A Multicenter, Open Label Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis (LIMMITLESS)
Phase: PHASE3
Conditions: Psoriasis
Sponsor: AbbVie

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
1
1.0
Title Page
Clinical Study Protocol M15-997
A multicenter, open Label study to assess the safety 
and efficacy of rIsankizuMab for MaInTenance in 
moderate to severe pLaquE type pSoriaSis
(LIMMITLESS)
Incorporating Administrative Change 1, 2, 3, 4, 5, 
and 6 and Amendments 1, 2, 3, 4, 5, 6, 7, and 8
AbbVie Investigational
  Product:
Risankizumab/ABBV-066/previously BI-655066
Date:
18 October 2021
Development Phase:
3
Study Design:
Global, multicenter, single-arm, open label extension 
study in subjects with moderate to severe plaque type 
psoriasis
EudraCT Number:
2016-003046-87
Investigator(s):
Investigator information is on file at AbbVie
Sponsor:
AbbVie*
 
NCT03047395

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
3
1.1
Protocol Amendment:  Summary of Changes
Previous Protocol Versions
Protocol 
Date
Original
22 September 2016
Amendment 1
09 December 2016
Administrative Change 1
19 April 2017
Amendment 1.01 (France Only)
05 May 2017
Amendment 2
06 June 2017
Amendment 3
10 January 2018
Amendment 3.01 (France Only)
30 January 2018
Amendment 3.02 (Japan Only)
30 January 2018
Amendment 4
21 June 2018
Amendment 4.01 (France Only)
09 July 2018
Amendment 4.02 (Japan Only)
09 July 2018
Amendment 4.02.01 (Japan Only)
30 November 2018
Amendment 5
24 September 2019
Administrative Change 2
07 October 2019
Amendment 5.01 (France Only)
28 October 2019
Administrative Change 3
01 November 2019
Amendment 6
26 November 2019
Amendment 6.01 (France Only)
13 December 2019
Amendment 6.02 (Japan Only)
30 December 2019
Administrative Change 4
21 July 2020
Amendment 7
17 November 2020
Amendment 7.01 (France Only)
07 December 2020
Amendment 7.02 (Japan Only)
08 December 2020
Administrative Change 5
18 March 2021
Administrative Change 6
01 September 2021
The purpose of this amendment is to:
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
4
●
Throughout the protocol, remove the requirement for the physical exam, 
clinical laboratory samples and efficacy assessments PASI, sPGA, NAPSI, 
PPASI, PSSI, and the DLQI at the End of Observation (EOO) visit and change 
the EOO visit from an in-person visit to a phone visit.
Rationale: Converting the EOO visit to a safety follow up call 20 weeks after 
the last study drug administration ensures that the safety monitoring measures 
in this study are consistent with all risankizumab trials in psoriasis and in other 
indications. All safety assessments that had not been scheduled for the EOT 
visit but cannot be performed during the EOO safety follow up call (i.e., annual 
TB testing and ECG) will now be completed at the EOT visit to ensure those 
parameters are assessed. Considering the availability of 5-year efficacy data 
from this study, the additional efficacy assessments at the EOO visit are not 
required and removing these will not impact the study objectives nor the 
scientific interpretation of the study results.
●
Change the End of Observation visit requirement to perform an ECG, TB 
testing and additional clinical laboratory testing to the EOT visit in Appendix C
("Study Activities Flow Chart").
Rationale: These procedures will no longer be performed at the End of 
Observation visit and will therefore be performed at the EOT visit to ensure 
that all appropriate safety monitoring is completed.
●
Clarify the analysis of the immunogenicity samples in Section 5.3.2.4
("Measurement Methods").
Rationale: To provide clarity on which samples will be analyzed for antibodies.
●
Add INR test to be performed if ALT or AST > 3 x ULN to Table 1 Clinical 
Laboratory Test in Section 5.3.1.1 ("Study Procedures").
Rationale: Although mentioned in the discontinuation criteria, the INR test was 
Previously not included in the Clinical Laboratory Test table. The Clinical 
Laboratory Test table has been updated to add the INR test to coincide with the 
specified discontinuation criteria in Section 5.4.1 ("Discontinuation of 
Individual Subjects").

Update the definition of hepatic injury to include marked peak 
aminotransferase elevations ≥ 8-fold ULN, instead of ≥ 10-fold ULN in 
Section 6.1.1.3 ("Adverse Events of Special Interests").
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
5
Rationale: To align with U.S. FDA Drug-Induced Liver Injury: Premarketing 
Clinical Evaluation guidelines.
●
Clarify in Section 6.1.1.3 Adverse Events of Special Interests, that the 
supplemental hepatic eCRFs have to be completed for any hepatic related AE 
leading to discontinuation or interruption of study drug or any hepatic related 
SAE, not meeting the hepatic injury definition. 
Rationale: To align guidance on supplemental hepatic eCRFs completion in 
Section 6.1.1.3 ("Adverse Events of Special Interests") with the standardized 
approach across the risankizumab development programs, which is based on 
U.S. FDA Drug-Induced Liver Injury: Premarketing Clinical Evaluation 
guidelines.
●
Add language to address potential use of SARS-CoV-2 vaccines to 
Section 5.2.3 ("Prior and Concomitant Therapy") and Section 6.1.5 ("Adverse 
Event Reporting").
Rationale: To provide guidance on COVID-19 vaccinations to investigators.
●
Update the Sponsor/Emergency contact/Primary Therapeutic Area Medical 
Director and Alternate Contact for Protocol Deviations in Section 1.0 ("Title 
Page"), Section 6.1.5 ("Adverse Event Reporting") and Section 7.0 ("Protocol 
Deviations").
Rationale:  Change in AbbVie company staff.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
6
1.2
Synopsis
AbbVie Inc.
Protocol Number: M15-997
Name of Study Drug:  Risankizumab/ABBV-066 
(previously known as BI 655066)
Phase of Development:  3
Name of Active Ingredient:
Risankizumab/ABBV-066
Date of Protocol Synopsis:  18 October 2021
Protocol Title:  A multicenter, open Label study to assess the safety and efficacy of rIsankizuMab for 
MaInTenance in moderate to severe pLaquE type pSoriaSis (LIMMITLESS)
Objectives:  The primary objective of Study M15-997 is to investigate long-term safety and tolerability 
of risankizumab in subjects with psoriasis who have completed one of the preceding Phase 2/3 studies.
The secondary objective of Study M15-997 is to investigate the long-term efficacy of risankizumab in 
the treatment of psoriasis.
Investigators:  Multicenter
Study Sites:  Approximately 235 sites globally
Study Population:  Adult subjects with a diagnosis of moderate to severe chronic plaque psoriasis who 
have completed one of the preceding Phase 2/3 Studies 1311.3, 1311.4, 1311.13, 1311.28, 1311.30, 
1311.38 and M16-178.
Number of Subjects to be Enrolled:  Approximately 2200
Methodology:
This is a Phase 3, single-arm, multicenter OLE study designed to investigate the long-term safety and 
efficacy of 150 mg risankizumab in the treatment of moderate to severe chronic plaque psoriasis.  
Approximately 2200 subjects who meet the entry criteria are planned to be enrolled in this study, rolling 
over from the preceding Phase 2/3 studies.
During this study, all subjects will receive risankizumab 150 mg subcutaneously every 12 weeks for 
252 weeks (last dose of study drug to be administered at visit Week 252 [EOT]).
Study visits will occur every 12 weeks starting from Baseline until the Week 156 visit.  From Week 156 
until the EOT visit, subject visits will occur every 24 weeks.  At Weeks 168, 192, 216 and 240, subjects 
or caregivers will self-administer risankizumab at home after having been instructed at Week 156 by the 
site staff on how to self-inject via the pre-filled syringe.  Alternatively, subjects may receive the study 
drug of Weeks 168, 192, 216 and 240 at the study site. 
All subjects will have an End of Observation Visit (EOO) via phone, approximately 20 weeks after their 
last administered dose of study drug.  Study completion is defined as a subject having completed the 
EOO visit.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
7
Diagnosis and Main Criteria for Inclusion/Exclusion:
Main Inclusion:
1.
Subjects with moderate to severe chronic plaque psoriasis who have completed one of the preceding 
Studies 1311.3, 1311.4, 1311.13, 1311.28, 1311.30, 1311.38 and M16-178.
2.
Subjects must be candidates for prolonged open label risankizumab treatment according to 
investigator judgment
Main Exclusion:
1.
Premature discontinuation for any reason in the preceding study.
Investigational Product:
Risankizumab (ABBV-066):  75 mg pre-filled syringe, 90 mg/mL, 
0.83 mL dispensed volume, 0.87 mL fill volume
Dose:
Risankizumab (ABBV-066):  150 mg administered every 12 weeks
Mode of Administration:
Subcutaneous injection 
Duration of Treatment:  The study duration is 252 weeks.
Criteria for Evaluation:
Efficacy:
Key variables to be summarized at all visits:

Proportion of subjects achieving ≥ 90% reduction in Psoriasis Area and Severity Index (PASI) 
score (PASI 90)

Proportion of subjects achieving the Static Physician Global Assessment (sPGA) score of clear 
or almost clear

Proportion of subjects achieving ≥ 75% reduction in PASI score (PASI 75)

Proportion of subjects achieving 100% reduction in PASI score (PASI 100)

Proportion of subjects achieving the sPGA score of clear
Pharmacokinetics (PK) and Immunogenicity:
Blood samples will be collected for measurement of risankizumab concentration and anti-drug antibody 
(ADA) and neutralizing antibody (NAb) just prior to dosing at Baseline, Week 48, Week 96, Week 156, 
Week 204 and End of Treatment (EOT) visit.
Safety:
Adverse events (AE)s, laboratory data and vital signs will be assessed throughout the study.
Statistical Methods:
Efficacy:
For all efficacy analyses (including the assessment of PASI responses), baseline refers to the last non-
missing value prior to the first dose of study drug in the preceding studies.
Summary statistics will be provided.  Continuous variables will be summarized by the number of 
observations, mean, standard deviation, median, minimum, maximum, 25th and 75th percentile, as well as 
the 95% confidence intervals (CIs) of mean values.  Categorical variables will be summarized by counts 
and percentages, as well as the 95% CIs of the percentages.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
8
Statistical Methods (Continued):
Pharmacokinetics (PK) and Immunogenicity:
Risankizumab plasma concentrations will be determined.  Descriptive statistics will be calculated for 
each sampling time (study visit).  The number and percentage of subjects with ADA will be calculated.
Additional analyses combining pharmacokinetic and ADA data from this study and other studies may be 
conducted if appropriate.  After completion of the study, PK and ADA plasma samples may be used for 
further methodological investigations, e.g., stability testing.
Safety:
All AEs, serious adverse events (SAE)s, AEs leading to discontinuation, and pre-specified AEs of 
Special interest and AEs of Safety Interest will be collected during the study.  A treatment-emergent AE 
(TEAE) is defined as an event with onset or worsening after the first study dose of risankizumab (either 
in the preceding study or this study) and within 20 weeks after the last study drug injection.  The number 
and percentages of subjects experiencing TEAE will be tabulated using the Medical Dictionary for Drug 
Regulatory Activities (MedDRA®) system organ class and preferred term.  Summaries (including 
percentages and event per 100 patient-years) of SAEs, deaths, AEs leading to discontinuation from the 
study, and pre-specified AESIs will be provided as well.  Mean change in laboratory and vital signs 
variables will be summarized.  For selected parameters, a listing of all subjects with clinically significant 
laboratory or vital sign determinations will be provided.  Shift tables for changes from baseline 
according to the normal range will also be provided.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
9
1.3
List of Abbreviations and Definition of Terms
Abbreviations
AAC
Anaphylaxis Adjudication Committee
ADA
Anti-Drug antibody
AE
Adverse event
AESI
Adverse event of special interest
AUC
Area under the curve
Cmax
Maximal concentration
COVID-19
Coronavirus Disease - 2019
CRF
Case report form
DLQI
Dermatology Life Quality Index
DMC
Data monitoring committee
DTP
Direct-to-Patient
E12W
Every 12 weeks
E24W
Every 24 weeks
ECG
Electrocardiogram
eCRF
Electronic case report form
EDC
Electronic data capture
EMA
European Medicines Agency
EOO
End Of Observation
EOT 
End Of Treatment
EudraCT
European Clinical Trials Database
FU
Follow-up
GCP
Good clinical practice
Hct
Hematocrit
Hb
Hemoglobin
HIV 
Human immunodeficiency virus
IB
Investigator's brochure
ICH
International Conference on Harmonization
IEC
Independent ethics committee
IFU
Instructions for Use
IGRA
Interferon gamma release assay
IL
Interleukin
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
10
INR
International Normalized Ratio
IP
Investigational Product
IRB
Institutional review board
IRT
Interactive response system
IUD
Intrauterine device
IUS
Intrauterine hormone-releasing system
LDH
Lactic dehydrogenase
LOCF
Last observation carried forward 
mAb
Monoclonal antibody
MACE
Major adverse cardiovascular event
MedDRA
Medical Dictionary for Drug Regulatory Activities
MTX
Methotrexate
NAb
Neutralizing antibody
NAPSI
Nail Psoriasis Severity Index
OLE
Open label extension
PASI
Psoriasis Area and Severity Index
PK
Pharmacokinetics
PMN
Polymorphonuclear
PoCC
Proof of clinical concept
POR
Proof of receipt
PPD
Purified protein derivative
PPASI
Palmoplantar Psoriasis Area and Severity Index
PSSI
Psoriasis Scalp Severity Index
RZB
Risankizumab
SAE
Serious adverse event
SAP
Statistical analysis plan
SARS-CoV-2
Severe acute respiratory syndrome coronavirus 2
s.c.
Subcutaneous
sPGA
Static Physician Global Assessment
TA MD
Therapeutic Area Medical Director
TB
Tuberculosis
TEAE
Treatment-emergent adverse event
TNF
Tumor necrosis factor
ULN
Upper limit of normal
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
11
2.0
Table of Contents
1.0
Title Page..................................................................................1
1.1
Protocol Amendment:  Summary of Changes ...........................................3
1.2
Synopsis .....................................................................................................6
1.3
List of Abbreviations and Definition of Terms..........................................9
2.0
Table of Contents...................................................................11
3.0
Introduction ...........................................................................15
3.1
Differences Statement..............................................................................17
3.2
Benefits and Risks....................................................................................17
4.0
Study Objective......................................................................20
5.0
Investigational Plan...............................................................20
5.1
Overall Study Design and Plan:  Description ..........................................20
5.2
Selection of Study Population..................................................................22
5.2.1
Inclusion Criteria .....................................................................................22
5.2.2
Exclusion Criteria ....................................................................................23
5.2.3
Prior and Concomitant Therapy...............................................................25
5.2.3.1
Prohibited Therapy...................................................................................25
5.2.4
Contraception Recommendations and Pregnancy Testing.......................26
5.3
Efficacy, Pharmacokinetic and Safety Assessments/Variables ...............28
5.3.1
Efficacy and Safety Measurements Assessed ..........................................28
5.3.1.1
Study Procedures .....................................................................................28
5.3.2
Drug Concentration Measurements .........................................................41
5.3.2.1
Collection of Samples for Analysis .........................................................41
5.3.2.2
Handling/Processing of Samples .............................................................41
5.3.2.3
Disposition of Samples ............................................................................42
5.3.2.4
Measurement Methods.............................................................................42
5.3.3
Efficacy Variables....................................................................................42
5.3.3.1
Key Variables...........................................................................................42
5.3.3.2
Additional Variables ................................................................................43
5.3.4
Safety Variables.......................................................................................43
5.3.5
Pharmacokinetic Variables ......................................................................43
5.4
Removal of Subjects from Therapy or Assessment.................................43
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
12
5.4.1
Discontinuation of Individual Subjects....................................................43
5.4.2
Discontinuation of Entire Study...............................................................46
5.5
Treatments................................................................................................46
5.5.1
Treatments Administered.........................................................................46
5.5.2
Identity of Investigational Product (IP) ...................................................46
5.5.2.1
Packaging and Labeling...........................................................................47
5.5.2.2
Storage and Disposition of Study Drug ...................................................47
5.5.3
Method of Assigning Subjects to Treatment Groups...............................48
5.5.4
Selection and Timing of Dose for Each Subject......................................48
5.5.5
Treatment Compliance.............................................................................49
5.5.6
Drug Accountability.................................................................................50
5.6
Discussion and Justification of Study Design..........................................51
5.6.1
Discussion of Study Design and Choice of Control Groups....................51
5.6.2
Appropriateness of Measurements...........................................................51
5.6.3
Suitability of Subject Population .............................................................51
5.6.4
Selection of Doses in the Study ...............................................................52
6.0
Complaints .............................................................................54
6.1
Medical Complaints.................................................................................54
6.1.1
Definitions................................................................................................55
6.1.1.1
Adverse Event..........................................................................................55
6.1.1.2
Serious Adverse Events ...........................................................................55
6.1.1.3
Adverse Events of Special Interest ..........................................................57
6.1.2
Adverse Event Severity............................................................................58
6.1.3
Relationship to Study Drug......................................................................58
6.1.4
Adverse Event Collection Period.............................................................59
6.1.5
Adverse Event Reporting.........................................................................59
6.1.6
Pregnancy.................................................................................................62
6.2
Product Complaint ...................................................................................62
6.2.1
Definition .................................................................................................62
6.2.2
Reporting..................................................................................................63
7.0
Protocol Deviations................................................................63
8.0
Statistical Methods and Determination of Sample 
Size ..........................................................................................64
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
13
8.1
Statistical and Analytical Plans................................................................64
8.1.1
Analysis Populations................................................................................64
8.1.2
Planned Methods of Statistical Analysis..................................................66
8.1.3
Demographics and Baseline Characteristics............................................66
8.1.4
Statistical Analysis of Efficacy................................................................66
8.1.5
Safety Analysis ........................................................................................67
8.1.6
Interim Analysis.......................................................................................67
8.1.7
Pharmacokinetic and Exposure-Response Analysis ................................68
8.1.8
Data Monitoring Committee....................................................................68
8.1.9
Cardio- and Cerebro-Vascular Event Adjudication Committee ..............68
8.2
Determination of Sample Size .................................................................68
9.0
Ethics.......................................................................................69
9.1
Independent Ethics Committee (IEC) or Institutional Review 
Board (IRB) .............................................................................................69
9.2
Ethical Conduct of the Study ...................................................................70
9.3
Subject Information and Consent.............................................................70
9.3.1
Informed Consent Form and Explanatory Material .................................70
10.0
Source Documents and Case Report Form 
Completion .............................................................................71
10.1
Source Documents ...................................................................................71
10.2
Case Report Forms...................................................................................71
11.0
Data Quality Assurance ........................................................73
12.0
Use of Information.................................................................73
13.0
Completion of the Study .......................................................74
14.0
Investigator's Agreement......................................................75
15.0
Reference List ........................................................................76
List of Tables
Table 1.
