A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of LY3041658 in Adults With Moderate-to-Severe Hidradenitis Suppurativa
Phase: PHASE2
Conditions: Hidradenitis Suppurativa
Sponsor: Eli Lilly and Company

Protocol I7P-MC-DSAD(a) 
 
 
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study 
to Evaluate the Efficacy and Safety of LY3041658 in Adults with Moderate-to- 
Severe Hidradenitis Suppurativa 
 
NCT04493502  
 
Approval Date: 13-Aug-2021 
 
 

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I7P-MC-DSAD(a)
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Title Page
Confidential Information
The information contained in this document is confidential and is intended for the use of clinical investigators. It is the property of 
Eli Lilly and Company or its subsidiaries and should not be copied by or distributed to persons not involved in the clinical 
investigation of LY3041658, unless such persons are bound by a confidentiality agreement with 
Eli Lilly and Company or its subsidiaries.
Note to Regulatory Authorities: This document may contain protected personal data and/or commercially confidential information 
exempt from public disclosure. Eli Lilly and Company requests consultation regarding release/redaction prior to any public release. 
In the United States, this document is subject to Freedom of Information Act (FOIA) Exemption 4 and may not be reproduced or 
otherwise disseminated without the written approval of Eli Lilly and Company or its subsidiaries.
Protocol Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study 
to Evaluate the Efficacy and Safety of LY3041658 in Adults with Moderate-to-
Severe Hidradenitis Suppurativa
Protocol Number: I7P-MC-DSAD
Amendment Number: a
Compound: LY3041658
Study Phase: 2
Short Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to 
Evaluate the Efficacy and Safety of LY3041658 in Adults with Moderate-to-Severe 
Hidradenitis Suppurativa
Sponsor Name: Eli Lilly and Company
Legal Registered Address: Indianapolis, Indiana, USA 46285
Regulatory Agency Identifier Numbers
IND: 121924
Approval Date: Protocol Electronically Signed and Approved by Lilly on date provided below.
Approval Date: 13-Aug-2021 GMT

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I7P-MC-DSAD(a)
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Medical monitor name and contact information will be provided separately.

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I7P-MC-DSAD(a)
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Protocol Amendment Summary of Changes Table
DOCUMENT HISTORY
Document
Date
Original Protocol
13 March 2020
Amendment a
This amendment is considered to be non-substantial based on the criteria set forth in 
Article 10(a) of Directive 2001/20/EC of the European Parliament and the Council of the 
European Union.
Overall Rationale for the Amendment
DSAD discontinuation rate has been higher than expected. The screening and enrollment 
numbers require increasing in order to reach the objective of the study.
Section Number and Name
Description of Change
Brief Rationale
Section 1.1 Synopsis
Increased number of patients 
enrolled
Number of patients required 
increasing to ensure the objective of 
the study is met
Section 5.2 Exclusion 
Criteria
Exclusion Criterion 12, added HS 
wording
Exclusion Criterion 16, the sites 
should use the 14 day/baseline 
(randomization) visit timing, not 
relative to the screening visit
Exclusion Criterion 35, 
hemoglobin level corrected to 
90.0 g/L
Clarification of prohibited 
concomitant therapy
Clarification of prohibited 
concomitant therapy
Error correction
Section 6.5.1 Washout 
Period Before Enrollment
Added HS wording
Clarification of prohibited 
concomitant therapy 
Section 6.5.4 Prohibited 
Concomitant Therapy
Added HS wording
Clarification of prohibited 
concomitant therapy rules
Section 8.1.1.2 Modified 
Sartorius Score (mSS)
Lesion distance corrected
Error correction
Section 8.1.6 Patient’s 
Global Impression of 
Severity – 7 Days 
(Hidradenitis Suppurativa) 
Clarified scoring system
Changed to match Patient’s Global 
Impression of Severity form

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Section Number and Name
Description of Change
Brief Rationale
Section 8.1.8 Inflammatory
Back Pain Assessment 
(ASAS Expert Criteria) and 
Spinal Pain Numeric Rating 
Scale (NRS) 
Removed “at or” wording before 
the age of 40 years 
To clarify that in reference it is <40 
and not <=40
Section 9.2 Sample Size 
Determination 
Number of patients enrolled 
increased
Number of patients required 
increasing to ensure the objective of 
the study is met
Section 10.3.4 
Electronic data collection is not 
occurring
Correction of SAE reporting 
Correction
Accuracy 

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I7P-MC-DSAD(a)
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Table of Contents
1.
Protocol Summary......................................................................................................8
1.1.
Synopsis.......................................................................................................................8
1.2.
Schema.......................................................................................................................10
1.3.
Schedule of Activities (SoA) ......................................................................................11
2.
Introduction..............................................................................................................24
2.1.
Study Rationale ..........................................................................................................24
2.2.
Background ................................................................................................................24
2.3.
Benefit/Risk Assessment ............................................................................................24
3.
Objectives and Endpoints.........................................................................................26
4.
Study Design .............................................................................................................27
4.1.
Overall Design............................................................................................................27
4.2.
Scientific Rationale for Study Design .........................................................................27
4.2.1.
Participant Input into Design ......................................................................................28
4.3.
Justification for Dose..................................................................................................28
4.4.
End-of-Study Definition .............................................................................................29
5.
Study Population ......................................................................................................30
5.1.
Inclusion Criteria........................................................................................................30
5.2.
Exclusion Criteria.......................................................................................................31
5.3.
Lifestyle Considerations .............................................................................................35
5.4.
Screen Failures...........................................................................................................35
5.4.1.
Allowed Retesting of Screening Investigations ...........................................................35
5.4.2.
Rescreening of Individuals Who Failed Screening ......................................................35
6.
Study Intervention....................................................................................................37
6.1.
Study Interventions Administered...............................................................................37
6.2.
Preparation/Handling/Storage/Accountability.............................................................37
6.3.
Measures to Minimize Bias: Randomization and Blinding..........................................38
6.4.
Study Intervention Compliance...................................................................................39
6.5.
Concomitant Therapy .................................................................................................39
6.5.1.
Washout Period Before Enrollment.............................................................................40
6.5.2.
Permitted Concomitant Therapy .................................................................................40
6.5.3.
Rescue Therapy..........................................................................................................40
6.5.4.
Prohibited Concomitant Therapy ................................................................................41
6.5.5.
Therapy After Permanent Discontinuation of Study Drug ...........................................41
6.6.
Dose Modification......................................................................................................41
6.7.
Intervention after the End of the Study........................................................................41
7.
Discontinuation of Study Intervention and Participant 
Discontinuation/Withdrawal....................................................................................42
7.1.
Discontinuation of Study Intervention ........................................................................42
7.1.1.
Criteria for Permanent Discontinuation of Study Drug................................................42
7.1.2.
Criteria for Temporary Interruption (Withholding) of Study Drug...............................44
7.2.
Participant Discontinuation/Withdrawal from the Study .............................................44
7.2.1.
Discontinuation of Inadvertently Enrolled Participants ...............................................45

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I7P-MC-DSAD(a)
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7.3.
Lost to Follow-up .......................................................................................................45
8.
Study Assessments and Procedures .........................................................................46
8.1.
Efficacy Assessments .................................................................................................46
8.1.1.
Lesion Assessments: Count, Measurement, and Severity ............................................46
8.1.2.
Skin Pain – HS Numeric Rating Scale (NRS) .............................................................48
8.1.3.
Dermatology Life Quality Index (DLQI) ....................................................................48
8.1.4.
Drainage Numeric Rating Scale (NRS).......................................................................48
8.1.5.
Smell Numeric Rating Scale (NRS)............................................................................48
8.1.6.
Patient’s Global Impression of Severity- 7 Days (Hidradenitis 
Suppurativa) ...............................................................................................................48
8.1.7.
Patient Global Impression of Change - 7 Days (Hidradenitis 
Suppurativa) ...............................................................................................................48
8.1.8.
Inflammatory Back Pain Assessment (ASAS Expert Criteria) and 
Spinal Pain Numeric Rating Scale (NRS) ...................................................................49
8.2.
Safety Assessments ....................................................................................................49
8.2.1.
Vital Signs..................................................................................................................50
8.2.2.
Physical Examinations................................................................................................50
8.2.3.
Electrocardiograms.....................................................................................................50
8.2.4.
Chest Radiography (CXR)..........................................................................................51
8.2.5.
Laboratory Tests.........................................................................................................51
8.2.6.
Tuberculosis Testing and Monitoring..........................................................................53
8.2.7.
Hepatitis B Testing and Monitoring ............................................................................54
8.2.8.
Hepatitis C Testing and Monitoring ............................................................................55
8.2.9.
Hepatic Safety Monitoring..........................................................................................55
8.2.10.
Suicidal Ideation and Behavior Risk Monitoring.........................................................56
8.3.
Adverse Events and Serious Adverse Events ..............................................................57
8.3.1.
Time Period and Frequency for Collecting Adverse Event and 
Serious Adverse Event Information ............................................................................57
8.3.2.
Method of Detecting Adverse Events and Serious Adverse 
Events.........................................................................................................................58
8.3.3.
Follow-up of Adverse Events and Serious Adverse Events .........................................58
8.3.4.
Regulatory Reporting Requirements for Serious Adverse Events................................58
8.3.5.
Pregnancy...................................................................................................................58
8.3.6.
Adverse Events of Special Interest..............................................................................59
8.3.7.
Complaint Handling ...................................................................................................59
8.4.
Treatment of Overdose ...............................................................................................60
8.5.
Pharmacokinetics........................................................................................................60
8.6.
Pharmacodynamics.....................................................................................................61
8.7.
Genetics .....................................................................................................................61
8.8.
Biomarkers.................................................................................................................62
8.9.
Immunogenicity Assessments.....................................................................................62
8.10.
Medical Resource Utilization and Health Economics..................................................63
9.
Statistical Considerations.........................................................................................64
9.1.
Statistical Hypotheses.................................................................................................64
9.1.1.
Estimands...................................................................................................................64
9.2.
Sample Size Determination.........................................................................................64

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9.3.
Populations for Analyses ............................................................................................65
9.4.
Statistical Analyses.....................................................................................................65
9.4.1.
General Considerations...............................................................................................65
9.4.2.
Primary Endpoint........................................................................................................66
9.4.3.
Secondary Endpoints ..................................................................................................66
9.4.4.
Exploratory Endpoints................................................................................................67
9.4.5.
Safety Analyses ..........................................................................................................67
9.4.6.
Other Analyses ...........................................................................................................68
9.5.
Interim Analyses.........................................................................................................68
9.6.
Data Monitoring Committee (DMC)...........................................................................69
10.
Supporting Documentation and Operational Considerations ................................70
10.1.
Appendix 1: Regulatory, Ethical, and Study Oversight 
Considerations............................................................................................................70
10.1.1.
Regulatory and Ethical Considerations........................................................................70
10.1.2.
Financial Disclosure ...................................................................................................70
10.1.3.
Informed Consent Process ..........................................................................................71
10.1.4.
Data Protection...........................................................................................................71
10.1.5.
Committees Structure .................................................................................................71
10.1.6.
Dissemination of Clinical Study Data .........................................................................72
10.1.7.
Data Quality Assurance ..............................................................................................72
10.1.8.
Source Documents......................................................................................................74
10.1.9.
Study and Site Start and Closure.................................................................................74
10.1.10. Publication Policy.......................................................................................................75
10.1.11. Investigator Information .............................................................................................75
10.1.12. Long-Term Sample Retention.....................................................................................75
10.2.
Appendix 2: Clinical Laboratory Tests........................................................................76
10.2.1.
Clinical Laboratory Tests............................................................................................76
10.2.2.
Laboratory Tests to be Obtained at Time of a Systemic 
Hypersensitivity Event................................................................................................79
10.3.
Appendix 3: Adverse Events: Definitions and Procedures for 
Recording, Evaluating, Follow-up, and Reporting.......................................................81
10.3.1.
Definition of AE.........................................................................................................81
10.3.2.
Definition of SAE.......................................................................................................82
10.3.3.
Recording and Follow-Up of AE and/or SAE .............................................................83
10.3.4.
Reporting of SAEs......................................................................................................85
10.4.
Appendix 4: Contraceptive Guidance and Collection of 
Pregnancy Information ...............................................................................................86
10.4.1.
Definitions..................................................................................................................86
10.4.2.
Contraception .............................................................................................................87
10.4.3.
Collection of Pregnancy Information ..........................................................................88
10.5.
Appendix 5: Liver Safety: Hepatic Monitoring Tests ..................................................90
10.6.
Appendix 6: Examples of Infections That May Be Considered 
Opportunistic in the Setting of Biologic Therapy ........................................................91
10.7.
Appendix 7: Abbreviations .........................................................................................93
11.
References.................................................................................................................98

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I7P-MC-DSAD(a)
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1.
Protocol Summary
1.1.
Synopsis
Protocol Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study 
to Evaluate the Efficacy and Safety of LY3041658 in Adults with Moderate-to-Severe 
Hidradenitis Suppurativa
Rationale: LY3041658 is a humanized immunoglobulin G (IgG) 4-variant monoclonal antibody 
(mAb) that binds to and neutralizes all 7 of the known ligands (referred to collectively as ELR+ 
[E = glutamic acid, L = leucine, R = arginine] chemokines) that signal through the human 
chemokine, CXC motif, receptors 1 and 2 (CXCR1 and CXCR2). LY3041658 binds to an 
epitope that is common to all 7 ELR+ chemokines. Signaling through CXCR1 and CXCR2 
modulates neutrophil migration and angiogenesis, and neutrophil migration into sites of 
inflammation is critical to the pathogenesis of hidradenitis suppurativa (HS). Thus, LY3041658 
is being developed for the treatment of HS. This proof-of-concept study will evaluate the safety 
and efficacy of LY3041658 in adults with HS.
Objectives and Endpoints
Objectives
Endpoints
Primary
●  To test the hypothesis that treatment with 
LY3041658 is superior to placebo in inducing 
Hidradenitis Suppurativa Clinical Response 
(HiSCR) in adult participants with moderate-to-
severe hidradenitis suppurativa (HS)
●  Proportion of participants achieving 
HiSCR response at Week 16
Secondary
●  To evaluate the efficacy of LY3041658 compared 
to placebo with respect to measures of signs and 
symptoms and pain in adult participants with 
moderate-to-severe HS
●  Mean change from baseline to Week 16 
in:
○  Total number of abscesses and 
inflammatory nodules (AN count)
○  Skin Pain – HS Numeric Rating 
Scale (NRS)
Note:  HiSCR is defined as at least a 50% reduction in the total abscess and inflammatory nodule count (AN count) 
with no increase in abscess count and no increase in draining fistulae count relative to baseline.
Overall Design
Study I7P-MC-DSAD (DSAD) is a multicenter, randomized, double-blind, placebo-controlled, 
parallel-group Phase 2 study to evaluate the efficacy and safety of LY3041658 600 mg given 
intravenously (IV) every 2 weeks (Q2W) in adults with HS.

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I7P-MC-DSAD(a)
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The study duration will be up to approximately 51 weeks over 4 study periods:
Screening: a period lasting up to 35 days before Week 0 (Visit 2, baseline)
Treatment Period 1: a 16-week, 2-group double-blind treatment period
Treatment Period 2: a 20-week, single-group open-label extension period, and
Post-treatment follow-up: a period lasting approximately 10 weeks.
Topical antiseptics will be required as concomitant therapy during the study. Participants who 
were on stable doses of oral antibiotics at screening will remain on the same stable dose 
throughout the study.
Disclosure Statement: In this study, the 2-arm parallel treatment period is participant-blinded 
and investigator-blinded and is followed by a single-arm open-label extension treatment period.
Number of Participants: Approximately 100 patients will be screened to achieve approximately 
63 randomized participants.
Intervention Groups and Duration:
At baseline, participants will be randomized in a 2:1 ratio to one of two treatments groups:
Approximately 42 participants will receive LY3041658 600 mg IV Q2W for 16 weeks, and
Approximately 21 participants will receive placebo IV Q2W for 16 weeks.
Starting at Week 16, all participants, including those previously assigned to placebo, will receive 
LY3041658 600 mg IV Q2W for 20 weeks.
Data Monitoring Committee: No

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1.2.
Schema
Note: Starting at Week 16 participants who received placebo in Treatment Period 1 will receive LY3041658 600 mg IV Q2W.
Abbreviations: FD = first dose; IV = intravenous; LD = last dose; Q2W = every 2 weeks; R = randomization visit; V =  visit; W = study week relative to 
randomization visit.
Figure 1. Schema of Study I7P-MC-DSAD, a Phase 2 study to evaluate the efficacy and safety of LY3041658 in adults with 
moderate-to-severe hidradenitis suppurativa.

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I7P-MC-DSAD(a)
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1.3.
Schedule of Activities (SoA)
Table 1. Schedule of activities for the Screening Period and Treatment Period 1 of Study I7P-MC-DSAD
Visit 1 procedures may be conducted over more than 1 day as long as all activities are completed within the allowable visit tolerance.
For procedures at an early termination visit, see ETV in Table 2.
For procedures at an unscheduled visit, see V997 in Table 2. Unscheduled visits are for participants needing rescue therapy or incision and drainage.
Visit number
V1
V2
V3
V4
V5
V6
V7
V8
V9
V10
Comment
Weeks from randomization
–5
—
2
4
6
8
10
12
14
16
Study day
—
1
15
29
43
57
71
85
99
113
Visit interval tolerance (days)
≤35
—
±2
±2
±2
±2
±2
±2
±2
±2
Fasting visit
X
X
Informed consent
X
Inclusion and exclusion criteria, 
review and confirm
X
X
Demographics
X
Preexisting conditions and 
medical history
X
Prespecified medical history 
(indication and history of 
interest)
X
Prior treatments for indication
X
Relevant surgical history
Concomitant medications
X
X
X
X
X
X
X
X
X
X
Adverse events
X
X
X
X
X
X
X
X
X
X
For AESIs, additional data are collected (Section 8.3.6).
Substance use (alcohol, 
caffeine, tobacco)
X
Surgical interventions related to 
HS
X
X
X
X
X
X
X
X
X
Physical Evaluation
Height
X
Without shoes.
Weight
X
X
Vital signs
X
X
X
X
X
X
X
X
X
X
Blood pressure, body temperature, pulse rate. Vital 
signs should be measured after participant has been 
sitting for at least 5 minutes.

