and regulations, including applicable privacy laws.
The protocol, protocol amendments, ICD, investigator’s brochure (IB), and other relevant 
documents (eg, advertisements) must be reviewed and approved by the sponsor and 
submitted to an IRB/EC by the investigator and reviewed and approved by the IRB/EC 
before the study is initiated.
Any amendments to the protocol will require IRB/EC approval before implementation of 
changes made to the study design, except for changes necessary to eliminate an immediate 
hazard to study participants.
The investigator will be responsible for the following:
!
Providing written summaries of the status of the study to the IRB/EC annually or 
more frequently in accordance with the requirements, policies, and procedures 
established by the IRB/EC;
!
Notifying the IRB/EC of SAEs or other significant safety findings as required by 
IRB/EC procedures;
!
Providing oversight of the conduct of the study at the site and adherence to 
requirements of 21 Code of Federal Regulations (CFR), ICH guidelines, the IRB/EC, 
European regulation 536/2014 for clinical studies (if applicable), and all other 
applicable local regulations.
10.1.1.1. Reporting of Safety Issues and Serious Breaches of the Protocol or ICH GCP
In the event of any prohibition or restriction imposed (ie, clinical hold) by an applicable 
regulatory authority in any area of the world, or if the investigator is aware of any new 
information that might influence the evaluation of the benefits and risks of the study 
intervention, Pfizer should be informed immediately. 
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In addition, the investigator will inform Pfizer immediately of any urgent safety measures 
taken by the investigator to protect the study participants against any immediate hazard, and 
of any serious breaches of this protocol or of ICH GCP that the investigator becomes aware 
of.
10.1.2. Financial Disclosure
Investigators and subinvestigators will provide the sponsor with sufficient, accurate financial 
information as requested to allow the sponsor to submit complete and accurate financial 
certification or disclosure statements to the appropriate regulatory authorities.  Investigators 
are responsible for providing information on financial interests during the course of the study 
and for 1 year after completion of the study.
10.1.3. Informed Consent Process
The investigator or his/her representative will explain the nature of the study to the 
participant or his/her legally authorized representative and answer all questions regarding the 
study.
Participants must be informed that their participation is voluntary.  Participants will be 
required to sign a statement of informed consent that meets the requirements of 21 CFR 50, 
local regulations, ICH guidelines, Health Insurance Portability and Accountability Act 
(HIPAA) requirements, where applicable, and the IRB/EC or study center.
The investigator must ensure that each study participant [or his or her legally authorized 
representative] is fully informed about the nature and objectives of the study, the sharing of 
data related to the study, and possible risks associated with participation, including the risks 
associated with the processing of the participant’s personal data. 
The participant must be informed that his/her personal study-related data will be used by the 
sponsor in accordance with local data protection law.  The level of disclosure must also be 
explained to the participant.
The participant must be informed that his/her medical records may be examined by Clinical 
Quality Assurance auditors or other authorized personnel appointed by the sponsor, by 
appropriate IRB/EC members, and by inspectors from regulatory authorities.
The investigator further must ensure that each study participant or his or her legally
authorized representative] is fully informed about his or her right to access and correct his or 
her personal data and to withdraw consent for the processing of his or her personal data.
The medical record must include a statement that written informed consent was obtained 
before the participant was enrolled in the study and the date the written consent was obtained.  
The authorized person obtaining the informed consent must also sign the ICD.
Participants must be reconsented to the most current version of the ICD(s) during their 
participation in the study.
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A copy of the ICD(s) must be provided to the participant or the participant’s legally 
authorized representative.
Participants who are rescreened are required to sign a new ICD.
 
 
 
 
 
10.1.4. Data Protection
All parties will comply with all applicable laws, including laws regarding the implementation 
of organizational and technical measures to ensure protection of participant data.
Participants’ personal data will be stored at the study site in [encrypted electronic and/or 
paper] form and will be [password protected or secured in a locked room] to ensure that only 
authorized study staff have access.  The study site will implement appropriate technical and 
organizational measures to ensure that the personal data can be recovered in the event of 
disaster.  In the event of a potential personal data breach, the study site shall be responsible 
for determining whether a personal data breach has in fact occurred and, if so, providing 
breach notifications as required by law.
To protect the rights and freedoms of natural persons with regard to the processing of 
personal data, participants will be assigned a single, participant-specific numerical code.  
Any participant records or data sets that are transferred to the sponsor will contain the 
numerical code; participant names will not be transferred.  All other identifiable data 
transferred to the sponsor will be identified by this single, participant-specific code.  The 
study site will maintain a confidential list of participants who participated in the study, 
linking each participant’s numerical code to his or her actual identity.  In case of data 
transfer, the sponsor will protect the confidentiality of participants’ personal data consistent 
with the clinical study agreement and applicable privacy laws.
10.1.5. Dissemination of Clinical Study Data
Pfizer fulfills its commitment to publicly disclose clinical study results through posting the 
results of studies on www.clinicaltrials.gov (ClinicalTrials.gov), the European Clinical Trials 
Database (EudraCT), and/or www.pfizer.com, and other public registries in accordance with 
applicable local laws/regulations.  In addition, Pfizer reports study results outside of the 
requirements of local laws/regulations pursuant to its standard operating procedures (SOPs).
In all cases, study results are reported by Pfizer in an objective, accurate, balanced, and
complete manner and are reported regardless of the outcome of the study or the country in 
which the study was conducted.
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www.clinicaltrials.gov
Pfizer posts clinical trial US Basic Results on www.clinicaltrials.gov for Pfizer-sponsored 
interventional studies (conducted in participants) that evaluate the safety and/or efficacy of a 
product, regardless of the geographical location in which the study is conducted.  US Basic 
Results are generally submitted for posting within 1 year of the primary completion date 
(PCD) for studies in adult populations or within 6 months of the PCD for studies in pediatric 
populations.
EudraCT
Pfizer posts clinical trial results on EudraCT for Pfizer-sponsored interventional studies in 
accordance with the format and timelines set forth by EU requirements.
www.pfizer.com
Documents within marketing authorization packages/submissions
Pfizer complies with the European Union Policy 0070, the proactive publication of clinical 
data to the European Medicines Agency (EMA) website.  Clinical data, under Phase 1 of this 
policy, includes clinical overviews, clinical summaries, CSRs, and appendices containing the 
protocol and protocol amendments, sample CRFs, and statistical methods.  Clinical data, 
under Phase 2 of this policy, includes the publishing of individual participant data.  Policy 
0070 applies to new marketing authorization applications submitted via the centralized 
procedure since 01 January 2015 and applications for line extensions and for new indications 
submitted via the centralized procedure since 01 July 2015.
Data Sharing
Pfizer provides researchers secure access to participant-level data or full CSRs for the 
purposes of “bona-fide scientific research” that contribute to the scientific understanding of 
the disease, target, or compound class.  Pfizer will make available data from these trials 
24 months after study completion.  Participant-level data will be anonymized in accordance 
with applicable privacy laws and regulations.  CSRs will have personally identifiable 
information redacted.
Data requests are considered from qualified researchers with the appropriate competencies to 
perform the proposed analyses.  Research teams must include a biostatistician.  Data will not 
be provided to applicants with significant conflicts of interest, including individuals 
requesting access for commercial/competitive or legal purposes.
10.1.6. Data Quality Assurance
All participant data relating to the study will be recorded on printed or electronic CRF unless 
transmitted to the sponsor or designee electronically (eg, laboratory data).  The investigator is 
responsible for verifying that data entries are accurate and correct by physically or 
electronically signing the CRF.
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The investigator must maintain accurate documentation (source data) that supports the 
information entered in the CRF.
The investigator must ensure that the CRFs are securely stored at the study site in [encrypted 
electronic and/or paper] form and are [password protected or secured in a locked room] to 
prevent access by unauthorized third parties.
The investigator must permit study-related monitoring, audits, IRB/EC review, and 
regulatory agency inspections and provide direct access to source data documents.  This 
verification may also occur after study completion.  It is important that the investigator(s) 
and their relevant personnel are available during the monitoring visits and possible audits or 
inspections and that sufficient time is devoted to the process.
Monitoring details describing strategy (eg, risk-based initiatives in operations and quality 
such as risk management and mitigation strategies and analytical risk-based monitoring), 
methods, responsibilities, and requirements, including handling of noncompliance issues and 
monitoring techniques (central, remote, or on-site monitoring), are provided in the 
[monitoring plan] [contracts].
The sponsor or designee is responsible for the data management of this study, including 
quality checking of the data.
Study monitors will perform ongoing source data verification to confirm that data entered 
into the CRF by authorized site personnel are accurate, complete, and verifiable from source 
documents; that the safety and rights of participants are being protected; and that the study is 
being conducted in accordance with the currently approved protocol and any other study 
agreements, ICH GCP, and all applicable regulatory requirements.
Records and documents, including signed ICDs, pertaining to the conduct of this study must 
be retained by the investigator for 15 years after study completion unless local regulations or 
institutional policies require a longer retention period.  No records may be destroyed during 
the retention period without the written approval of the sponsor.  No records may be 
transferred to another location or party without written notification to the sponsor.  The 
investigator must ensure that the records continue to be stored securely for as long as they are 
maintained.
When participant data are to be deleted, the investigator will ensure that all copies of such 
data are promptly and irrevocably deleted from all systems.
The investigator(s) will notify the sponsor or its agents immediately of any regulatory 
inspection notification in relation to the study.  Furthermore, the investigator will cooperate 
with the sponsor or its agents to prepare the investigator site for the inspection and will allow 
the sponsor or its agent, whenever feasible, to be present during the inspection.  The 
investigator site and investigator will promptly resolve any discrepancies that are identified 
between the study data and the participant's medical records.  The investigator will promptly 
provide copies of the inspection findings to the sponsor or its agent.  Before response 
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submission to the regulatory authorities, the investigator will provide the sponsor or its 
agents with an opportunity to review and comment on responses to any such findings.
10.1.7. Source Documents
Source documents provide evidence for the existence of the participant and substantiate the 
integrity of the data collected.  Source documents are filed at the investigator site.
Data reported on the CRF or entered in the electronic CRF (eCRF) that are transcribed from 
source documents must be consistent with the source documents or the discrepancies must be 
explained.  The investigator may need to request previous medical records or transfer 
records, depending on the study.  Also, current medical records must be available.
Definition of what constitutes source data can be found in the study completion guidelines. 
10.1.8. Study and Site Closure
The sponsor designee reserves the right to close the study site or terminate the study at any 
time for any reason at the sole discretion of the sponsor. Study sites will be closed upon study 
completion.  A study site is considered closed when all required documents and study 
supplies have been collected and a study-site closure visit has been performed.
The investigator may initiate study-site closure at any time upon notification to the contract 
research organization (CRO) if requested to do so by the responsible IRB/EC or if such 
termination is required to protect the health of study participants.
Reasons for the early closure of a study site by the sponsor may include but are not limited 
to:
!
Failure of the investigator to comply with the protocol, the requirements of the 
IRB/EC or local health authorities, the sponsor's procedures, or GCP guidelines;
!
Inadequate recruitment of participants by the investigator;
Discontinuation of further study intervention development. Study termination is also 
provided for in the clinical study agreement.  If there is any conflict between the contract and 
this protocol, the contract will control as to termination rights.
10.1.9. Publication Policy
The results of this study may be published or presented at scientific meetings by the 
investigator after publication of the overall study results or 1 year after end of the study (or 
study termination), whichever comes first. 
The investigator agrees to refer to the primary publication in any subsequent publications 
such as secondary manuscripts, and submits all manuscripts or abstracts to the sponsor 
30 days before submission.  This allows the sponsor to protect proprietary information and to 
provide comments and the investigator will, on request, remove any previously undisclosed 
confidential information before disclosure, except for any study or Pfizer 
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intervention- related- information necessary for the appropriate scientific presentation or 
understanding of the study results.
For all publications relating to the study, the investigator will comply with recognized ethical 
standards concerning publications and authorship, including those established by the 
International Committee of Medical Journal Editors.