Clinical Laboratory Tests.........................................................................35
Table 2.
Identity of Investigational Product...........................................................47
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
14
List of Figures
Figure 1.
Study Schematic.......................................................................................21
Figure 2.
Adverse Event Collection ........................................................................59
List of Appendices
Appendix A.
Responsibilities of the Clinical Investigator ............................................79
Appendix B.
List of Protocol Signatories......................................................................81
Appendix C.
Study Activities Flow Chart.....................................................................82
Appendix D.
Local Requirements – Japan ....................................................................86
Appendix E.
Psoriasis Area and Severity Index (PASI) ...............................................90
Appendix F.
Static Physician Global Assessment (sPGA)...........................................93
Appendix G.
Nail Psoriasis Severity Index (NAPSI)....................................................95
Appendix H.
Palmoplantar Psoriasis Area and Severity Index (PPASI).......................97
Appendix I.
Psoriasis Scalp Severity Index (PSSI) .....................................................99
Appendix J.
Dermatology Life Quality Index (DLQI)...............................................100
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
15
3.0
Introduction
Psoriasis is a chronic inflammatory disease with raised, well-demarcated erythematous 
plaques with adherent silvery scales.1  It is the most prevalent immune mediated skin 
disease, affecting 2% of the world population.2  Twenty-five percent of subjects have 
moderate to severe disease with considerable negative impact on psychosocial and 
economic status.3  It is increasingly recognized that psoriasis is more than a superficial 
disease, with 30% of subjects having joint involvement and a high correlation between 
psoriasis and obesity, diabetes, depression, metabolic syndrome and cardiovascular risk.4
While the majority of psoriasis subjects are managed initially with topical therapies, those 
with severe and/or refractory disease may require phototherapy and/or systemic therapy.  
Oral systemic agents provide modest efficacy, but increasingly subjects are treated with 
biological agents, such as tumor necrosis factor (TNF)-alpha inhibitors (etanercept, 
adalimumab) and the p40 Interleukin (IL)-12/23 inhibitor (ustekinumab).5  While the 
clinical efficacy of ustekinumab indicates a role for both IL-12 and IL-23 in the 
pathogenesis of psoriasis,6 more recent data suggest that IL-23 is disproportionately 
involved in the maintenance of chronic psoriasis,6 IL-23 is thought to be involved in the 
pathophysiology of psoriasis via induction and maintenance of Th17 type cells, and other 
IL-23 responsive cells.  This is supported by recent clinical data indicating that 
monoclonal antibodies (mAb) that block IL-17, the cytokine produced by Th17 cells, have 
high efficacy in psoriasis.7
There is still clinical need for increased efficacy as the most effective anti-TNF and 
IL12/23 agents provide only 75% improvement in psoriasis in about 60 – 70% of subjects 
and these responses tend to be lost over time.  While the anti-IL-17 agents 
(i.e., secukinumab) provide better efficacy, they require monthly injections, thus their 
long-term utility is still undetermined.  Risankizumab (ABBV-066) is a humanized mAb 
with high affinity for the p19 component of human IL-23A that specifically neutralizes 
IL-23.  Proof of clinical concept (PoCC) for risankizumab was demonstrated in a single 
dose Phase 1 study in 39 subjects with moderate to severe plaque psoriasis where 87% of 
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
16
subjects achieved at least 75% reduction in Psoriasis Area and Severity Index (PASI) 
from baseline (PASI 75) with no safety concerns.8
Positive results were observed from 4 pivotal Phase 3 clinical trials that evaluated 
risankizumab compared with ustekinumab, placebo, and adalimumab for the treatment of 
patients with moderate to severe plaque psoriasis.  Results from these pivotal studies 
demonstrated that risankizumab is highly effective for the treatment of psoriasis, meeting 
co-primary endpoints of achieving at least a 90% improvement in the Psoriasis Area and 
Severity Index (PASI 90) and static physician global assessment (sPGA) score of clear or 
almost clear (0 or 1) versus comparator or placebo at Week 16 across all 4 studies.9  
Risankizumab has been well tolerated in the completed and ongoing studies.
The current study is being performed to establish the long-term safety and efficacy of 
risankizumab.
Risankizumab is a fully humanized mAb of the IgG1 subclass directed towards IL-23p19.  
The antibody has been engineered to reduce Fcγ receptor and complement binding and 
potential charge heterogeneity.  Risankizumab binds with high affinity to human IL-23 
and inhibits IL-23 stimulated IL-17 production at inhibitory concentration (IC) 50 
concentrations below 10 pM, as compared with 167 pM for ustekinumab in the same 
system.  Risankizumab does not affect IL-12 at a maximum tested concentration (33 nM) 
and it does not inhibit IL-12 stimulated IFN-γ production.
The toxicology data suggest risankizumab can be safely administered to humans, as 
supported by chronic administration to monkeys for up to 26 weeks.  The monkey was 
identified as the most relevant toxicology species with no observed adverse effect level 
(NOAEL) of 50 mg/kg/dose, corresponding to an exposure (combined sex) of 677 µg/mL 
for the maximal concentration (Cmax) and 86,250 µg•h/mL (3594 µg•day/mL) for area 
under the curve (AUC) 0-168, respectively.
After a single intravenous administration in subjects with psoriasis, risankizumab 
geometric mean AUC0–inf ranged from 2.93 – 1650 µg•day/mL and Cmax from 0.311 –
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
17
110 µg/mL, with exposure increasing in a dose-proportional manner.  Group mean 
clearance and terminal phase volume of distribution were 0.33 L/day and 10.8 L, 
respectively.  Pharmacokinetic (PK) parameter variability, expressed as the geometric 
mean of coefficient variation (gCV) (%) was < 50%.  After a single subcutaneous (s.c.) 
administration of risankizumab, maximal exposures were reached between 4 – 10 days 
and subcutaneous estimated bioavailability was 73%.
For a more detailed description of the drug profile refer to the current Investigator's 
Brochure (IB).9
3.1
Differences Statement
Study M15-997 will assess long-term safety and efficacy of risankizumab in subjects with 
moderate to severe chronic plaque psoriasis.  The duration of this study will be 
252 weeks.
3.2
Benefits and Risks
Based on data from completed and ongoing studies with risankizumab, patients with 
moderate to severe plaque psoriasis are expected to benefit from long-term treatment with 
risankizumab.  In the Phase 2 study (Study 1311.2), treatment with 90 mg or 180 mg of 
risankizumab resulted in a higher percentage of patients achieving and maintaining 
PASI 90 through Week 48 as compared with ustekinumab, an approved therapy for 
moderate to severe plaque Psoriasis.  Favorable results were also observed from 4 pivotal 
Phase 3 clinical trials that evaluated risankizumab compared with ustekinumab, placebo, 
and adalimumab for the treatment of patients with moderate to severe plaque psoriasis.  
Results from these pivotal studies demonstrated that risankizumab administered 150 mg 
every 12 weeks is highly effective for the treatment of psoriasis, meeting co-primary 
endpoints of achieving at least a 90% improvement in the Psoriasis Area and Severity 
Index (PASI 90) and static physician global assessment (sPGA) score of clear or almost 
clear (0 or 1) versus comparator or placebo at Week 16 across all 4 studies.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
18
As of 29 March 2019, risankizumab safety data were available for 3236 subjects, 
including 2673 subjects with plaque psoriasis, 177 in subjects with PsA, 17 subjects with 
GPP/EP, 115 with CD, 149 with AS, and 105 with asthma.9  In the Phase 2 psoriasis study 
(Study 1311.2), 126 subjects received risankizumab and the most commonly occurring 
AEs were nasopharyngitis (32%), headache (9%), back pain (6%), and arthralgia (5%).  
There was no relationship between treatment groups or doses and the overall frequency of 
AEs or the occurrence of AEs in specific organ classes, or any individual AE based on 
available unblinded safety data.
As with any biologic therapy, hypersensitivity reactions may be possible.  There have 
been no reported instances of drug hypersensitivity to risankizumab.  Injection site 
erythema was reported in 4.8% of subjects who received 180 mg of risankizumab and 
3/126 (2.4%) of total subjects receiving risankizumab in Study 1311.2.  As an immune 
modulating agent, risankizumab may impair immune function resulting in a risk of 
infection.  This will be monitored by collection of all AEs during the treatment and 
observation periods.  Subjects with clinically important active infection will not be 
included in the study.
Subjects with a positive QuantiFERON®-test or a positive purified protein derivative 
(PPD) skin test for tuberculosis (TB) must fulfill entry criteria as specified in 
Section 5.2.2.
IL-23 inhibition is not known to increase the risk of TB infection or impair the response to 
TB infection in animal models.10,11  Thus, low risk subjects with positive QuantiFERON 
TB testing are not required to be treated with anti-tuberculosis therapy prior to receiving 
risankizumab, but should be carefully monitored for any sign of TB reactivation.  Absence 
of TB reactivation, despite not receiving anti-tuberculosis prophylaxis will provide 
important information in humans as to whether TB testing is required prior to treatment 
with risankizumab.12
There have been post marketing reports of the rapid appearance of multiple cutaneous 
squamous cell carcinomas in patients receiving ustekinumab, anti-IL12/23 mAb who had 
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
19
pre-existing risk factors for developing NMSC.13  Patients with moderate to severe PsO 
generally have risk factors for development of NMSC.  In the completed studies to date, 
risankizumab has not been associated with an increased risk of malignancies but the risk 
with long-term therapy is not known.
Increases in the incidence rate of major adverse cardiovascular events (MACE) including 
myocardial infarction, cerebrovascular accident, and cardiovascular death, reported in the 
12 week controlled portions of the clinical trials with anti-IL-12/23 agents, such as 
ustekinumab, have not been observed in longer term studies.14
In order to recognize any safety signals as early as possible, an independent Data 
Monitoring Committee (DMC) has been monitoring unblinded data from all studies where 
subjects are receiving risankizumab.  As the sponsor has comprehensive safety monitoring 
measures in place to enable signal detection in open label studies, monitoring by the 
independent DMC will no longer be in effect for this open-label study.  Routine 
pharmacovigilance surveillance will continue to be conducted.
An independent adjudication committee will be adjudicating all observed cardio- and 
cerebro-vascular events including major adverse cardiovascular events (MACE) in a 
blinded manner.
In conclusion, the benefit-risk profile of risankizumab is considered appropriate for 
allowing subjects to continue therapy under this long-term extension study.
In view of the coronavirus disease of 2019 (COVID-19) pandemic, the benefit-risk profile 
of various immunomodulatory therapies on COVID-19 is being evaluated based on real 
world and clinical trial data.  At this time, the effects of risankizumab on the course of 
COVID-19 are not well defined.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
20
4.0
Study Objective
The primary objective of Study M15-997 is to investigate long-term safety and tolerability 
of risankizumab in subjects with psoriasis who have completed one of the preceding 
Phase 2/3 studies.
The secondary objective of Study M15-997 is to investigate the long-term efficacy of 
risankizumab in the treatment of psoriasis.
5.0
Investigational Plan
5.1
Overall Study Design and Plan:  Description
This is a Phase 3, single-arm, multicenter, OLE study designed to investigate the 
long-term safety and efficacy of risankizumab 150 mg E12W in the treatment of moderate 
to severe chronic plaque psoriasis.  Approximately 2200 subjects who meet the entry 
criteria are planned to be enrolled in this study, rolling over from the preceding 
Studies 1311.3, 1311.4, 1311.13, 1311.28, 1311.30, 1311.38 and M16-178 (Phase 2/3, 
randomized clinical studies in subjects with moderate to severe chronic plaque psoriasis, 
conducted by Boehringer Ingelheim or AbbVie).
All subjects need to complete one of the preceding Phase 2/3 psoriasis studies.  The 
subject preferably has the Baseline visit of Study M15-997 on the same day of the 
completion visit of the preceding study; however, the Baseline visit can be delayed up to 
8 weeks if needed.
Study visits may be impacted due to the COVID-19 pandemic.  This may include changes 
such as phone or virtual visits, visits at alternative locations, or changes in the visit 
frequency and timing of study procedures, among others.  Additional details are provided 
in Section 5.3.1.1 Study Procedures.  Every effort should be made to ensure the safety of 
subjects and site staff, while maintaining the integrity of the study.  If visits cannot be 
conducted onsite due to logistical restrictions or other pandemic-related reasons, follow 
the updates below on how to proceed.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
21
Baseline Visit
Baseline assessments will include medical history, physical examination, 
electrocardiogram (ECG) and laboratory results including pregnancy testing, all of which 
will be reviewed by the study site to confirm selection criteria are met prior to enrolling 
the subject.
If the Baseline visit occurs on the same day or in the 4 days following the completion visit 
of the preceding study, only selected activities are required as some activities are common 
to both studies and are not required twice.  See Study Activities Flow Chart in 
Appendix C.  If the Baseline visit occurs > 4 days and ≤ 8 weeks after the completion visit 
of the preceding study, all procedures specified in Appendix C at the Baseline visit are 
required.
Subjects will be assigned a unique patient number via interactive response system (IRT).
Administration of study medication should be the last activity at the Baseline visit.
All subjects will be administered 150 mg risankizumab s.c. at the Baseline visit.
Treatment Period
From the Baseline visit onwards, risankizumab will be administered subcutaneously 
E12W during the study.
Figure 1.
Study Schematic
 
    
 
 
 
 
 
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
22
Study visits for dosing, efficacy and safety assessments will be performed E12W starting 
from Baseline until the Week 156 visit.  After this visit until the End of Treatment (EOT) 
visit at Week 252, study visits will be performed E24W.  There is a ± 7 days visit window 
for study visits.  Every effort will be made to bring subjects back to their original 
scheduled visit (calculated from Baseline) if they are out of the visit window.
At Weeks 168, 192, 216 and 240, subjects will self-administer risankizumab at home after 
proper training to the subject and/or caregiver on the injection technique with the pre-
filled syringe at Week 156 by the site staff.  Alternatively, subjects may receive the 
injection of study drug of Weeks 168, 192, 216 and 240 at the study site. Subjects who 
discontinue study drug treatment early will need to attend an early EOT visit ideally 
within 2 weeks after the decision and preferably prior to the administration of any new 
therapies (Section 5.4.1).
End of Observation Visit
All subjects, including those that prematurely discontinued study drug treatment, will 
have an End of Observation Visit (EOO) via phone, approximately 20 weeks after their 
last administered dose of study drug. Study completion is defined as a subject having 
completed the EOO visit.
5.2
Selection of Study Population
5.2.1
Inclusion Criteria
1.
Subjects with a history of moderate to severe chronic plaque psoriasis, who have 
completed one of the preceding studies.
2.
Subjects must be candidates for prolonged open label risankizumab treatment 
according to investigator judgment.
3.