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Table 1. Schedule of activities for the Screening Period and Treatment Period 1 of Study I7P-MC-DSAD
Visit 1 procedures may be conducted over more than 1 day as long as all activities are completed within the allowable visit tolerance.
For procedures at an early termination visit, see ETV in Table 2.
For procedures at an unscheduled visit, see V997 in Table 2. Unscheduled visits are for participants needing rescue therapy or incision and drainage.
Visit number
V1
V2
V3
V4
V5
V6
V7
V8
V9
V10
Comment
Weeks from randomization
–5
—
2
4
6
8
10
12
14
16
Study day
—
1
15
29
43
57
71
85
99
113
Visit interval tolerance (days)
≤35
—
±2
±2
±2
±2
±2
±2
±2
±2
Fasting visit
X
X
Physical examination
X
The complete physical exam will exclude pelvic, rectal, 
and breast exams and will include assessment for signs 
and symptoms of tuberculosis (TB), including 
peripheral lymph nodes (Section 8.2.2).
Symptom-directed physical 
examination
X
X
X
X
X
X
X
X
X
See Section 8.2.2.
12-lead ECG (local)
X
X
Chest x-ray (posterior-anterior 
view) (local)
X
Interpreted and reported by radiologist or 
pulmonologist. Not performed at screening if performed 
within 6 months before screening and if qualifying 
radiographs or equivalent imaging study and/or formal 
report are available for investigator’s review and 
sufficient for TB evaluation according to local standard 
of care (Section 8.2.4).
Patient-Reported Outcomes (Electronic)
DLQI
X
X
X
X
X
Skin Pain – HS NRS
X
X
X
X
X
X
X
X
X
Drainage NRS
X
X
X
X
X
X
X
X
X
Smell NRS
X
X
X
X
X
X
X
X
X
Patient’s Global Impression of 
Severity – 7 Days (Hidradenitis 
Suppurativa)
X
X
X
X
X
X
X
X
X
Patient Global Impression of 
Change – 7 Days (Hidradenitis 
Suppurativa)
X
X
X

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I7P-MC-DSAD(a)
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Table 1. Schedule of activities for the Screening Period and Treatment Period 1 of Study I7P-MC-DSAD
Visit 1 procedures may be conducted over more than 1 day as long as all activities are completed within the allowable visit tolerance.
For procedures at an early termination visit, see ETV in Table 2.
For procedures at an unscheduled visit, see V997 in Table 2. Unscheduled visits are for participants needing rescue therapy or incision and drainage.
Visit number
V1
V2
V3
V4
V5
V6
V7
V8
V9
V10
Comment
Weeks from randomization
–5
—
2
4
6
8
10
12
14
16
Study day
—
1
15
29
43
57
71
85
99
113
Visit interval tolerance (days)
≤35
—
±2
±2
±2
±2
±2
±2
±2
±2
Fasting visit
X
X
Patient-Reported Outcomes (Paper)
Spinal Pain NRS
X
X
See Section 8.1.8.
Clinician-Administered Questionnaires (Electronic)
Lesion assessments
X
X
X
X
X
X
X
X
X
X
Includes anatomical region, type and number (see 
Section 8.1.1).
Hurley stage
X
X
Clinician-Administered Questionnaires (Paper)
C-SSRS Screening/Baseline
X
C-SSRS Since Last Visit
X
X
X
X
X
X
X
X
X
Self-Harm Supplement Form
X
X
X
X
X
X
X
X
X
X
Self-Harm Follow-Up Form
X
X
X
X
X
X
X
X
X
X
Required if triggered by the Self-Harm Supplement 
Form per instructions.
Inflammatory Back Pain 
Assessment (ASAS Expert 
Criteria)
X
See Section 8.1.8.
Laboratory Tests and Sample Collections
Hematology
X
X
X
X
X
X
X
X
X
X
Clinical chemistry
X
X
X
X
X
X
X
X
X
X
Lipid panel
X
X
Participants should not eat or drink anything but water 
for 12 hours before the visit. Fasting is not required at 
an ETV. If a participant attends these visits in a 
nonfasting state, the sample should still be collected. 
This will not be considered a protocol violation.
Urinalysis
X
X
X

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Table 1. Schedule of activities for the Screening Period and Treatment Period 1 of Study I7P-MC-DSAD
Visit 1 procedures may be conducted over more than 1 day as long as all activities are completed within the allowable visit tolerance.
For procedures at an early termination visit, see ETV in Table 2.
For procedures at an unscheduled visit, see V997 in Table 2. Unscheduled visits are for participants needing rescue therapy or incision and drainage.
Visit number
V1
V2
V3
V4
V5
V6
V7
V8
V9
V10
Comment
Weeks from randomization
–5
—
2
4
6
8
10
12
14
16
Study day
—
1
15
29
43
57
71
85
99
113
Visit interval tolerance (days)
≤35
—
±2
±2
±2
±2
±2
±2
±2
±2
Fasting visit
X
X
Serum pregnancy
X
Only for WOCBP (Section 8.2.5.1, Appendix 10.4) and 
women with a history of tubal ligation. Central 
laboratory.
Urine pregnancy (local)
X
X
X
X
X
X
X
X
X
Only for WOCBP (Section 8.2.5.1, Appendix 10.4) and 
women with a history of tubal ligation. Result must be 
negative before dosing at each dosing visit.
Follicle-stimulating hormone 
(FSH)
X
Optional, performed to confirm postmenopausal status 
(Section 8.2.5.1)
Tuberculosis (TB) test
X
Patients who had a tuberculin skin test (TST) will return 
from 48 to 72 hours after placement to have their test 
results read (Section 8.2.6). Samples may be sent to a 
central or local laboratory based on the type of test. A 
local laboratory must be qualified by local regulations.
HIV screening tests
X
Hepatitis C virus (HCV) 
screening tests
X
HCV RNA will be measured to confirm positive 
hepatitis C virus antibody (Section 8.2.8).
Hepatitis B virus (HBV) 
screening tests
X
Includes testing for HBsAg and anti-HBc 
(Section 8.2.7)
C-reactive protein, 
high-sensitivity (hs-CRP)
X
X
X
X
IL-8
X
X
X
X
Total immunoglobulins (IgA, 
IgE, IgG, and IgM)
X
X
If a hypersensitivity event occurs, collect additional 
samples (see Appendix 10.2, Section 10.2.2).

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I7P-MC-DSAD(a)
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Table 1. Schedule of activities for the Screening Period and Treatment Period 1 of Study I7P-MC-DSAD
Visit 1 procedures may be conducted over more than 1 day as long as all activities are completed within the allowable visit tolerance.
For procedures at an early termination visit, see ETV in Table 2.
For procedures at an unscheduled visit, see V997 in Table 2. Unscheduled visits are for participants needing rescue therapy or incision and drainage.
Visit number
V1
V2
V3
V4
V5
V6
V7
V8
V9
V10
Comment
Weeks from randomization
–5
—
2
4
6
8
10
12
14
16
Study day
—
1
15
29
43
57
71
85
99
113
Visit interval tolerance (days)
≤35
—
±2
±2
±2
±2
±2
±2
±2
±2
Fasting visit
X
X
Pharmacokinetic (PK) sample
X
X
X
X
X
X
At Visit 2, Visit 10, and Visit 19, collect samples at 3 
time points:
If a hypersensitivity event occurs, collect additional 
samples (see (Appendix 10.2, Section 10.2.2).
Immunogenicity (ADA) sample
X
X
X
Collect samples before dosing, if dosing is scheduled. 
If a hypersensitivity event occurs, collect additional 
samples (see Appendix 10.2, Section 10.2.2).
See Section 8.9 for additional details.
Exploratory biomarker sample –
Whole blood for RNA and for 
epigenetics,
X
X
X
Pharmacogenetics sample 
(DNA)
X
Exploratory biomarker samples 
- other
X
X
X
X
X
X
At Visit 2 and Visit 10, collect samples before the 
infusion starts.
Randomization and dosing
Randomization
X
Dosing
X
X
X
X
X
X
X
X
X
No dosing at Visit 1, Visit 20, ETV, or V997.
CCI

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I7P-MC-DSAD(a)
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Abbreviations: ADA = anti-drug antibody; AESI = adverse event of special interest; anti-HBc = antibody to hepatitis B core antigen; ASAS = Assessment of 
SpondyloArthritis International Society; C-SSRS = Columbia Suicide-Severity Rating Scale; DLQI = Dermatology Life Quality Index; DNA = 
deoxyribonucleic acid; ECG = electrocardiogram; ETV = early termination visit; HBsAg = hepatitis B surface antigen; HIV = human immunodeficiency 
virus; HS = hidradenitis suppurativa; NRS = numeric rating scale; RNA = ribonucleic acid; V = visit; WOCBP = women of childbearing potential.

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I7P-MC-DSAD(a)
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Table 2. Schedule of activities for Treatment Period 2 of Study I7P-MC-DSAD
For procedures at an early termination visit, see ETV in Table 2.
For procedures at an unscheduled visit, see V997 in Table 2. Unscheduled visits are for participants needing rescue therapy or incision and drainage.
Visit number
V11
V12
V13
V14
V15
V16
V17
V18
V19
V20
ETV
V997
Comment
Week from randomization
18
20
22
24
26
28
30
32
34
36
—
—
Study day
127
141
155
169
183
197
211
225
239
253
—
—
Visit interval tolerance 
(days)
±2
±2
±2
±2
±2
±2
±2
±2
±2
±2
—
—
Fasting visit
X
Concomitant medications
X
X
X
X
X
X
X
X
X
X
X
X
Adverse events
X
X
X
X
X
X
X
X
X
X
X
X
For AESIs, additional data are 
collected (Section 8.3.6).
Surgical interventions 
related to HS
X
X
X
X
X
X
X
X
X
X
X
X
Physical Evaluation
Weight
X
X
Vital signs
X
X
X
X
X
X
X
X
X
X
X
X
Blood pressure, body temperature, 
pulse rate. Vital signs should be 
measured after participant has been 
sitting for at least 5 minutes.
Symptom-directed physical 
examination
X
X
X
X
X
X
X
X
X
X
X
X
See Section 8.2.2.
12-lead ECG (local)
X
X
Patient-Reported Outcomes (Electronic)
DLQI
X
X
X
X
Skin Pain – HS NRS
X
X
X
X
X
X
X
Drainage NRS
X
X
X
X
X
X
X
Smell NRS
X
X
X
X
X
X
X
Patient’s Global Impression 
of Severity – 7 Days 
(Hidradenitis Suppurativa)
X
X
X
X
X
X
X

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I7P-MC-DSAD(a)
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Table 2. Schedule of activities for Treatment Period 2 of Study I7P-MC-DSAD
For procedures at an early termination visit, see ETV in Table 2.
For procedures at an unscheduled visit, see V997 in Table 2. Unscheduled visits are for participants needing rescue therapy or incision and drainage.
Visit number
V11
V12
V13
V14
V15
V16
V17
V18
V19
V20
ETV
V997
Comment
Week from randomization
18
20
22
24
26
28
30
32
34
36
—
—
Study day
127
141
155
169
183
197
211
225
239
253
—
—
Visit interval tolerance 
(days)
±2
±2
±2
±2
±2
±2
±2
±2
±2
±2
—
—
Fasting visit
X
Patient Global Impression of 
Change – 7 Days 
(Hidradenitis Suppurativa)
X
X
X
Patient-Reported Outcomes (Paper)
Spinal Pain NRS
X
X
X
See Section 8.1.8.
Clinician-Administered Questionnaires (Electronic)
Lesion assessments
X
X
X
X
X
X
X
X
X
X
X
X
Includes anatomical region, type 
and number (see Section 8.1.1).
Clinician-Administered Questionnaires (Paper)
C-SSRS Since Last Visit
X
X
X
X
X
X
X
X
X
X
X
X
Self-Harm Supplement 
Form
X
X
X
X
X
X
X
X
X
X
X
X
Self-Harm Follow-Up Form
X
X
X
X
X
X
X
X
X
X
X
X
Required if triggered by the 
Self-Harm Supplement Form per 
instructions.
Laboratory Tests and Sample Collections
Hematology
X
X
X
X
X
X
X
X
X
X
X
Clinical chemistry
X
X
X
X
X
X
X
X
X
X
X

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I7P-MC-DSAD(a)
19
Table 2. Schedule of activities for Treatment Period 2 of Study I7P-MC-DSAD
For procedures at an early termination visit, see ETV in Table 2.
For procedures at an unscheduled visit, see V997 in Table 2. Unscheduled visits are for participants needing rescue therapy or incision and drainage.
Visit number
V11
V12
V13
V14
V15
V16
V17
V18
V19
V20
ETV
V997
Comment
Week from randomization
18
20
22
24
26
28
30
32
34
36
—
—
Study day
127
141
155
169
183
197
211
225
239
253
—
—
Visit interval tolerance 
(days)
±2
±2
±2
±2
±2
±2
±2
±2
±2
±2
—
—
Fasting visit
X
Lipid panel
X
X
Participants should not eat or drink 
anything but water for 12 hours 
before the visit. Fasting is not 
required at an ETV. If a participant 
attends these visits in a nonfasting 
state, the sample should still be 
collected. This will not be 
considered a protocol violation.
Urinalysis
X
X
Urine pregnancy (local)
X
X
X
X
X
X
X
X
X
X
X
Only for WOCBP (Section 8.2.5.1, 
Appendix 10.4) and women with a 
history of tubal ligation. Result 
must be negative before dosing at 
each dosing visit.
C-reactive protein, 
high-sensitivity (hs-CRP)
X
X
IL-8
X
X
X
X
Total immunoglobulins 
(IgA, IgE, IgG, and IgM)
X
X
If a hypersensitivity event occurs, 
collect additional samples (see 
Appendix 10.2, Section 10.2.2).

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I7P-MC-DSAD(a)
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Table 2. Schedule of activities for Treatment Period 2 of Study I7P-MC-DSAD
For procedures at an early termination visit, see ETV in Table 2.
For procedures at an unscheduled visit, see V997 in Table 2. Unscheduled visits are for participants needing rescue therapy or incision and drainage.
Visit number
V11
V12
V13
V14
V15
V16
V17
V18
V19
V20
ETV
V997
Comment
Week from randomization
18
20
22
24
26
28
30
32
34
36
—
—
Study day
127
141
155
169
183
197
211
225
239
253
—
—
Visit interval tolerance 
(days)
±2
±2
±2
±2
±2
±2
±2
±2
±2
±2
—
—
Fasting visit
X
Pharmacokinetic (PK) 
sample
X
X
X
X
X
X
X
At Visit 2, Visit 10, and Visit 19, 
collect samples at 3 time points: 
If a hypersensitivity event occurs, 
collect additional samples (see 
(Appendix 10.2, Section 10.2.2).
Immunogenicity (ADA) 
sample
X
X
X
X
X
Collect samples before dosing, if 
dosing is scheduled.
If a hypersensitivity event occurs, 
collect additional samples (see 
Appendix 10.2, Section 10.2.2).
See Section 8.9 for additional 
details.
Exploratory biomarker 
samples - other
X
X
X
X
X
Dosing
Dosing
X
X
X
X
X
X
X
X
X
No dosing at Visit 1, Visit 20, 
ETV, or V997.
CCI

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I7P-MC-DSAD(a)
21
Abbreviations:  ADA = anti-drug antibody; AESI = adverse event of special interest; C-SSRS = Columbia Suicide-Severity Rating Scale; DLQI = Dermatology 
Life Quality Index; ECG = electrocardiogram; ETV = early termination visit; HS = hidradenitis suppurativa; NRS = numeric rating scale; V = visit; WOCBP 
= women of childbearing potential.

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I7P-MC-DSAD(a)
22
Table 3. Schedule of activities for the Post-Treatment Follow-Up Period of Study I7P-MC-DSAD
For procedures at an early termination visit, see ETV in Table 2.
For procedures at an unscheduled visit, see V997 in Table 2. Unscheduled visits are only for participants needing rescue therapy or incision and drainage.
Visit number
V801
V802
Comment
Week relative to randomization
40 or 
ETV+4
46 or 
ETV+10
Study day
281
323
Visit interval tolerance (days)
±7
±7
Fasting visit
No fasting in this period.
Concomitant medications
X
X
Adverse events
X
X
For AESIs, additional data are collected (Section 8.3.6).
Surgical interventions related to HS
X
X
Physical Evaluation
Vital signs
X
X
Blood pressure, body temperature, pulse rate. Vital signs should be measured after 
participant has been sitting for at least 5 minutes.
Symptom-directed physical examination
X
X
See Section 8.2.2.
Patient-Reported Outcomes (Electronic)
Skin Pain – HS NRS
X
X
Drainage NRS
X
X
Smell NRS 
X
X
Patient’s Global Impression of Severity –
7 Days (Hidradenitis Suppurativa)
X
X
Patient-Reported Outcomes (Paper)
Spinal Pain NRS
X
X
See Section 8.1.8.
Clinician-Administered Questionnaires (Electronic)
Lesion assessments
X
X
Includes anatomical region, type and number (see Section 8.1.1).
Clinician-Administered Questionnaires (Paper)
C-SSRS Since Last Visit
X
X
Self-Harm Supplement Form
X
X
Self-Harm Follow-Up Form
X
X
Required if triggered by the Self-Harm Supplement Form per instructions.
Laboratory Tests and Sample Collections
Hematology
X
X
Clinical chemistry
X
X

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I7P-MC-DSAD(a)
23
Table 3. Schedule of activities for the Post-Treatment Follow-Up Period of Study I7P-MC-DSAD
For procedures at an early termination visit, see ETV in Table 2.
For procedures at an unscheduled visit, see V997 in Table 2. Unscheduled visits are only for participants needing rescue therapy or incision and drainage.
Visit number
V801
V802
Comment
Week relative to randomization
40 or 
ETV+4
46 or 
ETV+10
Study day
281
323
Visit interval tolerance (days)
±7
±7
Fasting visit
No fasting in this period.
Urine pregnancy (local)
X
X
Only for WOCBP (Section 8.2.5.1 and Appendix 10.4) and women with a history of 
tubal ligation.
C-reactive protein, high-sensitivity (hs-CRP)
X
Pharmacokinetic (PK) sample
X
X
If a hypersensitivity event occurs, collect additional samples (see Appendix 10.2, 
Section 10.2.2).
Immunogenicity (ADA) sample
X
If a hypersensitivity event occurs, collect additional samples (see Appendix 10.2, 
Section 10.2.2). See Section 8.9 for additional details.
Dosing
No dosing in this period
Abbreviations: ADA = anti-drug antibody; AESI = adverse event of special interest; C-SSRS = Columbia Suicide-Severity Rating Scale; ETV = early 
termination visit; HS = hidradenitis suppurativa; NRS = numeric rating scale; V = visit; WOCBP = women of childbearing potential.

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I7P-MC-DSAD(a)
24
2.
Introduction
2.1.
Study Rationale
LY3041658 is a humanized immunoglobulin G (IgG) 4-variant monoclonal antibody (mAb) that 
binds to and neutralizes all 7 of the known ligands (referred to collectively as ELR+ 
[E = glutamic acid, L = leucine, R = arginine] chemokines) that signal through the human 
chemokine, CXC motif, receptors 1 and 2 (CXCR1 and CXCR2). LY3041658 binds to an 
epitope that is common to all 7 ELR+ chemokines. Signaling through CXCR1 and CXCR2 
modulates neutrophil migration and angiogenesis, and neutrophil migration into sites of 
inflammation is critical to the pathogenesis of hidradenitis suppurativa (HS). Thus, LY3041658 
is being developed for the treatment of HS.
Study I7P-MC-DSAD (DSAD) is a Phase 2 study to evaluate the safety and efficacy of 
LY3041658 in adult patients with HS. Results of this study will provide information useful to 
guiding dose selection in future studies and to further characterize the benefit/risk profile of 
LY3041658.
2.2.
Background
Hidradenitis suppurativa (HS) or acne inversa is a chronic, recurrent, inflammatory, debilitating 
skin disease usually presenting after puberty with painful, deep, inflamed lesions in the apocrine 
gland-bearing areas of the body, commonly the inguinal axillaries, and anogenital regions
(Zouboulis et al. 2015; Zouboulis 2006).
Even when HS lesions heal, permanent fibrosis, dermal contractures, and induration of the skin 
frequently occur. These tissue changes can be physically, psychologically, and cosmetically 
debilitating. As tissue damage accumulates over time, patients frequently develop low 
self-esteem and loneliness (Kouris et al. 2016) and become socially withdrawn, unable to 
maintain employment, and susceptible to poverty, depression, and suicidality (Vekic and Cains 
2017).
There is currently no uniformly effective single therapy for HS. Numerous treatment modalities 
are employed, including antibiotics, retinoids, hormones, immunosuppressive and 
anti-inflammatory agents, neurotoxins, radiotherapy, and surgery. The tumor necrosis factor
inhibitor adalimumab has been approved in the United States, Europe, and Australia for the 
treatment of moderate-to-severe HS (Zouboulis et al. 2015; Kimball et al. 2016a; Vekic and 
Cains 2017). Yet substantial unmet medical needs remain, since adalimumab fails either to treat 
many patients adequately or to maintain treatment effect over time (Kimball et al. 2016a). 
Patients with HS are appropriate for a novel investigational product (IP) with immunomodulating 
properties.
2.3.
Benefit/Risk Assessment
The efficacy of LY3041658 in HS has not been established. However, LY3041658 decreased 
neutrophil migration into cantharidin-induced blisters in healthy participants (data on file, 
Study I7P-MC-DSAA [DSAA]). These findings support the hypothesis that LY3041658 has the 

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I7P-MC-DSAD(a)
25
potential for efficacy in HS and other neutrophilic skin diseases. Furthermore, participants may 
benefit by receiving personal health information from the physical examinations and from other 
routine safety assessments performed in this study.
At this time, there are no known adverse drug reactions (ADRs) or known risks considered to be 
associated with LY3041658. No dose-limiting events were observed in the Phase 1 studies 
DSAA and I7P-MC-DSAB [DSAB].
In the Phase 1 Study DSAA, single doses of up to 700 mg of LY3041658 administered to healthy 
study participants were generally well tolerated with the exception of a mild, short-lived, 
infusion-associated reaction in 1 participant in a 700-mg cohort.
In the Phase 1 Study DSAB, participants with psoriasis, HS, or palmoplantar pustulosis received 
40 mg to 600 mg doses of LY3041658 every 2 weeks. The most common treatment-emergent 
adverse events were infections such as cellulitis, sinusitis and respiratory tract infections. Most 
adverse events were mild to moderate (CTCAE Grade 1 or Grade 2) severity. There was one 
severe event of elevated gamma-glutamyl transferase (GGT) (CTCAE Grade 3); this event in a 
single participant assigned to LY3041658 300 mg, and it was not accompanied by symptoms or 
changes in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 3 
times the upper limit of normal (ULN).
To minimize participant risk in Study DSAD, all participants will be monitored closely after 
completion of each intravenous (IV) infusion (Section 6.1). In addition, all participants will 
undergo regular monitoring of routine laboratory safety tests (clinical chemistry, hematology, 
and urinalysis). Monitoring of safety data will be performed on an ongoing basis, as described in 
Section 8.2. Interim analyses to review unblinded safety data will also be conducted, as 
described in Section 9.5 and Appendix 10.1, Section 10.1.5.
In summary, in the context of the cumulative knowledge for LY3041658, the benefit/risk balance 
for this study is assessed to be favorable.
More detailed information about the known and expected benefits and risks and reasonably 
expected adverse events of LY3041658 may be found in the Investigator’s Brochure (IB).