The sponsor will comply with the requirements for publication of the overall study results 
covering all investigator sites.  In accordance with standard editorial and ethical practice, the 
sponsor will support publication of multicenter studies only in their entirety and not as 
individual site data.  In this case, a coordinating investigator will be designated by mutual 
agreement.
Authorship of publications for the overall study results will be determined by mutual 
agreement and in line with International Committee of Medical Journal Editors authorship 
requirements. 
If publication is addressed in the clinical study agreement, the publication policy set out in 
this section will not apply.
10.1.10. Sponsor’s Qualified Medical Personnel
The contact information for the sponsor's appropriately qualified medical personnel for the 
study is documented in the study contact list located in the supporting study 
documentation/team SharePoint site/study portal/clinical trial management system 
(CTMS)/study team on demand (SToD) system.  
To facilitate access to appropriately qualified medical personnel on study-related medical 
questions or problems, participants are provided with a contact card.  The contact card 
contains, at a minimum, protocol and study intervention identifiers, participant numbers, 
contact information for the investigator site, and contact details for a contact center in the 
event that the investigator site staff cannot be reached to provide advice on a medical 
question or problem originating from another healthcare professional not involved in the 
participant’s participation in the study.  The contact number can also be used by investigator 
staff if they are seeking advice on medical questions or problems; however, it should be used 
only in the event that the established communication pathways between the investigator site 
and the study team are not available.  It is therefore intended to augment, but not replace, the 
established communication pathways between the investigator site and the study team for 
advice on medical questions or problems that may arise during the study.  The contact 
number is not intended for use by the participant directly, and if a participant calls that 
number, he or she will be directed back to the investigator site.
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10.2. Appendix 2: Clinical Laboratory Tests
The following safety laboratory tests will be performed at times defined in the Schedule of 
Activities section of this protocol.  Additional laboratory results may be reported on these 
samples as a result of the method of analysis or the type of analyzer used by the clinical 
laboratory; or as derived from calculated values.  These additional tests would not require 
additional collection of blood.  Unscheduled clinical laboratory measurements may be 
obtained at any time during the study to assess any perceived safety concerns.
Table 5.
Laboratory Tests
Hematology
Chemistry
Urinalysis
Other
Hemoglobin
Hematocrit
RBC count
Platelet count
WBC count with 
differential
Total neutrophils (%, Abs)
Eosinophils (%, Abs)
Basophils (%, Abs)
Lymphocytes (%, Abs)
Monocytes (%, Abs)
Reticulocyte count (%, 
Abs)
PT/PTT/International 
Normalized Ratio (INR)
Complement (will include 
but are not limited to 
C3 and C4)
Direct Coombs test (local 
laboratories) 
BUN
Creatinine
Cystatin
eGFR Creatinine
eGFR Cystatin
Creatine 
Phosphokinase
Glucose (fasting & non 
fasting)
Sodium
Potassium
Chloride
Calcium
Total CO2
(Bicarbonate)
AST, ALT
Total Indirect and 
Direct Bilirubin 
Alkaline phosphatase
Uric acid
Albumin
Total protein
Lipid Profile Panel:a
Total Cholesterol
LDL-Cholesterol 
(direct)
HDL-Cholesterol
Triglycerides
pH
Glucose 
(qual)
Protein (qual)
Blood (qual)
Ketones
Nitrites
Leukocyte 
esterase
Myoglobin
Microscopyb
Spot Urine 
(Upr:Ucr)c
HBsAg
HBcAb
Hep B reflex, if applicable
HCVAb
Hep C reflex, if applicable
HIVd
∀-hCGe FSHf
IGRA (T-SPOT® TB test, QFT-GIT, QFT-G 
or QFT-G Plus)
 
 
 
 
 
 
 
 
a.
Lipid profile panel requires a minimum fast of 8 hours as possible.
b.
At all visits.
c.
Preferably collected after the first morning void; will be analyzed at the central laboratory using an aliquot 
of spot urine collected from participants.
d.
At screening only; confirmation and documentation of negative HIV test result within 12 weeks prior to 
screening is acceptable.
e.
Serum/urine pregnancy tests for WOCBP; serum pregnancy test must be performed at screening for all 
WOCBP as defined in the eligibility criteria; urine pregnancy test must be performed at Day 1 for all 
WOCBP prior to dosing with study intervention and at all subsequent visits.
f.
FSH at screening only to confirm post menopausal status.
 
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Investigators must document their review of each laboratory safety report.
Laboratory results that could unblind the study will not be reported to investigator sites or 
other blinded personnel until the study has been unblinded.
 
 
 
 
 
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10.3. Appendix 3: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-up, and Reporting
10.3.1. Definition of AE
AE Definition
!
An AE is any untoward medical occurrence in a patient or clinical study participant, 
temporally associated with the use of study intervention, whether or not considered 
related to the study intervention.
NOTE: An AE can therefore be any unfavorable and unintended sign (including an 
abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally 
associated with the use of study intervention.
Events Meeting the AE Definition
!
Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) 
or other safety assessments (eg, ECG, radiological scans, vital sign measurements), 
including those that worsen from baseline, considered clinically significant in the 
medical and scientific judgment of the investigator (ie, not related to progression of 
underlying disease).
!
Exacerbation of a chronic or intermittent preexisting condition including either an 
increase in frequency and/or intensity of the condition.
!
New conditions detected or diagnosed after study intervention administration even 
though it may have been present before the start of the study.
!
Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction.
!
Signs, symptoms, or the clinical sequelae of a suspected overdose of either study 
intervention or a concomitant medication.  Overdose per se will not be reported as 
an AE/SAE unless it is an intentional overdose taken with possible 
suicidal/self-harming intent.  Such overdoses should be reported regardless of 
sequelae.
!
“Lack of efficacy” or “failure of expected pharmacological action” per se will not 
be reported as an AE or SAE.  Such instances will be captured in the efficacy 
assessments.  However, the signs, symptoms, and/or clinical sequelae resulting 
from lack of efficacy will be reported as an AE or SAE if they fulfill the definition 
of an AE or SAE.
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Events NOT Meeting the AE Definition
!
Any clinically significant abnormal laboratory findings or other abnormal safety 
assessments which are associated with the underlying disease, unless judged by the 
investigator to be more severe than expected for the participant’s condition.
!
The disease/disorder being studied or expected progression, signs, or symptoms of 
the disease/disorder being studied, unless more severe than expected for the 
participant’s condition.
!
Medical or surgical procedure (eg, endoscopy, appendectomy): the condition that 
leads to the procedure is the AE.
!
Situations in which an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital).
!
Anticipated day-to-day fluctuations of preexisting disease(s) or condition(s) present 
or detected at the start of the study that do not worsen.
10.3.2. Definition of SAE
If an event is not an AE per definition above, then it cannot be an SAE even if serious 
conditions are met (eg, hospitalization for signs/symptoms of the disease under study, death 
due to progression of disease).
An SAE is defined as any untoward medical occurrence that, at any dose:
a. Results in death
b. Is life-threatening
The term “life-threatening” in the definition of “serious” refers to an event in which the 
participant was at risk of death at the time of the event.  It does not refer to an event that 
hypothetically might have caused death if it were more severe.
c.
Requires inpatient hospitalization or prolongation of existing hospitalization
In general, hospitalization signifies that the participant has been detained (usually 
involving at least an overnight stay) at the hospital or emergency ward for observation 
and/or treatment that would not have been appropriate in the physician’s office or 
outpatient setting.  Complications that occur during hospitalization are AEs.  If a 
complication prolongs hospitalization or fulfills any other serious criteria, the event is 
serious.  When in doubt as to whether “hospitalization” occurred or was necessary, the AE 
should be considered serious.
Hospitalization for elective treatment of a preexisting condition that did not worsen from 
baseline is not considered an AE.
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d. Results in persistent disability/incapacity
!
The term disability means a substantial disruption of a person’s ability to conduct 
normal life functions.
!
This definition is not intended to include experiences of relatively minor medical 
significance such as uncomplicated headache, nausea, vomiting, diarrhea, 
influenza, and accidental trauma (eg, sprained ankle) which may interfere with or 
prevent everyday life functions but do not constitute a substantial disruption.
e.
Is a congenital anomaly/birth defect
f.
Other situations:
!
Medical or scientific judgment should be exercised in deciding whether SAE 
reporting is appropriate in other situations such as important medical events that 
may not be immediately life-threatening or result in death or hospitalization but 
may jeopardize the participant or may require medical or surgical intervention to 
prevent one of the other outcomes listed in the above definition.  These events 
should usually be considered serious.
!
Examples of such events include invasive or malignant cancers, intensive treatment 
in an emergency room or at home for allergic bronchospasm, blood dyscrasias or 
convulsions that do not result in hospitalization, or development of drug 
dependency or drug abuse.
10.3.3. Recording/Reporting and Follow-up of AEs and/or SAEs
AE and SAE Recording/Reporting
The table below summarizes the requirements for recording adverse events on the CRF 
and for reporting serious adverse events on the Clinical Trial (CT) Serious Adverse Event 
(SAE) Report Form to Pfizer Safety.  These requirements are delineated for 3 types of 
events: (1) SAEs; (2) nonserious adverse events (AEs); and (3) exposure to the study 
intervention under study during pregnancy or breastfeeding, and occupational exposure. 
It should be noted that the CT SAE Report Form for reporting of SAE information is not 
the same as the AE page of the CRF.  When the same data are collected, the forms must be 
completed in a consistent manner.  AEs should be recorded using concise medical 
terminology and the same AE term should be used on both the CRF and the CT SAE 
Report Form for reporting of SAE information.
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Safety Event
Recorded on the 
CRF
Reported on the CT SAE 
Report Form to Pfizer 
Safety Within 24 Hours of 
Awareness
SAE
All
All
Nonserious AE
All
None
Exposure to the study 
intervention under study during 
pregnancy or breastfeeding, and 
occupational exposure
All AEs/SAEs 
associated with 
exposure during 
pregnancy or 
breastfeeding
Occupational 
exposure is not 
recorded.
All (and exposure during 
pregnancy [EDP] 
supplemental form for EDP)  
!
When an AE/SAE occurs, it is the responsibility of the investigator to review all 
documentation (eg, hospital progress notes, laboratory reports, and diagnostic 
reports) related to the event.
!
The investigator will then record all relevant AE/SAE information in the CRF.
!
It is not acceptable for the investigator to send photocopies of the participant’s 
medical records to Pfizer Safety in lieu of completion of the CT SAE Report 
Form/AE/SAE CRF page.
!
There may be instances when copies of medical records for certain cases are 
requested by Pfizer Safety.  In this case, all participant identifiers, with the 
exception of the participant number, will be redacted on the copies of the medical 
records before submission to Pfizer Safety.
!
The investigator will attempt to establish a diagnosis of the event based on signs, 
symptoms, and/or other clinical information.  Whenever possible, the diagnosis 
(not the individual signs/symptoms) will be documented as the AE/SAE.
Assessment of Intensity
The investigator will make an assessment of intensity for each AE and SAE reported 
during the study and assign it to 1 of the following categories: 
!
Mild: An event that is easily tolerated by the participant, causing minimal 
discomfort and not interfering with everyday activities.
!
Moderate: An event that causes sufficient discomfort and interferes with normal 
everyday activities.
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!
Severe: An event that prevents normal everyday activities.  An AE that is assessed 
as severe should not be confused with an SAE.  Severe is a category utilized for 
rating the intensity of an event; and both AEs and SAEs can be assessed as severe.
!
An event is defined as “serious” when it meets at least 1 of the predefined 
outcomes as described in the definition of an SAE, NOT when it is rated as severe.
Assessment of Causality
!
The investigator is obligated to assess the relationship between study intervention 
and each occurrence of each AE/SAE.
!
A “reasonable possibility” of a relationship conveys that there are facts, evidence, 
and/or arguments to suggest a causal relationship, rather than a relationship cannot 
be ruled out.
!
The investigator will use clinical judgment to determine the relationship.
!
Alternative causes, such as underlying disease(s), concomitant therapy, and other 
risk factors, as well as the temporal relationship of the event to study intervention 
administration will be considered and investigated.