Females of childbearing potential must have a negative urine pregnancy test result 
at Baseline.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
23
If female, subject must be either postmenopausal, OR permanently surgically sterile 
OR for women of childbearing potential practicing at least one protocol specified 
method of birth control (Section 5.2.4), starting at Baseline through at least 
20 weeks after the last dose of study drug.
4.
Subjects must have signed and dated a written informed consent in accordance with 
Good Clinical Practice (GCP) and local legislation prior to admission into the 
study.
Rationale for the Inclusion Criteria:
1, 2
To select the adequate subject population
3
The impact of risankizumab on pregnancy and reproduction is unknown
4
In accordance with harmonized Good Clinical Practice (GCP)
5.2.2
Exclusion Criteria
A subject will not be eligible for study participation if he/she meets any of the following 
criteria:
1.
Premature discontinuation for any reason in the preceding study.
2.
Subjects who have developed guttate, erythrodermic, pustular or drug-induced 
psoriasis as diagnosed by the investigator during the preceding study.
3.
Use of any prohibited medication as specified in Section 5.2.3.1 or any drug 
considered likely to interfere with the safe conduct of the study, as assessed by the 
investigator.
4.
Known tuberculosis (TB) or evidence of TB infection.  Subjects with a positive 
QuantiFERON® TB test or a positive purified protein derivate (PPD) skin test 
result may participate in the study if further work up (according to local 
practice/guidelines) establishes conclusively that the subject has no evidence of 
active TB.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
24
5.
Subjects who have developed active or suspected malignancy during the preceding
study, except appropriately treated basal cell or squamous cell carcinoma of the 
skin or in situ carcinoma of uterine cervix.
6.
Subjects who have laboratory evidence of Human Immunodeficiency Virus (HIV), 
hepatitis B or hepatitis C viral infection from laboratory testing within the 
preceding clinical trial or any other source.
7.
Evidence of a current or previous disease, medical condition (including chronic 
alcohol or drug abuse) other than psoriasis, surgical procedure (i.e., organ 
transplant), medical examination finding (including vital signs and ECG), or 
laboratory value outside the reference range that in the opinion of the investigator 
is clinically significant and would make the study participant unreliable to adhere 
to the protocol or to complete the study, compromise the safety of the subject, or 
compromise the quality of the data.
8.
History of allergy/hypersensitivity to a systemically administered biologic agent or 
its excipients.
9.
Previous enrollment in this study.
10.
Female subject who is pregnant, breastfeeding or is considering becoming pregnant 
during the study or within 20 weeks after the last dose of study drug.
11.
Time elapsed is > 8 weeks since the completion visit in the preceding study.
12.
Subject is considered by the investigator for any reason, to be an unsuitable 
candidate for the study and not able to comply with the study protocol.
Rationale for Exclusion Criteria:
10
The impact of risankizumab on pregnancy and reproduction is 
unknown
1, 7, 9, 11
To select the adequate subject population
2, 3, 4, 5, 6, 8, 12
To ensure the safety of the subjects throughout the study
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
25
5.2.3
Prior and Concomitant Therapy
Any medication or vaccine (including over-the-counter or prescription medicines, 
vitamins and/or herbal supplements) that the subject is receiving at the time of enrollment, 
or receives during the study, must be recorded along with the reason for use, date(s) of 
administration including start and end dates, and dosage information including dose, route 
and frequency on the appropriate electronic case report form (eCRF).
The AbbVie primary Therapeutic Area Medical Director (TA MD) identified in 
Section 6.1.5 should be contacted if there are any questions regarding concomitant or 
prior therapy(ies).
COVID-19 Pandemic-Related Vaccination Guidance
Non-live vaccines may be administered during screening or treatment period, if not 
contraindicated or medically inappropriate.  
The potential impact of risankizumab on SARS-CoV-2 vaccination is unknown. The 
decision to receive a locally available vaccine should be based on local guidance and an 
individual discussion between the treating physician and the subject and/or guardian.
Any SARS-CoV-2 vaccine information must be documented on the COVID-19 vaccine 
eCRF.  
5.2.3.1
Prohibited Therapy
Use of the following therapies are prohibited from administration of the first dose of study 
drug in the preceding study throughout the EOT visit of Study M15-997, including any 
gap between the preceding study and Study M15-997:
●
Investigational devices or products
●
anti-IL-12/23, and anti-IL-17 agents, including but not limited to guselkumab, 
tildrakizumab, ustekinumab, ixekizumab and secukinumab; only comparator 
drug use in previous study is allowed for ustekinumab
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
26
●
TNF inhibitors; only comparator drug use in preceding study is allowed for 
Adalimumab (Humira®)
●
Topical treatment for psoriasis or any other skin condition such as retinoids, 
vitamin D analogues, vitamin A analogs, anthralin and steroids.  Exception:  
Lower potency topical steroids such as alclometasone dipropionate cream, 
ointment 0.05, desonide cream, gel, foam, ointment 0.05, fluocinolone 
acetonide cream, solution 0.01, dexamethasone cream 0.1, hydrocortisone 
cream, lotion, ointment, solution 0.25, 0.5, 1, or hydrocortisone acetate cream, 
ointment 0.5 - 1 may be used for limited period of time defined as 
approximately 6 weeks without removing subjects from the study with a 
restriction of use within 24 hours prior to study visit.
●
Systemic immunomodulating medications including methotrexate (MTX), 
cyclosporine A and corticosteroids except steroids with only a topical effect 
(e.g., inhalative corticosteroids to treat asthma or drops used in the eye or ear)
●
Systemic psoriasis medications including retinoids and fumarates, or any other 
drugs known to possibly benefit psoriasis
●
Photochemotherapy (e.g., PUVA)
●
Phototherapy (e.g., UVA, UVB, Ultra Violet A/B)
●
Live vaccines (Live vaccines are not permitted up to 20 weeks after the last 
dose of study drug).
The AbbVie TA MD should be contacted if there are any questions regarding prohibited 
therapy. 
5.2.4
Contraception Recommendations and Pregnancy Testing
Female subjects of childbearing potential must be ready and able to use highly effective 
methods of birth control per International Conference on Harmonization (ICH) M3(R2) 
that result in a low failure rate of less than 1% per year when used consistently and 
correctly.  Or subjects must have only vasectomized sexual partner(s) (vasectomy at least 
1 year prior to enrolment), or be abstinent throughout the study for at least 20 weeks after 
the last dose of study drug is given.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
27
Women of childbearing potential are defined as:
●
having experienced menarche and are
●
not postmenopausal (12 months with no menses without an alternative medical 
cause) and are
●
not permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral 
oophorectomy or bilateral salpingectomy).
The following is a list of accepted contraception methods. 
●
Combined (estrogen and progestogen containing) hormonal contraception 
(oral, intravaginal, transdermal, injectable) associated with the inhibition of 
ovulation, initiated at least 1 month prior to Study Day 1.
●
Progestogen-only hormonal contraception (oral, injectable, implantable) 
associated with inhibition of ovulation, initiated at least 1 month prior to Study 
Day 1.
●
Bilateral tubal occlusion/ligation (can be via hysteroscopy, provided a 
hysterosalpingogram confirms success of the procedure).
●
Vasectomized partner(s), provided the vasectomized partner has received 
medical assessment of the surgical success and is the sole sexual partner of the 
WOCBP trial participant.
●
Intrauterine device (IUD).
●
Intrauterine hormone-releasing system (IUS).
●
True abstinence:  Refraining from heterosexual intercourse when this is in line 
with the preferred and usual lifestyle of the subject (periodic abstinence] 
e.g., calendar, ovulation, symptothermal, post-ovulation methods] and 
withdrawal are not acceptable).
See Pregnancy Testing paragraph in Section 5.3.1.1 for pregnancy testing instructions.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
28
5.3
Efficacy, Pharmacokinetic and Safety 
Assessments/Variables
5.3.1
Efficacy and Safety Measurements Assessed
Study procedures will be performed at the study visits as specified in Appendix C.  Study 
visits are scheduled E12W, starting from Baseline (Week 0) until Week 156 and E24W 
from Week 156 until the EOT visit.  Study procedures are discussed in detail in this 
section, with the exception of drug concentration measurements and antibody 
measurements (discussed in Section 5.3.2), study drug administration (discussed in 
Section 5.5.1), and the collection of AE information (discussed in Section 6.1.5).  All 
study data will be recorded in source documents and on the appropriate eCRFs.
5.3.1.1
Study Procedures
During the COVID-19 pandemic, if it is not possible for all study procedures to be 
performed as specified due to logistical restrictions or other reasons, the following 
modifications are allowed:
●
If permitted by local regulations, the IRB/IEC and the subject, the visits may 
be conducted in the subject's home.
●
If a subject is unable to go to the site for a study visit, a phone call/virtual visit 
from the site should be completed as close as possible to the planned date of 
the study visit.  The phone call will query for any AEs and review concomitant 
medications.  If possible, complete DLQI assessment.  An on-site study visit to 
complete the missed study procedures, including study drug administration, 
should be scheduled as soon as feasible.
●
If a subject is unable to come to the site for a study visit, a direct-to-patient 
(DTP) study drug shipment can be made from the study site to the subject if 
allowed by local regulations and if the subject has been trained for self-
injection.  For more information, please refer to Section 5.5.4.
●
If for any reason laboratory samples cannot be shipped to the central 
laboratory, a local laboratory may be used for routine assessment.  Local 
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
29
laboratory results should be reviewed by the Investigator as soon as possible.  
Local labs should be added to the Unscheduled local lab eCRF.
Informed Consent
The subject will sign and date a study specific, Independent Ethics Committee 
(IEC)/Institutional Review Board (IRB) approved, informed consent form before any 
study specific procedures are performed in order to participate in this study.  Details 
regarding how informed consent will be obtained and documented are provided in 
Section 9.3.
Due to the COVID-19 pandemic, it is possible that additional protocol modifications not 
outlined in this protocol may become necessary.  If this situation arises, in addition to the 
study informed consent, additional verbal consent may be obtained prior to these 
adaptations or substantial changes in study conduct in accordance with local regulations.
Inclusion/Exclusion Criteria
Subject will be eligible for study enrollment if he/she meets all inclusion criteria and none 
of the exclusion criteria at Baseline.
Demographics
The subject's demographic data, including date of birth, gender, race, ethnicity, and 
disease status that has been collected at the screening visit of the preceding study will be 
used in Study M15-997, so does not need to be collected again.
Medical and Surgical History
Medical history collected in the preceding study will be used in Study M15-997.  Only 
new information and updates will need to be collected at the Study M15-997 Baseline 
Visit.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
30
Physical Examination
Symptom directed physical examination will be performed at visits as described in 
Appendix C.  Clinically relevant abnormal findings will be reported as medical history or 
AEs.
Vital Signs Assessment
Vital signs assessments include temperature, pulse rate, sitting blood pressure, and 
respiratory rate, after subjects have been seated comfortably for at least 5 minutes.
Measurement of vital signs must precede blood sampling and be assessed pre-dose at all 
dosing visits.
Additional vital signs assessments should be made 5 (± 2) minutes post-dose and 
60 (± 10) minutes post-dose at Visit 1 and Visit 2.
Body Weight 
Body weight measurements should be done on the same scale for each subject, as 
possible.  In order to get comparable body weight values, body weight measurements 
should be performed in the following manner:
●
after the urine sampling (body weight after bladder voiding)
●
shoes and coat/jackets should be taken off
●
pockets should be emptied of heavy objects (i.e., keys, coins etc.)
12-Lead Electrocardiogram (ECG) 
The 12-lead ECGs will be performed as scheduled in Appendix C. 
ECGs will be recorded after the subject has rested for at least 5 minutes in a supine 
position and will always precede blood sampling.  Six limb leads, as specified by 
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
31
Einthoven (I, II and III) and Goldberger (aVR, aVL, aVF), and six pre-cordial leads
(V1 – V6), according to Wilson, will be used.
ECGs may be repeated for quality reasons and the repeat used for analysis.  Additional 
ECGs may be collected for safety reasons.  Clinically relevant, abnormal findings will be 
reported as AEs. 
Dated and signed printouts will be stored in the subject's medical file.
In the event a scheduled ECG may not be performed due to study modifications related to 
the COVID-19 pandemic, perform the 12-lead ECG at the next earliest feasible visit or 
arrange to have an alternative acceptable local facility perform the ECG for the subject.
Psoriasis Area and Severity Index (PASI) Evaluation
The PASI score is an established measure of clinical efficacy for psoriasis medications.12  
If possible, the efficacy assessor from the preceding study should perform the efficacy 
assessments in this study.  If not possible, a qualified and delegated site staff member will 
perform the PASI assessment at the designated study visits identified in Appendix C. 
Information and instructions on the calculation of the PASI score are provided in 
Appendix E.
Static Physician Global Assessment (sPGA)
The sPGA is a 5 point score ranging from 0 to 4, based on the physician's assessment of 
the average thickness, erythema, and scaling of all psoriatic lesions.  If possible, the 
assessor from the preceding study should perform the efficacy assessments in this study.  
If not possible, a qualified and delegated site staff member will perform the sPGA 
assessment at the designated study visits identified in Appendix C.  Information and 
instructions on the calculation of the sPGA score are provided in Appendix F.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
32
Nail Psoriasis Severity Index (NAPSI)
The NAPSI assesses how much of the fingernail is affected with psoriasis.  If a subject 
has nail psoriasis, if possible, the assessor from the preceding study should perform this 
assessment in this study.  If not possible, a qualified and delegated site staff member will 
assess the nail psoriasis at the designated study visits identified in Appendix C.  Use of 
artificial nails and/or nail polish should be avoided for subjects with nail psoriasis 
throughout the study in order to ensure accuracy of assessments.  Information and 
instructions on the calculation of the NAPSI score are provided in Appendix G.
Palmoplantar Psoriasis Area and Severity Index (PPASI)
The PPASI provides a numeric scoring for psoriasis affecting the hands and feet.  It is a 
linear combination of percent of surface area of hands and feet that are affected and the 
severity of erythema, induration, and desquamation.
If a subject has palmoplantar psoriasis, if possible, the assessor from the preceding study 
should perform this assessment in this study.  If not possible, a qualified and delegated 
site staff member will assess the psoriasis at each protocol defined time point. 
Information and instructions on the calculation of the PPASI score are provided in 
Appendix H.
Psoriasis Scalp Severity Index (PSSI)
If a subject has scalp psoriasis, if possible, the assessor from the preceding study should 
perform this assessment in this study.  If not possible, a qualified and delegated site staff 
member will assess the erythema (redness), induration (hardness), desquamation 
(shedding of skin) and percent of scalp covered at each protocol defined time point. 
Information and instructions on the calculation of the PSSI score are provided in 
Appendix I.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
33
Dermatology Life Quality Index (DLQI)
DLQI is a self-administered, ten-question questionnaire used to assess the effect of 
different skin diseases on a subject's quality of life, overall health, and disability status.  
The questionnaire covers six domains including symptoms and feelings, daily activities, 
leisure, work and school, personal relationships and treatment and has a 1 week recall 
period.15  The questionnaire should be completed by the subject on his/her own.  A 
schedule of assessments for the DLQI is provided in Appendix C and instructions on the 
calculation of DLQI score are provided in Appendix J.
Due to the COVID-19 pandemic, subject visits may be conducted via phone or video 
conference.  In this situation, sites will read the DLQI questions and response options to 
the subject and record the subject's responses.  The subject's ability to view the DLQI to 
understand the questions and response options should be preserved.  Sites may share the 
questionnaire by videoconference or send the questionnaires (email or hard copy) to the 
subjects to allow them to read/understand the questions and responses when the subject is 
providing responses over the phone.  The date and time of DLQI data collection should be 
recorded along with who collected the information.
Pregnancy Testing
Urine pregnancy testing for all women of child-bearing potential will be conducted on-site 
at every study visit and must be negative to further treat the subject.  Additional serum 
pregnancy testing will occur in case of a positive urine test result at any of the visits.
Urine pregnancy self-testing for women of child-bearing potential will be required prior to 
self-injection of risankizumab at home at Weeks 168, 192, 216 and 240. If the result is 
positive, the injection should not be performed.
Females of non-childbearing potential (either postmenopausal or permanently surgically 
sterile as defined in Section 5.2.4) at Baseline in Study M15-997 do not require pregnancy 
testing.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
34
Laboratory Testing
Laboratory sample collection should be the last procedure prior to study drug 
administration.
A certified central laboratory will be utilized to process and provide results for the clinical 
laboratory tests.  Instructions regarding sample collection, sample handling/processing 
and sample shipping are provided in the Laboratory Manual.  Laboratory sampling will be 
done at each study visit as outlined in Appendix C.  The following clinical laboratory tests 
only need to be done at the Visit 5, Visit 10, Visit 14, Visit 16 and the EOT visit:  
Electrolytes, C-reactive protein, cholesterol, urinalysis, urine sediment and urine.  During 
these visits, the subject should be fasting for at least 8 hours prior to the blood sample 
being taken.  If a subject comes in non-fasted where a fasting condition is required, the 
visit should be performed, the non-fasted condition documented on the laboratory 
requisition, and the subject reminded about the expected conditions.