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I7P-MC-DSAD(a)
26
3.
Objectives and Endpoints
Objectives
Endpoints
Primary
●  To test the hypothesis that treatment with 
LY3041658 is superior to placebo in inducing 
Hidradenitis Suppurativa Clinical Response 
(HiSCR) in adult participants with moderate-to-
severe hidradenitis suppurativa (HS)
●  Proportion of participants achieving 
HiSCR response at Week 16
Secondary
●  To evaluate the efficacy of LY3041658 
compared to placebo with respect to measures 
of signs and symptoms and pain in adult 
participants with moderate-to-severe HS
●  Mean change from baseline to Week 16 
in:
○  Total number of abscesses and 
inflammatory nodules (AN count)
○  Skin Pain – HS Numeric Rating 
Scale (NRS)
Exploratory
Exploratory objectives and endpoints may include the following:
●  To evaluate, at various time points, the efficacy of LY3041658 compared to placebo in 
inducing improvements in signs and symptoms and quality of life
●  To characterize the pharmacokinetics (PK) of LY3041658 and to explore relationships 
between LY3041658 exposure and select biomarkers and clinical efficacy endpoints
●  To assess the potential development of anti-LY3041658 antibodies and their impact on the 
safety profile and PK of LY3041658
Note:  HiSCR is defined as at least a 50% reduction in the total abscess and inflammatory nodule count (AN count) 
with no increase in abscess count and no increase in draining fistulae count relative to baseline.

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I7P-MC-DSAD(a)
27
4.
Study Design
4.1.
Overall Design
Study I7P-MC-DSAD (DSAD) is a multicenter, randomized, double-blind, placebo-controlled, 
parallel-group Phase 2 study to evaluate the efficacy and safety of LY3041658 600 mg given 
intravenously (IV) every 2 weeks (Q2W) in adults with HS. 
The study duration will be up to approximately 51 weeks over 4 study periods:
Screening: a period lasting up to 35 days before Week 0 (Visit 2, baseline)
Treatment Period 1: a 16-week, 2-group double-blind treatment period:
●  At baseline (Visit 2, Week 0), eligible participants will be randomized in a 
2:1 ratio to receive either LY3041658 600 mg IV Q2W or placebo IV Q2W, 
starting at the baseline visit.
Treatment Period 2: a 20-week, single-group open-label extension period: 
●  Starting at Week 16, all participants, including those previously assigned to 
placebo, will receive LY3041658 600 mg IV Q2W until the last dosing visit.
Post-treatment follow-up: a period lasting approximately 10 weeks.
●  Participants will not receive study drug in this period.
●  The last dose of study drug is given at Visit 19 (Week 34). Thus, participants will 
have been withdrawn from study drug for a total of 12 weeks at the last 
post-treatment follow-up visit (Visit 802, Week 46).
The study schema is presented in Section 1.2.
Unscheduled visits are for participants needing rescue therapy or incision and drainage. The use 
of concomitant medications, including rescue therapy, is described in Section 6.5.
Participants who permanently discontinue the study drug early (Section 7.1) will undergo early 
termination procedures, including an early termination visit (ETV) and the post-treatment 
follow-up visits specified in the Schedule of Activities (SoA) (Section 1.3).
4.2.
Scientific Rationale for Study Design
The primary endpoint of this study is the proportion of patients achieving Hidradenitis 
Suppurativa Clinical Response (HiSCR) at Week 16. HiSCR is defined as at least a 50% 
reduction in the total abscess and inflammatory nodule count (AN count) with no increase in 
abscess count and no increase in draining fistulae count relative to baseline. HiSCR has been 
used in previous HS trials and has been accepted by the Food and Drug Administration as a 
primary endpoint (Kimball et al. 2014; Kimball et al. 2016a; Kimball et al. 2016b). Evaluation of 
the primary endpoint at the Week 16 time point is appropriate based on current clinical trials of 
systemic immunomodulatory therapies in HS (guselkumab NCT03628924, secukinumab 
NCT03713632 and NCT03713619; bimekizumab NCT04242498 and NCT04242446).

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I7P-MC-DSAD(a)
28
A double-blind, placebo-controlled design through the first treatment period limits bias for the 
participant and investigator assessments and enables a clearer interpretation of the effects of 
active drug.
The second treatment period (open-label) allows for evaluation of both safety and changes in 
efficacy over time in participants who received LY3041658 in the placebo-controlled treatment 
period. The second treatment period also allows participants who were randomized to placebo in 
the first treatment period to receive LY3041658 in the open-label period for a treatment duration 
similar to that of the placebo-controlled period.
The post-treatment follow-up period allows for continued safety monitoring after the last dose. 
The last dose is given at Week 34. This is 2 weeks before the last visit in the second treatment 
period (Week 36) and a total of 12 weeks before the last post-treatment follow-up visit 
(Week 46). LY3041658 concentrations are expected to be significantly decreased in the plasma
after 5 half-lives. The terminal half-life of LY3041658 is approximately 2 weeks, based on 
pharmacokinetic (PK) data from the Phase 1 Study DSAB. Therefore, for the present study, the 
planned duration of safety follow-up is adequate, as this duration covers approximately 6 half-
lives. A follow-up period of a similar duration was used after the last dose of LY3041658 in the 
single-dose Study DSAA and multiple-dose Study DSAB.
4.2.1.
Participant Input into Design
The sponsor involved patients in the design of this study by engaging patients in simulations and 
other face-to-face or virtual collaborative events for related HS trials. The insights gained from 
these events were used to ensure that this study design is supportive of the well-being of the 
study participants and that the study procedures can be implemented effectively at the 
investigative sites.
4.3.
Justification for Dose
The dose of 600 mg IV Q2W matches the highest dose administered in the multiple-dose 
Study DSAB. The Q2W dosing frequency was selected because the LY3041658 terminal 
half-life is approximately 2 weeks. In Study DSAB, three participants with HS received 4 doses 
of LY3041658 Q2W. There were no deaths, serious adverse events, or treatment-emergent 
adverse events leading to discontinuation in Study DSAB.
Exploratory modeling of neutrophil migration into cantharidin-induced blisters in healthy 
participants (Study DSAA) was performed. Although the neutrophil data was highly variable, a 
trend of dose-dependent decreases of neutrophils in the blister fluid was observed. Based on 
simulations using the exploratory PK/PD model, a 600 mg IV Q2W dose was predicted to reduce 
neutrophil migration to <20% of the baseline value.
The margin of safety (MOS) calculation is summarized in the IB. The estimated AUC(0-168) 
exposure based on three HS participants at the clinical IV dose of 600 mg (71500 µg*hr/mL) in 
humans is 7.2-fold lower than the AUC(0-168) at the NOAEL (125 mg/kg IV) in cynomolgus 
monkeys administered LY3041658 once weekly for 6 months. 
See the IB for additional information.

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29
4.4.
End-of-Study Definition
A participant is considered to have completed the study if he or she has completed all required 
phases of the study, including the last visit or the last scheduled procedure shown in the SoA 
(Section 1.3).
The “end of the study” is defined as the date of the last visit or last scheduled procedure shown 
in the SoA for the last participant in the study globally.

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30
5.
Study Population
Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as 
protocol waivers or exemptions, is not permitted.
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.
For screen failures and rescreening activities within the screening period, see Section 5.4.
5.1.
Inclusion Criteria
Participants are eligible to be included in the study only if they meet all of the following criteria 
during the screening period, unless otherwise specified below:
Informed consent
[1]  Are capable of giving signed informed consent as described in Appendix 10.1, which 
includes compliance with the requirements and restrictions listed in the informed consent 
form (ICF) and in this protocol.
Participant characteristics
[2] Are male or female patients from 18 to 65 years of age (inclusive), at the time of signing the 
ICF.
Note:  Contraceptive use by men or women should be consistent with local regulations 
regarding the methods of contraception for those participating in clinical studies.
Contraception requirements for participants in this study are provided in Appendix 10.4.
HS-related inclusion criteria
[3]   Have a diagnosis of HS for at least 6 months before baseline (the randomization visit).
Note: a participant with a clinical history of HS may be considered for enrollment if other 
eligibility criteria are met and if the clinical history is documented by the investigator based 
on review of the participant’s medical history at screening.
[4]   Have HS lesions in at least 2 distinct anatomical regions (for example, right and left axilla; 
or right axilla and right inguino-crural fold); and at least one of the lesions must be at least 
Hurley Stage II or Hurley Stage III.
[5]   Have had an inadequate response or intolerance to a 28-day course of oral antibiotics.
Examples of inadequate response include the following: any lesion increased in Hurley 
stage, any lesion requiring intra-lesional steroid injection or incision and drainage, and/or 
any new anatomic areas developed lesions during the antibiotic course.
[6]   Have a total abscess and inflammatory nodule (AN) count greater than or equal to 4.
[7]   Must agree to use daily, and throughout the duration of the study, one of the following 
over-the-counter topical antiseptics on body areas affected with HS lesions: chlorhexidine 
gluconate, triclosan, benzoyl peroxide, or dilute bleach in water.

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[8]  Are able and willing to comply with the following requirements for use of antibiotics:
If using topical antibiotics for HS at screening, the participant must stop them at least 
14 days before baseline (the randomization visit) and must not resume topical antibiotics 
throughout the duration of the study.
If using oral antibiotics for HS at screening and intends to continue them during the study, 
the participant must have been on a stable dose for at least 4 weeks before screening and 
must remain on the same stable dose throughout the duration of the study.
If using oral antibiotics for HS at screening and intends not to take them during the study, 
the participant must have stopped using them at least 14 days before the planned 
randomization visit (see Section 6.5).
Note: Participants may be considered for enrollment if they have received oral antibiotics 
for HS prior to screening but have stopped that use at least 14 days before the planned 
randomization visit.
5.2.
Exclusion Criteria
Participants will be excluded from study enrollment if they meet any of the following criteria 
within the screening period, unless otherwise specified:
Skin diseases and conditions
[9]    Have more than 20 draining fistulae.
[10]  Have had surgical treatment for HS in the last 4 weeks prior to baseline (the randomization 
visit).
[11]  Have active skin disease or condition (for example, bacterial, fungal or viral infection) that 
could interfere with assessment of HS.
Prior or concomitant therapy
[12] Are unwilling or unable to stop treatment with topical antibiotics for HS 14 days prior to 
baseline (the randomization visit) and for the duration of the study.
[13] Have received any biologic agent for treatment of HS (for example, adalimumab) at any 
time.
[14] Have received any biologic agent (such as monoclonal antibodies, whether investigational 
or marketed) for any indication other than HS within 3 months or 5 half-lives (whichever is 
longer) before baseline (the randomization visit).
Note:  Participants may be considered for enrollment if they have stopped receiving a 
biologic agent for an indication other than HS at least 3 months or 5 half-lives (whichever 
is longer) before baseline (the randomization visit) and if all other eligibility criteria are 
met.
[15]  Have received any systemic nonbiologic immunosuppressive medication for any indication 
within 28 days before baseline (the randomization visit).

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[16]  Have received oral opioids for HS-related pain within 14 days before baseline (the 
randomization visit) or are anticipated to receive oral opioids for HS-related pain during the 
study.
Note:  Participants may be considered for enrollment if they have stopped receiving oral 
opioids for HS-related pain more than 14 days before the baseline visit and if all other 
eligibility criteria are met.
[17] Have received any systemic (including oral) antibiotic or anti-infective treatment within 
28 days prior to baseline (the randomization visit), unless as required for latent tuberculosis 
infection (LTBI) treatment (see criterion #25) or prescribed for HS (see criterion #8).
[18]  Have a history of chronic alcohol abuse, IV drug abuse, or other illicit drug abuse within 
1 year prior to the screening visit.
Note: Marijuana is considered an illicit drug for the purposes of this study, regardless of 
local laws. Cannabidiol (CBD) products may be used during the study if they are derived 
exclusively from hemp. Participants who use hemp-based CBD products must be on a 
stable dose for at least 14 days prior to baseline (the randomization visit), and participants 
must remain on that stable dose during the study.
Current or historical infections
[19]  Have a current or recent acute, active infection. For at least 30 days prior to screening and 
up to the randomization visit, participants must have no symptoms or signs of confirmed or 
suspected infection, and must have completed any appropriate anti-infective treatment.
Note: Participants with an active upper respiratory infection that is being treated only 
symptomatically and does not require anti-infectives may be considered for enrollment if 
other eligibility criteria are met.
[20]  Have had, within 12 weeks of screening and up to the randomization visit, any of the 
following types of infection
○  Serious (requiring hospitalization, and/or IV or equivalent oral antibiotic treatment)
○  Opportunistic (as defined in Winthrop at al. 2015; see Appendix 10.6).
Note: Herpes zoster is considered active and ongoing until all vesicles are dry and 
crusted over.
○  Chronic (duration of symptoms, signs, and/or treatment of 6 weeks or longer)
○  Recurring (including, but not limited to, herpes simplex, herpes zoster, recurring 
cellulitis, chronic osteomyelitis).
Note: Participants with only recurrent, mild and uncomplicated orolabial and/or genital 
herpes may be discussed with the sponsor’s designated medical monitor and may be 
considered for enrollment if other eligibility criteria are met.
[21]  Have human immunodeficiency virus (HIV) infection
[22]  Have a current or past infection with hepatitis B virus (HBV) (that is, positive for 
hepatitis B surface antigen [HBsAg] and/or hepatitis B core antibody) (see Section 8.2.7).

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[23]  Have a current infection with hepatitis C virus (that is, positive for HCV ribonucleic acid 
[RNA]).
[24]  Have current or past history of active tuberculosis (TB) (see Section 8.2.6).
[25]  Have or have had LTBI that has not been treated with a complete course of appropriate 
therapy as defined by the World Health Organization and/or the United States Centers for 
Disease Control and Prevention, unless such treatment is underway (see Section 8.2.6).
Vaccines
[26]  Have received a Bacillus Calmette-Guerin (BCG) vaccination or treatment within 
12 months before screening; or received any live vaccine (that is, live attenuated) within 
3 months before screening, or intend to receive a live vaccine (or live attenuated) during 
the study. Note: Use of nonlive (inactivated) vaccinations is allowed for all participants.
Other medical conditions or history
[27]  Have a diagnosis or history of malignant disease within 5 years before baseline (the 
randomization visit), with the following exceptions:
○  basal cell or squamous epithelial carcinomas of the skin that have been resected with no 
evidence of metastatic disease for 3 years
○  cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to 
baseline.
[28]  Have answered “yes” to either Question 4 or Question 5 on the “Suicidal Ideation” portion 
of the Columbia-Suicide Severity Rating Scale (C-SSRS) or
have answered “yes” to any of the suicide-related behaviors on the “suicidal behavior” 
portion of the C-SSRS,
and the ideation or behavior occurred within 4 weeks prior to screening and up to the 
randomization visit.
[29]  Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at 
significant risk for suicide.
[30]  Have significant history of or current cardiovascular, respiratory, hepatic, renal, 
gastrointestinal, endocrine, hematological, or neurological disorders capable of 
significantly altering the absorption, metabolism, or elimination of drugs; of constituting a 
risk when taking the IP; or of interfering with the interpretation of data.
[31]  Are immunocompromised.
[32]  Have clinically significant multiple or severe drug allergies, or intolerance to topical 
corticosteroids, or severe posttreatment hypersensitivity reactions (including, but not 
limited to, erythema multiforme major, linear immunoglobulin [Ig] A dermatosis, toxic 
epidermal necrolysis, or exfoliative dermatitis).
[33]  Have significant allergies to humanized monoclonal antibodies or any components of the 
LY3041658 product formulation.

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Diagnostic assessments
[34]  Have screening electrocardiogram (ECG) abnormalities that, in the opinion of the 
investigator, are clinically significant and indicate an unacceptable risk for the participant’s 
safety in the study.
[35]  Have any of the following specific abnormalities on screening laboratory tests:
a.  Creatinine ≥2 times ULN
b.  AST or ALT ≥2 times ULN
c.  Alkaline phosphatase (ALP) ≥2 times ULN
d.  Total bilirubin level (TBL) ≥1.5 times ULN
e.  Hemoglobin <9.0 g/dL (<90.0 g/L)
f.  Total white blood cell (WBC) count <2500 cells/L (<2.50x103/L or <2.50 GI/L)
g.  Neutropenia (absolute neutrophil count <1200 cells/L) (<1.20x103/L or 
<1.20 GI/L)
h.  Lymphopenia (absolute lymphocyte count <750 cells/L) (<0.75x103/L or 
<0.75 GI/L)
i.  Thrombocytopenia (platelet count <100,000 cells/L) (<100x103/L or <100 GI/L)
Note: For each aforementioned test, 1 repeat testing is allowed during screening, and values 
resulting from repeat testing may be accepted for a participant’s enrollment eligibility if the 
other eligibility criteria are met (see Section 5.4.1).
Prior or concurrent clinical study experience
[36]  Have participated, within the last 30 days before baseline (the randomization visit), in a 
clinical trial involving any investigational product (IP) . If the previous IP has a half-life of 
greater than 7 days, at least 3 months or 5 half-lives (whichever is longer) should have 
passed before enrollment in this study.
[37]  Have previously completed or withdrawn from this study or from any other study 
investigating LY3041658, and have previously received the IP.
[38]  Are currently enrolled in any other clinical study involving an IP or any other type of 
medical research judged not to be scientifically or medically compatible with this study.
Other exclusions
[39]  Are pregnant or breastfeeding, or intend to become pregnant or breastfeed during the study.
[40]  Have donated more than a single unit of blood within 4 weeks prior to the screening visit or 
intend to donate blood during the course of the study.
[41]  Have no contraindication to, and in the investigator’s opinion are candidate for use of, at 
least one of the following: chlorhexidine gluconate, triclosan, benzoyl peroxide, or dilute 
bleach in water.