!
The investigator will also consult the investigator’s brochure (IB) and/or product 
information, for marketed products, in his/her assessment.
!
For each AE/SAE, the investigator must document in the medical notes that he/she 
has reviewed the AE/SAE and has provided an assessment of causality.
!
There may be situations in which an SAE has occurred and the investigator has 
minimal information to include in the initial report to the sponsor.  However, it is 
very important that the investigator always make an assessment of causality 
for every event before the initial transmission of the SAE data to the sponsor.
!
The investigator may change his/her opinion of causality in light of follow-up 
information and send an SAE follow-up report with the updated causality 
assessment.
!
The causality assessment is one of the criteria used when determining regulatory 
reporting requirements.
!
If the investigator does not know whether or not the study intervention caused the 
event, then the event will be handled as “related to study intervention” for reporting 
purposes, as defined by the sponsor.  In addition, if the investigator determines that
an SAE is associated with study procedures, the investigator must record this 
causal relationship in the source documents and CRF, and report such an 
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assessment in the dedicated section of the CT SAE Report Form and in accordance 
with the SAE reporting requirements.
Follow-up of AEs and SAEs
!
The investigator is obligated to perform or arrange for the conduct of supplemental 
measurements and/or evaluations as medically indicated or as requested by the 
sponsor to elucidate the nature and/or causality of the AE or SAE as fully as 
possible.  This may include additional laboratory tests or investigations, 
histopathological examinations, or consultation with other healthcare professionals.
!
If a participant dies during participation in the study or during a recognized 
follow-up period, the investigator will provide Pfizer Safety with a copy of any 
postmortem findings including histopathology.
!
New or updated information will be recorded in the originally completed CRF.
!
The investigator will submit any updated SAE data to the sponsor within 24 hours 
of receipt of the information.
10.3.4. Reporting of SAEs
SAE Reporting to Pfizer Safety via an Electronic Data Collection Tool
!
The primary mechanism for reporting an SAE to Pfizer Safety will be the electronic 
data collection tool.
!
If the electronic system is unavailable, then the site will use the paper SAE data 
collection tool (see next section) in order to report the event within 24 hours.
!
The site will enter the SAE data into the electronic system as soon as the data 
become available.
!
After the study is completed at a given site, the electronic data collection tool will 
be taken off-line to prevent the entry of new data or changes to existing data.
!
If a site receives a report of a new SAE from a study participant or receives updated 
data on a previously reported SAE after the electronic data collection tool has been 
taken off-line, then the site can report this information on a paper SAE form (see 
next section) or to Pfizer Safety by telephone.
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SAE Reporting to Pfizer Safety via CT SAE Report Form
!
Facsimile transmission of the CT SAE Report Form is the preferred method to 
transmit this information to Pfizer Safety.
!
In circumstances when the facsimile is not working, notification by telephone is 
acceptable with a copy of the CT SAE Report Form sent by overnight mail or 
courier service.
!
Initial notification via telephone does not replace the need for the investigator to 
complete and sign the CT SAE Report Form pages within the designated reporting 
time frames.
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10.4. Appendix 4: Contraceptive Guidance and Collection of Pregnancy Information
10.4.1. Male Participants
No contraception methods are required for male participants in this study, as the calculated 
safety margin is ≥100-fold between the estimated maternal exposure due to seminal transfer 
and the NOAEL for serious manifestations of developmental toxicity in nonclinical studies.
10.4.2. Female Participant Reproductive Inclusion Criteria
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at 
least 1 of the following conditions applies:
!
Is not a WOCBP (see definitions below in Section 10.4.3).
OR
!
Is a WOCBP and using a contraceptive method that is highly effective (with a failure 
rate of <1% per year), as described below during the intervention period and for at 
least 28 days after the last dose of study intervention, which corresponds to the time 
needed to eliminate any study intervention(s).  The investigator should evaluate the 
effectiveness of the contraceptive method in relationship to the first dose of study 
intervention. 
The investigator is responsible for review of medical history, menstrual history, and recent 
sexual activity to decrease the risk for inclusion of a woman with an early undetected 
pregnancy. 
10.4.3. Woman of Childbearing Potential (WOCBP)
A woman is considered fertile following menarche and until becoming postmenopausal 
unless permanently sterile (see below).
If fertility is unclear (eg, amenorrhea in adolescents or athletes) and a menstrual cycle cannot 
be confirmed before the first dose of study intervention, additional evaluation should be 
considered.
Women in the following categories are not considered WOCBP:
1. Premenopausal female with 1 of the following:
!
Documented hysterectomy;
!
Documented bilateral salpingectomy;
!
Documented bilateral oophorectomy.
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For individuals with permanent infertility due to an alternate medical cause other than the 
above, (eg, mullerian agenesis, androgen insensitivity), investigator discretion should be 
applied to determining study entry.
Note: Documentation for any of the above categories can come from the site personnel’s 
review of the participant’s medical records, medical examination, or medical history 
interview.  The method of documentation should be recorded in the participant’s medical 
record for the study.
2. Postmenopausal female:
!
A postmenopausal state is defined as age 60 years or older or no menses for 
12 months without an alternative medical cause.
!
A high follicle-stimulating hormone (FSH) level in the postmenopausal range 
may be used to confirm a postmenopausal state in women not using hormonal 
contraception or hormone replacement therapy (HRT). 
!
Females on HRT and whose menopausal status is in doubt will be required to use 
one of the nonestrogen hormonal highly effective contraception methods if they 
wish to continue their HRT during the study.  Otherwise, they must discontinue 
HRT to allow confirmation of postmenopausal status before study enrollment.
10.4.4. Contraception Methods
Highly Effective Methods That Have Low User Dependency 
1. Implantable progestogen-only hormone contraception associated with inhibition of 
ovulation*.
2. Intrauterine device (IUD).
3. Intrauterine hormone-releasing system (IUS).
4. Bilateral tubal occlusion.
5. Vasectomized partner.
Vasectomized partner is a highly effective contraceptive method provided that the partner is 
the sole sexual partner of the WOCBP and the absence of sperm has been confirmed.  If not, 
an additional highly effective method of contraception should be used.  The spermatogenesis 
cycle is approximately 90 days.
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Highly Effective Methods That Are User Dependent
1. Combined (estrogen- and progestogen-containing) hormonal contraception associated 
with inhibition of ovulation:
!
oral;
!
intravaginal*;
!
transdermal*.
2. Progestogen-only hormone contraception associated with inhibition of ovulation:
!
oral;
!
injectable.
3. Sexual abstinence:
!
Sexual abstinence is considered a highly effective method only if defined as 
refraining from heterosexual intercourse during the entire period of risk associated 
with the study intervention.  The reliability of sexual abstinence needs to be 
evaluated in relation to the duration of the study and the preferred and usual 
lifestyle of the participant.
*not approved in Japan.
Collection of Pregnancy Information
For both unapproved/unlicensed products and for marketed products, an exposure during 
pregnancy (EDP) occurs if:
!
A female becomes, or is found to be, pregnant either while receiving or having been 
exposed (eg, because of treatment or environmental exposure) to the study 
intervention; or the female becomes or is found to be pregnant after discontinuing 
and/or being exposed to the study intervention;
!
An example of environmental exposure would be a case involving direct contact 
with a Pfizer product in a pregnant woman (eg, a nurse reports that she is pregnant 
and has been exposed to chemotherapeutic products).
!
A male has been exposed (eg, because of treatment or environmental exposure) to the 
study intervention prior to or around the time of conception and/or is exposed during 
his partner’s pregnancy.
If a participant or participant’s partner becomes or is found to be pregnant during the 
participant’s treatment with the study intervention, the investigator must report this 
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information to Pfizer Safety on the CT SAE Report Form and an EDP supplemental form, 
regardless of whether an SAE has occurred.  In addition, the investigator must submit 
information regarding environmental exposure to a Pfizer product in a pregnant woman (eg, a 
participant reports that she is pregnant and has been exposed to a cytotoxic product by 
inhalation or spillage) to Pfizer Safety using the EDP supplemental form.  This must be done 
irrespective of whether an AE has occurred and within 24 hours of awareness of the 
exposure.  The information submitted should include the anticipated date of delivery (see 
below for information related to termination of pregnancy).
Follow-up is conducted to obtain general information on the pregnancy and its outcome for 
all EDP reports with an unknown outcome.  The investigator will follow the pregnancy until 
completion (or until pregnancy termination) and notify Pfizer Safety of the outcome as a 
follow-up to the initial EDP supplemental form.  In the case of a live birth, the structural 
integrity of the neonate can be assessed at the time of birth.  In the event of a termination, the 
reason(s) for termination should be specified and, if clinically possible, the structural 
integrity of the terminated fetus should be assessed by gross visual inspection (unless 
preprocedure test findings are conclusive for a congenital anomaly and the findings are 
reported).
If the outcome of the pregnancy meets the criteria for an SAE (ie, ectopic pregnancy, 
spontaneous abortion, intrauterine fetal demise, neonatal death, or congenital anomaly [in a 
live-born baby, a terminated fetus, an intrauterine fetal demise, or a neonatal death]), the 
investigator should follow the procedures for reporting SAEs.
Additional information about pregnancy outcomes that are reported to Pfizer Safety as SAEs 
follows: 
!
Spontaneous abortion includes miscarriage and missed abortion;
!
Neonatal deaths that occur within 1 month of birth should be reported, without regard 
to causality, as SAEs.  In addition, infant deaths after 1 month should be reported as 
SAEs when the investigator assesses the infant death as related or possibly related to 
exposure to the study intervention. 
Additional information regarding the EDP may be requested by the sponsor.  Further 
follow-up of birth outcomes will be handled on a case-by-case basis (eg, follow-up on 
preterm infants to identify developmental delays).  In the case of paternal exposure, the 
investigator will provide the participant with the Pregnant Partner Release of Information 
Form to deliver to his partner.  The investigator must document in the source documents that 
the participant was given the Pregnant Partner Release of Information Form to provide to his 
partner.
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10.6. Appendix 6: Liver Safety: Suggested Actions and Follow-up Assessments
Potential Cases of Drug-Induced Liver Injury
Humans exposed to a drug who show no sign of liver injury (as determined by elevations in 
transaminases) are termed “tolerators,” while those who show transient liver injury, but adapt 
are termed “adaptors.”  In some participants, transaminase elevations are a harbinger of a 
more serious potential outcome.  These participants fail to adapt and therefore are 
"susceptible" to progressive and serious liver injury, commonly referred to as drug-induced 
liver injury (DILI).  Participants who experience a transaminase elevation above 3 times the 
upper limit of normal (× ULN) should be monitored more frequently to determine if they are 
an “adaptor” or are “susceptible.”
In the majority of DILI cases, elevations in aspartate aminotransferase (AST) and/or alanine 
aminotransferase (ALT) precede total bilirubin (TBili) elevations (>2 × ULN) by several 
days or weeks.  The increase in TBili typically occurs while AST/ALT is/are still elevated 
above 3 × ULN (ie, AST/ALT and TBili values will be elevated within the same laboratory 
sample).  In rare instances, by the time TBili elevations are detected, AST/ALT values might 
have decreased.  This occurrence is still regarded as a potential DILI.  Therefore, abnormal 
elevations in either AST OR ALT in addition to TBili that meet the criteria outlined below 
are considered potential DILI (assessed per Hy’s law criteria) cases and should always be 
considered important medical events, even before all other possible causes of liver injury 
have been excluded.
The threshold of laboratory abnormalities for a potential DILI case depends on the 
participant’s individual baseline values and underlying conditions.  Participants who present 
with the following laboratory abnormalities should be evaluated further as potential DILI 
(Hy’s law) cases to definitively determine the etiology of the abnormal laboratory values:
!
Participants with AST/ALT and TBili baseline values within the normal range who 
subsequently present with AST OR ALT values >3 × ULN AND a TBili value 
>2 × ULN with no evidence of hemolysis and an alkaline phosphatase value 
<2 × ULN or not available.
!