Laboratory results (i.e., all safety laboratory and clinical laboratory data relevant for 
current clinical practice) of the subjects will be available in real time to the respective 
investigator (via laboratory reports) and to the sponsor (via the central laboratory website) 
and selected abnormal laboratory alerts will be flagged to the site and sent to sponsor in 
real time.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
35
Table 1.
Clinical Laboratory Tests
Category
Test Name
Hematology
Hematocrit (Hct)
Hemoglobin (Hb)
Red blood cell count/Erythrocytes
Reticulocyte count
White blood cells/Leukocytes
Platelet count/Thrombocytes
Differential test automatic
Neutrophils (relative count)
Eosinophils (relative count)
Basophils (relative count)
Monocytes (relative count)
Lymphocytes (relative count)
Differential test manual (if differential 
test automatic is abnormal)
Neutrophils, bands (Stabs) 
Neutrophils, polymorphonuclear (PMN)
Eosinophils
Basophils
Monocytes
Lymphocytes
Coagulation
International Normalized Ratio (INR)a
Enzymes
AST (GOT)
ALT (GPT)
Alkaline phosphatase (AP)
Creatine kinase (CK)
CK-MB, only if CK is elevated
Gamma-glutamyl transferase (GGT/γ-GT)
Lactic dehydrogenase (LDH)
Amylase
Lipase
Electrolytes
Calcium
Sodium
Potassium
Chloride
Bicarbonate
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
36
Table 1.
Clinical Laboratory Tests (Continued)
Category
Test Name
Substrates
Glucose
BUN (blood urea nitrogen)
Uric acid
Creatinine
eGFR (estimated by CKD-EPI formula; for Japan)
Bilirubin total
Bilirubin direct (if total is elevated)
Bilirubin indirect (if total is elevated)
Troponin I (Reflex when CK is elevated)
Albumin
C-reactive protein (high sensitive)
Cholesterol, total
Triglycerides
LDL-cholesterol (calculated by Friedewald formula)
HDL-cholesterol
Urine pregnancy test (only for female 
subjects of childbearing potential)
Human chorionic gonadotropin in urine
Dipstick not performed at central laboratory
Serum pregnancy test (only for female 
subjects of childbearing potential if 
urine pregnancy test is positive)
Human serum chorionic gonadotropin (quantitative)
Urinalysis (dipstick)
Urine nitrite
Urine protein
Urine glucose
Urine ketone
Urobilinogen
Urine bilirubin
Urine RBC/Erythrocytes
Urine WBC/Leukocytes
Urine pH
Urine sediment (microscopic 
examination, only if urine analysis 
abnormal)
Urine sediment bacteria
Urine cast in sediment
Urine squamous epithelial cells
Urine sediment crystals, unspecified
Urine sediment RBC/Erythrocytes
Urine sediment WBC/Leucocytes
Urine
Urine albumin/creatinine ratio
Albumin (quantitative)
Urine creatinine (quantitative)
a.
INR test only performed if ALT or AST > 3 × ULN (upper limit of normal).
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
37
Clinically relevant abnormal findings will be reported as AEs.  A clinically relevant value 
may be either in- or outside the reference range.  Clinically relevant abnormal laboratory 
test results must be confirmed using an unscheduled visit laboratory kit and should be 
repeated until normalization or stabilization or until an alternative explanation has been 
found.
If logistical restrictions or other changes in local regulations in light of the COVID-19 
pandemic prevent the subject from having blood drawn for laboratory testing at the study 
site, if possible, arrange for subjects to have laboratory work done at a local lab, hospital, 
or other facility.  Local lab results should be obtained along with reference ranges and 
kept within the subjects' source documentation.  Local lab results should be reviewed by 
the investigator as soon as possible.
If laboratory samples cannot be obtained, study drug administration may be continued 
provided the investigator has reviewed all prior laboratory results and confirms and 
discusses with the subject that there is no safety concern for the subject to continue use of 
the study drug in the absence of current labs.  The subject should be scheduled for 
laboratory draws as soon as feasible.
Tuberculosis Testing
All subjects that had a negative TB test during the last testing in the preceding study or 
Study M15-997 will be tested for TB by either the QuantiFERON®-TB Gold Test (or 
equivalent) or a TB Skin Test (PPD) at the Visit 5, Visit 10, Visit 14, Visit 16 and EOT 
visit as specified in Appendix C.  If PPD and/or the QuantiFERON®-TB Gold test (or 
Interferon gamma release assay (IGRA) equivalent) is positive, or if there is a repeat 
indeterminate QuantiFERON®-TB Gold test (or IGRA equivalent) upon retesting, 
subjects may participate in the study if further work up (according to local 
practice/guidelines) establishes conclusively that the patient has no evidence of active 
tuberculosis.  If presence of latent tuberculosis is established, then tuberculosis 
prophylaxis should be pursued according to clinical judgment of investigator and local 
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
38
country guidelines.  It is also necessary to report a positive TB test as an adverse event in 
the source documents and eCRFs (AE and TB supplemental forms).
Monitoring Adverse Events
New AEs or unresolved AEs from the preceding study will be assessed at every study 
visit from the first dose of study drug at Baseline through the EOO visit.  Refer to 
Section 6.1.1.1 for additional information.
Prior and Concomitant Therapy Assessment
Any medication that the subject is receiving at the time of Baseline or receives during the 
study must be recorded on the source documents as well as the appropriate eCRF.  See 
Section 5.2.3 for full details regarding documentation of prior and concomitant therapy.
Local Tolerability Assessment
Local tolerability at the administration site of the previous s.c. injection will be assessed 
by the investigator or representative according to "swelling," "induration," "heat,"
"redness," "pain," or "other findings" at all dosing visits.  This assessment should be done 
pre-dose.  Any abnormal findings at the injection site will be reported as AEs.
Study Drug Administration
Until the Week 156 visit, and at visits Week 180, 204, 228, study medication will be 
administered at the study site in accordance with the protocol by authorized study 
personnel (e.g., study nurse) or optionally subjects can self-administer at the study site 
following successful completion of training and demonstration of adequate injection 
technique.
At Weeks 168, 192, 216 and 240, subjects will self-administer study medication at home.  
Alternatively, subjects may receive the injection of study drug of Weeks 168, 192, 216 
and 240 at the study site.  Injections will be given in an open label fashion with each 
subject receiving s.c. injections of risankizumab as two 75 mg (150 mg total) prefilled 
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
39
syringes at each dosing visit (every 12 weeks). Syringes will be administered as assigned 
by IRT.
Risankizumab will be administered as a s.c. injection in the abdomen, thigh or arm.  The 
two injections done subsequently should be at least 2 cm apart and should not be close to 
a vein.  The injection sites should avoid sites of psoriasis involvement as well as sites 
where the skin is tender, bruised, erythematous, or indurated, and should be alternated to 
other areas for subsequent doses.
Training on Self-Administration
At Visit Week 156, a site staff member will provide training to the subject and/or 
caregiver on how to administer the study drug using the PFS.  During this training, the 
subject and/or caregiver will be provided the IFU and proceed with self-injection under 
supervision of the observer.
Training will consist of the site staff member using a PFS for injection.  The site staff 
member will use the IFU to walk through all steps of injection with the subject.  The 
subject or caregiver will then repeat the steps using the same PFS to complete a self-
injection.
The subjects will be provided a dosing diary to record the date and time of the home-
injections.
Monitoring for Hypersensitivity Reactions
Subjects should be closely monitored for signs and symptoms of hypersensitivity for 
approximately 2 hours after administration of the first dose (Baseline visit) and 
approximately 1 hour after dose administration for all study visits thereafter.
While no concerns with systemic hypersensitivity have been identified with the use of 
risankizumab, the sponsor has established an independent, blinded, expert committee to 
adjudicate events of anaphylaxis based on pre-specified definition.  This independent 
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
40
external Anaphylaxis Adjudication Committee (AAC) will be adjudicating observed 
suspected anaphylactic reactions and will remain blinded to treatment allocation.  The 
events that are adjudicated and the adjudication process will be detailed in the 
Anaphylaxis Adjudication Committee Charter.  A supplemental 
Hypersensitivity/Anaphylactic reactions eCRF will be used to collect information 
pertinent to the events.  In addition, the site may be contacted for additional source 
documentation for relevant events.
In the event of a suspected systemic post-dose hypersensitivity reaction, a PK, ADA, and 
NAb sample should be collected once within 24 hours of the reaction.  In addition to PK, 
ADA and NAb assays, blood tests to be conducted in the event of a systemic 
hypersensitivity reaction are: 
●
Serum tryptase:  Optimally, measurement needs to be obtained from 
15 minutes to 3 hours of symptom onset, and no later than 6 hours (as tryptase 
may remain elevated for 6 or more hours after the onset and therefore may still 
be informative if obtained after 3 hours); it is also requested to collect a 
follow-up tryptase level a minimum of 2 weeks after the recorded event or at 
the next study visit
●
Plasma histamine: optimally, within 5 to 15 minutes of the onset of symptoms, 
and no later than 1 hour
Subjects will be given instructions regarding management of signs and symptoms of 
anaphylaxis to be followed during home dosing at Weeks 168, 192, 216 and 240.  
Hypersensitivity reactions should be treated according to medical standards.  Any events 
of hypersensitivity should be reported as an adverse event on the AE eCRF and 
additionally the supplemental hypersensitivity reaction eCRF should be completed.  
Pre-medications for further injections might be considered and will be agreed on between 
investigator and the AbbVie TA MD.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
41
5.3.2
Drug Concentration Measurements
5.3.2.1
Collection of Samples for Analysis
Blood Samples for Risankizumab Assay
Blood samples, approximately 3 mL, for risankizumab assay will be collected by 
venipuncture into appropriately labeled collection tubes at the time points specified in 
Appendix C.  Blood samples for the PK assay should be collected as closely as possible 
relative to the time of dosing and within 60 minutes prior to dosing.  Date and exact time 
(to the nearest minute) of drug administration and PK and anti-drug antibody (ADA) 
sampling will be recorded in the source documents.
Blood Samples for Risankizumab Anti-Drug Antibody (ADA) Assay
Blood samples, approximately 3 mL, for risankizumab ADA assay will be collected at the 
time points specified in Appendix C.  Blood samples for the ADA assay should be 
collected as closely as possible relative to the time of dosing and within 60 minutes prior 
to dosing.  Date and exact time (to the nearest minute) of drug administration and PK and 
ADA sampling will be recorded in the source documents.
The PK and ADA samples collected under previous protocol amendments may not be 
analyzed for PK and ADA per protocol Amendment 4 and 5.
After completion of the study, PK and ADA plasma samples may be used for further 
methodological investigations, e.g., stability testing.
5.3.2.2
Handling/Processing of Samples
Details for the handling and processing of the samples will be provided outside this 
protocol in the laboratory manual.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
42
5.3.2.3
Disposition of Samples
The frozen plasma samples for risankizumab and risankizumab ADA assays will be 
packed and shipped from the study site to the Central Laboratory according to instructions 
in the central laboratory manual.  An inventory of the samples included will accompany 
the package.
5.3.2.4
Measurement Methods
Plasma concentrations of risankizumab and relative titers of risankizumab ADA will be 
determined using validated methods under the supervision of the Bioanalysis department 
at AbbVie.  Any additional analytes may be analyzed using non-validated methods.  
Plasma samples collected for risankizumab and risankizumab ADA analysis may be used 
for future assay development or validation activities.
The presence of ADA to risankizumab will be assessed via a tiered approach using a 
validated electrochemiluminescence assay (screening, confirmatory, and titration analysis 
as appropriate).  Samples that are confirmed positive may be further characterized in a 
validated neutralizing antibody (NAb) assay.  The ADA samples collected under previous 
protocol amendments may not be analyzed for NAb per protocol Amendment 4. All 
immunogenicity samples drawn at the visits specified in Appendix C will be analyzed.
5.3.3
Efficacy Variables
5.3.3.1
Key Variables
Key variables to be summarized at all visits:
●
Proportion of subjects achieving PASI 90
●
Proportion of subjects achieving the sPGA score of clear or almost clear
●
Proportion of subjects achieving PASI 75
●
Proportion of subjects achieving PASI 100
●
Proportion of subjects achieving the sPGA score of clear
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
43
5.3.3.2
Additional Variables
●
Additional variables include proportion of subjects achieving ≥ 50% reduction 
in PASI score (PASI 50), absolute PASI of < 3, DLQI score of 0, DLQI score 
of 0 or 1, a reduction of at least 5 points in DLQI, as well as change and 
percent change from baseline in PASI, DLQI, NAPSI, PPASI, and PSSI.  
Summaries will be provided at all visits that the corresponding variables are 
evaluated.
5.3.4
Safety Variables
Safety will be assessed descriptively based on AEs, physical examination, vital signs, 
local tolerability and laboratory data during the entire study.
5.3.5
Pharmacokinetic Variables
Risankizumab plasma concentrations will be determined.  Descriptive statistics will be 
calculated for each sampling time (study visit).  The number and percentage of subjects 
with ADA will be calculated.  Additional analyses combining pharmacokinetic and ADA 
data from this study and other studies may be conducted if appropriate.
5.4
Removal of Subjects from Therapy or Assessment
5.4.1
Discontinuation of Individual Subjects
A subject may voluntarily withdraw from the study drug and/or study at any time.  
Subjects must be withdrawn from the study drug and/or study for reasons including, but 
not limited to, the following:  
●
The subject requests withdrawal from the study.
●
Inclusion and exclusion criteria violation was noted after the subject started 
study drug, when continuation of the study drug would place the subject at 
risk.
●
The subject becomes pregnant while on study drug.
●
Malignancy, except for localized NMSC or carcinoma in-situ of the cervix
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
44
●
The investigator believes it is in the best interest of the subject.
●
Subject is significantly noncompliant with study procedures, which would put 
the subject at risk for continued participation in the trial.
●
Clinically significant abnormal laboratory results or AEs, which rule out 
continuation of the study drug, as determined by the investigator or the 
AbbVie Therapeutic Area Medical Director.
●
Post-Baseline occurrence of one or more of the following hepatic test 
abnormalities (confirmed on a second separate sample at least 48 hours apart):
○
ALT or AST > 8 × ULN
○
ALT or AST > 5 × ULN for more than 2 weeks
○
ALT or AST > 3 × ULN and (TBL > 2 × ULN or INR > 1.5)
○
ALT or AST > 3 × ULN with the appearance of fatigue, nausea, vomiting, 
right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia 
(> 5%)
●
If prohibited medication is used during the study for any indication, the subject 
must discontinue the use of the prohibited medication if he/she wants to 
continue on study drug.  In case of undue safety risk for the subject, the subject 
should discontinue study drug at the discretion of the investigator.
●
If the subject received a live virus vaccination during the study, the subject 
must discontinue study drug.
●
If the subject develops laboratory evidence of or is known to be infected with 
HIV, hepatitis B or hepatitis C, the subject must be discontinued from the 
study drug and undergo early EOT Visit activities.  Additionally, all subjects 
who develop laboratory evidence of infection with HIV, hepatitis B or 
hepatitis C must be referred to an appropriate clinician for management of 
their viral infection according to medical standards.
●
Subject develops active TB at any time during the study.
●
If the subject experiences an intolerable increase of psoriasis during the course 
of the study the subject will be discontinued from the study drug to receive 
rescue treatment as deemed appropriate by the investigator.
●
If the subject experiences a serious infection, the study drug should be held 
until the infection is resolved or stabilized.  The study drug dosing visit could 
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
45
be postponed such that the study drug of the following visit will not be 
administered within 14 days.  If the subject has not received study drug due to 
this serious infection for at least 24 weeks, the subject will be permanently 
withdrawn from study drug.
If, during the course of study drug administration, the subject prematurely discontinues 
study drug use, the subject has the option to continue in the study and complete the 
remaining visits as scheduled.  If remaining visits will be completed, an early EOT visit is 
not required.  If the subject does not continue in the study, the procedures outlined for the 
early EOT visit must be completed, ideally within 2 weeks of the decision and preferably 
prior to the initiation of another therapy.  However, these procedures should not interfere 
with the initiation of any new treatments or therapeutic modalities that the Investigator 
feels are necessary to treat the subject's condition.  For subjects that prematurely 
discontinue, study drug will not be given at the early EOT visit and subjects should have 
the telephonic EOO visit, 20 weeks after their last administered dose of study drug to 
determine the status of any ongoing AEs/SAEs or the occurrence of any new AEs/SAEs.
Following discontinuation of the study drug, the subject will be treated in accordance with 
the Investigator's best clinical judgment.
All attempts must be made to determine the primary reason for premature discontinuation.  
The information will be recorded on the appropriate eCRF page.
For subjects that are considered lost to follow-up, reasonable attempts must be made to 
obtain information on the final status of the subject.  At a minimum, two phone calls must 
be made and one certified letter must be sent and documented in the subject's source 
documentation.