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[42]  Are investigative site personnel directly affiliated with this study and/or their immediate 
families. Immediate family is defined as a spouse, parent, child, or sibling, whether 
biological or legally adopted.
[43]  Are employees of Eli Lilly and Company (Lilly) or are employees of a third-party 
organization involved in the study which requires exclusion of their employees.
[44]  Are, in the opinion of the investigator or sponsor, unsuitable for inclusion in the study.
5.3.
Lifestyle Considerations
Not applicable.
5.4.
Screen Failures
Screen failures are defined as participants who consent to participate in the clinical study but are 
not subsequently randomly assigned to study intervention. A minimal set of screen failure 
information is 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.
5.4.1.
Allowed Retesting of Screening Investigations
Repeating laboratory tests during the screening period does not constitute rescreening.
See Section 8.2.6 for retesting related to TB.
5.4.2.
Rescreening of Individuals Who Failed Screening
Informed consent for rescreenings
Individuals who are to be rescreened must first sign a new ICF (Appendix 10.1, Section 10.1.3). 
Such individuals will be assigned a new participant number.
Rescreening after failure to meet study eligibility criteria
An individual who does not meet the criteria for participation in this study may be rescreened 
one time if the reason for the screen failure has resolved and if the sponsor has approved the 
rescreening. The interval between the failure to meet study entry criteria and the start of 
rescreening should be at least 4 weeks.
Allowed rescreening for administrative reasons
An individual may be rescreened one time for an administrative reason such as falling out of the 
screening window because of scheduling conflicts. The sponsor does not need to approve 
rescreening for an administrative reason. The rescreening can start immediately after the 
administrative reason has resolved.
Procedures not required to be repeated during rescreening
Individuals in rescreening who have already completed the protocol-required ECG, screening 
chest x-ray (CXR), or TB tests are not required to repeat these procedures if these procedures 

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were performed within 90 days before the date of signing the ICF for rescreening. However, 
these procedures can be repeated at the discretion of the investigator.
All other screening procedures must be repeated during rescreening to ensure that all the study 
eligibility criteria are met.

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6.
Study Intervention
Study intervention is defined as any investigational intervention, marketed product, placebo, or 
medical device intended to be administered to a study participant according to the study protocol.
6.1.
Study Interventions Administered
Study interventions
This study involves one dose level of LY3041658 and placebo, as shown below.
Treatment Name
LY3041658
Placebo
Dosage Formulation
3-mL vial delivers 
300 mg LY3041658
0.9% sodium chloride
Dosage Levels
600 mg
not applicable
Routes of Administration
IV
IV
Dosing Instructions
One dose every 2 weeks
One dose every 2 weeks
Abbreviation:  IV = intravenous.
LY3041658 drug product will be provided as a solution formulation in a glass vial. The drug 
product vials will be supplied in cartons, with the appropriate quantity specific to the planned 
dispensing schedule of the IPs.
When the dosing solutions are prepared according to the provided instructions (Section 6.2) it 
will not be possible to distinguish LY3041658 from placebo.
Monitoring after dose administration
All participants should be monitored for 30 minutes or longer after completion of each IV 
infusion, according to investigator practice or local standard of care.
Sites must have resuscitation equipment, emergency drugs, and appropriately trained staff 
available during the infusion and monitoring period, or until completion of all required post-
dosing activities (whichever is longer).
Packaging and labeling
Study interventions (LY3041658 and placebo) will be supplied by the sponsor or its designee in 
accordance with current Good Manufacturing Practice (cGMP). Clinical trial materials will be 
labeled according to the country’s regulatory requirements. All IPs will be stored, inventoried, 
reconciled, and destroyed according to applicable regulations.
6.2.
Preparation/Handling/Storage/Accountability
The Pharmacy Manual provides instructions for the preparation, handling, and storage of 
LY3041658 drug product and placebo, and describes site responsibility and accountability for
the administered products.
Investigators should consult the information provided in the Pharmacy Manual or the label for 
specific administration information, including warnings, precautions, contraindications, adverse 
reactions, and dose modifications.

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Preparation
The IPs must be prepared by an unblinded pharmacist (or other unblinded qualified individual) 
who is not involved in any other study-related procedures.
Handling and storage
Follow the storage and handling instructions on the IP packaging.
Site responsibilities and accountability
The following are responsibilities of the investigator or his or her designee:
●  The investigator or designee must confirm appropriate temperature conditions have been 
maintained during transit for all study intervention received and that any discrepancies are 
reported and resolved before use of the study intervention.
●  Only participants enrolled in the study may receive study intervention, and only 
authorized site staff may supply or administer study intervention. All study intervention 
must be stored in a secure, environmentally controlled, and monitored (manual or 
automated) area in accordance with the labeled storage conditions with access limited to 
the investigator and authorized site staff.
●  The investigator, institution, or the head of the medical institution (where applicable) is 
responsible for study intervention accountability, reconciliation, and record maintenance 
(that is, receipt, reconciliation, and final disposition records).
Further guidance and information for the final disposition of unused study interventions are 
provided in the Pharmacy Manual.
The investigator or designee is also responsible for
  explaining the correct use of the study interventions
  verifying that instructions are followed properly
  maintaining accurate records of IP dispensing and collection, and
  returning all unused medication to Lilly or its designee at the end of the study.
Note:  In some cases, sites may destroy the material if, during the investigative site 
selection, the evaluator has verified and documented that the site has appropriate 
facilities and written procedures to dispose of clinical materials.
6.3.
Measures to Minimize Bias: Randomization and Blinding
Blinding will be maintained throughout the conduct of the study as described in the separate 
Unblinding Plan.
Method of treatment assignment
Assignment to treatment groups will be determined by a computer-generated random sequence 
using an interactive web-response system (IWRS).

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Unblinded pharmacist
Investigators and all individuals involved in administering the blinded treatment or performing 
assessments will remain blinded to each participant’s assigned study intervention throughout the 
study’s blinded treatment period. To maintain this blind, an otherwise uninvolved party 
(unblinded pharmacist or other unblinded qualified individual) will be responsible for the 
reconstitution and dispensation of all study intervention. Blinded site personnel will administer 
the intervention to the participant.
Emergency unblinding
Emergency unblinding for adverse events may be performed through the IWRS. This option may 
be used ONLY if the participant’s well-being requires knowledge of the participant’s treatment 
assignment. All actions resulting in an unblinding event are recorded and reported by the IWRS.
If a participant’s study treatment assignment is unblinded to the investigator, to site personnel 
performing assessments, or to the participant, the participant must be discontinued from the 
study, unless the investigator obtains specific approval from the sponsor’s medical monitor for 
the participant to continue in the study (Section 7.1.1).
In case of an emergency, the investigator has the sole responsibility for determining if unblinding 
of a participants’ intervention assignment is warranted. Participant safety must always be the first 
consideration in making such a determination. If the investigator decides that unblinding is 
warranted, it is the responsibility of the investigator to promptly document the decision and 
rationale and notify the sponsor as soon as possible.
In cases where there are ethical reasons to have the participant remain in the study, the 
investigator must obtain specific approval from a sponsor clinical research physician (CRP) for 
the participant to continue in the study.
6.4.
Study Intervention Compliance
Participants will receive study intervention directly from the investigator or designee at the study 
site, under medical supervision. The date and time of each dose administered in the clinic will be 
recorded in the source documents and recorded in the electronic case report form (eCRF). 
Deviations from the prescribed dosage regimen should be recorded in the eCRF.
6.5.
Concomitant Therapy
Any medication or vaccine (including over-the-counter or prescription medicines, vitamins, 
and/or herbal supplements) that the participant is receiving at the time of enrollment or receives 
during the study must be recorded along with
Reason for use
Dates of administration including start and end dates, and
  Dosage information, including dose for concomitant therapies of special interest.
Participants will be instructed to consult the investigator or other appropriate study site personnel 
before taking any new medications or supplements during the study.
The sponsor’s medical monitor should be contacted if there are any questions.

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6.5.1.
Washout Period Before Enrollment
For the following medications, participants must complete a washout period before enrolling in 
the study, as stated in Section 5.1 and Section 5.2:
  topical antibiotics for HS
  oral opioids for HS-related pain
  systemic (including oral) antibiotic or anti-infective treatments except those taken for HS 
(see Section 6.5.2) or latent TB
Note: A participant taking oral antibiotics for HS at the screening visit may continue 
them if the participant intends to continue them for the duration of the study 
(Section 5.1).
  systemic non-biologic immunosuppressant, and
  biologic taken for any indication other than HS.
6.5.2.
Permitted Concomitant Therapy
The following will be required as concomitant therapy during the study:
  one of the following over-the-counter topical antiseptics to be used on body areas affected 
with HS lesions: 
○  chlorhexidine gluconate
○  triclosan
○  benzoyl peroxide, or 
○  dilute bleach in water.
Other medications are permitted during the study, including, but not limited to, these:
  wound care dressings: alginates, hydrocolloids, and hydrogels
  oral antibiotics: Participants on a stable dose of an oral antibiotic for HS before screening 
must remain on the same stable dose throughout the study, unless a change is required for 
the participant’s safety. The permitted oral antibiotics will be recorded on the eCRF as 
concomitant medications.
  CBD products derived exclusively from hemp: Participants who use these products must 
be on a stable dose before the randomization visit and remain on the stable dose 
throughout the study.
6.5.3.
Rescue Therapy
Participants who need rescue pain management during the study will be allowed to use the 
following, alone or in combination:
  tramadol, NSAIDs, or acetaminophen

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  intra-lesional triamcinolone, or equivalent corticosteroid, injection (10 mg/mL
triamcinolone, maximum 1 mL/lesion; a given lesion should receive injections no more 
than every 2 weeks), and
  incision and drainage.
Unscheduled visits are allowed for acutely painful lesions requiring intervention (either intra-
lesional triamcinolone or incision and drainage).
An intervention can occur on maximally 2 different lesions at the same visit or on the same 
lesion at 2 different study visits. The same lesion cannot be treated 2 times at the same visit.
6.5.4.
Prohibited Concomitant Therapy
The following will be prohibited as concomitant therapy during the study:
  topical antibiotics for HS
  any biologic agent, whether marketed or investigational
  any non-biologic systemic immunosuppressant
  oral opioids for HS-related pain, and
  cannabis (marijuana).
6.5.5.
Therapy After Permanent Discontinuation of Study Drug
The restrictions on concomitant therapy described above are applicable to participants 
throughout the study, including any periods of time off study drug such as the post-treatment 
follow-up period.
6.6.
Dose Modification
Modification of the dose of the study intervention is not permitted in this study.
6.7.
Intervention after the End of the Study
LY3041658 will not be available to participants following completion of the study.

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7.
Discontinuation of Study Intervention and Participant 
Discontinuation/Withdrawal
In rare instances, it may be necessary for a participant to permanently discontinue study drug.
These sections describe reasons for a participant’s
  permanent or temporary discontinuation of study drug (Section 7.1), or
  discontinuation (withdrawal) from the study (Section 7.2).
Discontinuation of specific sites or of the trial as a whole are handled as part of regulatory, 
ethical, and trial oversight considerations in Appendix 10.1, Section 10.1.9.
7.1.
Discontinuation of Study Intervention
Study drug may be permanently discontinued or temporarily withheld during the study.
Participants who permanently discontinue study drug early will undergo early termination 
procedures, which include
an ETV
   AND,
post-treatment follow-up visits, as shown in the SoA (Section 1.3).
7.1.1.
Criteria for Permanent Discontinuation of Study Drug
Data collection and safety follow-up when study drug is permanently discontinued
If study drug is permanently discontinued, the participant will remain in the study to have an 
ETV, as well as post-treatment follow-up visits, as shown in the SoA (Section 1.3).
See the SoA for data to be collected at the time of discontinuation and follow-up and for any 
further evaluations that need to be completed. Safety follow-up is as outlined in the SoA 
(Section 1.3), Section 8.2 (“Safety Assessments), and Section 8.3 (“Adverse Events and Serious 
Adverse Events”).
Criteria for permanent discontinuation of study drug
Possible reasons leading to permanent discontinuation of study drug include, but are not limited 
to, the following:
Participant decision
●  The participant requests to discontinue the study drug.
Prohibited concomitant medication use
●  The participant requires treatment with a prohibited medication (Section 6.5.4).
Pregnancy
●  The participant becomes pregnant during the study (see Section 8.2.5.1).

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Safety considerations
●  The participant develops any of the following conditions during the study:
  malignancy (except for successfully treated basal or squamous cell skin carcinoma)
  HIV/acquired immune deficiency syndrome (AIDS) infection
  active TB infection (Section 8.2.6)
  HCV RNA positive (Section 8.2.8)
●  The participant answered yes" to Question 4 or Question 5 on the "Suicidal Ideation" 
portion of the C-SSRS, or answered "yes" to any of the suicide-related behaviors on the 
Suicidal Behavior portion of the C-SSRS (Section 8.2.10).
Note:  A psychiatrist or appropriately trained professional may assist in the 
decision to discontinue the participant.
●  The investigator, after consultation with the sponsor’s designated medical monitor, 
determines that a systemic hypersensitivity reaction has occurred and is related to study 
drug administration.
●  The participant experiences any 1 of the following events on 2 consecutive samples taken 
at least 48 hours, but no more than 1 week, apart.
  Total WBC <1000 cells/L
  Absolute neutrophil count (ANC) <500 cells/L
  Absolute lymphocyte count (ALC) <200 cells/L
●  The participant has an adverse event or serious adverse event or a clinically significant 
change in a laboratory value that, in the opinion of the investigator or sponsor, would 
preclude the participant from continuing to receive study drug.
Hepatic event or liver test abnormality
●  Participants who are discontinued from study drug because of a hepatic event or liver test 
abnormality should have additional hepatic safety data collected via the hepatic eCRF 
packet. Discontinuation of study drug because of abnormal liver tests should be 
considered by the investigator when a participant meets one of the following conditions 
after consultation with the medical monitor (see Section 8.2.9).
  ALT or AST >8 times ULN
  ALT or AST >5 times ULN sustained for more than 2 weeks
  ALT or AST >3 times ULN and TBL >2 times ULN or international normalized ratio 
(INR) >1.5
  ALT or AST >3 times ULN with the appearance of fatigue, nausea, vomiting, right 
upper-quadrant pain or tenderness, fever, rash, and/or eosinophilia (>5%)
  ALP >3 times ULN
  ALP >2.5 times ULN and TBL >2 times ULN, or

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  ALP >2.5 times ULN with the appearance of fatigue, nausea, vomiting, right upper 
quadrant pain or tenderness, fever, rash, and/or eosinophilia (>5%).
Other reasons
●  Unblinding: If an investigator, site personnel performing assessments, or participant is 
unblinded, the participant must be discontinued from the study drug and continue to 
post-treatment follow-up. In cases where there are ethical reasons to have the participant 
continue on study drug, the investigator must obtain specific approval from the sponsor or 
designee for the participant to continue.
7.1.2.
Criteria for Temporary Interruption (Withholding) of Study Drug
7.1.2.1.
Infection-Related Criteria for Temporary Withholding of Study Drug
If a participant develops an infection, study intervention is to be withheld until resolution of all 
acute clinical signs and symptoms, and completion of all appropriate anti-infective treatment.
7.1.2.2.
Other Criteria for Temporary Withholding of Study Drug
Dosing may be interrupted and resumed in participants who experience the following reductions 
but do not meet the criteria for permanent discontinuation:
●  interrupt if total WBC count is <2000 cells/L (leukopenia) and resume when total WBC 
count is ≥2000 cells/L
●  interrupt if ANC is <1000 cells/L (neutropenia) and resume when ANC is 
≥1000 cells/L
●  interrupt if ALC is <500 cells/L (lymphopenia) and resume when ALC is ≥500 cells/L.
7.2.
Participant Discontinuation/Withdrawal from the Study
Participant discontinuation (withdrawal from the study) is expected to be uncommon.
A participant may withdraw from the study in the following circumstances:
●  at any time at his or her own request, or at the request of his or her designee (for example, 
parents or legal guardian)
●  at the discretion of the investigator for safety, behavioral, compliance, or administrative 
reasons
●  if the participant enrolls in any other clinical study involving an investigational medicinal 
product or enrollment in any other type of medical research judged not to be scientifically 
or medically compatible with this study
●  if the participant, for any reason, requires treatment with another therapeutic agent that has 
been demonstrated to be effective for treatment of the study indication. In this case, 
discontinuation from the study occurs prior to introduction of the new agent.
Data collection and follow-up for participants who discontinue the study
At the time of discontinuing from the study, if possible, an ETV should be conducted, if possible, 
as shown in the SoA. See the SoA for data to be collected at the time of study discontinuation 

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and follow-up and for any further evaluations that need to be completed. The participant will be 
permanently discontinued both from the study intervention and from the study.
Withdrawal of consent for disclosure
If the participant withdraws consent for disclosure of future information, the sponsor may retain 
and continue to use any data collected before such a withdrawal of consent. If a participant
withdraws from the study, he or she may request destruction of any samples taken and not tested,
and the investigator must document this in the site study records.
7.2.1.
Discontinuation of Inadvertently Enrolled Participants
If the sponsor or investigator identifies a participant who did not meet enrollment criteria and 
was inadvertently enrolled, then the participant should be discontinued from study treatment 
unless there are extenuating circumstances that make it medically necessary for the participant to 
continue on study treatment. If the investigator and the sponsor’s clinical research physician 
agree that it is medically appropriate to continue, the investigator must obtain documented 
approval from the sponsor’s clinical research physician to allow the inadvertently enrolled 
participant to continue in the study with or without treatment with investigational medicinal 
product. Safety follow-up is as outlined in the SoA (Section 1.3), Section 8.2 (“Safety 
Assessments), and Section 8.3 (“Adverse Events and Serious Adverse Events”).
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. Site personnel are expected to 
make diligent attempts to contact participants who fail to return for a scheduled visit or were 
otherwise unable to be followed up by the site.

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8.
Study Assessments and Procedures
Study procedures and their timing are summarized in the SoA (Section 1.3). Protocol waivers or 
exemptions are not allowed. Adherence to the study design requirements, including those 
specified in the SoA, is essential and required for study conduct.
All assessments and sample collections should be finished before a dose is administered at the 
dosing visits.
8.1.
Efficacy Assessments
Order of efficacy assessments
Efficacy assessments should be timed so that participants’ self-assessments are completed before 
clinical assessments or sample collections are performed.
Appropriateness of efficacy assessments
The primary measure of disease activity, HiSCR, has been recognized as a valid and meaningful 
endpoint and has been used in previous HS trials (Section 4.2). The secondary and exploratory 
measures of disease activity and quality of life are also generally recognized as reliable, accurate, 
and relevant.
The patient-reported outcomes (PRO) questionnaires will be administered electronically and only 
in countries where the questionnaires have been translated into the native language of the region 
and linguistically validated.
8.1.1.
Lesion Assessments: Count, Measurement, and Severity
At the visits designated in the SoA (Section 1.3), the investigator will examine the participant’s 
skin. Using an electronic device, the investigator will record which anatomical regions have 
lesions, the type and number of lesions, and the Hurley stage for each affected region.
The anatomical regions are to be examined for lesions are these:
●  left axilla
●  right axilla
●  left inframammary area
●  right inframammary area
●  intermammary area
●  left buttock
●  right buttock
●  left inguino-crural fold
●  right inguino-crural fold
●  perianal area
●  perineal area, and
●  other.
The types of lesions to be counted and recorded are these:
●  abscesses (A)
●  draining fistulas (DF)
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●  inflammatory nodules (N)
●  non-inflammatory nodules (xN)
The severity stages (Hurley stages [1989]) to be assigned and recorded are these:
Stage I:  Abscess formation, single or multiple, without sinus tracts and cicatrization
Stage II:  Recurrent abscesses with tract formation and cicatrization, single or multiple, 
widely separated lesions
Stage III:  Diffuse or near diffuse involvement, or multiple interconnected tracts and abscesses 
across the entire area.
For each anatomical region, the investigator will measure and record the longest distance 
between 2 relevant lesions. If there is only 1 lesion, the investigator will measure and record the 
diameter of that lesion. The investigator will also determine and record (as yes or no) whether
the lesions are clearly separated by normal skin.
To reduce inter-rater variability, the investigative site personnel should attempt to ensure that a 
participant’s lesions are assessed by the same investigator throughout the study.
The lesion assessments by the investigator are used to calculate HiSCR, modified Sartorius Score 
(mSS), and International Hidradenitis Suppurativa Severity Score System (IHS4).
8.1.1.1.
Hidradenitis Suppurativa Clinical Response (HiSCR)
The HiSCR (Kimball et al. 2014; Kimball et al. 2016b) is defined as at least a 50% reduction in 
the total abscess and inflammatory nodule count (sum of abscesses and inflammatory nodules 
[AN count]) with no increase in abscess count (A count) and no increase in draining fistulae 
count (DF count) relative to baseline.
8.1.1.2.
Modified Sartorius Score (mSS)
The mSS (Sartorius et al. 2009) is a measure for disease severity calculated by the investigator’s 
assignment of a score to each anatomical region based on the
●  presence of lesions (3 points if at least 1 lesion is present; 0 if no lesion is present)
●  number and type of lesions in each region (each fistula = 6 points; each nodule = 1 point)
●  longest distance between relevant lesions within each region or else the diameter of the 
lesion if the region has only 1 lesion (≥10 cm = 9 points; <10 cm and ≥5 cm = 3 points; <5
cm = 1 point; 0 points if no lesion), and 
●  presence of normal skin clearly separating all lesions (no [that is, Hurley stage III] = 9 
points; yes = 0 points).
A participant’s total mSS is the sum of his or her regional Sartorius scores. Higher mSS scores, 
for which there is no predefined upper limit, indicate increasingly severe disease.
8.1.1.3.
International Hidradenitis Suppurativa Severity Score System (IHS4)
The IHS4 score (Zouboulis et al. 2017) is a measure of disease severity calculated by summing
the number of