For participants with baseline AST OR ALT OR TBili values above the ULN, the 
following threshold values are used in the definition mentioned above, as needed, 
depending on which values are above the ULN at baseline:
!
Preexisting AST or ALT baseline values above the normal range: AST or ALT 
values >2 times the baseline values AND >3 × ULN; or >8 × ULN (whichever is 
smaller).
!
Preexisting values of TBili above the normal range: TBili level increased from 
baseline value by an amount of at least 1 × ULN or if the value reaches 
>3 × ULN (whichever is smaller).
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Rises in AST/ALT and TBili separated by more than a few weeks should be assessed 
individually based on clinical judgment; any case where uncertainty remains as to whether it 
represents a potential Hy’s law case should be reviewed with the sponsor.  
The participant should return to the investigator site and be evaluated as soon as possible, 
preferably within 48 hours from awareness of the abnormal results.  This evaluation should 
include laboratory tests, detailed history, and physical assessment.  
In addition to repeating measurements of AST and ALT and TBili for suspected cases of 
Hy’s law, additional laboratory tests should include albumin, creatine kinase (CK), direct and 
indirect bilirubin, gamma-glutamyl transferase (GGT), prothrombin time (PT)/international 
normalized ratio (INR), total bile acids, and alkaline phosphatase.  Consideration should also 
be given to drawing a separate tube of clotted blood and an anticoagulated tube of blood for 
further testing, as needed, for further contemporaneous analyses at the time of the recognized 
initial abnormalities to determine etiology.  A detailed history, including relevant 
information, such as review of ethanol, acetaminophen (either by itself or as a coformulated 
product in prescription or over-the-counter medications), recreational drug, supplement 
(herbal) use and consumption, family history, sexual history, travel history, history of contact 
with a jaundiced person, surgery, blood transfusion, history of liver or allergic disease, and 
potential occupational exposure to chemicals, should be collected.  Further testing for acute 
hepatitis A, B, C, D, and E infection and liver imaging (eg, biliary tract) and collection of 
serum sample for acetaminophen drug and/or protein adduct levels may be warranted. 
All cases demonstrated on repeat testing as meeting the laboratory criteria of AST/ALT and 
TBili elevation defined above should be considered potential DILI (Hy’s law) cases if no 
other reason for the liver function test (LFT) abnormalities has yet been found.  Such 
potential DILI (Hy’s law) cases are to be reported as SAEs, irrespective of availability 
of all the results of the investigations performed to determine etiology of the LFT 
abnormalities.
A potential DILI (Hy’s law) case becomes a confirmed case only after all results of 
reasonable investigations have been received and have excluded an alternative etiology.
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10.7. Appendix 7: ECG Findings of Potential Clinical Concern
ECG Findings That May Qualify as Adverse Events (AEs)
!
Marked sinus bradycardia (rate <40 bpm) lasting minutes.
!
New PR interval prolongation >280 msec.
!
New prolongation of QTcF to >480msec (absolute) or by ≥60 msec from baseline.
!
New-onset atrial flutter or fibrillation, with controlled ventricular response rate:
ie, rate <120 bpm.
!
New-onset type I second-degree (Wenckebach) AV block of >30 seconds’ 
duration.
!
Frequent premature ventricular complexes (PVCs), triplets, or short intervals 
(<30 seconds) of consecutive ventricular complexes.
ECG Findings That May Qualify as Serious Adverse Events (SAEs)
!
QTcF prolongation >500 msec (will require discontinuation of study drug).
!
New ST-T changes suggestive of myocardial ischemia.
!
New-onset left bundle branch block (QRS >120 msec).
!
New-onset right bundle branch block (QRS >120 msec).
!
Symptomatic bradycardia. 
!
Asystole:
!
In awake, symptom-free patients in sinus rhythm, with documented periods of 
asystole ≥3.0 seconds or any escape rate <40 bpm, or with an escape rhythm 
that is below the AV node; 
!
In awake, symptom-free patients with atrial fibrillation and bradycardia with 1 
or more pauses of at least 5 seconds or longer; 
!
Atrial flutter or fibrillation, with rapid ventricular response rate: rapid = rate 
>120 bpm.
!
Sustained supraventricular tachycardia (rate >120 bpm) (“sustained” = short 
duration with relevant symptoms or lasting >1 minute).
!
Ventricular rhythms >30 seconds’ duration, including idioventricular rhythm 
(rate <40 bpm), accelerated idioventricular rhythm (40< x <100), and 
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monomorphic/polymorphic ventricular tachycardia >100 bpm (such as torsades 
de pointes).
!
Type II second-degree (Mobitz II) AV block.
!
Complete (third-degree) heart block.
ECG Findings That Qualify as Serious Adverse Events
!
Change in pattern suggestive of new myocardial infarction. 
!
Sustained ventricular tachyarrhythmias (>30 seconds’ duration).
!
Second- or third-degree AV block requiring pacemaker placement.
!
Asystolic pauses requiring pacemaker placement.
!
Atrial flutter or fibrillation with rapid ventricular response requiring cardioversion.
!
Ventricular fibrillation/flutter.
!
At the discretion of the investigator, any arrhythmia classified as an adverse 
experience.
The enumerated list of major events of potential clinical concern are recommended as “alerts” or 
notifications from the core ECG laboratory to the investigator and Pfizer study team, and not to be 
considered as all inclusive of what to be reported as AEs/SAEs.
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10.8. Appendix 8: 1997 Update on the 1982 Revised American College of Rheumatology 
(ACR) Criteria for the Classification of SLE 
The American College of Rheumatology (ACR) requires that any 4 or more of the 11 criteria 
are present, simultaneously or in succession to be classified as having SLE: 
Criterion
Definition/Examples
1. Malar rash
Fixed erythema over the malar eminences, tending to spare nasolabial 
folds
2. Discoid rash
Erythematous raised patches with adherent keratotic scaling and 
follicular plugging, atrophic scarring may occur in older lesions
3. Photosensitivity
Skin rash as a result of unusual reaction to sunlight, by patient history 
or physician observation
4. Oral ulcers
Usually painless oral or nasopharyngeal ulcers, observed by physician
5. Arthritis
Non-erosive, involving two or more peripheral joints, characterized by 
tenderness, swelling or effusion
6. Serositis
a. Pleuritis-- convincing history of pleuritic pain or rubbing heard by a 
physician or evidence of pleural effusion,
OR
b. Pericarditis--documented by electrocardiogram or rub or evidence 
of pericardial effusion
7. Renal disorders
a. Persistent proteinuria (>3+ or 500 mcg/day), OR
b. Cellular casts in urine--may be red cell, hemoglobin, granular, 
tubular or mixed
8. Neurological disorder
a. Seizures--in the absence of offending drugs or known metabolic 
derangements, eg, uremia, ketoacidosis or electrolyte imbalance.
OR
b. Psychosis--in the absence of offending drugs or known metabolic 
derangements, eg, uremia, ketoacidosis or electrolyte imbalance.
9. Hematological 
disorder
a. Hemolytic anemia--with reticulocytosis, OR
b. Leukopenia --<4000/cmm total on ≥2 occasions, OR
c. Lymphopenia --<1500/cmm or two or more occasions, OR
d. Thrombocytopenia --<100,000/cmm in the absence of offending 
drugs
10. Immunological 
disorder
a. Anti-DNA antibody to native DNA in abnormal titer, OR
b. Anti-SM antibody to SM nuclear antigen, OR
c. Anti-Phospholipid antibodies
11. Anti-nuclear antibody
Abnormal titer of ANA by immunofluorescence or an equivalent assay 
at any point in time and excluding drug causes
Tan EM, Cohen AS, Fries JF, et al.  The 1982 revised criteria for the classification of systemic lupus erythematosus.  
Arthritis Rheum 1982; 25:1271-7 and Hochberg MC.  Updating the American College of Rheumatology revised criteria for 
the classification of systemic lupus erythematosus [letter].  Arthritis Rheum 1997; 40:1725.
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10.9. Appendix 9: Systemic Lupus International Collaborating Clinics (SLICC) criteria 
The SLICC criteria for SLE classification requires: 1) Fulfillment of at least four criteria, 
with at least one clinical criterion AND one immunologic criterion OR 2) Lupus nephritis as 
the sole clinical criterion in the presence of ANA or anti-dsDNA antibodies. 
Clinical Criteria: 
1. Acute cutaneous lupus.
2. Chronic cutaneous lupus.
3. Oral ulcers: palate.
4. Nonscarring alopecia (diffuse thinning or hair fragility with visible broken hairs).
5. Synovitis involving two or more joints, characterized by swelling or effusion OR 
tenderness in two or more joints and thirty minutes or more of morning stiffness.
6. Serositis.
7. Renal.
8. Neurologic.
9. Hemolytic anemia.
10. Leukopenia (<4000/mm3 at least once).
11. Thrombocytopenia (<100,000/mm3) at least once.
Immunological Criteria 
1. ANA above laboratory reference range.
2. Anti-dsDNA above laboratory reference range, except enzyme linked immunosorbent 
assay (ELISA): twice above laboratory.
3. Anti-Sm.
4. Antiphospholipid antibody: any of the following.
5. Low complement.
6. Direct Coombs test in the absence of hemolytic anemia.
Petri M, Orbai AM, Alarcón GS, et al. Derivation and validation of the Systemic Lupus International Collaborating Clinics 
classification criteria for systemic lupus erythematosus. Arthritis Rheum.2012; 64(8):2677-2686.
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10.10. Appendix 10: Systemic Lupus International Collaborating Clinics 
(SLICC)/American College of Rheumatology (ACR) Damage Index for SLE
Score 
Item
Ocular (either eye, by clinical assessment)
0,1 
Any cataract ever
0,1 
Retinal change or optic atrophy
Neuropsychiatric
0,1 
Cognitive impairment (eg, memory deficit, difficulty with calculation, poor concentration,
difficulty in spoken or written language, impaired performance level) OR major psychosis
0,1 
Seizures requiring therapy for 6 months
0,1,2 
Cerebrovascular accident ever (score 2 if >1)
0,1 
Cranial or peripheral neuropathy (excluding optic)
0,1 
Transverse myelitis
Renal
0,1 
Estimated or measured glomerular filtration rate <50%
0,1 
Proteinuria ≥3.5g/24h
OR 
3
End-stage renal disease (regardless of dialysis or transplantation)
Pulmonary
0,1 
Pulmonary hypertension (right ventricular prominence, or loud P2)
0,1 
Pulmonary fibrosis (physical and radiograph)
0,1 
Shrinking lung (radiograph)
0,1 
Pleural fibrosis (radiograph)
0,1 
Pulmonary infarction (radiograph)
Cardiovascular
0,1 
Angina OR coronary artery bypass
0,1,2 
Myocardial infarction ever (score 2 if >1)
0,1 
Cardiomyopathy (ventricular dysfunction)
0,1 
Valvular disease (diastolic murmur or systolic murmur >3/6)
0,1 
Pericarditis for 6 months, OR pericardectomy
Peripheral vascular
0,1 
Claudication for 6 months
0,1 
Minor tissue loss (pulp space)
0,1,2 
Significant tissue loss ever (eg, loss of digit or limb)(score 2 if >1 site)
0,1 
Venous thrombosis with swelling, ulceration, OR venous stasis
Gastrointestinal
0,1,2 
Infarction or resection of bowel below duodenum, spleen, liver or gallbladder ever, for any
cause (score 2 if >1 site)
0,1 
Mesenteric insufficiency
0,1 
Chronic peritonitis
0,1 
Stricture OR upper gastrointestinal tract surgery ever
0,1 
Chronic pancreatitis
Musculoskeletal
0,1 
Muscle atrophy or weakness
0,1 
Deforming or erosive arthritis (including reducible deformities, excluding avascular necrosis)
0,1 
Osteoporosis with fracture or vertebral collapse (excluding avascular necrosis)
0,1,2 
Avascular necrosis (score 2 if >1)
0,1 
Osteomyelitis
0,1 
Tendon rupture
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Skin
0,1 
Scarring chronic alopecia
0,1 
Extensive scarring of panniculum other than scalp and pulp space
0,1 
Skin ulceration (excluding thrombosis for >6 months)
0,1 
Premature gonadal failure
0,1 
Diabetes (regardless of treatment)
0,1,2 
Malignancy (exclude dysplasia) (score 2 if >1 site)
Damage (nonreversible change, and related to active inflammation) occurring since onset of lupus, ascertained by clinical 
assessment and present for at least 6 months unless otherwise stated.  Repeat episodes must occur at least 6 months apart to 
score 2.  The same lesion cannot be scored twice.