Interruption/Discontinuation of Study Drug Due to COVID-19 
For subjects with documented COVID-19, the timing of next administration of study drug 
or possibility of premature discontinuation from study drug should be discussed with the 
AbbVie Medical Contact. 
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
46
5.4.2
Discontinuation of Entire Study
AbbVie may terminate this study prematurely, either in its entirety or at any study site, for 
reasonable cause provided that written notice is submitted in advance of the intended 
termination.  The investigator may also terminate the study at his/her site for reasonable 
cause, after providing written notice to AbbVie in advance of the intended termination.  
Advance notice is not required by either party if the study is stopped due to safety 
concerns.  If AbbVie terminates the study for safety reasons, AbbVie will immediately 
notify the investigator by telephone and subsequently provide written instructions for 
study termination.
5.5
Treatments
5.5.1
Treatments Administered
All subjects will receive s.c. injections of risankizumab as two 75 mg (150 mg total) 
pre-filled syringes every 12 weeks.
5.5.2
Identity of Investigational Product (IP)
Information about the risankizumab formulation to be used in this study is presented in 
Table 2.
Risankizumab supplies will be provided by Boehringer Ingelheim Pharma GmbH & Co 
KG, Biberach, Germany.
●
Risankizumab (ABBV-066) 75 mg/0.83 mL Solution for Injection Pre-filled 
Syringe
Risankizumab is presented in a 1 mL pre-filled syringe with 0.87 mL of solution for 
injection.  Dispensed volume is 0.83 mL.  The solution in the risankizumab syringes has a 
concentration of 90 mg/mL, to deliver 75 mg per syringe.  Two (2) syringes will be used 
to achieve the 150 mg dose.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
47
Table 2.
Identity of Investigational Product
Study Drug
Dosage Form
Strength
Route of 
Administration
Manufacturer
Risankizumab 
(ABBV-066)
Solution for 
injection in pre-
filled syringe
75 mg/0.83 mL
Subcutaneous 
injection
Boehringer 
Ingelheim Pharma 
GmbH & Co. KG
5.5.2.1
Packaging and Labeling
Study drug packaged in 75 mg pre-filled syringes will be provided in open-label fashion 
and packaged in cartons containing one (1) syringe per carton.  Each kit will be labeled as 
required per local requirements.  The number identifying the kits dispensed will be 
managed by the IRT.
All labels must remain affixed to the study drug at all times and should never be removed 
for any reason.
5.5.2.2
Storage and Disposition of Study Drug
Risankizumab kits will be kept protected from light in their original packaging, in a 
refrigerator between 2°C to 8°C (36°F to 46°F), and within a secure limited access storage 
area, and in accordance with the recommended storage conditions on the label.  Study 
drug must not be frozen at any time.  A temperature log must be maintained for 
documentation.
All clinical supplies must be stored and locked in a secure place until they are dispensed 
for subject use or are returned to AbbVie.
Upon receipt of study drugs, the site will acknowledge receipt within the IRT system.
At Visits Week 156, 180, 204 and 228, subjects will be provided with a cooler bag and ice 
pack to maintain adequate storage temperature of the study drug kits during transport from 
the clinical site to their home. Subjects will need to store study kits in the refrigerator 
between 2°C to 8°C (36°F to 46°F). Subjects will also receive a tote and sharps container 
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
48
at Visit Weeks 156, 180, 204 and 228 to safely transport the used PFS back to the study 
site at Visits Week 180, 204, 228 and EOT. Biohazard bags will also be provided in case 
of a product complaint.
5.5.3
Method of Assigning Subjects to Treatment Groups
This is an open-label study.  The treatment is the same for all subjects so there is no 
assignment of subjects to treatment groups.
5.5.4
Selection and Timing of Dose for Each Subject
An IRT will be used to allocate study drug to subjects.  At visits where study drug is to be 
administered, study sites will be required to complete the study drug resupply module in 
the IRT to receive assigned study drug/kit numbers.  Details regarding the use of the IRT 
are described in the site-user manual.
Study drug will be administered at the study site by authorized study personnel 
(e.g., study nurse).  Optionally subjects are allowed to self-administer the study drug at 
the study site following completion of training and successful demonstration of self-
injection.
Once subjects and/or caregivers are trained to self-administer study drug at the 
investigative site at the visit Week 156, risankizumab will be self-administered by the 
subject or caregiver at home starting at the visit Week 168, and thereafter according to the 
schedule as outlined in Appendix C.
Alternatively, subjects may receive the injection of study drug of Weeks 168, 192, 216 
and 240 at the study site. Dose modifications or adjustments are not permitted.  In 
exceptional cases of missed or delayed visits, study drug of the following visit should not 
be administered within 14 days of the prior dose.  There should be at least 14 days 
between two consecutive study drug administrations.
If a subject is unable to come to the study site for a study visit due to COVID-19, a direct-
to-patient (DTP) study drug shipment can be made from the study site to the subject if 
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
49
allowed by local regulations and if the subject has been trained for self-injection.  AbbVie 
will submit any required notifications to the regulatory authority as applicable. 
Study drug may be shipped from the study site directly to the subject's home if all the 
following criteria are met:
●
Direct-to-patient (DTP) shipment of study drug is allowed by local regulations 
and the relevant ethics committee
●
Study drug can be administered by the subject (or subject's caregiver) at home
●
Subject agrees to have the study drug shipped directly to their home
○
Shipments may also include other study supplies (e.g., home pregnancy 
test, drug dosing diaries, paper copies of DLQI).  Instructions will be 
provided by AbbVie as to how a study site can initiate a DTP shipment 
using Marken, a global vendor selected by AbbVie to provide this service 
when necessary.  Shipments of study drugs from the study site to a 
subject's home will be appropriately temperature controlled (qualified 
shipper or temperature monitoring) within the labeled storage conditions.  
Signature is required upon delivery; due to COVID-19 related social 
distancing, this may be provided by the courier after delivery.  
Documentation of the shipment is to be retained by the clinical site.
○
AbbVie will not receive subject identifying information related to these 
shipments, as the site will work directly with the courier.
The study site is responsible for meeting IRB/IEC reporting requirements related to DTP 
shipments of study drug, and for obtaining consent to provide delivery information to the 
courier and documenting this consent in source documents.
5.5.5
Treatment Compliance
The investigator or his/her designated and qualified representatives will administer study 
drug only to subjects enrolled in the study in accordance with the protocol.  The study 
drug must not be used for reasons other than that described in the protocol.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
50
In order to document compliance with the treatment regimen, the injection dates and times 
of the administrations done at site should be documented on the source documents. The 
injection dates and times of the home-administrations should be documented in the dosing 
diary.  Female subjects of child-bearing potential are asked to also report the outcome of 
the urine pregnancy tests prior to home-administration on the dosing diary.
5.5.6
Drug Accountability
The investigator or representative will verify that study drug supplies are received intact at 
the appropriate temperature (temperature recording devices [e.g., TempTales] are 
provided in the shipments), and in the correct amounts from the drug depot.
This will be documented by signing and dating the Proof of Receipt (POR) or similar 
document included with each drug shipment, and via direct reporting in the IRT.  The 
original POR note or similar document will be kept in the site files as a record of what 
was received.
IRT will be used to keep an accurate running inventory of study drug, and will include the 
kit number, lot number, subject number, the number of pre-filled syringes dispensed and 
the date study drug was assigned to each subject.
All empty Investigational Product (IP) boxes and used pre-filled syringes will be 
inventoried by the site.  Each site will be given their own sharps disposal container to 
store used pre-filled syringes.
At Visits Week 180, 204, 228 and EOT, site personnel will review the dosing diary, 
review returned used PFS in the provided sharps container, and empty study drug 
packaging to verify compliance of the study drug administration of the Weeks 168, 192, 
216 and 240 visit at home.
An overall accountability of the study drug will be performed by the site and verified by 
an AbbVie monitor throughout the study and at the site close-out visit.  Used syringes 
must be destroyed at the site according to local regulations governing biohazardous waste.  
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
51
Destruction of used study supplies must be documented.  All unused supplies must be 
inventoried, accounted for and destroyed on site according to local procedures or 
regulation or returned to a destruction facility by the AbbVie Monitor.  A copy of the 
Drug Accountability Form, in accordance with instructions provided by the AbbVie 
Monitor, will be included in the return shipments.
5.6
Discussion and Justification of Study Design
5.6.1
Discussion of Study Design and Choice of Control Groups
The primary objective of Study M15-997 is to investigate long-term safety and tolerability 
of risankizumab 150 mg E12W in subjects with psoriasis who have completed one of the 
preceding Phase 2/3 studies.
The secondary objective of Study M15-997 is to investigate the long-term efficacy of 
risankizumab in the treatment of psoriasis.
Safety and efficacy measurements will be collected at each visit.  Study design is 
consistent with current standards investigating long-term safety and maintenance of 
efficacy of novel treatment in psoriasis.
5.6.2
Appropriateness of Measurements
Standard statistical, clinical, and laboratory procedures will be utilized in this study.  The 
main clinical efficacy measurements used in this study (PASI and sPGA) have been used 
in multiple pivotal clinical studies in assessing disease activity in subjects with psoriasis.  
All clinical and laboratory procedures in this study are standard and generally accepted.
5.6.3
Suitability of Subject Population
Subjects with moderately to severely chronic plaque psoriasis who have completed one of 
the preceding Studies 1311.3, 1311.4, 1311.13, 1311.28, 1311.30, 1311.38 and M16-178, 
who meet all inclusion criteria and none of the exclusion criteria are eligible for this 
study.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
52
This study will provide an opportunity for subjects that completed any of the preceding 
studies to have extended access to an active therapy until risankizumab is approved and 
available on the market in the subject's country.
5.6.4
Selection of Doses in the Study
Risankizumab is currently in Phase 3 development for treatment of subjects with 
moderate to severe chronic plaque psoriasis.  Four Phase 3 studies are currently ongoing, 
planning to enroll approximately 2100 subjects, and evaluating risankizumab dose of 
150 mg administered at Week 0, 4 and thereafter E12W.  Subjects from these ongoing 
Phase 3 studies will enter in the current study.  Hence, the 150 mg dose administered 
E12W is selected for this study, so the subjects will continue to receive the same dose as 
in preceding Phase 3 studies to establish the long-term safety and efficacy of 
risankizumab. In Japanese Phase 2/3 Protocol 1311.38 some subjects (N = 56) will be 
treated with risankizumab 75 mg E12W dose.  As risankizumab has been well tolerated in 
the completed and ongoing studies, and based on preliminary PK results indicating no 
clinically meaningful difference in exposure between Japanese and Caucasian subjects, 
(approximately 30% higher exposure in Japanese subjects compared to Caucasian 
subjects) AbbVie considers it appropriate to investigate 150 mg E12W dosing paradigm 
in these Japanese subjects.
Subjects currently enrolled in BI clinical Trial 1311.13 will also be offered the 
opportunity to continue receiving treatment for chronic plaque psoriasis with 
risankizumab in Study M15-997.  One-hundred and ten subjects were enrolled in this trial
and were treated with risankizumab 90 mg SC E12W with the option to increase the dose 
to 180 mg if there was evidence of lack of response. 
Preliminary results from the pivotal Phase 3 studies support the clinical benefit of the 
150 mg dose of risankizumab in subjects with moderate to severe plaque psoriasis.  
Approximately 1300 subjects received treatment with risankizumab 150 mg SC and all 
four pivotal trials achieved their co-primary endpoints which were defined as achievement 
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
53
of ≥ 90% reduction from baseline PASI score (PASI 90) at Week 16 and achievement of a 
sPGA score of clear or almost clear at Week 16.
Subjects treated with risankizumab experienced substantial skin clearance and clinical 
improvement in the extent and severity of plaque.  Across the four pivotal studies, the 
proportion of subjects with PASI 90, sPGA score of clear or almost clear, and PASI 100 
at Week 16 ranged from 72 – 75%, 84 – 88%, and 36 – 51%, respectively.
In these studies, risankizumab was superior to placebo, ustekinumab, and adalimumab as 
demonstrated by statistically significant differences between groups in favor of 
risankizumab in the proportions of subjects who achieved PASI 90 and sPGA clear or 
almost clear at Week 16.  Risankizumab's superiority to ustekinumab was maintained up 
to 52 weeks.  Risankizumab was well tolerated and had a similar safety profile to placebo, 
ustekinumab, and adalimumab.
Treatment with the risankizumab regimen of 150 mg SC 150 mg E12W is thus supported 
by pharmacokinetic/pharmacodynamic modeling of Phase 1 and Phase 2 data which 
indicate near-maximal efficacy would be attained and maintained with the 150 mg 
risankizumab dose and the robust Phase 3 clinical data in approximate 1300 subjects 
demonstrating clinical efficacy and safety of risankizumab compared to placebo and 
existing therapies.
Therefore subjects who have been receiving treatment with risankizumab 150 mg SC as 
well as those subjects receiving other doses of risankizumab are expected to receive 
clinical benefit from either continuing or switching to a dosing regimen of risankizumab 
150 mg SC E12W.
In this study the 150 mg dose will be administered as two prefilled syringes of 75 mg 
active drug each, as the 150 mg/mL formulation of risankizumab is still being developed.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
54
6.0
Complaints
A complaint is any written, electronic, or oral communication that alleges deficiencies 
related to the physical characteristics, identity, quality, purity, potency, durability, 
reliability, safety, effectiveness, or performance of a product/device after it is released for 
distribution.
The investigational product in this study contains both:
●
Biologic compound and
●
Device component (pre-filled syringe).
Complaints associated with any component of this investigational product must be 
reported to the Sponsor (Section 6.2.2).  For AEs, please refer to Sections 6.1 through 
6.1.6.  For product complaints, please refer to Section 6.2.
6.1
Medical Complaints
The investigator will monitor each subject for clinical and laboratory evidence of AEs on 
a routine basis throughout the study.  The investigator will assess and record any AE in 
detail including the date of onset, event diagnosis (if known) or sign/symptom, severity, 
time course (end date, ongoing, intermittent), relationship of the AE to study drug, and 
any action(s) taken.  For SAEs considered as having "no reasonable possibility" of being 
associated with study drug, the investigator will provide an 'Other' cause of the event.  For 
AEs to be considered intermittent, the events must be of similar nature and severity.  AEs, 
whether in response to a query, observed by site personnel, or reported spontaneously by 
the subject will be recorded.
All AEs will be followed to a satisfactory conclusion.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
55
6.1.1
Definitions
6.1.1.1
Adverse Event
An adverse event (AE) is defined as any untoward medical occurrence in a patient or 
clinical investigation subject administered a pharmaceutical product and which does not 
necessarily have a causal relationship with this treatment.  An AE can, therefore, be any 
unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or 
disease temporally associated with the use of a medicinal (investigational) product, 
whether or not the event is considered causally related to the use of the product.
Such an event can result from use of the drug as stipulated in protocol or labeling, as well 
as from accidental or intentional overdose, drug abuse, or drug withdrawal.  Any 
worsening of a pre-existing condition or illness is considered an AE.  Worsening in 
severity of a reported AE should be reported as a new AE.  Laboratory abnormalities and 
changes in vital signs are considered to be AEs only if they result in discontinuation from 
the study, necessitate therapeutic medical intervention, and/or if the investigator considers 
them to be AEs.
An elective surgery/procedure scheduled to occur during a study will not be considered an 
AE if the surgery/procedure is being performed for a pre-existing condition and/or the 
surgery/procedure has been pre-planned prior to study entry.  However, if the pre-existing 
condition deteriorates unexpectedly during the study (e.g., surgery performed earlier than 
planned), then the deterioration of the condition for which the elective surgery/procedure 
is being done will be considered an AE.
Prior to use, every attempt should be made to contact the AbbVie TA MD for direction on 
re-introduction of study drug therapy after prohibited medication administration.
6.1.1.2
Serious Adverse Events
If an AE meets any of the following criteria, it is to be reported to AbbVie as a serious 
adverse event (SAE) within 24 hours of the site being made aware of the SAE.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
56
Death of Subject
An event that results in the death of a subject.
Life-Threatening
An event that, in the opinion of the investigator, would have 
resulted in immediate fatality if medical intervention had 
not been taken.  This does not include an event that would 
have been fatal if it had occurred in a more severe form.
Hospitalization or 
Prolongation of 
Hospitalization
An event that results in an admission to the hospital for any 
length of time or prolongs the subject's hospital stay.  This 
does not include an emergency room visit or admission to 
an outpatient facility.
Congenital Anomaly
An anomaly detected at or after birth, or any anomaly that 
results in fetal loss.
Persistent or 
Significant 
Disability/Incapacity
An event that results in a condition that substantially 
interferes with the activities of daily living of a study 
subject.  Disability is not intended to include experiences of 
relatively minor medical significance such as headache, 
nausea, vomiting, diarrhea, influenza, and accidental trauma 
(e.g., sprained ankle).