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●  nodules multiplied by 1
●  abscesses multiplied by 2, and 
●  draining tunnels multiplied by 4.
A total score of 3 or less signifies mild disease, 4 to 10 signifies moderate disease, and 11 or 
greater signifies severe disease.
8.1.2.
Skin Pain – HS Numeric Rating Scale (NRS)
The Skin Pain – HS Numeric Rating Scale (NRS) is a patient-administered, single-question, 
11-point horizontal scale anchored at 0 and 10, with 0 representing “no pain” and 10 representing 
“pain as bad as I can imagine.” The recall period is 7 days.
8.1.3.
Dermatology Life Quality Index (DLQI)
The Dermatology Life Quality Index (DLQI) is a participant-rated, 10-item questionnaire that 
covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, 
personal relationships, and treatment. The recall period of this scale is over the “last week.” 
Response categories include “a little,” “a lot,” and “very much,” with corresponding scores of 1, 
2, and 3, respectively, and “not at all” or unanswered (“not relevant”) responses scored as 0. 
Scores range from 0 to 30, with higher scores indicating greater impairment of quality of life. A 
DLQI total score of 0 to 1 is considered as having no effect on a participant’s health-related 
quality of life (Hongbo et al. 2005), and a 4-point change from baseline is considered the 
minimal clinically important difference threshold in patients with inflammatory skin disease
(Basra et al. 2015).
8.1.4.
Drainage Numeric Rating Scale (NRS)
The Drainage Numeric Rating Scale (NRS) is a patient-rated, single-question, 11-point 
horizontal scale anchored at 0 and 10, with 0 representing “No drainage” and 10 representing 
“Drainage as bad as I can imagine.” The recall period is 7 days.
8.1.5.
Smell Numeric Rating Scale (NRS)
The Smell Numeric Rating Scale (NRS) is a patient-rated, single-question, 11-point horizontal 
scale anchored at 0 and 10, with 0 representing “No smell” and 10 representing “Smell as bad as 
I can imagine.” The recall period is 7 days.
8.1.6.
Patient’s Global Impression of Severity – 7 Days (Hidradenitis Suppurativa)
The Patient’s Global Impression of Severity – 7 Days for HS is a single-item question asking the 
participants how they would rate their overall HS severity over the past 7 days. The 5 categories 
of response are “no symptoms,” “very mild,” “mild,” “moderate,” and “severe.”
8.1.7.
Patient Global Impression of Change - 7 Days (Hidradenitis Suppurativa)
The Patient Global Impression of Change – 7 Days for HS is a single-item question asking the 
participants how they would rate the change in their HS symptoms since they started taking the 
study medication. The 5 categories of response are “much better,” “a little better,” “no change,” 
“a little worse,” and “much worse.”

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8.1.8.
Inflammatory Back Pain Assessment (ASAS Expert Criteria) and Spinal Pain 
Numeric Rating Scale (NRS)
The presence of inflammatory back pain (IBP) will be assessed at baseline using Assessment of 
SpondyloArthritis International Society (ASAS) expert criteria adapted from Sieper et al. 2009.
A participant is considered to have IBP when 4 of the 5 following parameters are present: 1) 
onset before the age of 40 years, 2) insidious (gradual or unperceived) onset, 3) improvement 
with exercise, 4) no improvement with rest, 5) pain at night with improvement upon getting up.
Participants meeting the IBP criteria at baseline will be asked questions about spinal pain during 
the study. They will be asked to respond to the following 2 questions (on average during the last 
week):
1. “How much pain of your spine do you have?”
2. “How much pain of your spine do you have at night?”
The answers are recorded on an NRS and are each rated between “0” (no pain) and “10” (most 
severe pain).
8.2.
Safety Assessments
Order of safety assessments
If multiple safety assessments are scheduled to occur during the same visit, the preferred order of 
completion is
1)  ECG (if applicable) and vital signs first
2)  other safety assessments, including physical examinations and nonleading (spontaneous)
adverse event collection, followed by C-SSRS (Section 8.3.1.1), and finally
3) sample collection for clinical laboratory, PK, pharmacodynamic (PD), pharmacogenetic, 
biomarker, and immunogenicity testing.
Data collection and reporting
The adverse event data collection and reporting requirements are described in Section 8.3 and 
Appendix 10.3. Additional requirements regarding adverse events of special interest (AESIs) are 
described in Section 8.3.
Any clinically significant findings that result in a diagnosis and that occur after the participant 
receives the first dose of study drug should be reported to Lilly or its designee as an adverse 
event via eCRF.
Safety monitoring
The principle investigator will monitor safety and laboratory data throughout the study and 
should discuss immediate safety concerns with the sponsor immediately upon occurrence or 
awareness to determine whether the participant should continue or discontinue the study 
intervention.
The sponsor will monitor the safety data, including adverse events and serious adverse events 
(SAEs), discontinuations, medical history, concomitant medications, vital signs, and clinical 
laboratory results by means of periodic blinded reviews and other appropriate methods. These 

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methods include reviews by a functionally independent safety physician and/or clinical research 
scientist who regularly reviews SAE reports in real time and across studies, and who reviews 
applicable clinical safety and epidemiological publications from the literature. If this safety 
monitoring uncovers an issue that needs to be addressed by unblinding at the individual or group 
level, additional analyses of the safety data can be performed by the sponsor’s independent 
internal safety review committee (Appendix 10.1, Section 10.1.5).
Appropriateness of safety assessments
The safety assessments used in this study are routine elements of clinical health assessment and 
Phase 2 drug development.
8.2.1.
Vital Signs
Vitals signs (body temperature, blood pressure, and pulse rate) will be measured at the visits 
specified in the SoA (Section 1.3) and as clinically indicated. Additional vital signs may be 
measured during the study visits if warranted, as determined by the investigator.
Blood pressure and pulse rate should be measured after the participant has been sitting for at 
least 5 minutes. Orthostatic vital signs should be assessed, if possible, during any adverse event
of dizziness or posture-induced symptoms. If orthostatic measurements are required, participants 
should be supine for at least 5 minutes and stand for at least 3 minutes. If the participant feels 
unable to stand, only supine vital signs will be recorded.
8.2.2.
Physical Examinations
A complete physical examination will be performed at the screening visit. This examination 
excludes pelvic, rectal, and breast examinations unless clinically indicated.
A symptom-directed physical examination will be performed at other visits, as specified in the 
SoA (Section 1.3) and as clinically indicated.
At the screening visit and at approximately every third month thereafter, the physical 
examination, whether it is complete or symptom-directed, should include an assessment of TB 
risk factors and symptoms or signs of TB, including an assessment of peripheral lymph nodes 
(Section 8.2.6).
Height (without shoes) and weight will also be measured and recorded as specified in the SoA.
8.2.3.
Electrocardiograms
For each participant, 12-lead ECGs will be collected as specified in the SoA (Section 1.3). 
Participants must be supine for approximately 5 to 10 minutes before ECG collection and remain 
supine but awake during ECG collection.
Electrocardiograms may be obtained at additional times, when deemed clinically necessary. 
Collection of additional ECGs at a particular time point is allowed to ensure high quality records.
Electrocardiograms will be interpreted by a qualified physician (the investigator or qualified 
designee) at the study site as soon after the time of ECG collection as possible, and ideally while 
the participant is still present, to determine whether the participant meets the study entry criteria 
and for immediate participant management, should any clinically relevant findings be identified.

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If a clinically significant finding is identified (including, but not limited to changes from baseline 
in QT/QTc interval from baseline), the investigator or qualified designee, in conjunction with the 
sponsor’s medical monitor, will determine if the participant can continue in the study and if any 
change in participant management is needed.
The investigator or qualified designee must document his or her review of the ECG printed at 
collection. Any new clinically relevant finding will be reported as an adverse event.
8.2.4.
Chest Radiography (CXR)
A posterior–anterior (PA) chest x-ray (CXR), interpreted and reported by a radiologist or 
pulmonologist, will be obtained as specified in the SoA (Section 1.3).
A lateral CXR can also be obtained if, in the opinion of the investigator, a lateral view is 
indicated.
Note:  Participants do not need to have a CXR at screening if, based on the judgment of 
the investigator, both of the following 2 conditions are met:
  the CXR was performed within 6 months before initial screening, and
  documentation of the CXR, read by a qualified radiologist or pulmonologist, is 
sufficient for TB evaluation according to local standard of care.
For each participant, the CXR films or images or a radiology report must be available to the 
investigator for review before the participant is randomized. Certain findings from CXR may be 
consistent with a condition that excludes a participant from the study; see Section 5.2.
Note: Results of a chest computerized tomography (CT) scan or other imaging study 
similar to a CXR may be substituted in place of the CXR as described above, in 
consultation with the sponsor’s medical monitor.
8.2.5.
Laboratory Tests
Appendix 10.2 lists the clinical laboratory tests to be performed, and the SoA (Section 1.3) 
specifies the study visits at which samples are collected for clinical laboratory tests.
Samples for laboratory testing will be obtained in the event of anaphylaxis or systemic 
allergic/hypersensitivity reactions, as described in Section 8.3.6.2 and Appendix 10.2.
Additional tests may be performed at any time during the study as deemed necessary by the 
investigator or as required by local regulations.
All protocol-required laboratory assessments, as defined in Appendix 10.2, must be conducted in 
accordance with the laboratory manual and the SoA.
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 (for example, SAE or adverse event or dose 
modification), then the results must be recorded in the CRF.
Reviewing and recording test results
The investigator must review the laboratory report, document this review, and record any 
clinically relevant changes occurring during the study in the adverse event section of the CRF. 

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The laboratory reports must be filed with the source documents. 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.
Repeat testing after clinically significant abnormal findings
All laboratory tests with values considered clinically significantly abnormal during participation 
in the study or within 12 weeks after the last dose of study intervention should be repeated until 
the values return to normal or baseline or are no longer considered clinically significant by the 
investigator or the 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.
Blinding of laboratory test results
Laboratory results that could unblind the study will not be reported to investigative sites or other 
blinded personnel (Appendix 10.2).
Sample retention
Unless otherwise specified in the subsections of Section 8 or in Appendix 10.1, Section 10.1.12
(“Long-Term Sample Retention”), all samples collected for specified laboratory tests will be 
destroyed within 60 days of receipt of confirmed test results. Certain samples may be retained for 
a longer period, if necessary, to comply with applicable laws, regulations, or laboratory 
certification standards.
8.2.5.1.
Pregnancy Testing
Pregnancy testing is to be performed on women of childbearing potential (WOCBP) and women 
with a history of tubal ligation. Participants who are pregnant will be discontinued from the study 
(Section 7.1.1).
Visits and times
Serum pregnancy test will be done at screening only, and results will be confirmed by the central 
laboratory.
Urine pregnancy testing will be performed locally, as specified in the SoA (Section 1.3). If the 
specified visit includes study drug administration, the urine pregnancy test must be “negative” 
within 24 hours before the study drug is administered.
Urine pregnancy testing may be performed at additional time points during the study treatment 
period and/or follow-up period, at the discretion of the investigator or if this is required by local 
regulations.
If a urine pregnancy test is not available, a local serum pregnancy test is an acceptable 
alternative.
Optional follicle-stimulating hormone (FSH) testing
The participant’s FSH level can be obtained during screening at the discretion of the investigator 
to assist in determining whether a woman meets the definition of “postmenopausal.” The FSH 
level can also be optionally obtained during the study to determine the participant’s 
postmenopausal status (see Section 1.3 and Section 10.4.1).

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8.2.6.
Tuberculosis Testing and Monitoring
Tuberculosis testing
During screening, all participants are to be assessed for risk factors, symptoms, and signs of TB 
with all of the following:
●  Thorough history to determine the lifetime risk factors for TB infection, for TB 
progression, and for symptoms and/or signs of active TB, and
●  Signs of previous or active TB by means of
Thorough physical examination for signs of active TB, including measurement of 
body temperature (Section 8.2.1) and assessment of peripheral lymph nodes 
(Section 8.2.2), and
PA CXR interpreted and reported by radiologist or pulmonologist (Section 8.2.4).
All participants with no history of LTBI or active TB, and no history of positive Mantoux 
tuberculin skin test (TST) using purified protein derivative (PPD) or positive Mycobacterium 
tuberculosis interferon gamma release assay (IGRA) must have one of the following:
●  Purified Protein Derivative (PPD) TST
The TST is performed by injecting 0.1 mL of tuberculin PPD into the inner surface of 
the forearm. The injection should be made with a tuberculin syringe. The TST is an 
intradermal injection. When placed correctly, the injection should produce a pale 
elevation of the skin (a wheal) 6 to 10 mm in diameter. Measure induration at site of 
intradermal injection 48 to 72 hours after intradermal injection. The test must be read 
during this window of time. The reaction should be measured in millimeters of 
induration (palpable, raised, hardened area or swelling). The reader should not 
measure erythema (redness). The diameter of the indurated area should be measured 
across the forearm (perpendicular to the long axis).
An induration of 5 or more millimeters is considered positive in
¤ HIV-infected persons
¤ A recent contact of a person with TB disease
¤ Persons with fibrotic changes on chest radiograph consistent with prior TB
¤ Persons with organ transplants
¤ Persons who are immunosuppressed for other reasons (for example, taking the 
equivalent of >15 mg/day of prednisone for 1 month or longer, taking tumor 
necrosis factor-α antagonists).
An induration of 10 or more millimeters is considered positive in all other potential 
clinical trial participants.
Two-step testing (repeat TST from 1 to 3 weeks after the first TST) is recommended 
for certain participant groups, including: 
¤ Persons receiving immunosuppressant treatment

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¤ Persons with a history of temporally remote increased risk of TB infection
¤ Persons for whom the first test is negative, as per local public health and/or 
professional medical society recommendations.
Interferon Gamma Release Assay (IGRA) for M tuberculosis. Ensure that specimen 
handling, transport, timing, and laboratory procedures meet all requirements per package 
insert. If the investigator suspects a false-positive IGRA result in a participant with no 
increased risk of TB infection during lifetime, and no evidence of prior or current TB on 
physical examination and/or on CXR interpreted by radiologist and/or pulmonologist 
(investigator assessment by history and physical examination, and CXR report documented 
in eCRF), the investigator may discuss retesting with the sponsor’s designated medical 
monitor.
Retesting
One retest is allowed for participants with an “indeterminate” QuantiFERON-TB Gold assay or 
“borderline” T-SPOT.TB assay. Participants with 2 indeterminate QuantiFERON-TB Gold 
assays or 2 borderline T-SPOT.TB assays will be excluded.
Diagnosed LTBI
Participants diagnosed with LTBI are excluded (Section 5.2) unless they are candidates for LTBI 
treatment, are treated for LTBI, and the following criteria are met:
After receiving at least 4 weeks of appropriate LTBI therapy (as per World Health 
Organization and/or the United States Centers for Disease Control guidelines), there is no 
evidence of hepatotoxicity (ALT/AST must remain ≤2 times ULN) or other treatment 
intolerance. The participant may be rescreened, and is not excluded due to LTBI.
The participant must continue and complete appropriate LTBI therapy in order to remain 
eligible to continue to receive study intervention.
Monitoring during the study
For all participants, monitoring for TB is to be continuous throughout the study. At a minimum, 
each participant is to have the following documented at least every 3 months:
  Thorough history to determine any risk factors for TB infection and for TB progression, 
symptoms or signs of active TB, and
  Physical examination that includes assessment for signs of active TB, including 
measurement of body temperature and assessment of peripheral lymph nodes.
8.2.7.
Hepatitis B Testing and Monitoring
Initial testing for HBV infection includes hepatitis B surface antigen (HBsAg) and antibody to 
hepatitis B core antigen (anti-HBc):
  If HBsAg is positive, the participant is excluded.
  If HBsAg is negative and anti-HBc is negative, the participant is not excluded.
  If HBsAg is negative and anti-HBc is positive, the participant is excluded.

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8.2.8.
Hepatitis C Testing and Monitoring
Initial testing for HCV infection includes testing for antibodies to HCV.
If anti-HCV is positive, a test for circulating HCV RNA is required.
If HCV RNA test is negative, the participant is not excluded.
If HCV RNA test is positive, the subject is excluded (see Section 5.2).
Participants who have had HCV infection and been successfully treated, defined as a sustained 
virologic response (HCV RNA by PCR negative for at least 24 weeks following treatment 
completion) are not excluded on the basis of HCV as long as HCV RNA test is negative at 
screening.
If HCV RNA is detected during the study, the study drug will be discontinued (Section 7.1.1), 
and the participant should receive appropriate follow-up medical care.
8.2.9.
Hepatic Safety Monitoring
Close hepatic monitoring
If a study participant experiences 

ALT or AST ≥3 times ULN,

ALP ≥2 times ULN, or 

TBL ≥2 times ULN (except for patients with Gilbert’s syndrome),
the laboratory tests listed in Appendix 10.5, including ALT, AST, ALP, TBL, direct bilirubin, 
GGT, and creatine kinase (CK), should be repeated within 48 to 72 hours, to confirm the 
abnormality and to determine whether it is increasing or decreasing.
If the abnormality persists or worsens, clinical and laboratory monitoring, and evaluation for the 
possible causes of the abnormal liver tests should be initiated by the investigator in consultation 
with the sponsor’s designated medical monitor. At a minimum, this evaluation should include a 
physical examination and a thorough medical history, including symptoms, recent illnesses (for 
example, heart failure, systemic infection, hypotension, or seizures), recent travel, history of 
concomitant medications (including over-the-counter), herbal and dietary supplements, history of 
alcohol drinking, and other substance abuse.
Initially, monitoring of symptoms and hepatic biochemical tests should be done at a frequency of 
1 to 3 times weekly, based on the participant’s clinical condition and hepatic biochemical tests. 
Subsequently, the frequency of monitoring may be lowered to once every 1 to 2 weeks, if the 
participant’s clinical condition and laboratory results stabilize. Monitoring of ALT, AST, ALP 
and TBL should continue until levels normalize or return to approximate baseline levels.
Comprehensive hepatic evaluation
If a study participant experiences:

ALT or AST ≥3 times ULN with hepatic signs/symptoms (severe fatigue, nausea, 
vomiting, right upper quadrant abdominal pain, fever, rash, and/or eosinophilia >5%.),  

ALT or AST ≥5 times ULN,

ALP ≥3 times ULN,

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
TBL ≥2 times ULN (except for patients with Gilbert’s syndrome),
the evaluation should include a physical examination and a thorough medical history, as outlined 
above, as well as tests for prothrombin time (PT-INR); viral hepatitis A, B, C, and E; tests for 
autoimmune hepatitis, and an abdominal imaging study (for example, ultrasound or CT scan).
Based on the patient’s history and initial results, further testing should be considered in 
consultation with the sponsor’s designated medical monitor, including tests for hepatitis D virus 
(HDV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), acetaminophen levels, 
acetaminophen protein adducts, urine toxicology screen, Wilson’s disease, blood alcohol levels, 
urinary ethyl glucuronide, and serum phosphatidylethanol.
Based on the circumstances and the investigator’s assessment of the participant’s clinical 
condition, the investigator should consider referring the participant for a hepatologist or
gastroenterologist consultation, magnetic resonance cholangiopancreatography (MRCP), 
endoscopic retrograde cholangiopancreatography (ERCP), cardiac echocardiogram, or a liver 
biopsy.
8.2.9.1.
Hepatic Safety eCRF
The following list describes when additional hepatic safety data collection in the hepatic safety 
eCRF should be done:

ALT to ≥5 times ULN on 2 or more consecutive blood tests

ALP to ≥2 times ULN on 2 or more consecutive blood tests

TBL to ≥2 times ULN (except for cases of known Gilbert’s syndrome)
Note:  the interval between the 2 consecutive blood tests should be at least 2 days.
Additional criteria include
●  a hepatic event considered to be an SAE, and
●  discontinuation of study intervention due to a hepatic event (Section 7.1.1).
8.2.10.
Suicidal Ideation and Behavior Risk Monitoring
Participants should be monitored appropriately and observed closely for suicidal ideation and 
behavior or any other unusual changes in behavior, especially at the beginning and end of the 
course of intervention. Participants who have signs of suicidal ideation or behavior should be 
considered for discontinuation of study drug, following a risk assessment (see Section 7.1.1). See 
Section 8.3.1.1 for timing of adverse event collection relative to collection of the C-SSRS.
8.2.10.1.
Columbia Suicide-Severity Rating Scale (C-SSRS)
The Columbia Suicide-Severity Rating Scale (C-SSRS) is a scale that captures the occurrence, 
severity, and frequency of suicidal ideation and behavior during the assessment period via a 
questionnaire. The scale was developed by the National Institute of Mental Health (NIMH) trial 
group (TASA) for the purpose of being counterpart to the Columbia Classification Algorithm of 
Suicide Assessment (C-CASA) categorization of suicidal events.