Gladman D, Goldsmith C, Urowitz M, et al. The Systemic Lupus International Collaborating Clinics/American College of 
Rheumatology (SLICC/ACR) Damage Index for Systemic Lupus Erythematosus International Comparison. J Rheumatol. 
2000; 27:373-6.
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10.11. Appendix 11: Systemic Lupus Erythematosus Disease Activity Index-2000 
(SLEDAI-2K)
Disease activity is assessed using a combination of the clinical history, physical exam (PE), organ specific 
functional tests, and serologic studies.  Check box:  If descriptor is present at the time of visit or in the 
preceding 30 days.
Score
Present
Descriptor
Definition
8
Seizure
Recent onset, exclude metabolic, infectious or drug causes.
8
Psychosis
Altered ability to function in normal activity due to severe 
disturbance in the perception of reality.  Include hallucinations, 
incoherence, marked loose associations, impoverished thought 
content, marked illogical thinking, bizarre, disorganized, or 
catatonic behavior.  Exclude uremia and drug causes.
8
Organic Brain Syndrome
Altered mental function with impaired orientation, memory, or 
other intelligent function, with rapid onset and fluctuating clinical 
features, inability to sustain attention to environment, plus at least 
2 of the following: perceptual disturbance, incoherent speech, 
insomnia or daytime drowsiness, or increased or decreased 
psychomotor activity.  Exclude metabolic, infectious or drug 
causes.
8
Visual Disturbance
Retinal changes of SLE.  Include cytoid bodies, retinal 
hemorrhages, serious exudate or hemorrhages in the choroid, or 
optic neuritis.  Exclude hypertension, infection, or drug causes.
8
Cranial Nerve
Disorder
New onset of sensory or motor neuropathy involving cranial 
nerves.
8
Lupus Headache
Severe, persistent headache; may be migrainous, but must be 
nonresponsive to narcotic analgesia.
8
CVA
New onset of cerebrovascular accident(s).  Exclude 
arteriosclerosis.
8
Vasculitis
Ulceration, gangrene, tender finger nodules, periungual infarction, 
splinter hemorrhages, or biopsy or angiogram proof of vasculitis.
4
Arthritis
≥ 2 joints with pain and signs of inflammation (ie, tenderness, 
swelling, or effusion).
4
Myositis
Proximal muscle aching/weakness, associated with elevated 
creatine phosphokinase/adolase or electromyogram changes or a 
biopsy showing myositis.
4
Urinary Casts
Heme-granular or red blood cell casts.
4
Hematuria
>5 red blood cells/high power field.  Exclude stone, infection or 
other cause.
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Score
Present
Descriptor
Definition
4
Proteinuria
>0.5 gram/24 hrs.  
4
Pyuria
>5 white blood cells/high power field.  Exclude infection.
2
Rash
Inflammatory type rash.
2
Alopecia
Abnormal, patchy or diffuse loss of hair.
2
Mucosal Ulcers
Oral or nasal ulcerations.
2
Pleurisy
Pleuritic chest pain with pleural rub or effusion, or pleural 
thickening.
2
Pericarditis
Pericardial pain with at least 1 of the following: rub, effusion, or 
electrocardiogram or echocardiogram confirmation.
2
Low Complement
Decrease in C3 or C4 below the lower limit of normal for testing 
laboratory.
2
Increased DNA
binding
  Increased DNA binding by Farr assay above normal range for 
testing laboratory.
1
Fever
>38°C. Exclude infectious cause.
1
Thrombocytopenia
<100,000 platelets / x 109/ L, exclude drug causes.
1
Leukopenia
<3,000 white blood cell / x 109/ L, exclude drug causes.
TOTAL SCORE
(Sum of weights next to descriptors marked present)
Gladman DD, Ibañez D, Urowitz MB.  Systemic lupus erythematosus disease activity index 2000.  J Rheumatol. 2002 
Feb;29(2):288-91.
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10.12. Appendix 12: British Isles Lupus Assessment Group Index (BILAG)-2004 
Isenberg DA, Rahman A, Allen E, et al.  BILAG 2004.  Development and initial validation of an updated version of the 
British Isles lupus assessment group’s disease activity index for participants with systemic lupus erythematosus.  
Rheumatology 2005;44:9026.
Note: Direct Coombs test to confirm hemolytic anemia may be performed at any visit but should only be performed if the 
investigator suspects a clinically significant hmolytic anemia that will be scored on the BILAG.
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10.13. Appendix 13: List of Prohibited and Permitted Concomitant Medications
Stable dose is defined as no new therapy or change in standard-of-care therapies as above 
within 12 weeks of Day 1 for immunosuppressives or within 2 weeks of Day 1 for 
corticosteroids.
Medications
Treatment Period
Follow-up 
Period
Corticosteroids 
Parenteral 
injections
(eg, IA, IM, IV or 
epidural 
injection)
Prohibited
!
An IM dose of methylprednisolone 
(DepoMedrol) 60 mg (or equivalent) 
administered as 1 injection can be 
substituted for the oral corticosteroid 
allowed increase described in the 
protocol.
!
Oral or parenteral (IV or IM) 
corticosteroids at doses >40 mg per day 
of prednisone (or equivalent) within 
8 weeks of Day 1 and on study.
!
Corticosteroids are permitted as clinically 
indicated for hypersensitivity reactions, 
insect bites or asthmatic exacerbations 
(up to 125 mg IV hydrocortisone or oral 
methylprednisolone dose pack with top 
dose of oral methylprednisolone 24 mg 
[or prednisone 30 mg or oral equivalent]) 
up to Week 12 and between Weeks 24 
and 40.
!
Epidural corticosteroid injections are 
prohibited within 12 weeks of Day 1 and 
on study.
!
Intra-articular corticosteroids or 
hyaluronic acid >4 weeks of Day 1 and 
on study.
Permitted 
Oral (prednisone 
or equivalent)
Permitted 
!
Prednisone up to 20 mg/day (or 
equivalent) provided dose is stable for at 
least two weeks prior to Day 1 and 
corticosteroids were started at least 
8 weeks prior to Day 1.  If a participant is 
receiving antimalarials in combination 
with corticosteroids as background 
medication without an 
immunosuppressant, the minimum dose 
of corticosteroids allowed at baseline is 
5 mg/day prednisone or equivalent.
!
Participants with active disease at 
baseline can receive the increased dose of 
corticosteroids as early as Day 1, up to 
Permitted
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Medications
Treatment Period
Follow-up 
Period
the Week 4 visit and then the dose should 
be tapered back to the preceding dose.  
The maximum additional dose allowed is 
10 mg/day prednisone equivalence above 
the Day 1 dose level, for a maximum of 
14 days after which the previous dose 
must be resumed.
!
A single intramuscular dose of 
methylprednisolone (Depo-Medrol; 
maximum dose 60 mg) is allowed up to 
Week 4 as an alternative to increasing the 
oral dose. 
!
Steroid tapering is required (if 
appropriate) between Weeks 2-12 and 
Weeks 24-40; reductions of steroids 
should not take place outside of these 
windows.
!
For participants who have had 
corticosteroids tapered during the 
allowed windows, the corticosteroid dose 
may be increased once during each of the 
2 tapering windows to the dose preceding 
the last taper step.
!
Rectal administration of corticosteroids, 
if necessary, should be short-term and 
using topical preparations.
Topical
Permitted 
!
Low potency topical steroids [class 6 
(mild, such as desonide) or class 7 (least 
potent, such as hydrocortisone)] are 
allowed except on day of study visit.
!
Medium or high potency topical 
corticosteroids must be discontinued 
≥4 weeks prior to Day 1.
Immunosuppressive or 
immunomodulatory agents including 
methotrexate (MTX), azathioprine 
(AZA) 6-mercaptopurine (6-MP),
leflunomide, mizoribine or 
mycophenolate (including 
mycophenolate mofetil, 
mycophenolate mofetil hydrochloride, 
and mycophenolate sodium).
Permitted 
!
Provided preexisting dose is as stable as 
possible for 12 weeks prior to Day 1.
!
No new immunosuppressives or increase 
in dose is allowed during the treatment 
period.
!
Participants can be on 1 of the following 
cytotoxic agents: MTX (maximum 
25 mg/week), AZA (maximum 
200 mg/day), 6-MP, (maximum 
100 mg/day) mizoribine (maximum 
150 mg/day), leflunomide (maximum 
Permitted
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Medications
Treatment Period
Follow-up 
Period
dose 20 mg/day), mycophenolate 
(2 g/day of MMF or 1.44 g/d of MPA), 
but not on any combination of these 
cytotoxic agents. 
!
Substitution of one immunosuppressive 
medication or antimalarial drug for 
another may be permitted for safety 
related issues after discussion with the 
sponsor.
Sulfasalazine
Prohibited
Prohibited
Thymopetidum
Prohibited
Must be discontinued 4 weeks prior to 
baseline.
Prohibited
Antimalarials (eg, 
hydroxychloroquine, chloroquine,)
Permitted 
!
Provided preexisting dose is stable for at 
least 12 weeks and treatment is not 
started/or stopped within 12 weeks of 
Day 1.
!
No new antimalarial drugs or increase in 
dose is allowed during the treatment 
period.
!
Maximal doses: HCQ 400 mg/day; 
chloroquine 250 mg/day.
!
Antimalarials produced by a licensed 
compounding pharmacy (eg, quinacrine) 
in the country of administration and 
using pharmaceutical grade components 
are allowed.
!
Substitution of one antimalarial 
medication for another may be permitted 
for safety related issues after discussion 
with the sponsor.
Permitted
High potency opioid (eg, fentanyl, 
morphine, buprenorphine, 
hydromorphone, methadone, 
oxycodone)
Prohibited for at home use by the participant.
Prohibited
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Medications
Treatment Period
Follow-up 
Period
Lower potency 
Permitted except for within 12 hours of 
scheduled clinical visits:
!
Tramadol (Ultram, Zydol; Zamadol, 
Ultracet, Tramal) ≤300 mg/day.
!
Hydrocodone (Vicodin, Lortab) 
≤30 mg/day.
!
Codeine (Paveral, Tylenol #2 and #3) 
≤200 mg/day.
!
Propoxyphene HCl (Darvon, Darvocet, 
Doloxene), Propoxyphene napsylate 
(DarvonN, DarvocetN 100) ≤300 mg/day
Thalidomide, lenalidomide, dapsone, 
adrenocorticotropic hormone (ACTH) 
by injection  
Prohibited during treatment and within 
28 days of Day 1
Prohibited
Investigational or marketed biologics 
(including but not limited
to), etanercept, infliximab, 
certolizumab, adalimumab, 
golimumab, anakinra, belimumab, 
tocilizumab, abatacept, anifrolumab & 
ustekinumab.  
Prohibited during treatment and prior to 
Day 1 
!
Anti TNF therapies (etanercept, 
infliximab, certolizumab, adalimumab, 
golimumab), belimumab or anakinra 
within 12 weeks of Day 1. 
!
Tocilizumab, abatacept or ustekinumab 
within 24 weeks of Day 1.
!
Rituximab or any other lymphocyte 
depleting biologic therapy within 
24 weeks of Day 1.
!
Any other biologic therapy (including 
investigational and approved agents) 
within 12 weeks of Day 1.
Prohibited
HMG CoA reductase inhibitors 
(“statins” such as simvastatin, 
rosuvastatin, atorvastatin, lovastatin, 
pravastatin, fluvastatin)
Permitted
Permitted
Angiotensin pathway 
antihypertensives (eg, ACE inhibitors, 
angiotensin receptor blockers (ARBs)
Permitted
Permitted
Parental (IV or IM) antibiotics 
(antibacterials, antivirals, antifungals, 
or anti-parasitic agents)
Prohibited 60 days prior to Day 1.