Important Medical 
Event Requiring 
Medical or Surgical 
Intervention to 
Prevent Serious 
Outcome
An important medical event that may not be immediately 
life-threatening or result in death or hospitalization, but 
based on medical judgment may jeopardize the subject and 
may require medical or surgical intervention to prevent any 
of the outcomes listed above (i.e., death of subject, 
life-threatening, hospitalization, prolongation of 
hospitalization, congenital anomaly, or persistent or 
significant disability/incapacity).  Additionally, any elective 
or spontaneous abortion or stillbirth is considered an 
important medical event.  Examples of such events include 
allergic bronchospasm requiring intensive treatment in an 
emergency room or at home, blood dyscrasias or 
convulsions that do not result in inpatient hospitalization, or 
the development of drug dependency or drug abuse.
For SAEs with the outcome of death, the date and cause of death will be recorded on the 
appropriate case report form.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
57
6.1.1.3
Adverse Events of Special Interest
The term AESI relates to any specific AE that has been identified at the compound level
as being of particular interest for prospective safety monitoring and safety assessment 
within this study, e.g., the potential for AEs based on knowledge from other compounds 
in the same class.  Ongoing evaluation of adverse events may identify future AESI.
The following are considered as AESI:
Hepatic Injury
A hepatic injury is defined by the following alterations of hepatic laboratory parameters:
●
an elevation of AST and/or ALT > 3-fold ULN combined with an elevation of 
total bilirubin > 2-fold ULN measured in the same blood draw sample, and/or
●
marked peak aminotransferase (ALT, and/or AST) elevations ≥ 8-fold ULN.
These lab findings constitute a hepatic injury alert and the subjects showing these lab 
abnormalities need to be followed up according to instructions from the sponsor including 
completion of the adverse event and supplemental hepatic eCRFs.
The supplemental hepatic eCRFs will also need to be completed for any hepatic related 
AE leading to discontinuation or interruption of study drug or any hepatic related SAE, 
not meeting the hepatic injury definition. 
In case of clinical symptoms of hepatic injury (icterus, unexplained encephalopathy, 
unexplained coagulopathy, right upper quadrant abdominal pain, etc.) without lab results 
(ALT, AST, total bilirubin) available, the investigator should make sure these parameters 
are analyzed, if necessary with an unscheduled blood test.  Should the results meet the 
criteria of hepatic injury alert, investigators are advised to provide a hepatic workup as 
directed by the patient's clinical presentation.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
58
6.1.2
Adverse Event Severity
Intensity of Adverse Events
The intensity grading of AEs will be performed according to Rheumatology Common 
Toxicity Criteria (RCTC) Version 2.0 developed by OMERACT.14  Refer to the 
Investigator Site File (ISF) for intensity/severity classification.  Intensity options are:
Grade 1
mild
Grade 2
moderate
Grade 3
severe
Grade 4
life-threatening
6.1.3
Relationship to Study Drug
The investigator will use the following definitions to assess the relationship of the AE to 
the use of study drug:
Reasonable 
Possibility
After consideration of factors including timing of the event, biologic 
plausibility, clinical judgment, and potential alternative causes, there 
is sufficient evidence (information) to suggest a causal relationship.
No Reasonable 
Possibility
After consideration of factors including timing of the event, biologic 
plausibility, clinical judgment, and potential alternative causes, there 
is insufficient evidence (information) to suggest a causal 
relationship
For causality assessments, events assessed as having a reasonable possibility of being 
related to the study drug will be considered "associated."  Events assessed as having no 
reasonable possibility of being related to study drug will be considered "not associated."  
In addition, when the investigator has not reported a causality or deemed it not assessable, 
AbbVie will consider the event associated.
If an investigator's opinion of no reasonable possibility of being related to study drug is 
given, an 'Other' cause of event must be provided by the investigator for the SAE.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
59
6.1.4
Adverse Event Collection Period
All AEs reported from the time of study drug administration until the End of Observation 
(EOO) visit will be collected, whether solicited or spontaneously reported by the subject.  
In addition, SAEs and protocol-related non-serious AEs will be collected from the time 
the subject signed the study-specific informed consent.
AE information will be collected as shown in Figure 2.
Figure 2.
Adverse Event Collection
6.1.5
Adverse Event Reporting
In the event of an SAE, whether associated with study drug or not, the Investigator will 
notify Clinical Pharmacovigilance within 24 hours of the site being made aware of the 
SAE event by entering the SAE data into the electronic data capture (EDC) system.  SAEs 
that occur prior to the site having access to the RAVE® system, or if RAVE is not 
operable, should be documented on the SAE Non-Case Report Form (CRF) and emailed 
(preferred route) or faxed to Clinical Pharmacovigilance within 24 hours of the site being 
made aware of the SAE.
Email:  PPDINDPharmacovigilance@abbvie.com
FAX to:  +1 (847) 938-0660
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
60
For safety concerns, contact the Immunology Safety Team at:
Immunology Clinical Trial Patient Safety Management
AbbVie Inc.
1 North Waukegan Road
Bldg. AP51-3
North Chicago, IL  60064-3537
USA
Contact Information:
Fax:
+1 (847) 785-8227
Safety Hotline:
+1 (847) 938-8737
Email:
GPRD_SafetyManagement_Immunology@Abbvie.com
For any subject safety concerns, please contact the physician listed below:
Primary Therapeutic Area Medical Director:
AbbVie
Immunology Clinical Development
1 North Waukegan Road
 
North Chicago, IL 60064 USA
Office:
Mobile:
Email:
In emergency situations involving study subjects when the primary TA MD is not 
available by phone, please contact the 24-hour AbbVie Medical Escalation Hotline where 
your call will be re-directed to a designated backup TA MD:
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
61
Phone:  +1 (973) 784-6402
The sponsor will be responsible for Suspected Unexpected Serious Adverse Reactions 
(SUSAR) reporting for the Investigational Medicinal Product (IMP) in accordance with 
Directive 2001/20/EC.  The reference document used for SUSAR reporting in the EU 
countries will be the most current version of the IB.
In Japan, the principal investigator will provide documentation of all SAEs to the Director 
of the investigative site and the Sponsor.
Supplemental study case report forms should be completed in the event of COVID-19 
related missed/virtual visits, study drug interruptions or discontinuations, or adverse 
events (including capture of specific signs/symptoms of infection and testing results).
COVID-19 infections should be captured as adverse events.  If the event meets the criteria 
for a serious adverse event (SAE), then follow the SAE reporting directions per the 
protocol and above.  The following COVID-19 related supplemental eCRFs should be 
completed (for both serious and non-serious events):
●
COVID-19 Supplemental Signs/Symptoms
●
COVID-19 Status Form
If a subject has a confirmed or suspected COVID-19 infection and study drug was 
interrupted, the investigator should contact the sponsor/emergency medical contact listed 
above before reintroducing study drug.
Reactions known to be associated with the SARS-CoV-2 vaccine should be reported as 
adverse events. If the event meets the criteria for an SAE, then follow the SAE reporting 
directions. All adverse events associated with the SARS-CoV-2 vaccine will be linked to 
the vaccine on the COVID-19 Vaccine eCRF.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
62
6.1.6
Pregnancy
Pregnancy in a study subject must be reported to AbbVie within 24 hours of the site 
becoming aware of the pregnancy.  Subjects who become pregnant during the study must 
be discontinued (Section 5.4.1).
Information regarding a pregnancy occurrence in a study subject and the outcome of the 
pregnancy will be collected.
Pregnancy in a study subject is not considered an AE.  The medical outcome for either 
mother or infant, meeting any serious criteria including an elective or spontaneous 
abortion, stillbirth or congenital anomaly is considered a SAE and must be reported to 
AbbVie within 24 hours of the site becoming aware of the event.
6.2
Product Complaint
6.2.1
Definition
A product complaint is any complaint (see Section 6.0 for the definition) related to the 
biologic or drug component of the product or to the medical device component.
For a product this may include, but is not limited to, damaged/broken product or 
packaging, product appearance whose color/markings do not match the labeling, labeling 
discrepancies/inadequacies in the labeling/instructions (example:  printing illegible), 
missing components/product, device not working properly, or packaging issues.
For medical devices, a product complaint also includes all deaths of a subject using the 
device, any illness, injury, or AE in the proximity of the device, an AE that could be a 
result of using the device, any event needing medical or surgical intervention including 
hospitalization while using the device and use errors.
Any information available to help in the determination of causality by the device to the 
events outlined directly above should be captured.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
63
6.2.2
Reporting
Product complaints concerning the investigational product and/or device must be reported 
to the Sponsor within one business day of the study site's knowledge of the event via the 
Product Complaint Form.  Product complaints occurring during the study will be 
followed-up to a satisfactory conclusion.  All follow-up information is to be reported to 
the Sponsor (or an authorized representative) and documented in source as required by the 
Sponsor.  Product complaints associated with AEs will be reported in the study summary.  
All other complaints will be monitored on an ongoing basis.
For product complaints occurring during home-administration subjects will be requested 
to contact the study site.
Product complaints may require return of the product with the alleged complaint condition 
(syringe).  In instances where a return is requested, every effort should be made by the 
investigator to return the product within 30 days.  If returns cannot be accommodated 
within 30 days, the site will need to provide justification and an estimated date of return.
The description of the complaint is important for AbbVie in order to enable AbbVie to 
investigate and determine if any corrective actions are required.
7.0
Protocol Deviations
AbbVie does not allow intentional/prospective deviations from the protocol unless when 
necessary to eliminate an immediate hazard to study subjects.  The principal investigator 
is responsible for complying with all protocol requirements, and applicable global and 
local laws regarding protocol deviations.  If a protocol deviation occurs (or is identified, 
including those that may be due to the COVID-19 pandemic) after a subject has been 
enrolled, the principal investigator is responsible for notifying IEC/IRB and regulatory 
authorities (as applicable), and the following AbbVie clinical monitor(s):
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
64
Primary Contact:
Study Project Manager II
Wegalaan 9
2132JD Hoofddorp
The Netherlands
Office:
Mobile:
Email:
Alternate Contact:
Program Lead I
1 North Waukegan Road
North Chicago, IL 60064
USA
Office:
Mobile:
Email:
Such contact must be made as soon as possible to permit a review by AbbVie to 
determine the impact of the deviation on the subject and/or the study.
8.0
Statistical Methods and Determination of Sample 
Size
8.1
Statistical and Analytical Plans
Safety and efficacy analysis will be performed on all subjects who received at least 
one dose of study drug in the OLE.  Key objective of the analysis is to investigate 
long-term safety and efficacy of risankizumab.  Additional objectives include but are not 
limited to investigating the safety and efficacy of risankizumab in subjects treated with 
ustekinumab, adalimumab, or participated in the randomized withdrawal/retreatment 
phase in the preceding Phase 2/3 studies.
Complete, specific details of the statistical analysis will be described and fully 
documented in the Statistical Analysis Plan (SAP).  The SAP will be finalized prior to the 
study database lock.
8.1.1
Analysis Populations
Subjects are required to have at least one dose of study drug in Study M15-997 to be 
included in the following populations.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
65
The following populations are to be used for efficacy analyses:
●
RZB Population:  consists of subjects who were randomized to risankizumab 
in Studies 1311.3, 1311.30, 1311.28, 1311.38 (150 mg arm only), and 
M16-178.  This population will be used to evaluate the long-term efficacy of 
risankizumab with loading dose. For subjects from Japan, data after the 
first dose of RZB from the preceding studies and prior to the start of 75 mg 
dose will be used for the analyses.
●
RZB_NL Population:  consists of subjects who were randomized to placebo in 
the initial study and continued to risankizumab (without loading dose) in 
Studies 1311.3, 1311.4, 1311.28, and 1311.38 (150 mg arm only).  This 
population will be used to evaluate the long-term efficacy of risankizumab 
without initial loading dose.  For subjects from Japan, data after the first dose 
of RZB from the preceding studies and prior to the start of 75 mg dose will be 
used for the analyses.
●
Retreatment Population:  consists of subjects who were re-randomized to 
placebo in Part B of Study 1311.4.  This population will be used to evaluate 
the efficacy of re-treatment after temporary withdrawal. For subjects from 
Japan, data after the re-treatment and prior to the start of 75 mg dose will be 
used for the analyses.
●
UST_RZB Population:  consists of subjects who were randomized to 
ustekinumab in Studies 1311.3 and 1311.28.  This population will be used to 
assess the efficacy of risankizumab when subjects switch from ustekinumab to 
risankizumab. For subjects from Japan, data prior to the start of 75 mg dose 
will be used for the analyses.
●
ADA_RZB Population:  consists of subjects who were randomized to 
adalimumab in Study 1311.30.  This population will be used to assess the 
efficacy of risankizumab when subjects switch from adalimumab to 
risankizumab.
●
FUM_RZB Population: consists of subjects who were randomized to 
FUMADERM in Study M16-178. This population will be used to assess the 
safety and efficacy of risankizumab when subjects switch from 
FUMADERM® to risankizumab.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
66
●
RZB Japan Population: consists of subjects from Japan. This population will 
be used to assess safety and efficacy during the OLE period, regardless of 
dosing changes in subjects.
Additional analysis populations may be defined when deemed appropriate.
To assess the benefit-risk profile, safety summaries will be provided for each of the above 
analysis populations as well.  In addition, an All Risankizumab Treated Population, 
defined as all subjects who received at least one dose of risankizumab in this study, will 
be used to provide a comprehensive summary of safety.
8.1.2
Planned Methods of Statistical Analysis
Since this is an open-label continuation study, no statistical test will be conducted.  
Summary statistics will be provided.  Data from preceding studies will be integrated with 
data from this study in the summaries.
The analysis will be performed using SAS® (SAS Institute Inc., Cary, NC, USA).
8.1.3
Demographics and Baseline Characteristics
Demographics and baseline characteristics will be summarized for each population.  
Baseline will be defined as the last non-missing measurement prior to the first dose of 
study drug in the preceding studies.
8.1.4
Statistical Analysis of Efficacy
Continuous variables will be summarized by the number of observations, mean, standard 
deviation, median, minimum, maximum 25th and 75th percentiles, as well as the 95% 
confidence intervals (CIs) of the mean values.  Categorical variables will be summarized 
by counts and percentages, as well as the 95% CIs of the percentages.
The efficacy summary will be conducted in the populations defined in Section 8.1.1.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
67
Visit windows and the data-handling convention for summarizing efficacy results will be 
defined in the SAP.  Unless otherwise specified, the "baseline" for efficacy variables is 
the baseline assessment in the preceding studies.
Missing data will be imputed using the following methods for the efficacy analysis:
●
Last Observation Carried Forward (LOCF):  The LOCF analyses will use the 
completed evaluation from the previous visit to impute missing data at later 
visits.
●
As-observed:  The as observed analysis will not impute values for missing 
evaluations, and thus a subject who did not have an evaluation on a scheduled 
visit will be excluded from the as observed analysis for that visit.
8.1.5
Safety Analysis
All AEs, SAEs, AEs leading to discontinuation, and pre-specified AESIs will be collected 
during the study.  A treatment-emergent AE (TEAE) is defined as an event with onset or 
worsening after the first study dose of a risankizumab (either in a preceding Phase 2/3 
psoriasis study or this study) and within 20 weeks (140 days) after the last study drug 
injection.  The number and percentages of subjects experiencing TEAE will be tabulated 
using the Medical Dictionary for Drug Regulatory Activities (MedDRA®) system organ 
class and preferred term.  Summaries (including percentages and event per 
100 patient-years) of SAEs, deaths, AEs leading to discontinuation from the study, and 
pre-specified AESIs will be provided as well.  Mean change in laboratory and vital signs 
variables will be summarized.  For selected parameters, a listing of all subjects with 
clinically significant laboratory or vital sign values will be provided.  Shift tables for 
changes from baseline according to the normal range will also be provided.
8.1.6
Interim Analysis
An interim analysis will be conducted in the fourth quarter of 2017.  The interim analysis 
will include all available patient data up to the interim analysis data cut-off date.  
Additional interim analyses may be performed based on regulatory or other requirements.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
68
8.1.7
Pharmacokinetic and Exposure-Response Analysis
Individual risankizumab plasma concentrations will be tabulated and summarized with 
appropriate statistical methods.  In addition, ADA titers will be tabulated for each subject 
at the respective study visits.  The number and percentage of subjects with ADA will be 
calculated.
Additional analyses combining pharmacokinetic and ADA data from this study and other 
studies may be conducted if appropriate, this may include exploratory analyses of the 
effect of ADA on risankizumab pharmacokinetics and efficacy as well as the relationships 
between exposure and clinical observations (efficacy or safety variables of interest).  Such 
analyses, if conducted, may be summarized in a separate report rather than in the CSR for 
this study.
8.1.8
Data Monitoring Committee
As no new safety signals have been identified to date, the independent Data Monitoring 
Committee (DMC) that initially reviewed data from this study is no longer in effect.  