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8.3.
Adverse Events and Serious Adverse Events
Adverse events 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 adverse event or SAE and remain responsible for 
following up adverse events that are serious, considered related to the study intervention or study 
procedures, or that caused the participant to discontinue the study intervention or the study (see 
Section 7).
Pregnancy after maternal or paternal exposure to investigational product does not meet the 
definition of an adverse event. However, to fulfill regulatory requirements, any pregnancy should 
be reported using the SAE process described in Appendix 10.3, Section 10.3.4, to collect data on 
the outcome for both mother and fetus. See also Section 8.3.5.
8.3.1.
Time Period and Frequency for Collecting Adverse Event and Serious Adverse 
Event Information
All adverse events will be collected from the time of the participant’s signing of the ICF until the 
participant’s last post-treatment follow-up visit.
Likewise, all SAEs will be collected from the signing of the ICF until the last post-treatment 
follow-up visit.
Adverse events that begin before the start of study intervention but after signing of the ICF will 
be recorded on the Adverse Event CRF.
Although all adverse events after signing the ICF are recorded by the site in the CRF/electronic 
data entry tool, SAE reporting to the sponsor begins after the participant has signed the ICF and 
has received study drug. However, if an SAE occurs after signing the ICF but prior to receiving 
study drug, the SAE needs to be reported ONLY if the SAE is considered reasonably possibly 
related to study procedures.
All SAEs will be recorded and reported to the sponsor or the sponsor’s designee immediately,
and under no circumstance should this exceed 24 hours, as indicated in Appendix 10.3. The 
investigator will submit any updated SAE data to the sponsor within 24 hours of it being 
available.
Investigators are not obligated to actively seek adverse events or SAEs after the conclusion of 
study participation, that is, once the participants have discontinued and/or completed the study 
(the Participant Study Disposition eCRF has been completed). However, if the investigator learns 
of any SAE, including a death, at any time after a participant has been discharged from the study, 
and the investigator considers the event to be reasonably related to the study intervention or 
study participation, the investigator must promptly notify the sponsor.
8.3.1.1.
Adverse Event Monitoring with a Systematic Questionnaire
Nonleading (spontaneous) adverse event collection should occur before the collection of the 
C-SSRS.

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If a suicide-related event is discovered during the C-SSRS collection but was not captured during 
the nonleading adverse event collection, sites should not change the adverse event form.
However, if an adverse event is serious or leads to discontinuation, the adverse event should be 
included on the adverse event form. Also, the process for reporting SAEs should be followed.
8.3.2.
Method of Detecting Adverse Events and Serious Adverse Events
The method of recording, evaluating, and assessing causality of adverse events and SAEs and the 
procedures for completing and transmitting SAE reports are provided in Appendix 10.3.
Care will be taken not to introduce bias when detecting adverse events and/or SAEs. Open-ended 
and non-leading verbal questioning of the participant is the preferred method to inquire about 
adverse event occurrences.
8.3.3.
Follow-up of Adverse Events and Serious Adverse Events
After the initial adverse event or SAE report, the investigator is required to proactively follow 
each participant at subsequent visits/contacts. All SAEs and AESIs, as defined in Section 8.3.6, 
“Adverse Events of Special Interest”), will be followed until resolution, stabilization, the event is 
otherwise explained, or the participant is lost to follow-up (Section 7.3). Further information on 
follow-up procedures is provided in Appendix 10.3, Section 10.3.3.
8.3.4.
Regulatory Reporting Requirements for Serious Adverse Events
Prompt notification by the investigator to the sponsor of a 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)/Independent Ethics Committees 
(IECs), and investigators.
An investigator who receives an investigator safety report describing a SAE or other specific 
safety information (for example, summary or listing of SAEs) from the sponsor will review and 
then file it along with the IB and will notify the IRB/IEC, if appropriate according to local 
requirements.
8.3.5.
Pregnancy
For female participants and female partners of male participants, details will be collected for 
pregnancies occurring from after the start of study intervention and until 12 weeks 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 10.4, Section 10.4.3.
Abnormal pregnancy outcomes (for example, spontaneous abortion, fetal death, stillbirth, 
congenital anomalies, ectopic pregnancy) are considered SAEs.

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8.3.6.
Adverse Events of Special Interest
Adverse events of special interest for this study include infusion reactions, systemic 
hypersensitivity reactions, and infections. If such adverse events are reported, sites will be 
prompted to collect additional data as described in the following subsections.
8.3.6.1.
Infusion Site Reactions
Symptoms of a local infusion site reaction may include erythema, induration, pain, pruritus, and 
edema. If an infusion site event is reported, the adverse event will be recorded, and additional 
data will be provided to the sponsor in the eCRF.
8.3.6.2.
Systemic Hypersensitivity Reactions
Many drugs, but particularly biologic agents, carry the risk of systemic hypersensitivity 
reactions. If such a reaction occurs, additional data describing each symptom should be provided 
to the sponsor in the eCRF.
Sites should have appropriately trained medical staff and appropriate medical equipment 
available when the study participants are receiving study drug. Participants who experience a 
systemic hypersensitivity reaction should be treated per the local standard of care.
Blood sample collection for systemic hypersensitivity reactions
In the case of generalized urticaria or anaphylaxis, additional blood samples should be collected 
as described in Appendix 10.2, Section 10.2.2. Laboratory results are provided to the sponsor via 
the central laboratory.
8.3.6.3.
Infections
Completion of the Infection eCRF page is required for each infection reported as an adverse 
event or SAE. The sponsor will identify infections considered to be opportunistic based on the 
article by Winthrop et al. (2015) (Appendix 10.6).
8.3.7.
Complaint Handling
A product complaint is any written, electronic, or oral communication that alleges deficiencies 
related to the identity, quality, durability, reliability, safety, effectiveness or performance of a 
trial intervention. The sponsor collects product complaints on investigational products and drug 
delivery systems used in clinical studies in order to ensure the safety of study participants, 
monitor quality, and to facilitate process and product improvements.
Participants will be instructed to contact the investigator as soon as possible if they have a 
complaint or problem with the investigational product so that the situation can be assessed.
Note: Any adverse events/SAEs that are associated with a product complaint will also follow the 
processes outlined in Section 8.3.3 and Appendix 10.3.
Time period for detecting product complaints
Product complaints that result in an adverse event will be detected, documented, and reported to 
the sponsor during all periods of the study in which the drug/device is used. If the investigator 
learns of any product complaint at any time after a participant has been discharged from the 

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study, and such incident is considered reasonably related to a drug/device provided for the study, 
the investigator will promptly notify the sponsor.
Prompt reporting of product complaints to sponsor
Product complaints will be reported to the sponsor within 24 hours after the investigator becomes 
aware of the complaint. The Product Complaint Form will be sent to the sponsor by a method 
designated by the sponsor.
Follow-up of product complaints
Follow-up applies to all participants, including those who discontinue study intervention. The 
investigator is responsible for ensuring that follow-up includes any supplemental investigations 
as indicated to elucidate the nature and/or causality of the product complaint. New or updated 
information will be recorded on the originally completed form with all changes signed and dated 
by the investigator and submitted to the sponsor.
8.4.
Treatment of Overdose
For this study, an overdose of LY3041658 is considered any dose higher than the dose assigned 
through randomization. In case of suspected overdose, hematology, chemistry, vital signs, and 
oxygen saturation should be monitored and supportive care provided as necessary.
In the event of an overdose, the investigator should:
1.  Contact the sponsor’s medical monitor immediately.
2.  Closely monitor the participant for any adverse event or SAE and laboratory 
abnormalities until the study intervention can no longer be detected systemically, that is, 
approximately 12 weeks.
Decisions regarding dose interruptions or modifications will be made by the investigator in 
consultation with the sponsor’s medical monitor based on clinical evaluation of the participant.
8.5.
Pharmacokinetics
Visits and times
At the visits and times specified in the SoA (Section 1.3), venous blood samples will be collected 
to determine the plasma concentrations of LY3041658. The actual date and time (24-hour clock 
time) of dosing and sample collection must be recorded accurately on the appropriate forms.
Collection, handling, and analysis of samples
Instructions for the collection and handling of blood samples will be provided by the sponsor. 
Samples will be analyzed at a laboratory approved by the sponsor. Concentrations of LY3041658
will be assayed using a validated PK assay. Analyses of samples collected from participants who 
received placebo are not planned.
Additional and unused samples
A maximum of 3 additional samples may be collected at additional time points during the study 
if warranted and agreed upon between both the investigator and sponsor. Any excess samples 
collected for PK testing may be used for exploratory analyses such as bioanalytical assay 
validation or cross-validation exercises.

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In the case of systemic allergic/hypersensitivity reactions, additional blood samples will be 
obtained for PK analyses (Section 8.3.6.2).
Blinding
Drug concentration information that may unblind the study will not be reported to investigative 
sites or to personnel who are blinded to study data.
Sample retention
The purpose of retention, the maximum duration of retention, and facility for long-term storage 
of samples is described in Appendix 10.1, Section 10.1.12.
8.6.
Pharmacodynamics
The exploratory pharmacodynamics (PD) endpoints include IL-8 and hs-CRP.
Visits and times
At the visits and times specified in the SoA (Section 1.3), blood samples will be collected for the 
exploratory analysis of PD endpoints.
Sample retention
The purpose of retention, the maximum duration of retention, and facility for long-term storage 
of samples is described in Appendix 10.1, Section 10.1.12.
8.7.
Genetics
A whole blood sample will be collected for pharmacogenetic analysis as specified in the SoA 
(Section 1.3), where local regulations and ethical review boards (ERBs) allow.
Sample use
Samples will not be used to conduct unspecified disease or population genetic research either 
now or in the future. Genetic variation may impact a participant’s response to study intervention, 
susceptibility to, and severity and progression of disease. Variable response to study intervention 
may be due to genetic determinants that impact drug absorption, distribution, metabolism, and 
excretion; mechanism of action of the drug; disease etiology; and/or molecular subtype of the 
disease being treated. Samples may be used for research related to LY3041658 and its 
mechanism of action, the drug target, genetic variants thought to play a role in HS, on the disease 
process and pathways associated with the disease or related diseases. The samples may also be 
used to develop tests or diagnostic tools or assays related to HS or to LY3041658. The samples 
may also be used to investigate variable exposure or response to LY3041658. The assessment of 
variable response may include evaluation of adverse events or differences in efficacy.
Molecular technologies are expected to improve during storage period and therefore cannot be 
specifically named. However, existing genetic research approaches include whole genome or 
exome sequencing, genome-wide association studies, and candidate gene studies. Regardless of 
technology utilized, genotyping data generated will be used only for the specific research scope 
described in this protocol. The samples may be analyzed as part of single or multi-study 
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this class to improve understanding of the disease or related conditions, and additional analyses 
may be conducted if necessary to further understand the clinical data of this study.
Confidentiality
All samples will be coded with the participant number. These samples and any data generated 
can be linked back to the participant only by the investigative site personnel. The sponsor will 
store the blood and/or deoxyribonucleic acid (DNA) samples in a secure storage space with 
adequate measures to protect confidentiality.
Sample retention
Samples will be retained at a facility selected by the sponsor or its designee. Samples will be 
retained as long as research on the study indication, study intervention, or the class of study 
intervention continues, but no longer than the maximum retention time specified in Appendix 
10.1, Section 10.1.12.
8.8.
Biomarkers
Serum and plasma for exploratory nonpharmacogenetic biomarker research will be collected at 
the visits and times specified in the SoA (Section 1.3), where local regulations allow.
Sample use
Biomarker research is performed to address questions of relevance to drug disposition, target 
engagement, PD, mechanism of action, variability of participant response (including safety), 
and/or clinical outcome. Sample collection is incorporated into clinical studies to enable 
examination of these questions through measurement of biomolecules, including DNA for 
epigenetics, RNA, proteins, lipids, and other cellular elements.
Samples may be used for research on the drug target, disease process, variable response 
to LY3041658, pathways associated with HS, mechanism of action of LY3041658, and/or 
research methods or in validating diagnostic tools or assays related to HS or to LY3041658.
Confidentiality
All samples will be coded with the participant number. These samples and any data generated 
can be linked back to the participant only by the investigative site personnel.
Sample retention
The purpose of retention, the maximum duration of retention, and facility for long-term storage 
of samples is described in Appendix 10.1, Section 10.1.12.
8.9.
Immunogenicity Assessments
Visits and times
At the visits and times specified in the SoA (Section 1.3), predose blood samples will be 
collected to determine antibody production against LY3041658. The actual date and time 
(24-hour clock time) of each sample collection will be recorded.
If the immunogenicity sample at the last scheduled assessment or discontinuation visit is 
treatment-emergent (TE) anti-drug antibody (ADA) positive (as defined in Section 9.4.4.3), 

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additional samples may be taken until the potential signal returns to baseline (that is, no longer 
TE-ADA positive) or for up to 1 year after last dose.
To aid interpretation of these results, a predose blood sample for PK analysis will be collected at 
the same time points, as shown in the SoA.
Sample collection, handling, and use
Instructions for the collection and handling of blood samples will be provided by the sponsor.
Immunogenicity will be assessed by a validated assay designed to detect ADAs in the presence 
of LY3041658 at a laboratory approved by the sponsor. Antibodies may be further characterized 
for their ability to neutralize the activity of LY3041658.
Sample retention
The purpose of retention, the maximum duration of retention, and facility for long-term storage 
of samples is described in Appendix 10.1, Section 10.1.12.
8.10.
Medical Resource Utilization and Health Economics
This section is not applicable.

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9.
Statistical Considerations
9.1.
Statistical Hypotheses
The study will compare LY3041658 with placebo in adults with HS. The primary study objective 
is to demonstrate superior efficacy of LY3041658 over placebo.
The primary comparison of interest is the proportion of participants achieving HiSCR response 
at Week 16.
Secondary comparisons include the mean change of AN count and Skin Pain – HS NRS from 
baseline to Week 16.
Efficacy comparisons will be made without regard to changes to any background therapies. No 
adjustments for multiplicity will be made across the efficacy assessments. Participants who 
discontinue the treatment or the study prior to Week 16 will be considered a nonresponder for all 
relevant analyses.
9.1.1.
Estimands
The study will compare LY3041658 with placebo in participants with HS.
The primary comparison of interest is the difference in proportion of participants who achieve 
HiSCR response at Week 16. The primary objective is to demonstrate superiority of LY3041658 
versus placebo.
The primary comparison will be assessed using a composite estimand where the intercurrent 
events of premature discontinuation and use of prohibited medication are part of the response 
definition.
9.2.
Sample Size Determination
Approximately 100 patients will be screened to achieve approximately 63 participants 
randomized in a 2:1 ratio to one of two treatment groups:
approximately 42 participants randomized to LY3041658, and
approximately 21 participants randomized to placebo.
For all randomized patients, approximately 45 patients are expected to complete the 16 weeks’
treatment period. This sample size provides at least 80% power to the primary endpoint of HiSCR 
response. This calculation is a 2-sided test for superiority of LY3041658 compared to placebo on 
HiSCR response rate with significance level of 0.05 CCI
CCI

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9.3.
Populations for Analyses
The following populations are defined for this study:
Population
Description
Entered
All participants who sign the informed consent form
Modified Intent-to-Treat (mITT)
All participants randomly assigned to study intervention and who receive
at least 1 dose of study intervention. Participants will be analyzed 
according to the intervention to which they were assigned.
Safety
All participants randomly assigned to study intervention and who receive
at least 1 dose of study intervention. Participants will be analyzed 
according to the intervention they actually received within each study 
period.
Pharmacokinetic (PK) Analysis
All participants randomly assigned to study intervention and who receive
at least 1 dose of study intervention and have PK data available.
9.4.
Statistical Analyses
Statistical analysis of this study will be the responsibility of the sponsor or its designee.
Any change to the data analysis methods described in the protocol will require an amendment 
only if it changes a principal feature of the protocol. Any other change to the data analysis 
methods described in the protocol, and the justification for making the change, will be described 
in the statistical analysis plan (SAP) and clinical study report. Additional exploratory analyses of 
the data will be conducted as deemed appropriate.
The SAP will be finalized prior to unblinding. It will include a more technical and detailed 
description of the statistical analyses described in this section. This section is a summary of the 
planned statistical analyses of the most important endpoints including primary and key secondary 
endpoints.
9.4.1. General Considerations
Efficacy analyses will be conducted on the Modified Intent-to-Treat (mITT) Population. This set 
includes all data from all randomized participants receiving at least 1 dose of the IP according to 
the treatment the participants were assigned.
Safety analyses will be conducted on the Safety Population. This set includes all data from all 
randomized participants receiving at least 1 dose of the IP according to the treatment the 
participants actually received.
All tests of treatment effects will be conducted at a 2-sided alpha level of 0.05, unless otherwise 
stated. All confidence intervals (CIs) will be given at a 2-sided 95% level. Descriptive 
summaries of continuous data will present the group mean, standard deviation, median, 
minimum, maximum, and sample size. Descriptive summaries of discrete data will report the 
number of participants and incidence as a frequency and as a percentage.
The baseline value for Treatment Period 1 is defined as the last nonmissing measurement on or 
before the date of first study drug administration (expected at Week 0). The baseline value for 
Treatment Period 2 is the last available value before Visit 10 (Week 16), the visit at which 