Permitted during treatment period. 
Permitted
Cyclophosphamide or chlorambucil or 
other alkylating agents
Prohibited during treatment and 24 weeks 
prior to Day 1
Prohibited
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Medications
Treatment Period
Follow-up 
Period
CNIs (cyclosporine, tacrolimus, 
picrolimus, or voclosporin)
Prohibited during treatment and within 
12 weeks of Day 1: 
!
No systemic calcineurin inhibitors within 
12 weeks of Day 1.
!
Optic topical preparations (eye drops) are 
permitted on study. 
!
Topical creams and ointments must be 
discontinued within 4 weeks of Day 1.
Prohibited
Other investigational drugs or 
investigational combinations
Prohibited
Prohibited
B-cell depleting therapy 
(eg, rituximab, epratuzumab, atacicept)
Prohibited during treatment and 24 weeks or 
5 half-lives (if known), whichever is longer 
prior to Day 1. 
Prohibited
Non B cell depleting therapies eg, 
alemtuzumab [Lemtrada®, CamPath®] 
or total lymphoid irradiation, etc
Prohibited
Prohibited
Any live (live attenuated) vaccines
Prohibited
Prohibited
ANY bone marrow stimulating agents 
(eg, filgrastim, pegfilgrastim, 
erythropoietin
Prohibited during treatment and for 12 weeks 
prior to screening.
Prohibited
Inactivated vaccine and boosters
Permitted
Permitted
JAK Kinase inhibitors (eg, tofacitinib, 
ruxolitinib)
Prohibited
Prohibited
NSAIDS
Permitted, participants should endeavor to 
maintain a stable dose during the study 
duration
PRN NSAID are permitted for treatment of 
non-SLE events eg. fever, headache, they 
should not be taken within 12 hrs of joint 
assessment. 
Moderate and strong CYP3A inducers:
Efavirenz
nevirapine
barbiturates
carbamazepine
modafinil
phenobarbital
phenytoin
rifampin
troglitazone
pioglitazone
rifabutin
St. John’s Wort
Prohibited
Permitted after a 
minimum of 
48 hours 
(approximately 
5 half-lives) 
following last 
dose of study 
intervention.
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Medications
Treatment Period
Follow-up 
Period
Strong P-gp inhibitors: 
Quinidine
P-gp substrates with narrow TI:
Digoxin
Substrates of OCT2/MATE:
dofetilide
Herbal Medication 
Herbal medications with known 
pharmaceutical properties are allowed, only if 
there is documented evidence of no moderate 
to strong CYP3A induction, otherwise these 
medications must be discontinued at least 4 
weeks prior to randomization. 
Permitted after a 
minimum of 
48 hours 
(approximately 
5 half-lives) 
following last 
dose of study 
intervention.
Colchicine
Permitted: Dose must not exceed 0.6 mg BID 
for at least 8 weeks prior to Day 1.
Permitted after a 
minimum of 
48 hours 
(approximately 
5 half-lives) 
following last 
dose of study 
intervention.
Medications know to prolong QT 
interval with potential risk of Torsades 
de Pointes.
Antiarrhythmics (eg, disopyramide, 
procainamide, quinidine, sotalol)
Macrolides (eg, azithromycin, 
clarithromycin, erythromycin)
Fluoroquinolones (eg, ciprofloxacin, 
levofloxacin, moxifloxacin)
Antifungals (eg. fluconazole, 
ketoconazole, pentamidine, 
voriconazole)
Antipsychotics (eg, haloperidol, 
thioridazine, ziprasidone)
Antidepressants (eg, citolopram, 
escitalopram)
Opioids (eg, methadone)
Others (eg, cocaine, cilostazol, 
donepezil)
Prohibited; This is general guidance and 
specific medications should be checked. 
Please contact Pfizer clinical with any 
questions. 
Permitted after a 
minimum of 48 
hours 
(approximately 
5 half-lives) 
following last 
dose of study 
intervention.
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10.14. Appendix 14: Oral Corticosteroids, Systemic Equivalencies
Glucocorticoid
Equivalent Dose (mg)
Short Acting
Cortisone
25
Hydrocortisone
20
Intermediate Acting
Methylprednisolone
4
Prednisolone
5
Prednisone
5
Triamcinolone
4
Long Acting
Betamethasone
0.6
Dexamethasone
0.75
Lacy CF, Armstrong LL, Goldman MP, et al.  Drug Information Handbook, Ninth Edition.  Cleveland, OH: LexiComp 
Inc;2001-2002:1354.
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10.15. Appendix 15: Columbia Suicide Severity Rating Scale (CSSRS) 
C-SSRS for Screening (Baseline) Visit:
At the screening visit (baseline), if there are “yes” answers on items 4 and/or 5 in the past year, or on any 
question in the suicidal behavior section of the C-SSRS in the past 5 years, the participant will be excluded from 
the study. 
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C-SSRS for Post-Baseline Visits:
At Week 24 visit the Since Last Visit version of the C-SSRS should be utilized.  The Since Last Visit version 
refers to the participants experience since their last visit. If there are “yes” answers on items 4 and/or 5 or on 
any suicidal behavior question of the C-SSRS, the participant will be discontinued from treatment and referred 
to a mental health professional for appropriate evaluation and treatment.  If the participant cannot be seen by a 
mental health professional within 24 hours, then the participant should be sent to a local emergency room for 
psychiatric assessment.
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Posner K, Oquendo MA, Gould M, et al.  Columbia classification algorithm of suicide assessment (C-CASA): classification 
of suicidal events in the FDA’s pediatric suicidal risk analysis of antidepressants.  Am J Psychiatry 2007;164(7):1035-43.
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10.16. Appendix 16: Select Laboratory Values from the Common Terminology Criteria 
for Adverse Events (CTCAE) v4.03 
CTCAE v4.03 
Term
Grade 1
Grade 2
Grade 3
Grade 4
CTCAE v4.03
Adverse Event Term 
Definition
Alanine 
aminotransferase 
(ALT) increased
>ULN - 3.0 x 
ULN
>3.0 - 5.0 x ULN >5.0 - 20.0 x ULN >20.0 x ULN
A finding based on 
laboratory test results 
that indicate an increase 
in the level of alanine 
aminotransferase (ALT 
or SGPT) in the blood 
specimen.
Alkaline phosphatase 
increased
>ULN   2.5 x ULN >2.5 5.0 x ULN
>5.0   20.0 x ULN >20.0 x ULN
A finding based on 
laboratory test results 
that indicate an increase 
in the level of alkaline 
phosphatase in a blood 
specimen.
Anemia
Hemoglobin (Hgb) 
<LLN -
10.0 g/dL; <LLN -
6.2 mmol/L; 
<LLN - 100 g/L
Hgb <10.0 - 8.0 
g/dL; <6.2 - 4.9 
mmol/L; <100 -
80g/L
Hgb <8.0 g/dL; 
<4.9 mmol/L; 
<80 g/L; 
transfusion 
indicated
Life-threatening
consequences; 
urgent
intervention 
indicated
A disorder characterized 
by a reduction in the 
amount of hemoglobin in 
100 ml of blood. Signs 
and symptoms of anemia 
may include pallor of the 
skin and mucous 
membranes, shortness of 
breath, palpitations of the 
heart, soft systolic 
murmurs, lethargy, and 
fatigability.
APTT 
Prolonged
>ULN - 1.5 x 
ULN
>1.5 - 2.5 x ULN >2.5 x ULN; 
hemorrhage
-
An abnormal laboratory 
test result in which the 
partial thromboplastin 
time is found to be 
greater than the control 
value.  As a possible 
indicator of 
coagulopathy, a 
prolonged partial 
thromboplastin time 
(PTT) may occur in a 
variety of diseases and 
disorders, both primary 
and related to treatment.
Aspartate 
aminotransferase 
(AST) increased
>ULN - 3.0 x 
ULN
>3.0 - 5.0 x ULN >5.0 - 20.0 x ULN >20.0 x ULN
A finding based on 
laboratory test results 
that indicate an increase 
in the level of aspartate 
aminotransferase (AST 
or SGOT) in a blood 
specimen.
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CTCAE v4.03 
Term
Grade 1
Grade 2
Grade 3
Grade 4
CTCAE v4.03
Adverse Event Term 
Definition
Blood bilirubin 
increased
>ULN - 1.5 x 
ULN
>1.5 - 3.0 x ULN >3.0 - 10.0 x ULN >10.0 x ULN
A finding based on 
laboratory test results 
that indicate an 
abnormally high level of 
bilirubin in the blood.  
Excess bilirubin is 
associated with jaundice.
Cholesterol high
>ULN - 300 
mg/dL; 
>ULN - 7.75 
mmol/L
>300 - 400 
mg/dL; 
>7.75 - 10.34 
mmol/L
>400 - 500 
mg/dL; 
>10.34 - 12.92 
mmol/L
>500 mg/dL; 
>12.92 mmol/L
A finding based on 
laboratory test results 
that indicate higher than 
normal levels of 
cholesterol in a blood 
specimen.
CPK increased
>ULN - 2.5 x 
ULN
>2.5 x ULN - 5 x 
ULN
>5 x ULN - 10 x 
ULN
>10 x ULN
A finding based on 
laboratory test results 
that indicate an increase 
in levels of creatine 
phosphokinase in a blood 
specimen.
Hemoglobin 
increased
Increase in >0 - 2 
gm/dL above ULN 
or above baseline 
if baseline is 
above ULN
Increase in >2 - 4 
gm/dL   above 
ULN or above 
baseline if 
baseline is above 
ULN
Increase in 
>4 gm/dL above 
ULN or above 
baseline if 
baseline is above 
ULN
-
A finding based on 
laboratory test results 
that indicate increased 
levels of hemoglobin in a 
biological specimen.
Hypercalcemia
Corrected serum 
calcium of 
>ULN - 11.5 
mg/dL; 
>ULN - 2.9 
mmol/L; Ionized 
calcium 
>ULN - 1.5 
mmol/L
Corrected serum 
calcium of 
>11.5 - 12.5 
mg/dL; 
>2.9 - 3.1 
mmol/L; Ionized 
calcium >1.5 - 1.6 
mmol/L; 
symptomatic
Corrected serum 
calcium of 
>12.5 - 13.5 
mg/dL; >3.1 - 3.4 
mmol/L; Ionized 
calcium >1.6 - 1.8 
mmol/L; 
hospitalization 
indicated
Corrected serum 
calcium of 
>13.5 mg/dL; 
>3.4 mmol/L; 
Ionized calcium 
>1.8 mmol/L; 
life-threatening 
consequences
A disorder characterized 
by laboratory test results 
that indicate an elevation 
in the concentration of 
calcium (corrected for 
albumin) in blood.
Hyperglycemia
Fasting glucose 
value >ULN - 160 
mg/dL; Fasting 
glucose value 
>ULN - 8.9 
mmol/L
Fasting glucose 
value >160 - 250 
mg/dL; Fasting 
glucose value 
>8.9 - 13.9 
mmol/L
>250 - 500 
mg/dL; 
>13.9 - 27.8 
mmol/L; 
hospitalization 
indicated
>500 mg/dL; 
>27.8 mmol/L; 
life-threatening 
consequences
A disorder characterized 
by laboratory test results 
that indicate an elevation 
in the concentration of 
blood sugar.  It is usually 
an indication of diabetes 
mellitus or glucose 
intolerance.
Hyperkalemia
>ULN - 5.5 
mmol/L
>5.5 - 6.0 
mmol/L
>6.0 - 7.0 
mmol/L; 
hospitalization 
indicated
>7.0 mmol/L; 
life-threatening 
consequences
A disorder characterized 
by laboratory test results 
that indicate an elevation 
in the concentration of 
potassium in the blood; 
associated with kidney 
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CTCAE v4.03 
Term
Grade 1
Grade 2
Grade 3
Grade 4
CTCAE v4.03
Adverse Event Term 
Definition
failure or sometimes with 
the use of diuretic drugs.