Routine pharmacovigilance surveillance will continue to be conducted.
8.1.9
Cardio- and Cerebro-Vascular Event Adjudication 
Committee
An independent adjudication committee will be adjudicating all observed cardio- and 
cerebro-vascular events including MACE, in a blinded manner.  The events that are 
adjudicated and the adjudication process will be detailed in the Adjudication Committee 
Charter.  Supplemental eCRF will be used to collect information pertinent to the events.  
The Investigator might be contacted for additional information on relevant events.
8.2
Determination of Sample Size
The sample size is determined by the completion of preceding studies and the consenting 
for the extension.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
69
Multiple clinical studies will be rolling into this OLE study.  Eligible subjects from 
Studies 1311.3, 1311.4, 1311.13, 1311.28, 1311.30, 1311.38 and M16-178 will be offered 
participation in this OLE study at their respective or referring sites.  The check for subject 
eligibility will be based upon a successful completion of the preceding study, signing the 
informed consent for this study, and the other inclusion and exclusion criteria.
A 10 to 15% dropout rate from preceding studies is expected, leaving approximately 
2200 subjects to be entered in this study.
9.0
Ethics
9.1
Independent Ethics Committee (IEC) or Institutional Review 
Board (IRB)
Good clinical practice (GCP) requires that the clinical protocol, any protocol amendments, 
the IB, the informed consent and all other forms of subject information related to the 
study (e.g., advertisements used to recruit subjects) and any other necessary documents be 
reviewed by an IEC/IRB.  The IEC/IRB will review the ethical, scientific and medical 
appropriateness of the study before it is conducted.  IEC/IRB approval of the protocol, 
informed consent and subject information and/or advertising, as relevant, will be obtained 
prior to the authorization of drug shipment to a study site.
Any amendments to the protocol will require IEC/IRB approval prior to implementation 
of any changes made to the study design.  The investigator will be required to submit, 
maintain and archive study essential documents according to the International Conference 
on Harmonization (ICH) GCP.
Any SAEs that meet the reporting criteria, as dictated by local regulations, will be 
reported to both responsible ethics committees and regulatory agencies, as required by 
local regulations.  During the conduct of the study, the investigator should promptly 
provide written reports (e.g., ICH Expedited Reports, and any additional reports required 
by local regulations) to the IEC/IRB of any changes that affect the conduct of the study 
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
70
and/or increase the risk to subjects.  Written documentation of the submission to the 
IEC/IRB should also be provided to AbbVie.
9.2
Ethical Conduct of the Study
The study will be conducted in accordance with the protocol, ICH guidelines, applicable 
regulations and guidelines governing clinical study conduct and the ethical principles that 
have their origin in the Declaration of Helsinki.  Responsibilities of the clinical 
investigator are specified in Appendix A.
9.3
Subject Information and Consent
The investigator or his/her representative will explain the nature of the study to the 
subject, and answer all questions regarding this study.  Prior to any study-related 
screening procedures being performed on the subject, the informed consent statement will 
be reviewed and signed and dated by the subject, the person who administered the 
informed consent, and any other signatories according to local requirements.  A copy of 
the informed consent form will be given to the subject and the original will be placed in 
the subject's medical record.  An entry must also be made in the subject's dated source 
documents to confirm that informed consent was obtained prior to any study-related 
procedures and that the subject received a signed copy.
Information regarding incentives for subjects and information regarding provisions for 
treating and/or compensating subjects who are harmed as a consequence of participation 
in the study can be found in the informed consent form.
9.3.1
Informed Consent Form and Explanatory Material
Prior to the performance of any study specific procedures, including discontinuation of 
any protocol prohibited medications, the investigator or representative will explain the 
nature of study procedures and the study to the subject and if applicable per local 
requirements the subject's legal representative, and all questions regarding the study will 
be answered.  The informed consent form will be reviewed and consent to participate 
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
71
documented by dated signature of the representative and the person administering the 
informed consent.
See Appendix D for Japan specific requirements.
10.0
Source Documents and Case Report Form 
Completion
10.1
Source Documents
Source documents are defined as original documents, data and records.  This may include 
hospital records, clinical and office charts, laboratory data/information, subjects' diaries or 
evaluation checklists, pharmacy dispensing and other records, recorded data from 
automated instruments, microfiches, photographic negatives, microfilm or magnetic 
media, and/or x-rays.  Data collected during this study must be recorded on the 
appropriate source documents.
The investigator(s)/institution(s) will permit study-related monitoring, audits, IEC/IRB 
review, and regulatory inspection(s), providing direct access to source data documents.
10.2
Case Report Forms
Case report forms (CRF)s must be completed for each subject screened/enrolled in this 
study.  These forms will be used to transmit information collected during the study to 
AbbVie and regulatory authorities, as applicable.  The CRF data for this study are being 
collected with an EDC system called Rave® provided by the technology vendor Medidata 
Solutions Incorporated, NY, USA.  The EDC system and the study-specific eCRFs will
comply with Title 21 CFR Part 11.  The documentation related to the validation of the 
EDC system is available through the vendor, Medidata, while the validation of the study-
specific eCRFs will be conducted by AbbVie and will be maintained in the Trial Master 
File at AbbVie.
The investigator or representative will document subject data in his/her own subject files.  
These subject files will serve as source data for the study.  All eCRF data required by this 
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
72
protocol will be recorded by investigative site personnel in the EDC system.  All data 
entered into the eCRF will be supported by source documentation.
Supplemental study case report forms should be completed in the event of COVID-19 
related missed/virtual visits, study drug interruptions or discontinuations, or adverse 
events (including capture of specific signs/symptoms of infection and testing results).
The investigator or an authorized member of the investigator's staff will make any 
necessary corrections to the eCRF.  All change information, including the date and person 
performing the corrections, will be available via the audit trail, which is part of the EDC 
system.  For any correction, a reason for the alteration will be provided.  The eCRFs will 
be reviewed periodically for completeness, legibility, and acceptability by AbbVie 
personnel (or their representatives).  AbbVie (or their representatives) will also be allowed 
access to all source documents pertinent to the study in order to verify eCRF entries.  The 
principal investigator will review the eCRFs for completeness and accuracy and provide 
his or her electronic signature and date to eCRFs as evidence thereof.
During the COVID-19 pandemic, remote monitoring of data may be employed if allowed 
by the local regulatory authority, IRB/IEC, and the study site.
Medidata will provide access to the EDC system for the duration of the study through a 
password-protected method of internet access.  Such access will be removed from 
investigator sites at the end of the site's participation in the study.  Data from the EDC 
system will be archived on appropriate data media (CD-ROM, etc.) and provided to the 
investigator at that time as a durable record of the site's eCRF data.  It will be possible for 
the investigator to make paper printouts from that media.
Patient reported data must be completed for each subject enrolled in this study.  This data 
is collected directly onto paper CRFs by the subjects.  The completion of these forms is 
verified by the site staff.  The site will enter the forms into the EDC system.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
73
11.0
Data Quality Assurance
To ensure data integrity and subject safety, a study monitor will continuously, throughout 
the study, verify that all subjects signed the informed consent prior to any study specific 
procedures being conducted, that the investigator is complying with the protocol, GCP 
and applicable regulations, and that the information provided in the eCRF is complete, 
accurate, and supported by information in source documents.
Computer logic and manual checks will be created to identify items such as inconsistent 
study dates.  Any necessary corrections will be made to the eCRF.
12.0
Use of Information
All information concerning risankizumab and AbbVie operations, such as AbbVie patent 
applications, formulas, manufacturing processes, basic scientific data, or formulation 
information, supplied by AbbVie and not previously published is considered confidential 
information.
The information developed during the conduct of this clinical study is also considered 
confidential and will be used by AbbVie in connection with the development of 
risankizumab.  This information may be disclosed as deemed necessary by AbbVie to 
other clinical investigators, other pharmaceutical companies, and to governmental 
agencies.  To allow for the use of the information derived from this clinical study and to 
ensure complete and thorough analysis, the investigator is obligated to provide AbbVie 
with complete test results and all data developed in this study and to provide direct access 
to source data/documents for trial-related monitoring, audits, IEC/IRB review and 
regulatory inspection.
This confidential information shall remain the sole property of AbbVie, shall not be 
disclosed to others without the written consent of AbbVie, and shall not be used except in 
the performance of this study.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
74
The investigator will maintain a confidential subject identification code list of all subjects 
enrolled in the study (by name and subject number).  This list will be maintained at the 
site and will not be retrieved by AbbVie.  Researchers will have no access to subject 
identifiers.  Individual results will not be reported to anyone not directly involved in this 
research other than for regulatory purposes.
13.0
Completion of the Study
The investigator will conduct the study in compliance with this protocol and complete the 
study within the timeframe specified in the contract between the investigator and AbbVie.  
Continuation of this study beyond this date must be mutually agreed upon in writing by 
both the investigator and AbbVie.  The investigator will provide a final report to the 
IEC/IRB following conclusion of the study, and will forward a copy of this report to 
AbbVie or their representative.
AbbVie will select the signatory investigator from the investigators who participate in the 
study.  Selection criteria for this investigator will include level of participation as well as 
significant knowledge of the clinical research, investigational drug and study protocol.  
The signatory investigator for the study will review and sign the final study report in 
accordance with the European Agency for the Evaluation of Medicinal Products (EMEA) 
Guidance on Investigator's Signature for Study Reports.
The end-of-study is defined as the date of the last subject's last visit, 20 weeks after the 
final dose of study drug, see Appendix C.
See Appendix D for Japan specific requirements.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
75
14.0
Investigator's Agreement
1.
I have received and reviewed the Investigator's Brochure for 
Risankizumab/ABBV-066.
2.
I have read this protocol and agree that the study is ethical.
3.
I agree to conduct the study as outlined and in accordance with all applicable 
regulations and guidelines.
4.
I agree to maintain the confidentiality of all information received or developed in 
connection with this protocol.
5.
I agree that all electronic signatures will be considered the equivalent of a 
handwritten signature and will be legally binding.
Protocol Title: 
A multicenter, open Label study to assess the safety and efficacy of 
rIsankizuMab for MaInTenance in moderate to severe pLaquE
type pSoriaSis (LIMMITLESS)
Protocol Date:
18 October 2021
Signature of Principal Investigator
Date
Name of Principal Investigator (printed or typed)
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
76
15.0
Reference List
1.
Nestle FO, Kaplan DH, Barker J.  Human immunodeficiency virus.  N Engl J Med.  
2009;361(5):496-509.
2.
Lowes MA, Bowcock AM, Krueger JG.  Pathogenesis and therapy of psoriasis.  
Nature.  2007;445(7130):866-73.
3.
Menter A, Griffiths CEM.  Psoriasis 2:  current and future management of 
psoriasis.  Lancet.  2007;370:272-84.
4.
Davidovici BB, Sattar N, Joerg PC, et al.  Psoriasis Education and Learning 
Syllabus (PEARLS).  Psoriasis and systemic inflammatory diseases:  potential 
mechanistic links between skin disease and co-morbid conditions.  J Invest 
Dermatol.  2010;130(7):1785-96.
5.
Reich K, Puig L, Paul C, et al.  One-year safety and efficacy of ustekinumab and 
results of dose adjustment after switching from inadequate methotrexate treatment:  
the TRANSIT randomized trial in moderate-to-severe plaque psoriasis.  Br J 
Dermatol.  2014;170(2):435-44.
6.
Smith RLI, Warren RB, Eyre S, et al.  Polymorphisms in the IL-12beta and IL-23R 
genes are associated with psoriasis of early onset in a UK cohort.  J Invest 
Dermatol.  2008;128:1325-7.
7.
Cosentyx® (Secukinumab) [package insert].  East Hanover, New Jersey; Novartis 
Pharmaceuticals Corporation, 2016.
8.
Dorleacq N, Steimle-Goerttler C, Bai X, et al.  Safety, tolerability, efficacy, 
pharmacokinetics, and pharmacodynamics of single rising i.v. (stage 1) and s.c. 
(stage 2) doses of BI 655066 in male and female patients with moderate to severe 
psoriasis (randomised, double-blind, placebo-controlled within dose groups) 
(Trial 1311.1).  26 March 2015.  (c02434648).
9.
AbbVie.  Rizankizumab Investigator's Brochure Edition 5.  13 May 2019.
10.
Khader SA, Pearl JE, Sakamoto K, et al.  IL-23 compensates for the absence of 
IL-12p70 and is essential for the IL-17 response during tuberculosis but is 
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
77
dispensable for protection and antigen-specific IFN-y responses if IL-12p70 is 
available.  J Immunol.  2005;175(2):788-95.
11.
O'Garra A, Redford PS, McNab FW, et al.  The immune response in tuberculosis.  
Annu Rev Immunol.  2013;31:475-527.
12.
Tsai TF, Blauvelt A, Gong Y, et al.  Secukinumab treatment shows no evidence for 
reactivation of previous or latent TB infection in subjects with psoriasis:  a pooled 
phase 3 safety analysis.  J Am Acad Dermatol.  2015;607.
13.
STELARATM (ustekinumab) [package insert].  Horsham, PA; Janssen Biotech, 
Inc., 2016.
14.
Rungapiromnan W, Yiu ZZ, Warren RB, et al.  Impact of biologic therapies on risk 
of major adverse cardiovascular events in patients with psoriasis:  systematic 
review and meta-analysis of randomised controlled trials.  Br J Dermatol.  
2016 Aug 12.  doi:  10.1111/bjd.14964.  [Epub ahead of print].
15.
Finlay AY, Khan GK.  Dermatology Life Quality Index (DLQI)--a simple practical 
measure for routine clinical use.  Clin Exp Dermatol.  1994;19(3):210-6.
16.
Fredriksson T, Pettersson U.  Severe psoriasis:  oral therapy with a new retinoid.  
Dermatologica.  1978;157(4):238-44.
17.
Marks R, Barton SP, Shuttleworth D, et al.  Assessment of disease progress in 
psoriasis.  Arch Dermatol.  1989;125(2):235-40.
18.
Woodworth T, Furst DE, Alten R, et al.  Standardizing assessment and reporting of 
adverse effects in rheumatology clinical trials II:  the Rheumatology Common 
Toxicity Criteria v.2.0.  J Rheumatol.  2007;34(6):1401-14.
19.
Basra MKA, Fenech R, Gatt RM, et al.  The Dermatology Life Quality Index 
1994-2007:  a comprehensive review of validation data and clinical results.  Br J 
Dermatol.  2008;159(5):997-1035.
20.
Basra MK, Salek MS, Camilleri L, et al.  Determining the minimal clinically 
important difference and responsiveness of the Dermatology Life Quality Index 
(DLQI):  further data.  Dermatology.  2015;230(1):27-33.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
78
21.
Available from:  http://www.cardiff.ac.uk/dermatology/quality-of-
life/dermatology-quality-of-life-index-dlqi/dlqi-instructions-for-use-and-scoring/.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
79
Appendix A.
Responsibilities of the Clinical Investigator
Clinical research studies sponsored by AbbVie are subject to the GCP and local 
regulations and guidelines governing the study at the site location.  In signing the 
Investigator Agreement in Section 14.0 of this protocol, the investigator is agreeing to the 
following:
1.
Conducting the study in accordance with the relevant, current protocol, making 
changes in a protocol only after notifying AbbVie, except when necessary to 
protect the safety, rights or welfare of subjects.
2.
Personally conducting or supervising the described investigation(s).
3.
Informing all subjects, or persons used as controls, that the drugs are being used for 
investigational purposes and complying with the requirements relating to informed 
consent and ethics committees (e.g., independent ethics committee [IEC] or 
institutional review board [IRB]) review and approval of the protocol and 
amendments.
4.
Reporting adverse experiences that occur in the course of the investigation(s) to 
AbbVie and the site director.
5.
Reading the information in the investigator's brochure/safety material provided, 
including the instructions for use and the potential risks and side effects of the 
investigational product(s).
6.
Informing all associates, colleagues, and employees assisting in the conduct of the 
study about their obligations in meeting the above commitments.
7.
Maintaining adequate and accurate records of the conduct of the study, making 
those records available for inspection by representatives of AbbVie and/or the 
appropriate regulatory agency, and retaining all study-related documents until 
notification from AbbVie.
8.
Maintaining records demonstrating that an ethics committee reviewed and 
approved the initial clinical investigation and all amendments.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
80
9.
Reporting promptly, all changes in the research activity and all unanticipated 
problems involving risks to human subjects or others, to the appropriate individuals 
(e.g., coordinating investigator, institution director) and/or directly to the ethics 
committees and AbbVie.
10.
Following the protocol and not making any changes in the research without ethics 
committee approval, except where necessary to eliminate apparent immediate 
hazards to human subjects.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
81
Appendix B.
List of Protocol Signatories
Name
Title
Functional Area
Clinical Development, Immunology
Clinical Development, Immunology
Data and Statistical Sciences
Data and Statistical Sciences
Data and Statistical Sciences
Clinical Pharmacology & Pharmacometrics
Clinical Development Operations
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
82
Appendix C.