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participants who previously received placebo will receive their first dose of LY3041658. Other 
definitions of the baseline value may be used to conduct additional supporting analyses.
9.4.1.1.
Participant Disposition
A description of participant disposition will be provided, including a summary of the number and 
percentage of participants entered into the study, enrolled in the study, and treated, as well as 
number and percentage of participants completing the study (participants who receive at least 
1 dose of study drug and have at least 1 postbaseline assessment), or discontinuing (overall and 
by reason for discontinuation). A summary of important protocol deviations will be provided.
9.4.1.2.
Participant Characteristics
Demographic data are collected and reported to demonstrate that the study population represents 
the target patient population. A summary of baseline participants and disease characteristics, 
historical diagnoses, pre-existing conditions, and prior therapies will be reported by cohort using 
descriptive statistics. Other participant baseline characteristics will be summarized by group as 
deemed appropriate.
9.4.1.3.
Missing Data Imputation
Missing data on the primary endpoint, HiSCR response, will be imputed as nonresponse. For 
other endpoints, including continuous secondary endpoints, missing data may be imputed using 
the last observation prior to missingness or other appropriate imputation methods.
9.4.2.
Primary Endpoint
The primary comparison of interest is the proportion of participants achieving HiSCR response 
at Week 16. The objective of the primary endpoint is to establish superiority of LY3041658 over 
placebo (see Section 9.4.1).
The primary endpoint will be analyzed using logistic regression on the mITT population. The 
treatment difference and 95% CIs will be reported.
9.4.3.
Secondary Endpoints
Secondary comparisons of interest are the mean change from baseline to Week 16 for
●  total number of abscesses and inflammatory nodules (AN count), and 
●  Skin Pain – HS NRS.
An analysis of covariance (ANCOVA) model will be used for analysis of these secondary 
endpoints.
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9.4.4.
Exploratory Endpoints
Exploratory analyses will be further described in the SAP that is finalized before database lock.
9.4.4.1.
Patient-Reported Outcomes
Categorical variables will be analyzed using logistic regression analyses, whereas mixed-effects 
model of repeated measures (MMRM) will be the primary method of analysis for continuous 
endpoints. The analyses will be based on the mITT population, unless otherwise specified.
9.4.4.2.
Pharmacokinetic Analyses
Plasma concentrations of LY3041658 will be listed by time point using descriptive statistics. The 
data may also be analyzed using a population approach via nonlinear mixed effects modeling 
(NONMEM) with the NONMEM software. The PK data from Study DSAD may be combined 
with data from another study in the clinical development program to improve PK parameter 
estimation.
9.4.4.3.
Evaluation of Immunogenicity
Frequencies and percentages will be tabulated for the following:
●  participants with pre-existing ADA, and
●  participants who are TE-ADA positive (TE-ADA+) to LY3041658.
Treatment-emergent ADAs are defined as those with a titer 2-fold (1 dilution) greater than the 
minimum required dilution if no ADAs were detected at baseline (treatment-induced ADA) or 
those with a 4-fold (2 dilutions) increase in titer compared with baseline if ADAs were detected 
at baseline (treatment-boosted ADA). For the TE-ADA+ participants, the distribution of 
maximum titers will be described. The frequency of neutralizing antibodies, if assessed, may also 
be tabulated for the TE-ADA+ participants.
The relationship between the presence of ADA and the LY3041658 concentrations and PD 
response to LY3041658, including safety and efficacy, may also be assessed. Additional details 
may be provided in the SAP.
9.4.4.4.
Other Exploratory Endpoints
Exploratory efficacy endpoint data, PD data, and biomarker data will be analyzed as described in 
the SAP. Relationships between LY3041658 exposure and select biomarkers and clinical 
efficacy endpoints may be explored.
9.4.5.
Safety Analyses
Safety analyses will include adverse events, SAEs, AESIs, C-SSRS, vital signs, ECGs, and 
laboratory analytes, using the Safety Population data descriptively summarized by treatment 
group. Categorical safety measures will be summarized with incidence rates. Continuous safety 
measures will be summarized as mean change by visit. Exposure to study intervention will be 
calculated for each participant and summarized by treatment group.
Adverse events will be coded according to the Medical Dictionary for Regulatory Activities
(MedDRA) and summarized by system organ class (SOC), preferred term, severity, and 

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relationship to the study intervention. A treatment-emergent adverse event (TEAE) is defined as 
an event that first occurred or worsened in severity after baseline, with baseline defined as all 
pre-existing conditions recorded at Visit 1 and any adverse events recorded before the first dose 
of study intervention (that is, during the interval between Visits 1 and 2 and recorded with the 
time of onset before the first dose of study intervention). The treatment periods will be used as 
the postbaseline period for the analysis. Safety analyses will be conducted separately for each 
treatment period. For events that are gender specific, the denominator and computation of the 
percentage will include only participants from the given gender.
The number and percentage of participants who experienced TEAEs, TEAEs by maximum 
severity, deaths, SAEs, TEAEs related to study intervention, discontinuations from the treatment 
due to an adverse event, and AESIs will be summarized. Treatment-emergent adverse events (all, 
by maximum severity), SAEs including deaths, and adverse events that lead to treatment 
discontinuation will be summarized and analyzed by MedDRA SOC and preferred term.
Treatment-related TEAEs (TEAEs related to study intervention) are defined as events that are 
indicated by the investigator on the eCRF to be related to treatment.
Adverse events of special interest will be identified by a standardized MedDRA query (SMQ) or 
a Lilly-defined MedDRA preferred term listing.
Suicide-related thoughts and behaviors occurring during treatment will be summarized based on 
responses to the C-SSRS consistent with the C-SSRS Scoring and Data Analysis Guide 
(Columbia Lighthouse Project WWW).
Follow-up emergent adverse events, SAEs including deaths, and adverse events that lead to 
study discontinuation will be summarized. All adverse events, including pre-existing conditions, 
will be listed by participant, visit, preferred term, treatment group, severity, and relationship to 
the treatment.
9.4.6.
Other Analyses
Sensitivity Analyses
Fisher’s exact test may be used as an alternative to logistic regression on the primary endpoint 
due to the small sample size for this analysis. Other sensitivity analyses will be considered for 
the secondary endpoints.
9.5.
Interim Analyses
The analysis for the primary database lock will be conducted when all participants have either
completed the double-blind treatment period (Treatment Period 1) or have discontinued.
Interim analyses at other time points, including time points prior to the primary database lock,  
may be conducted using safety and/or efficacy data. These interim analyses will be used to 
support planning activities associated with the development program and to aid in the 
development of PK/PD modeling. No adjustment of type I error will be performed.
Unblinding details will be specified in the unblinding plan section of the SAP or in a separate 
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Assessments of unblinded interim data will be conducted by an Internal Assessment Committee 
(IAC) with a limited number of prespecified team members who do not have direct site contact 
or data entry or data validation responsibilities (see Appendix 10.1, Section 10.1.5). Only the 
IAC will be authorized to evaluate unblinded interim efficacy and safety analyses.
To minimize bias, the SAP and PK/PD analysis plan will be finalized and approved before any 
unblinding. Information that may unblind the study during the analyses will not be reported to 
study sites or the blinded study team until the study has been unblinded.
Study sites will receive information about interim analysis results only if the investigators need 
to know for the safety of their participants.
The SAP will describe the planned interim analyses in greater detail.
9.6.
Data Monitoring Committee (DMC)
Not applicable. An IAC will be used to conduct the interim analysis (see Section 9.5 and 
Appendix 10.1, Section 10.1.5).

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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, and
●  Applicable laws and regulations.
The protocol, protocol amendments and addenda, ICF, IB, and other relevant documents (for 
example, advertisements) must be submitted to an IRB/IEC by the investigator and reviewed and 
approved by the IRB/IEC before the study is initiated.
Any amendments to the protocol will require IRB/IEC 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/IEC annually or more 
frequently in accordance with the requirements, policies, and procedures established by 
the IRB/IEC
●  Notifying the IRB/IEC of SAEs or other significant safety findings as required by 
IRB/IEC procedures, and
●  Providing oversight of the conduct of the study at the site and adherence to requirements 
of 21 United States Code of Federal Regulations (CFR), ICH guidelines, the IRB/IEC, 
European regulation 536/2014 for clinical studies (if applicable), and all other applicable 
local regulations.
●  After reading the protocol, each principal investigator will sign the separate protocol 
signature page and send a copy of the signed page to a Lilly representative.
Investigator sites are compensated for participation in the study as detailed in the clinical trial 
agreement.
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.

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10.1.3.
Informed Consent Process
The investigator or his or her representative will explain the nature of the study, including the 
risks and benefits, to the participant or his or her legally authorized representative and answer all
questions regarding the study.
Participants must be informed that their participation is voluntary.
Participants or their legally authorized representatives 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/IEC or study center. The sponsor or its representatives must approve the ICFs, 
including any changes made by the ERBs, before the ICFs are used at the investigative sites.
The medical record must include a statement that written informed consent was obtained before 
the participant was entered in the study. The statement must include the date on which the 
written consent was obtained. The authorized person obtaining the informed consent must also 
sign the ICFs.
Participants who are rescreened are required to sign a new ICF (see Section 5.4).
Participants must be re-consented to the most current version of the ICF during their 
participation in the study.
A copy of the ICFs must be provided to the participant or the participant’s legally authorized 
representative and must be kept on file.
10.1.4.
Data Protection
Participants will be assigned a unique identifier by the sponsor. Any participant records, datasets
or tissue samples that are transferred to the sponsor will contain the identifier only; participant 
names or any information which would make the participant identifiable will not be transferred.
The participant must be informed that his or 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 who will be required to give consent for his or her data to be used as 
described in the informed consent.
The participant must be informed that his or her medical records may be examined by Clinical 
Quality Assurance auditors or other authorized personnel appointed by the sponsor, by 
appropriate IRB/IEC members, and by inspectors from regulatory authorities.
10.1.5.
Committees Structure
Internal Assessment Committee (IAC)
In addition to the safety reviews routinely performed by the blinded study team, an IAC will 
review the efficacy and safety data in an unblinded fashion periodically or on an ad hoc basis 
during the study and will determine whether any changes (for example, dose reductions or other 
protocol modifications) should be made.
The IAC reviewing the safety data will be fully independent from the study team and will 
include, at a minimum, a Lilly medical physician, a statistician, and a representative from the 
Lilly Global Patient Safety organization. Details about the IAC membership, purpose, 

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responsibilities, and operation will be described in an IAC charter, which will be approved prior 
to the first unblinding.
10.1.6.
Dissemination of Clinical Study Data
Reports
The sponsor will disclose a summary of study information, including tabular study results, on 
publicly available websites where required by local law or regulation.
Data
The sponsor provides access to all individual participant data collected during the trial, after 
anonymization, with the exception of pharmacokinetic (PK) or genetic data. Data are available to 
request 6 months after the indication studied has been approved in the US and EU and after 
primary publication acceptance, whichever is later. No expiration date of data requests is 
currently set once data are made available. 
Access is provided after a proposal has been approved by an independent review committee 
identified for this purpose and after receipt of a signed data sharing agreement. Data and 
documents, including the study protocol, statistical analysis plan, clinical study report, blank or 
annotated case report forms, will be provided in a secure data sharing environment for up to 
2 years per proposal. 
For details on submitting a request, see the instructions provided at www. vivli.org.
10.1.7.
Data Quality Assurance
Investigator responsibilities
All participant data relating to the study will be recorded on printed or electronic CRF unless 
transmitted to the sponsor or designee electronically (for example, laboratory data).
The investigator is responsible for verifying that data entries are accurate and correct by 
physically or electronically signing the CRF.
The investigator must maintain accurate documentation (source data) that supports the 
information entered in the CRF. This documentation might include laboratory and diagnostic test 
reports, medical records, and clinical notes.
The investigator must permit study-related monitoring, audits, IRB/IEC review, and regulatory 
agency inspections and provide direct access to source data documents.
Data monitoring and management
Monitoring details describing strategy (for example, 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 are provided in the Monitoring Plan.
The sponsor or designee is responsible for the data management of this study, including quality 
checking of the data. The sponsor assumes accountability for actions delegated to other 
individuals (for example, contract research organizations).

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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 retention and audits
Records and documents, including signed ICFs, 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.
In addition, the sponsor or its representatives will periodically check a sample of the participant 
data recorded against source documents at the study site. The study may be audited by the 
sponsor or its representatives, and/or regulatory agencies at any time. Investigators will be given 
notice before an audit occurs.
Data Capture System
The investigator is responsible for ensuring the accuracy, completeness, legibility, and timeliness 
of the data reported to the sponsor.
An electronic data capture system (EDC) will be used in this study for the collection of CRF 
data. The investigator maintains a separate source for the data entered by the investigator or 
designee into the sponsor-provided EDC system. The investigator is responsible for the 
identification of any data to be considered source and for the confirmation that data reported are 
accurate and complete by signing the CRF.
Additionally, clinical outcome assessment (COA) data (participant-focused outcome instrument) 
will be collected by the investigative site personnel, via a paper source document and will be 
transcribed by the investigative site personnel into the EDC system.
Additionally, electronic Clinical Outcome Assessment (eCOA) data (participant-focused 
outcome instrument) will be directly recorded by the participant and the investigative site 
personnel, into an instrument (for example, tablet). The eCOA data will serve as the source 
documentation and the investigator does not maintain a separate, written or electronic record of 
these data.
Data collected via the sponsor-provided data capture systems will be stored at third parties. The 
investigator will have continuous access to the data during the study and until decommissioning 
of the data capture systems. Prior to decommissioning, the investigator will receive an archival 
copy of pertinent data for retention.
Data managed by a central vendor, such as laboratory test data, will be stored electronically in 
the central vendor’s database system and reports will be provided to the investigator for review 
and retention. Data will subsequently be transferred from the central vendor to the sponsor’s data 
warehouse.
Data from complaint forms submitted to the sponsor will be encoded and stored in the global 
product complaint management system.

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10.1.8.
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’s site.
Data reported on the CRF or entered in the 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.
The definition of what constitutes source data can be found in Section 10.1.7.
10.1.9.
Study and Site Start and Closure
The study start date is the date on which the clinical study is open for recruitment of participants.
The sponsor or designee reserves the right to close the study site or to terminate the study at any 
time for any reason at the sole discretion of the sponsor.
Site Closure
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, provided a reasonable cause exists 
and sufficient notice is given in advance of the intended termination.
Reasons for the early closure of a study site by the sponsor or investigator may include, but are 
not limited to, these:
●  Failure of the investigator to comply with the protocol, the requirements of the IRB/IEC or 
local health authorities, the sponsor's procedures, or GCP guidelines
●  Inadequate recruitment of participants by the investigator, and
●  Discontinuation of further study intervention development.
Premature Termination or Suspension of the Study 
The Internal Assessment Committee (IAC) will evaluate unblinded safety data if 
●  three or more participants experience TEAEs in the same system organ class, and
●  these TEAEs are assessed as severe by the investigator and/or meet at least 1 serious 
criterion and 
●  these TEAEs are judged as related to blinded study treatment.
Pending the evaluation by the Internal Assessment Committee Study, enrollment and/or further 
dosing may be stopped, or the dose and/or other study parameters may be modified (Section 9.5
and Section 10.1.5).
If the study is prematurely terminated or suspended, the sponsor shall promptly inform the 
investigators, the IECs/IRBs, the regulatory authorities, and any contract research organizations 
used in the study of the reason for termination or suspension, as specified by the applicable 

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regulatory requirements. The investigator shall promptly inform the participant and assure 
appropriate participant therapy and/or follow-up.
10.1.10.
Publication Policy
In accordance with the sponsor’s publication policy, the results of this study will be submitted 
for publication by a peer-reviewed journal.
10.1.11.
Investigator Information
Physicians with a specialty and experience in treatment of patients with hidradenitis suppurativa
may participate as investigators.
10.1.12.
Long-Term Sample Retention
Sample retention enables use of new technologies, response to regulatory questions, and 
investigation of variable responses that may not be observed until later in the development of 
LY3041658 or after it becomes commercially available.
The following table lists the maximum retention period for sample types. The retention period 
begins after the last participant visit for the study.
The maximum retention times may be shorter, if specified in local regulations and/or if 
ERBs/IRBs impose shorter time limits.
Any samples remaining after the specified retention period will be destroyed.
The sample retention facility will be selected by the sponsor or its designee.
Sample Type
Custodian
Retention Period after Last Participant Visit
Pharmacokinetics
Sponsor or designee
1 year
Long-term storage samples
Sponsor or designee
15 years
    Biomarkers (serum, plasma, whole 
blood for RNA, whole blood for 
epigenetics)
Sponsor or designee
15 years
    Pharmacogenetics sample
Sponsor or designee
15 years
    Immunogenicity
Sponsor or designee
15 years

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10.2.
Appendix 2: Clinical Laboratory Tests
10.2.1.
Clinical Laboratory Tests
The clinical laboratory tests listed in the table below will be performed by a central laboratory or 
by a local laboratory as specified in the table.
Additional tests may be performed at any time during the study as determined necessary by the 
investigator or as required by local regulations.
Protocol-specific requirements for the inclusion or exclusion of participants are specified in 
Section 5 of the protocol.
Pregnancy testing is described in the SoA, in Section 8.2.5.1, and in the table below.
Investigators must document their review of each laboratory safety report.
Laboratory test results that could unblind the study will not be reported to investigative sites or 
other blinded personnel.
Notes
Hematology
Assayed by Lilly-designated laboratory.
Hemoglobin
Hematocrit
Erythrocyte count (red blood cells [RBC])
Mean cell volume
Mean cell hemoglobin
Mean cell hemoglobin concentration
Leukocytes (white blood cells [WBC])
Absolute count of:
    Neutrophils, segmented
    Neutrophils, juvenile (bands)
    Lymphocytes
    Monocytes
    Eosinophils
    Basophils
Platelets
Cell morphology (RBC and WBC)

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Notes
Clinical Chemistry
Assayed by Lilly-designated laboratory.
Sodium
Potassium
Chloride
Bicarbonate
Total bilirubin (TBL)
Direct bilirubin
Alkaline phosphatase (ALP)
Alanine aminotransferase (ALT)
Aspartate aminotransferase (AST)
Gamma-glutamyl transferase (GGT)
Blood urea nitrogen (BUN)
Creatinine
Creatine kinase (CK)
Uric acid
Total protein
Albumin
Calcium
Phosphorus
Glucose
Notes
Lipid Panel
Assayed by Lilly-designated laboratory.
Low-density lipoprotein (LDL)
High-density lipoprotein (HDL)
Cholesterol (total)
Triglycerides
Notes
Urinalysis
Assayed by Lilly-designated laboratory.
Specific gravity
pH
Protein
Glucose
Ketones
Bilirubin
Urobilinogen
Blood
Nitrite
Urine leukocyte esterase
Microscopic examination of sediment

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Notes
Hormones (females)
Pregnancy test – serum
Assayed by Lilly-designated laboratory.
To be performed only on women of childbearing potential 
and women with history of tubal ligation.
Pregnancy test – urine
Local testing.
To be performed only on women of childbearing potential 
and women with history of tubal ligation. 
Result must be negative before dosing at each dosing visit.
Follicle-stimulating hormone (FSH)
Assayed by Lilly-designated laboratory 
Optional, performed to confirm postmenopausal status. 
Notes
Serology
Tuberculosis (TB) test:
TB test based on local standard of care (see Section 8.2.6).
     QuantiFERON-TB Gold test
Assayed by Lilly-designated laboratory.
     T-SPOT.TB
Local testing.
Local laboratory must be qualified by local regulations.
     Tuberculin skin test (TST)
Local testing.
Local laboratory must be qualified by local regulations.
Human immunodeficiency virus (HIV)
Assayed by Lilly-designated laboratory.
Hepatitis C virus (HCV):
     Hepatitis C antibody
Assayed by Lilly-designated laboratory.
     HCV RNA
Assayed by Lilly-designated laboratory.
Hepatitis B virus (HBV) testing:
      Hepatitis B core antibody (anti-HBc)
Assayed by Lilly-designated laboratory.
      Hepatitis B surface antigen (HBsAg)
Assayed by Lilly-designated laboratory.
Notes
Biomarkers
Assayed by Lilly-designated laboratory.
Results will not be provided to the investigative sites.
IL-8
C reactive protein, high-sensitivity
(hs-CRP)
Total immunoglobins:
     IgA
     IgE
     IgG
     IgM

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Notes
Pharmacokinetics (PK) Samples
Assayed by Lilly-designated laboratory.
Results will not be provided to the investigative sites.
LY3041658 concentration
Notes
Immunogenicity (ADA) Samples
Assayed by Lilly-designated laboratory.
Results will not be provided to the investigative sites.
Anti-LY3041658 antibodies
Anti-LY3041658 antibody neutralization 
Notes
Pharmacogenetics Samples
Assayed by Lilly-designated laboratory.
Results will not be provided to the investigative sites.
Pharmacogenetics sample
Notes
Long-Term Stored Samples:
Exploratory Biomarker Samples
Assayed by Lilly-designated laboratory.
Results will not be provided to the investigative sites.
Exploratory biomarker samples:
     Serum
     Plasma
     Whole blood RNA
     Whole blood for epigenetics
10.2.2.
Laboratory Tests to be Obtained at Time of a Systemic Hypersensitivity Event
Selected tests should be obtained at the time of a systemic hypersensitivity event, particularly in 
the presence of generalized urticaria or if anaphylaxis is suspected.
After the participant has been stabilized, obtain a sample within 1 to 2 hours of the event.
Samples may be obtained as late as 12 hours after the event.
Record the time at which the sample was collected.