Hypernatremia
>ULN - 150 
mmol/L
>150 - 155 
mmol/L
>155 - 160 
mmol/L; 
hospitalization 
indicated
>160 mmol/L; 
life-threatening 
consequences
A disorder characterized 
by laboratory test results 
that indicate an elevation 
in the concentration of 
sodium in the blood.
Hypertriglyceridemia 150 mg/dL - 300 
mg/dL; 1.71 
mmol/L - 3.42 
mmol/L
>300 mg/dL - 500 
mg/dL; >3.42 
mmol/L - 5.7 
mmol/L
>500 
mg/dL - 1000 
mg/dL; >5.7 
mmol/L - 11.4 
mmol/L
>1000 mg/dL; 
>11.4 mmol/L; 
life-threatening 
consequences
A disorder characterized 
by laboratory test results 
that indicate an elevation 
in the concentration of 
triglyceride 
concentration in the 
blood.
Hyperuricemia
>ULN - 10 mg/dL 
(0.59 mmol/L) 
without 
physiologic 
consequences
-
>ULN - 10 mg/dL 
(0.59 mmol/L) 
with physiologic 
consequences
>10 mg/dL; >0.59 
mmol/L; 
life-threatening 
consequences
A disorder characterized 
by laboratory test results 
that indicate an elevation 
in the concentration of 
uric acid.
Hypoalbuminemia
<LLN - 3 g/dL; 
<LLN - 30 g/L
<3 - 2 g/dL; 
<30 - 20 g/L
≥2 g/dL; <20 g/L Life-threatening 
consequences; 
urgent 
intervention 
indicated
A disorder characterized 
by laboratory test results 
that indicate a low 
concentration of albumin 
in the blood.
Hypocalcemia
Corrected serum 
calcium of 
<LLN - 8.0 
mg/dL; 
<LLN - 2.0 
mmol/L; Ionized 
calcium 
<LLN - 1.0 
mmol/L
Corrected serum 
calcium of 
<8.0 - 7.0 mg/dL; 
<2.0 - 1.75 
mmol/L; Ionized 
calcium <1.0 - 0.9 
mmol/L; 
symptomatic
Corrected serum 
calcium of 
<7.0 - 6.0 mg/dL; 
<1.75 - 1.5 
mmol/L; Ionized 
calcium <0.9 - 0.8 
mmol/L; 
hospitalization 
indicated
Corrected serum 
calcium of <6.0 
mg/dL; <1.5 
mmol/L; Ionized 
calcium <0.8 
mmol/L; 
life-threatening 
consequences
A disorder characterized 
by laboratory test results 
that indicate a low
concentration of calcium 
(corrected for albumin) 
in the blood.
Hypoglycemia
<LLN - 55 mg/dL; 
<LLN - 3.0 
mmol/L
<55 - 40 mg/dL; 
<3.0 - 2.2 
mmol/L
<40 - 30 mg/dL; 
<2.2 - 1.7 mmol/L
<30 mg/dL; <1.7 
mmol/L; 
life-threatening 
consequences; 
seizures
A disorder characterized 
by laboratory test results 
that indicate a low 
concentration of glucose 
in the blood.
Hypokalemia
<LLN - 3.0 
mmol/L
<LLN - 3.0 
mmol/L; 
symptomatic; 
intervention 
indicated
<3.0 - 2.5 
mmol/L; 
hospitalization 
indicated
<2.5 mmol/L; 
life-threatening 
consequences
A disorder characterized 
by laboratory test results 
that indicate a low 
concentration of 
potassium in the blood.
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CTCAE v4.03 
Term
Grade 1
Grade 2
Grade 3
Grade 4
CTCAE v4.03
Adverse Event Term 
Definition
Hyponatremia
<LLN - 130 
mmol/L
-
<130 - 120 
mmol/L
<120 mmol/L; 
life-threatening 
consequences
A disorder characterized 
by laboratory test results 
that indicate a low 
concentration of sodium 
in the blood.
Hypophosphatemia
<LLN - 2.5 
mg/dL; 
<LLN - 0.8 
mmol/L
<2.5 - 2.0 mg/dL; 
<0.8 - 0.6 
mmol/L
<2.0 - 1.0 mg/dL; 
<0.6 - 0.3 mmol/L
<1.0 mg/dL; <0.3 
mmol/L; 
life-threatening 
consequences
A disorder characterized 
by laboratory test results 
that indicate a low 
concentration of 
phosphates in the blood.
Lipase increased
>ULN   1.5 x ULN >1.5   2.0 x ULN >2.0   5.0 x ULN
>5.0 x ULN
A finding based on 
laboratory test results 
that indicate an increase 
in the level of lipase in a 
biological specimen.
Lymphocyte count 
increased
-
>4000/mm3
20,000/mm3
>20,000/mm3
-
A finding based on 
laboratory test results 
that indicate an abnormal 
increase in the number of 
lymphocytes in the 
blood, effusions or bone 
marrow.
Neutrophil count 
decreased
<LLN -
1500/mm3; <LLN 
- 1.5 x 10e9 /L
<1500 -
1000/mm3; <1.5 -
1.0
x 10e9 /L
<1000 - 500/mm3; 
<1.0 - 0.5 x 10e9 
/L
<500/mm3; <0.5 x 
10e9 /L
A finding based on 
laboratory test results 
that indicate a decrease 
in number of neutrophils 
in a blood specimen.
Platelet count 
decreased
<LLN -
75,000/mm3; 
<LLN - 75.0 x 
10e9 /L
<75,000 -
50,000/mm3; 
<75.0
- 50.0 x 10e9 /L
<50,000 -
25,000/mm3; 
<50.0
- 25.0 x 10e9 /L
<25,000/mm3; 
<25.0 x 10e9 /L
A finding based on 
laboratory test results 
that indicate a decrease 
in number of platelets in 
a blood specimen.
Proteinuria
1+ proteinuria; 
urinary protein 
<1.0 g/24 hrs
Adults: 2+ 
proteinuria; 
urinary protein 
1.0 - 3.4 g/24 hrs; 
Adults: urinary 
protein >=3.5 g/24 
hrs;
-
A disorder characterized 
by laboratory test results 
that indicate the presence 
of excessive protein in 
the urine.  It is 
predominantly albumin, 
but also globulin.
Serum amylase 
increased
>ULN   1.5 x ULN >1.5   2.0 x ULN >2.0   5.0 x ULN
>5.0 x ULN
A finding based on 
laboratory test results 
that indicate an increase 
in the levels of amylase 
in a serum specimen.
Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 published May 28, 2009 (V 4.03: June 14, 1010).  
U.S. Department of Health and Human Services/National Institute of Health/ National Cancer Institute.
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10.17. Appendix 17: Guidelines for Participant Safety Monitoring and Discontinuation
These guidelines for participant safety monitoring and discontinuation are to be applied to all 
participants in study B7931028.  Additional individual participant monitoring is at the 
discretion of the investigator and dependent on any perceived safety concerns.  Unscheduled 
clinical labs may be obtained at any time during the study to assess such concerns, and a 
participant may be withdrawn at any time at the discretion of the investigator.  If it is not 
possible for a participant to return to a site for a repeat labs prior to the next scheduled visit, 
the investigator should note this in the source document. For participants who have a history 
of known intermittent out of range laboratory assessments, repeat assessments between 
scheduled visits may be waived by the Pfizer Clinical team following discussion with the 
principal investigator.
10.17.1. Safety Monitoring
!
The following laboratory abnormalities require re-testing within 1 week:
!
Neutrophil counts <1000 neutrophils/mm3;
!
Lymphocyte counts <500 lymphocytes/mm3;
!
Platelet counts <50,000 platelets/mm3;
!
eGFR that is 40% or greater reduction from baseline,
!
UPCR >3 mg/mg
!
Any single AST and/or ALT elevation ≥3 times the upper limit of normal (repeat 
laboratory testing should include albumin, creatine kinase, total bilirubin, direct and 
indirect bilirubin, GGT, PT [prothrombin time] with INR [international normalized 
ratio], and alkaline phosphatase), regardless of the total bilirubin.  (Please note that 
3 times the upper limit of normal increases in ALT, AST need confirmation on 
separate blood draw before undertaking thorough evaluation for liver injury);
!
Any single hemoglobin value <8.0 g/dL or one that drops 2 gm/dL below baseline;
!
For women of child-bearing potential with any positive urine beta-human chorionic 
gonadotrophin (∀-hCG) test, the participant will have study drug interrupted and a 
serum sample submitted to the central laboratory for ∀-hCG testing.
10.17.2. Permanent Discontinuation of Study Intervention
The sponsor’s Clinical team should be consulted as soon as possible and participants may be 
discontinued from study intervention if any of the following occur during the study.  All 
participants who are randomized should be encouraged to remain in the study through to the 
end of the double-blind period for safety and efficacy assessments, whether or not they 
continue to receive study intervention for the full 52 week treatment period, to reduce 
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missing data as much as possible.  Participants may be discontinued from study intervention
if any of the following occur during the study: 
!
Serious infections defined as any infection (viral, bacterial, and fungal) requiring 
parenteral antimicrobial therapy, hospitalization for treatment, or meeting other 
criteria that require the infection to be classified as serious adverse event;
!
Other serious or severe AEs, at the discretion of the investigator or sponsor;
!
Participants who require high potency opioids for pain control for more than 
10 consecutive days or within the last 7 days before the last dose;
!
All of the following laboratory abnormalities require discontinuation if they are 
confirmed (confirmation through re-testing should occur within 1 week): 
!
Two sequential absolute neutrophil counts <0.75 x 109/L (<750/mm3);
!
Two sequential platelet counts <50 x 109/L (<50,000/mm3);
!
Two sequential AST or ALT elevation ≥3 times the upper limit of normal with at 
least one total bilirubin value ≥2 times the upper limit of normala;
!
Two sequential AST or ALT elevation ≥3 times the upper limit of normal 
accompanied by signs or symptoms consistent with hepatic injurya;
!
Two sequential AST or ALT elevation ≥5 times the upper limit of normal, 
regardless of total bilirubin or accompanying signs or symptomsa;
!
Female participants found to be pregnant during the study; 
!
Marked prolongation of the QTcF interval to >500 msec or >60 msec change 
from baseline (Day 1) ECG.  If QTcF exceeds these limits, the ECG should be 
repeated 2 more times and the average of the 3 QTcFs should be used to 
determine the discontinuation;
!
Reduction of eGFR cystatin of greater than 40% from baseline value.  If the 
eGFR cystatin decreases by greater than 40%, the test should be repeated to 
confirm the decrease, study intervention discontinued and the participant refered 
to a nephrologist;
!
Increase of UPCr to >3 mg/mg for any participant who entered the study with a 
UPCR ≤2 mg/mg Or a 50% increase in UPCR for participants who entered the 
study with a UPCR >2 mg/mg;
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!
Participants who are definitively diagnosed with any thromboembolic event such 
as a pulmonary embolism or deep venous thrombosis, arterial thrombosis or 
cerebrovascular events (thromboembolic stroke, transient ischemic attack [TIA], 
etc.) for which the participant is hospitalized and/or requires intravenous or 
invasive (surgical or interventional radiological) treatment.  Participants should 
have appropriate diagnostic testing performed to document the thrombotic event 
(ultrasound, CT angiography, lung scintigraphy, pulmonary angiography, CT 
venography) and the Pfizer medical monitor should be notified;
!
Other serious or severe AEs, after consultation with the Pfizer medical monitor or 
designee.
a.
In each case, there is a need for additional investigations, such as review of ethanol, recreational drug 
and dietary supplement consumption; testing for acute hepatitis A, B or C infection and biliary tract 
imaging should be promptly discussed with the Pfizer medical monitor or designee.