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Hypersensitivity Tests a
Anti-3041658 antibodies (immunogenicity)
Tryptase *
LY3041658 concentration (pharmacokinetics)
N-methylhistamine
Total immunoglobulins (IgA, IgE, IgG, IgM)
Complements
Cytokine Panel
a
Assayed by Lilly-designated laboratory.
* If a tryptase sample is obtained more than 2 hours after the event (that is, within 2 to 12 hours) or is not obtained 
because more than 12 hours have lapsed since the event, obtain urine for N-methylhistamine (NMH) testing. 
Note that for tryptase serum samples obtained within 2 to 12 hours of the event, urine NMH testing is performed 
in addition to tryptase testing. Collect the first void urine following the event. Obtain a follow-up urine for NMH 
testing at the next regularly scheduled visit or after 4 weeks, whichever is later.

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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 (for example, ECG, radiological scans, vital signs measurements), 
including those that worsen from baseline, considered clinically significant in the medical 
and scientific judgment of the investigator (that is, not related to progression of underlying 
disease).
–  Exacerbation of a chronic or intermittent pre-existing condition, including either an increase 
in frequency and/or in intensity of the condition.
–  New conditions detected or diagnosed after study intervention administration even though 
they 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; 
report such overdoses 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.
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.

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–  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 (for example, 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 pre-existing diseases or conditions 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 (for example, 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. The term does not refer to an event 
which hypothetically might have caused death if the event were more severe.
c.  Requires inpatient hospitalization or prolongation of existing hospitalization
–  In general, hospitalization signifies that the participant has been admitted to hospital 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 pre-existing condition that did not worsen from 
baseline is not considered an AE.
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 (for example, sprained ankle) which may interfere with or prevent 
everyday life functions but do not constitute a substantial disruption.

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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 and Follow-Up of AE and/or SAE
AE and SAE Recording
When an AE/SAE occurs, it is the responsibility of the investigator to review all 
documentation (for example, hospital progress notes, laboratory reports, and diagnostics 
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 the sponsor or designee in lieu of completion of the AE/SAE CRF page.
There may be instances when copies of medical records for certain cases are requested by the 
sponsor or designee. 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 
the sponsor or designee.
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 one 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.
Severe: An event that prevents normal everyday activities. An AE that is assessed as 
severe should not be confused with a 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.

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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 diseases, 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 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 or designee. 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 or designee.
The investigator may change his/her opinion of causality in light of follow-up information and 
send a SAE follow-up report with the updated causality assessment.
The causality assessment is one of the criteria used when determining regulatory 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 or 
designee 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 health care professionals.
If a participant dies during participation in the study or during a recognized follow-up period,
the investigator will provide the sponsor or designee with a copy of any post-mortem 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 or designee within 24 hours 
of receipt of the information.

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10.3.4.
Reporting of SAEs
SAE Reporting via an Electronic Data Collection Tool
Not applicable
SAE Reporting via Paper CRF
Facsimile or secure email transmission of the SAE paper CRF is the preferred method to 
transmit this information to the sponsor.
Initial notification via telephone does not replace the need for the investigator to complete and 
sign the SAE CRF pages within the designated reporting time frames.
Contacts for SAE reporting can be found in in site training documents.

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10.4.
Appendix 4: Contraceptive Guidance and Collection of Pregnancy 
Information
10.4.1.
Definitions
Woman of Childbearing Potential (WOCBP)
A woman is considered fertile following menarche and until becoming post-menopausal 
unless permanently sterile (see below). If fertility is unclear (for example, amenorrhea in 
adolescents or athletes) and a menstrual cycle cannot be confirmed before first dose of study 
intervention, consider additional evaluation.
Woman NOT of Childbearing Potential (not WOCBP)
Women in the following categories are not considered WOCBP:
●  Premenarchal
●  Premenopausal female with 1 of the following:
○  Documented hysterectomy
○  Documented bilateral salpingectomy
○  Documented bilateral oophorectomy
For individuals with permanent infertility due to an alternate medical cause other than the 
above (for example, mullerian agenesis, androgen insensitivity), apply investigator 
discretion to determining study entry. Determination can come from the site personnel’s 
review of the participant’s medical records, medical examination, or medical history 
interview.
●  Postmenopausal female, defined as a woman meeting one of the following criteria:
○  At least 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy, 
confirmed by operative note.
○  Spontaneous amenorrhea for at least 12 months, not induced by a medical condition 
such as anorexia nervosa and not taking medications during the amenorrhea (for 
example, oral contraceptives, hormones, gonadotropin-releasing hormone, 
anti-estrogens, selective estrogen receptor modulators [SERMs], or chemotherapy 
that induced the amenorrhea); additionally, if less than or equal to 50 years of age, 
has a FSH of ≥40 mIU/mL.
○  At least 40 years of age with an intact uterus, not on hormone therapy, with
cessation of menses for at least 1 year, and without an alternative medical cause, 
AND a FSH of ≥40 mIU/mL.
○  At least 55 years of age, not on hormone therapy, having at least 12 months of 
spontaneous amenorrhea.
○  At least 55 years of age with a diagnosis of menopause prior to starting hormone 
replacement therapy.

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10.4.2.
Contraception
Females
Women of childbearing potential
●  Women of childbearing potential who are abstinent (if this is complete abstinence, as their 
preferred and usual lifestyle) or in a same sex relationship (as part of their preferred and usual 
lifestyle) must agree to either remain abstinent or stay in a same sex relationship without 
sexual relationships with males. Periodic abstinence (for example, calendar, ovulation, 
symptothermal, post-ovulation methods), declaration of abstinence just for the duration of a 
trial, and withdrawal are not acceptable methods of contraception.
●  Otherwise, women of childbearing potential participating must agree to use 2 forms of 
effective contraception, where at least 1 form is highly effective (less than 1% failure rate), for 
the entirety of the study. Abstinence or contraception must continue following completion of 
study drug administration for 12 weeks.
○  Women of childbearing potential participating must test negative for pregnancy prior to 
initiation of treatment as indicated by a negative serum pregnancy test at the screening visit 
followed by a negative urine pregnancy test within 24 hours prior to exposure.
○  Two forms of effective contraception, where at least 1 form is highly effective, (such as 
combination oral contraceptives, implanted contraceptives or intrauterine devices) will be 
used. Effective contraception (such as male or female condoms with spermicide, 
diaphragms with spermicide or cervical sponges) may be used as the second therapy. 
Barrier protection methods without concomitant use of a spermicide are not a reliable or 
acceptable method. Thus, each barrier method must include use of a spermicide (that is, 
condom with spermicide, diaphragm with spermicide, female condom with spermicide). It 
should be noted that the use of male and female condoms as a double barrier method is not 
considered acceptable due to the high failure rate when these methods are combined.
Women not of childbearing potential (not WOCBP)
Women who are not WOCBP may participate in the study if they meet all study entry criteria. 
For such women, there are no conception requirements.
Males
●  Men, regardless of their fertility status, with nonpregnant WOCBP partners must agree to 
either remain abstinent (if this is their preferred and usual lifestyle) or use condoms as well as 
1 additional highly effective (less than 1% failure rate) method of contraception (such as 
combination oral contraceptives, implanted contraceptives or intrauterine devices) or effective 
method of contraception (such as diaphragms with spermicide or cervical sponges) for the 
duration of the study and until their plasma concentrations are below the level that could result 
in a relevant potential exposure to a possible fetus, that is, 90 days following the last dose.
○  Men and their partners may choose to use a double–barrier method of contraception. 
(Barrier protection methods without concomitant use of a spermicide are not an effective or 
acceptable method of contraception. Thus, each barrier method must include use of a 
spermicide. It should be noted, however, that the use of male and female condoms as a 

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double barrier method is not considered acceptable due to the high failure rate when these 
barrier methods are combined).
○  Periodic abstinence (for example, calendar, ovulation, symptothermal, post-ovulation 
methods), declaration of abstinence just for the duration of a trial, and withdrawal are not 
acceptable methods of contraception.
●  Men with pregnant partners should use condoms during intercourse for the duration of the 
study and until the end of estimated relevant potential exposure in WOCBP (90 days 
following the last dose).
●  Men should refrain from sperm donation for the duration of the study and until their plasma 
concentrations are below the level that could result in a relevant potential exposure to a 
possible fetus, that is, 90 days following the last dose. 
●  Men who are in exclusively same sex relationships (as their preferred and usual lifestyle) are 
not required to use contraception.
10.4.3.
Collection of Pregnancy Information
Male participants with partners who become pregnant
The investigator will attempt to collect pregnancy information on any male participant’s female 
partner who becomes pregnant while the male participant is in this study. This applies only to 
male participants who receive study intervention.
After obtaining the necessary signed informed consent from the pregnant female partner directly, 
the investigator will record pregnancy information on the appropriate form and submit it to the 
sponsor within 24 hours of learning of the partner’s pregnancy. The female partner will be 
followed to determine the outcome of the pregnancy. Information on the status of the mother and 
child will be forwarded to the sponsor. Generally, the follow-up will be no longer than 6 to 
8 weeks following the estimated delivery date. Any termination of the pregnancy will be 
reported regardless of fetal status (presence or absence of anomalies) or indication for the 
procedure.
Female participants who become pregnant
The investigator will collect pregnancy information on any female participant who becomes 
pregnant while participating in this study. The initial information will be recorded on the 
appropriate form and submitted to the sponsor within 24 hours of learning of a participant's 
pregnancy.
The participant will be followed to determine the outcome of the pregnancy. The investigator 
will collect follow-up information on the participant and the neonate, and the information will be 
forwarded to the sponsor. Generally, follow-up will not be required for longer than 6 to 8 weeks 
beyond the estimated delivery date. Any termination of pregnancy will be reported, regardless of 
fetal status (presence or absence of anomalies) or indication for the procedure.
While pregnancy itself is not considered to be an adverse event (AE) or SAE, any pregnancy 
complication or elective termination of a pregnancy for medical reasons will be reported as an 
AE or SAE.

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A spontaneous abortion (occurring at <22 weeks gestational age) or still birth (occurring at 
>22 weeks gestational age) is always considered to be an SAE and will be reported as such.
Any post-study pregnancy-related SAE considered reasonably related to the study intervention 
by the investigator will be reported to the sponsor as described in Section 8.3.4. While the 
investigator is not obligated to actively seek this information in former study participants, he or 
she may learn of an SAE through spontaneous reporting.
Any female participant who becomes pregnant while participating in the study will discontinue 
study intervention and be withdrawn from the study.

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10.5.
Appendix 5: Liver Safety: Hepatic Monitoring Tests
Sampling in the case of a treatment-emergent hepatic abnormality
Samples for selected tests may be obtained in the event of a treatment-emergent hepatic 
abnormality and may be required during follow-up with participants in consultation with the 
clinical research physician of the sponsor or sponsor’s designee.
Hepatic Monitoring Tests
Hepatic Hematologya
Haptoglobina
Hemoglobin
Hematocrit
Hepatic Coagulationa
RBC
Prothrombin Time
WBC
Prothrombin Time, INR
Neutrophils, segmented
Lymphocytes
Hepatic Serologiesa,b
Monocytes
Hepatitis A antibody, total
Eosinophils
Hepatitis A antibody, IgM
Basophils
Hepatitis B surface antigen
Platelets
Hepatitis B surface antibody
Hepatitis B core antibody
Hepatic Chemistrya
Hepatitis C antibody
Total bilirubin
Hepatitis E antibody, IgG
Direct bilirubin
Hepatitis E antibody, IgM
Alkaline phosphatase
ALT
Anti-nuclear antibodya
AST
GGT
Alkaline Phosphatase Isoenzymesa
CPK
Anti-smooth muscle antibody (or anti-actin antibody)a
Abbreviations:  ALT = alanine aminotransferase; AST = aspartate aminotransferase; CPK = creatinine
phosphokinase; GGT = gamma-glutamyl transferase; Ig = immunoglobulin; INR = international normalised 
ratio; RBC = red blood cells; WBC = white blood cells.
a
Assayed by sponsor-designated or local laboratory.
b
Reflex/confirmation dependent on regulatory requirements and/or testing availability.

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10.6.
Appendix 6: Examples of Infections That May Be Considered 
Opportunistic in the Setting of Biologic Therapy
The following table lists examples of infections that may be considered opportunistic in the 
setting of biologic therapy (adapted from Winthrop et al. [2015]). This table is provided to aid 
the investigator in recognizing such infections. This list is not exhaustive. Infections will be 
categorized by Lilly as opportunistic according to Opportunistic Infections and Biologic 
Therapies in Immune-Mediated Inflammatory Diseases: Consensus Recommendations for 
Infection Reporting during Clinical Trials and Postmarketing Surveillance by 
Winthrop et al. (2015).

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Examples of Infections That May Be Considered Opportunistic in the Setting of Biologic 
Therapy
Bacterial
Bartonellosis (disseminated disease only)
Campylobacteriosis (invasive disease only)
Legionellosis
Listeriosis (invasive disease only)
Nocardiosis
Tuberculosis
Non-tuberculous mycobacterial disease
Salmonellosis (invasive disease only)
Shigellosis (invasive disease only)
Vibriosis (invasive disease due to Vibrio vulnificus)
Viral
BK virus disease including polyomavirus-associated nephropathy
Cytomegalovirus disease
Hepatitis B virus reactivation
Hepatitis C virus progression
Herpes simplex (invasive disease only)
Herpes zoster (any form)
Post-transplant lymphoproliferative disorder (Epstein-Barr virus)
Progressive multifocal leukoencephalopathy (PML), John Cunningham (JC) virus
Fungal
Aspergillosis (invasive disease only)
Blastomycosis
Candidiasis (invasive disease or oropharyngeal, esophageal. Not isolated lingual.)
Coccidioidomycosis
Cryptococcosis
Histoplasmosis
Paracoccidioides infections
Penicilliosis
Pneumocystosis
Sporotrichosis
Other invasive molds:  Mucormycosis (zygomycosis) (Rhizopus, Mucor, and Lichtheimia), 
Scedosporium/Pseudallescheria boydii, Fusarium
Parasitic
Leishmaniasis (visceral only)
Strongyloidosis (hyperinfection syndrome or disseminated disease)
Microsporidiosis
Toxoplasmosis
Trypanosoma cruzi infection (Chagas’ disease progression) (disseminated disease only)
Cryptosporidiosis (chronic disease only)
Source:  Adapted from Winthrop et al. (2015).

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10.7.
Appendix 7: Abbreviations
Term
Definition
A
abscesses, when used in the context of lesion counts
ADA
anti-drug antibody
ASAS
Assessment of SpondyloArthritis International Society
AESI
adverse event of special interest
ALC
absolute lymphocyte count
ALP
alkaline phosphatase
ALT
alanine aminotransferase
AN count
total abscess and inflammatory nodule count
ANC
absolute neutrophil count
anti-HBc
antibody to hepatitis B core antigen
AST
aspartate aminotransferase
blinding
A double-blind study is one in which neither the participant nor any of the investigator 
or sponsor staff who are involved in the treatment or clinical evaluation of the subjects 
are aware of the treatment received.
CBD
cannabidiol
CFR
United States Code of Federal Regulations
complaint
A complaint is any written, electronic, or oral communication that alleges deficiencies 
related to the identity, quality, purity, durability, reliability, safety or effectiveness, or 
performance of a drug or drug delivery system.
compliance
Adherence to all study-related, good clinical practice (GCP), and applicable regulatory 
requirements.
C-SSRS
Columbia Suicide-Severity Rating Scale
CT
computerized tomography
CTCAE
Common Terminology Criteria for Adverse Events
CXR
chest x-ray
DF
draining fistulas, when used in the context of lesion counts
DLQI
Dermatology Life Quality Index

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DNA
deoxyribonucleic acid
ECG
electrocardiogram
eCOA/COA
electronic Clinical Outcome Assessment/Clinical Outcome Assessment
eCRF/CRF
electronic case report form/case report form
enroll
The act of assigning a participant to a treatment. Participants who are enrolled in the 
study are those who have been assigned to a treatment.
enter
Participants entered into a study are those who sign the informed consent form directly 
or through their legally acceptable representatives.
ERB
Ethical Review Board (see IRB)
ETV
early termination visit
F
nondraining fistulas, when used in the context of lesion counts
FSH
follicle-stimulating hormone
GCP
good clinical practice
GGT
gamma-glutamyl transferase
HBsAg
hepatitis B surface antigen
HBV
hepatitis B virus
HCV
hepatitis C virus
HiSCR
Hidradenitis Suppurativa Clinical Response, defined as at least a 50% reduction in the 
total abscess and inflammatory nodule count (AN count) with no increase in abscess 
count and no increase in draining fistulae count relative to baseline
HIV
human immunodeficiency virus
HS
hidradenitis suppurativa
hs-CRP
C reactive protein, high-sensitivity
IAC
Internal Assessment Committee
IB
Investigator’s Brochure
ICF
informed consent form
ICH
International Council for Harmonisation
IEC
Independent Ethics Committee (see IRB)
Ig
immunoglobulin

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IGRA
interferon gamma release assay
IHS4
International Hidradenitis Suppurativa Severity Score System
IL
interleukin
informed consent
A process by which a participant voluntarily confirms his or her willingness to 
participate in a particular study, after having been informed of all aspects of the study 
that are relevant to the participant’s decision to participate. Informed consent is 
documented by means of a written, signed and dated informed consent form.
INR
international normalized ratio
interim analysis
An interim analysis is an analysis of clinical study data, separated into treatment groups, 
that is conducted before the final reporting database is created/locked.
investigational 
product (IP)
A pharmaceutical form of an active ingredient or placebo being tested or used as a 
reference in a clinical trial, including products already on the market when used or 
assembled (formulated or packaged) in a way different from the authorized form, or 
marketed products used for an unauthorized indication, or marketed products used to 
gain further information about the authorized form.
IRB
Institutional Review Board (IRB), also called Independent Ethics Committee (IEC) or 
Ethical Review Board (ERB)
mITT
modified intent-to-treat
ITT
intention to treat:  The principle that asserts that the effect of a treatment policy can be 
best assessed by evaluating on the basis of the intention to treat a participant (that is, the 
planned treatment regimen) rather than the actual treatment given. It has the 
consequence that participant allocated to a treatment group should be followed up, 
assessed, and analyzed as members of that group irrespective of their compliance to the 
planned course of treatment.
IV
intravenous
IWRS
interactive web-response system
LTBI
latent tuberculosis infection
mSS
modified Sartorius Score
N
inflammatory nodules, when used in the context of lesion counts
NOAEL
no-observed-adverse-effect level
NONMEM
nonlinear mixed effects modeling
NRS
numeric rating scale
NSAID
nonsteroidal anti-inflammatory drug
PA
posterior–anterior

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participant
Equivalent to Clinical Data Interchange Standards Consortium (CDISC) term “subject,” 
meaning an individual who participates in a clinical trial, either as recipient of an 
investigational medicinal product or as a control.
In this protocol, the term “participant” is used to indicate an individual who participates 
in a clinical trial, either as a recipient of an investigational medicinal product or as a 
control. This usage reflects preferences indicated by patient advocates to more 
accurately reflect the role of people who take part in clinical trials.
PD
pharmacodynamics
PK
pharmacokinetics
PK/PD
pharmacokinetics/pharmacodynamics
PPD
purified protein derivative
PRO/ePRO
patient-reported outcomes/electronic patient-reported outcomes
Q2W
every 2 weeks
QTc
corrected QT interval
RNA
ribonucleic acid
SAE
serious adverse event
SAP
statistical analysis plan
screen
The act of determining if an individual meets minimum requirements to become part of 
a pool of potential candidates for participation in a clinical study. 
SoA
Schedule of Activities
study drug
See “study intervention”
study intervention
Any investigational intervention, marketed product, placebo, or medical device 
intended to be administered to a study participant according to the study protocol
TB
tuberculosis
TBL
total bilirubin level
TE
treatment emergent
TEAE
Treatment-emergent adverse event:  An untoward medical occurrence that emerges 
during a defined treatment period, having been absent pretreatment, or worsens relative 
to the pretreatment state, and does not necessarily have to have a causal relationship 
with this treatment.
TST
tuberculin skin test
ULN
upper limit of normal

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USA
United States of America; also United States
WBC
white blood cell
WOCBP
women of childbearing potential (see Appendix 10.4, Section 10.4.1.)
xN
non-inflammatory nodules, when used in the context of lesion counts

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11.
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10.1111/bjd.15748

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