Any participant who elects to discontinue study intervention but does not withdraw consent 
should return for all scheduled visits and safety and efficacy assessments, and complete all 
study-specified assessments through Week 56. Any participant who withdraws consent must 
enter follow-up with their first follow-up visit occurring 1 week after their last dose 
whenever possible, until the event has returned to normal or baseline levels or is deemed 
clinically stable.  If a participant is lost to follow up, the site should document attempts to 
contact the participant to continue in the study by registered mail (at last 2 attempts); phone 
calls and offers to provide transportation to the clinic should be extended. The procedures 
scheduled for the early withdrawal visit will be performed on the last day the participant 
takes study intervention or as soon as possible thereafter.  The only exception to this is when 
a participant specifically withdraws consent for any further contact with him/her or persons 
previously authorized by the participant to provide this information. 
Participants will be followed post drug discontinuation for 28 days.  Additional follow-up 
visits may occur as needed until any clinically relevant abnormalities or adverse events have 
resolved, returned to a baseline state, or are deemed clinically stable.
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10.18. Appendix 18: Physician Global Assessment (PhGA)
Evaluate the participants lupus activity since the last visit using the visual analog scale 
(VAS):
Place a vertical mark (|) across the line in the position that best describes your response.
[Note: Scale will be 100 mm in length]
0
None
1
Mild
2
Moderate
3
Severe
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10.19. Appendix 19: modified SELENA-SLEDAI Flare Index (mSSFI)
Mild or Moderate Flare 
 Increase in SLEDAI instrument score of 3 points or more (but not to more than 12)
 New/worse: Discoid, photosensitive, profundus, bullous lupus,
Nasopharyngeal ulcers 
Pleuritis 
Pericarditis 
Arthritis 
Fever (SLE) 
 Increase in prednisone, but not to >0.5 mg/kg/day 
 Added NSAID or hydroxychloroquine for SLE activity 
 ≥1.0 increase in PGA score, but not to more than 2.5 
Severe Flare
 Increase in SLEDAI instrument score to greater than 12
 New/worse: CNS-SLE
Cutaneous vasculitis, 
Vasculitis
Nephritis
Myositis
Plt <60,000
Hemolytic anemia: Hb <70 g/L or decrease in Hb >30 g/L
       Requiring: double prednisone, or prednisone increase to >0.5 mg/kg/day, or =
hospitalization
 Increase in prednisone to >0.5 mg/kg/day
 New cyclophosphamide, azathioprine, methotrexate for SLE activity
 Hospitalization for SLE activity
 Increase in Physician’s Global Assessment score to >2.5
Petri M, Buyon J, Kim M. Classification and definition of major flares in SLE clinical trials. Lupus. 1999; 8: 685-91. 
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10.20. Appendix 20: Cutaneous Lupus Erythematosus Disease Area and Severity Index 
(CLASI)
Albrecht J, Taylor L, Berlin JA, et al. The CLASI (Cutaneous LE Disease Area and Severity Index): an outcome 
instrument for cutaneous lupus erythematosus. J Invest Dermatol 2005;125(5): 889-894.
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10.21. Appendix 21: Joint Assessment (28-Count)
Starz TW, Moreland LW, Levesque MC.  Quantitative joint assessment to improve RA outcomes.  J Musculoskel 
Med 2011;28:79-84.
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10.22. Appendix 22: eGFR Calculations
The estimated GFR (eGFR) will be calculated using the 2 sets of equations developed by the 
Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), which utilize serum 
creatinine (SCr) and serum Cystatin C respectively.
CKD-EPI2009Scr
If female and SCr is ≤0.7 mg/dL:
!
GFR (mL/min/1.73 m2) = 144 x (Scr/0.7) – 0.329 x 0.993age (x 1.159, if black).
If female and SCr is >0.7 mg/dL:
!
GFR (mL/min/1.73 m2) = 144 x (Scr/0.7) – 1.209 x 0.993age (x 1.159, if black).
If male and SCr is ≤0.9 mg/dL:
!
GFR (mL/min/1.73 m2) = 141 x (Scr/0.9) – 0.411 x 0.993age (x 1.159, if black).
If male and SCr is >0.9 mg/dL:
!
GFR (mL/min/1.73 m2) = 141 x (Scr/0.9) – 1.209 x 0.993age (x 1.159, if black).
CKD-EPI2012cys
If female and Scys is ≤0.8 mg/L:
!
GFR (mL/min/1.73 m2) = 133 x (Scys /0.8) –0.499 x 0.996age x 0.932.
If female and Scys is >0.8 mg/L:
!
GFR (mL/min/1.73 m2) = 133 x (Scys /0.8) –1.328 x 0.996age x 0.932.
If male and Scys is ≤0.8 mg/L:
!
GFR (mL/min/1.73 m2) = 133 x (Scys /0.8) –0.499 x 0.996age.
If male and Scys is >0.8 mg/L:
!
GFR (mL/min/1.73 m2) = 133 x (Scys /0.8) –1.328 x 0.996age.
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10.23. Appendix 23: Abbreviations
Abbreviation
Term
6-MP
6-mercaptopurine
ACR
American College of Rheumatology
AE
adverse event
ALC
absolute lymphocyte count
ALT
alanine aminotransferase
ANC
absolute neutrophil count
 
AZA
Azathioprine
∀-hCG
beta-human chorionic gonadotropin
BCG
Bacillus Calmette-Guérin
BICLA
British Isles Lupus Assessment Group-Based Composite 
Lupus Assessment
BID
twice a day
BILAG
British Isles Lupus Assessment Group
BP
blood pressure
C-CASA
Columbia-Classification Algorithm of Suicide Assessment
Cmax
maximum (or peak) serum concentration
CFR
Code of Federal Regulations
CIOMS
Council for International Organizations of Medical Sciences
CK
creatine kinase
CKD-EPI
Chronic Kidney Disease Epidemiology Collaboration
CLASI
Cutaneous Lupus Erythematosus Disease Area and Severity 
Index
CLASI-A
Cutaneous Lupus Erythematosus Disease Area and Severity 
Index activity score
CMV
Cytomegalovirus
CNS
central nervous system
CMH
Cochran-Mantel-Haenszel
CONSORT
Consolidated Standards of Reporting Trials
COVID-19
Coronavirus disease 2019
CRF
case report form
CRO
contract research organization
CS
Corticosteroids
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CCI
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Abbreviation
Term
CSR
Clinical Study Report
C-SSRS
Columbia-Suicide Severity Rating Scale
CT
clinical trial; computed tomography
CTCAE
Common Terminology Criteria for Adverse Events
CTMS
clinical trial management system
CVA
cerebrovascular accident
CYP3A
cytochrome P450 3A
DCT
data capture tool
DILI
drug-induced liver injury
DMARDs
Disease modifying anti-rheumatic drugs
DMC
Data management committee
DNA
deoxyribonucleic acid
DU
dispensable unit
EBV
Epstein-Barr virus
EC
ethics committee
ECG
Electrocardiogram
E-DMC
external data monitoring committee
EDP
exposure during pregnancy
ED50
Median effective dose
eGFR
estimated glomerular filtration rate
ELISA
Enzyme linked immunosorbent assay
EMA
European Medicines Agency
EOS
end of study
EU
European Union
EudraCT
European Clinical Trials Database
EW
early withdrawal
FACIT-F
Functional Assessment of Chronic Illness Therapy-Fatigue
FAS
Full analysis set
FDA
Food and Drug Administration 
FSH
follicle-stimulating hormone
GCP
Good Clinical Practice
GGT
gamma-glutamyl transferase
GI
Gastrointestinal
GLMMRM
generalized linear marginal model for repeated measures
HBcAb
hepatitis B core antibody
HBsAb
hepatitis B surface antibody
HBsAg
hepatitis B surface antigen
HBV DNA
hepatitis B virus deoxyribonucleic acid
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Abbreviation
Term
HCVAb
hepatitis C virus antibody
HCV RNA
hepatitis C virus ribonucleic acid
HDL
High density lipoprotein
HEENT
head, eyes, ears, nose and throat
Hep B
hepatitis B
Hep C
hepatitis C 
HIPAA
Health Insurance Portability and Accountability Act
HIV
human immunodeficiency virus
HR
heart rate
HRT
Hormone replacement therapy
IAP
Interim Analysis Plan
IB
Investigator’s Brochure
IBD
Inflammatory bowel disease
ICD
informed consent document
ICH
International Council for Harmonisation of Technical 
Requirements for Pharmaceuticals for Human Use
ID
Identification
IGRA
interferon gamma release assay
IM
Intramuscular
IND
investigational new drug 
INF
Interferon
INH
Isoniazid
INR
international normalized ratio
IRB
institutional review board
IRT
interactive response technology
IUD
intrauterine device
IUS
Intrauterine hormone-releasing system
IV
Intravenous
IVIg
intravenous immunoglobulin
IWR
interactive web-based response
JAK
Janus kinase
K2EDTA
potassium edetic acid (ethylenediaminetetraacetic acid)
LDL
Low density lipoprotein
LFT
liver function test
LLDAS
Lupus Low disease activity score
LLN
lower limit of normal
Lupus QoL
Lupus Quality of Life
MAD
multiple ascending dose
MCP
Metacarpophalangeal
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Abbreviation
Term
MCS
mental component summary
mSSFI
modified SELENA-SLEDAI Flare Index
MMF
mycophenolate mofetil
MPA
mycophenolic acid 
MTX
Methotrexate
N/A
not applicable
NOAEL
no-observed-adverse-effect-level
NSAIDs
nonsteroidal anti-inflammatory drugs
OCT2/MATE
organic cation transporter
OCS
oral corticosteroids
PASI
Psoriasis Area and Severity Index
PBMC
peripheral blood mononuclear cells
PCD
primary completion date
PCS
physical component summary
s
PE
physical examination
P-gp
p-glycoprotein
PhGA
physician global assessment
PI
Principal Investigator
PIP
proximal interphalangeal
PR interval
period of time on the ECG, in milliseconds, that extends from 
beginning of P wave until beginning of QRS complex 
PRN
pro re nata or as needed
PRO
participant reported outcome
PT
prothrombin time
PVC
Premature ventricular complexes
PTT
partial thromboplastin time
QD
once a day
QFT-G
QuantiFERON® - TB Gold
QFT-GIT
QuantiFERON® - TB Gold In-Tube test
QFT-G plus
QuantiFERON® - TB Gold Plus test  
QoL
quality of life
QRS complex
combination of the Q wave, R wave and S wave on the ECG
QTc
Correct QT interval
QTcF
Frederica’s corrected QT interval
QT interval
ECG measure between Q wave and T wave 
QW
Once weekly
RNA
ribonucleic acid
SAD
single ascending dose
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Abbreviation
Term
SAE
serious adverse event
SAP
statistical analysis plan
SCr
Serum creatinine
SELENA
Safety of Estrogen in Lupus Erythematosus:  National 
Assessment
SELENA-SLEDAI 
SLE Flare Index
Safety of Estrogen in Lupus:  National Assessment-Systemic 
Lupus Erythematosus Disease Activity Index Systemic Lupus 
Erythematosus Flare Index
SFI
Systemic Lupus Erythematosus Flare Index
SJC
swollen joint count
SLE
systemic lupus erythematosus
SLEDAI
Systemic Lupus Erythematosus Disease Activity Index
SLEDAI-2K
Systemic Lupus Erythematosus Disease Activity Index-2000
SLICC
Systemic Lupus International Collaborating Clinics
SOC
System Organ Class
SOP
standard operating procedure
SPC
summary of product characteristics
SRI
systemic lupus erythematosus responder index
SRI-4
systemic lupus erythematosus responder index change of 4
SRSD
single reference safety document
SToD
Study team on demand
SUSAR
suspected unexpected serious adverse reactions
TB
Tuberculosis
TEAE
treatment-emergent adverse event
Tmax
time drug is present at maximum concentration in serum
TIA
Transient ischemic attack 
TYK2
tyrosine kinase 2
ULN
upper limit of normal
Upr:Ucr 
urine protein to urine creatinine ratio
US
United States
VAS
visual analog scale
VHP
Voluntary Harmonization Procedure
VTE
venous thromboembolic events
VZV
varicella zoster virus
WBC
white blood cell
WOCBP
women of childbearing potential
WONCBP
women of non-childbearing potential
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