Study Activities Flow Chart
Activity
Visit 1/Baselinea
Visit 2/Week 12
Visit 3/Week 24
Visit 4/Week 36
Visit 5/Week 48
Visit 6/Week 60
Visit 7/Week 72
Visit 8/Week 84
Visit 9/Week 96
Visit 10/Week 108
Visit 11/Week 120
Visit 12/Week 132
Visit 13/Week 144
Visit 14/Week 156
Week 168
Visit 15/Week 180
Week 192
Visit 16/Week 204
Week 216
Visit 17/Week 228
Week 240
EOT Visitb
EOO Visit
Informed Consentc
X
Inclusion/exclusion criteria
X
Demographicsd
X
Medical/Surgical Historye
X
Prior and Concomitant Therapy 
Assessment
Xf
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Adverse Event Assessmentg
Xf
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Physical Examh
Xf
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Electrocardiogram (ECG)
Xf
X
X
X
X
X
Vital Signsi
Xf,i
Xi
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Body Weight
X
X
X
X
X
X
TB Testingj
X
X
X
X
X
Pregnancy Testingk,q
Xf
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Local Tolerability Assessment
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
83
Activity
Visit 1/Baselinea
Visit 2/Week 12
Visit 3/Week 24
Visit 4/Week 36
Visit 5/Week 48
Visit 6/Week 60
Visit 7/Week 72
Visit 8/Week 84
Visit 9/Week 96
Visit 10/Week 108
Visit 11/Week 120
Visit 12/Week 132
Visit 13/Week 144
Visit 14/Week 156
Week 168
Visit 15/Week 180
Week 192
Visit 16/Week 204
Week 216
Visit 17/Week 228
Week 240
EOT Visitb
EOO Visit
Clinical Laboratory Tests 
(Chemistry, Hematology, 
Urinalysis)l
Xf
X
X
X
X l
X
X
X
X
X l
X
X
X
Xl
X
Xl
X
Xl
Blood Sampling for PK
Xf
X
X
X
X
X
Blood Sampling for ADA Assay
Xf
X
X
X
X
X
PASI, sPGA
Xf
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
NAPSI, PPASI, PSSI
Xf
X
X
X
X
X
X
X
X
X
X
X
Dermatology Life Quality Index 
(DLQI)m
Xf
X
X
X
X
X
X
X
X
X
X
X
Study Drug Administration
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Xr
X
Xr
X
Xr
X
Xr
Xo
Study Drug Dispensation for 
Self-Administrationp
X
X
X
X
Training subject on self-
administration and product 
complaints
X
Monitoring for Hypersensitivity 
Reactions
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
a.
The Baseline visit date will serve as reference for all subsequent visits.  A ± 7-day window is permitted around all study visits after Baseline.
b.
Premature discontinuation:  For subjects who prematurely discontinue the study before study end (for any reason) an early EOT visit is required. 
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
84
If the decision to discontinue study participation is made at a regular study visit, the visit should be turned into an EOT visit, i.e., an EOT visit is to be performed instead of 
the scheduled visit. 
If the decision to discontinue study participation is made in between study visits, an EOT visit is to be scheduled at the earliest convenience or at the latest the next upcoming 
visit according to the Flow Chart.  This early EOT visit will include the same procedures as the normal EOT visit and the subject will subsequently enter a follow up period of 
20 weeks, until a final EOO visit is performed.
c.
Informed consent must not be signed before the date of the last visit in the preceding study, but needs to be completed prior to initiation of any Study M15-997 study 
procedures.
d.
The subject's demographic data has been collected at the screening visit of the preceding study, so does not need to be collected again.
e.
Medical history collected in the preceding study will be used in Study M15-997.  Only new information and updates will need to be collected at the Study M15-997 Baseline 
visit.
f.
For subjects rolling over from the preceding study with ≤ 4 day delay from the last visit per protocol in the preceding study, these procedures do not need to be repeated if 
already performed at this last visit of the preceding study.  Results assessed at this last visit will serve as Baseline visit results for Study M15-997.  Subjects initiating the OLE 
with a delay of > 4 days from completion of the last visit per protocol in the preceding study will need to complete all activities for Baseline.
g.
New Adverse Events or unresolved Adverse Events from the preceding study to be followed up in this study.
h.
Symptom directed physical exam.
i.
Vital Signs must precede blood sampling and must be assessed pre-dose at all dosing visits.  Additional vital signs assessments should be made 5 (± 2) minutes post-dose and 
60 (± 10) minutes post-dose at Visit 1 and Visit 2.
j.
Only subjects that had a negative TB test during the last testing in the preceding study or Study M15-997 will be tested for TB.
k.
Urine pregnancy testing at every dosing visit.  Additional serum pregnancy testing will occur in case of a positive urine test result at any visit.
l.
The following clinical laboratory tests only need to be done at the Visit 5, Visit 10, Visit 14, Visit 16 and the EOT visit: Electrolytes, C-reactive protein, cholesterol, 
urinalysis, urine sediment and urine.  During these visits, the subject should be fasting for at least 8 hours prior to the blood sample being taken.
m.
Self-administered patient questionnaire DLQI assessments to be done on paper by the subject and should be completed before any other visit assessments or treatments and, if 
possible, before any interaction with the investigator or other members of the study team.
n.
Study drug must be administered after all laboratory procedures have been completed.
o.
Not to be performed for subjects who prematurely discontinue the study drug.
p.
Study drug for self-administration will be dispensed to subject at Visit 14, Visit 15, Visit 16 and Visit 17 for self-injection at Week 168, Week 192, Week 216 and Week 240.  
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
85
q.
Urine pregnancy self-testing for females of child-bearing potential will be required prior to self-injection at home at Week 168, Week 192, Week 216 and Week 240.  Subjects 
receiving the injection at the study site at these visits will have an urine pregnancy test at the study site.  Negative urine pregnancy test results must be confirmed prior to 
study drug dosing.
r.
Subjects preferring not to self-administer study drug at home at Weeks 168, 192, 216 and 240 may receive the injection at the study site.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
86
Appendix D.
Local Requirements – Japan
5.3.1.1
Study Procedures
Clinical Laboratory Tests
eGFR (estimated by CKD-EPI Japan formula)
Tuberculosis Screening
All subjects will be tested for TB by either the QuantiFERON®-TB Gold Test (or 
equivalent) or a TB skin test or equivalent, most commonly the PPD, at Visit 5, Visit 10 
and EOT visit.
A TB skin test or equivalent should be utilized only when a QuantiFERON®-TB Gold 
Test is not possible for any reason (unless both tests are required per local guidelines).
●
QuantiFERON®-TB Gold Test will be analyzed by the central laboratory 
(QuantiFERON test is preferred over TB skin test).
●
If the QuantiFERON®-TB Gold Test is NOT possible (or if both the 
QuantiFERON®-TB Gold Test and the PPD skin test are required per local 
guidelines) the PPD skin test will be performed according to standard clinical 
practice.
●
The PPD skin test should be read by a licensed healthcare professional 
between 48 and 72 hours after administration.  A subject who does not return 
within 72 hours will need to be rescheduled for another skin test.
●
The reaction will be measured in millimeters (mm) of induration and 
induration ≥ 5 mm is considered a positive reaction.  The absence of induration 
will be recorded as "0 mm" not "negative."
●
If PPD and/or the QuantiFERON®-TB Gold test (or IGRA equivalent) is 
positive, or if there is a repeat indeterminate QuantiFERON®-TB Gold test (or 
IGRA equivalent) upon retesting, subjects may continue in the study if further 
work up (according to local practice/guidelines) establishes conclusively that 
the subject has no evidence of active TB.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
87
●
If the subject is diagnosed with active TB, the subject should not receive any 
further study drug and follow the premature treatment discontinuation 
procedure (Early EOT visit) in Section 5.4.1.
●
If presence of latent TB is established treatment should be initiated and 
maintained according to local country guidelines.  It is also necessary to 
report it as an AE in the source documents and eCRFs.
●
If subject is known to have a positive QuantiFERON®-TB Gold or PPD test in 
the preceding study, do not repeat in this study.
●
Subjects who have had an ulcerating reaction to the TB skin test in the past 
should not be re-exposed and should not be tested by a PPD skin test.
In the case of a TB-related AE, a supplemental TB case report form that provides 
additional information is be completed by the investigator or designee.
7.0
Protocol Deviations
AbbVie does not allow intentional/prospective deviations from this protocol unless when 
necessary to eliminate an immediate hazard to study subjects.  The principal investigator 
is responsible for complying with all protocol requirements, and applicable global and 
local laws regarding protocol deviations.  If a protocol deviation occurs (or is identified) 
after a subject has been enrolled, the principal investigator is responsible for notifying 
IEC/IRB and regulatory authorities (as applicable), and the following AbbVie clinical 
monitor(s):
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
88
Primary Contact:
Study Project Manager II
Wegalaan 9
2132JD Hoofddorp
The Netherlands
Office:
Mobile:
Email:
Alternate Contact:
Program Lead I
1 North Waukegan Road
North Chicago, IL 60064
USA
Office:
Mobile:
Email:
Such contact must be made as soon as possible to permit a review by AbbVie to 
determine the impact of the deviation on the subject and/or the study.
In Japan, the Investigator will record all protocol deviations in the appropriate medical 
records at site.
9.3.1
Informed Consent Form and Explanatory Material
Prior to the performance of any study specific procedures, including discontinuation of 
any protocol prohibited medications, the investigator or representative will explain the 
nature of study procedures and the study to the subject and if applicable per local 
requirements the subject's legal representative, and all questions regarding the study will 
be answered.  The informed consent form will be reviewed and consent to participate 
documented by dated signature of the representative and the person administering the 
informed consent.
In Japan, the principal investigator will prepare the consent form and explanatory material 
required to obtain subject's consent to participate in the study with the cooperation of the 
sponsor and will revise these documents as required.  The prepared or revised consent 
forms and explanatory material will be submitted to the sponsor.  Approval of the 
IEC/IRB will be obtained prior to use in the study.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
89
9.3.2
Revision of the Consent Form and Explanatory Material
In Japan, when important new information related to the subject's consent becomes 
available, the principal investigator will revise the consent form and explanatory material 
based on the information without delay and will obtain the approval of the IEC/IRB prior 
to use in the study.  The investigator will provide the information, without delay, to each 
subject already participating in the study, and will confirm the intention of each subject to 
continue the study or not.  The investigator shall also provide a further explanation using 
the revised form and explanatory material and shall obtain written consent from each 
subject of their own free will to continue participating in the study.
13.0
Completion of the Study
The investigator will conduct the study in compliance with this protocol and complete the 
study within the timeframe specified in the contract between the investigator (Director of 
the Site in Japan) and AbbVie.  Continuation of this study beyond this date must be 
mutually agreed upon in writing by both the investigator (Director of the Site in Japan) 
and AbbVie.  The investigator will provide a final report to the IEC/IRB following 
conclusion of the study, and will forward a copy of this report to AbbVie or their 
representative.
The investigator (Director of the Site in Japan) must retain any records related to the study 
according to local requirements.  If the investigator is not able to retain the records, he/she 
must notify AbbVie to arrange alternative archiving options.
AbbVie will select the signatory investigator from the investigators who participate in the 
study.  Selection criteria for this investigator will include level of participation as well as 
significant knowledge of the clinical research, investigational drug and study this 
protocol.  The signatory investigator for the study will review and sign the final study 
report in accordance with the European Medicines Agency (EMA) Guidance on 
Investigator's Signature for Study Reports.
The end-of-study is defined as the date of the last subject's last visit.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
90
Appendix E.
Psoriasis Area and Severity Index (PASI)
To calculate the Psoriasis Area and Severity Index (PASI)16,17 score, the four main body 
areas are assessed:  head (h), trunk (t), upper extremities (u) and lower extremities (l).
The area affected by psoriasis within these four areas site is estimated as a percentage of 
the total area of that anatomic site and assigned a numerical value according to the degree 
of psoriatic involvement as follows:
●
0 = no involvement
●
1 = < 10%
●
2 = 10% to < 30%
●
3 = 30% to < 50%
●
4 = 50% to < 70%
●
5 = 70% to < 90%
●
6 = 90% to 100%
The signs of severity, erythema (E), induration (I) and desquamation (D) of lesions are 
assessed using a numeric scale 0 – 4:
●
0 = No symptoms
●
1 = Slight
●
2 = Moderate
●
3 = Marked
●
4 = Very marked
The table below outlines the characteristics of each category.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
91
Erythemaa
Desquamation
Induration
0 = none
No redness
No scaling
No elevation over normal 
skin
1 = slight
Faint redness
Fine scale partially 
covering lesions
Slight but definite 
elevation, typically edges 
indistinct or sloped
2 = moderate
Red coloration
Fine to coarse scale 
covering most of all of 
the lesions
Moderate elevation with 
rough or sloped edges
3 = marked
Very or bright red 
coloration
Coarse, non-tenacious 
scale predominates 
covering most or all of 
the lesions
Marked elevation 
typically with hard or 
sharp edges
4 = very marked
Extreme red coloration; 
dusky to deep red 
coloration
Coarse, thick, tenacious 
scale over most or all 
lesions; rough surface
Very marked elevation 
typically with hard sharp 
edges
a.
Do not include residual hyperpigmentation or hypopigmentation as erythema.
Assignments for the following body regions are as follows:
●
Neck:  include with the head
●
Buttocks:  include with the lower extremities
●
Axillae:  include with the trunk
●
Genitals:  include with the trunk
●
The inguinal canal separates the trunk and legs anteriorly
The PASI score for each body region is obtained by multiplying the sum of the severity 
scores by the area score, then multiplying the result by the constant weighted value 
assigned to that body region.  Since the head, upper extremities, trunk, and lower 
extremities correspond to approximately 10%, 20%, 30%, and 40% of BSA, respectively, 
the PASI score is calculated using the formula:
PASI = 0.1(Eh + Ih + Dh)Ah + 0.2(Eu + Iu + Du)Au + 0.3(Et + It + Dt)At + 0.4(El + Il + Dl)Al
where E, I, D, and A denote erythema, induration, desquamation, and area, respectively, 
and h, u, t, and l denote head, upper extremities, trunk, and lower extremities, 
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
92
respectively.  PASI scores range from 0.0 to 72.0 with the highest score representing 
complete erythroderma of the severest degree.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
93
Appendix F.
Static Physician Global Assessment (sPGA)
The sPGA is a 5 point score ranging from 0 to 4, based on the physician's or 
representative's assessment of the average thickness, erythema, and scaling of all psoriatic 
lesions.  The assessment is considered "static" which refers to the subject's disease state at 
the time of the assessments, without comparison to any of the subject's previous disease 
states, whether at baseline or at a previous visit.
A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
Erythema  (0)   Normal (Post-inflammatory hyperpigmentation may be present)
(1)    Pink coloration of lesions
(2)    Light red coloration of lesions
(3)   Dull to bright red coloration of lesions
(4)   Bright to Deep red coloration of lesions
Induration (0)   None
(1)    Just detectable 
(2)    Mild thickening
(3)    Clearly distinguishable to moderate thickening
(4)    Severe thickening with hard edges
Scaling
(0)    No scaling
(1)    Minimal focal scaling
(2)    Predominately fine scaling
(3)    Moderate scaling
(4)    Severe/coarse scaling covering almost all or all lesions
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
94
Scoring:
a composite score is generated from the above data and the final sPGA is 
determined from this composite score as follows:
Clear 
0 = 0 for all three 
Almost clear 1 = mean > 0, < 1.5
Mild
2 = mean >= 1.5, < 2.5
Moderate 
3 = mean >= 2.5, < 3.5
Severe
4 = mean >= 3.5
sPGA Rating Scale for Overall Psoriatic Disease
Score
Short Description
Detailed Description
0
clear
No signs of psoriasis.  Post-inflammatory hyperpigmentation 
may be present
1
Almost clear
Normal to pink coloration;
No thickening
No to minimal focal scaling
2
mild
Pink to light red coloration
Just detectable to mild thickening
Predominantly fine scaling
3
moderate
Dull to bright red coloration
Clearly distinguishable to moderate thickening 
Moderate scaling
4
severe
Bright to deep dark red coloration; 
Severe thickening with hard edges 
Severe coarse scaling covering almost all or all lesions
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
95
Appendix G.
Nail Psoriasis Severity Index (NAPSI)
The nails will be graded for nail matrix psoriasis and nail bed psoriasis.  The sum of the 
two scores is the total score for that nail.18
Nail Matrix Psoriasis
The Nail Matrix Psoriasis consists of any of the following:  pitting, leukonychia, red spots 
in the lunula, and nail plate crumbling.
Score for Matrix Psoriasis
0
=     none
1
=     present in 1 quadrant of nail
2
=     present in 2 quadrants of nail
3
=     present in 3 quadrants of nail
4
=     present in 4 quadrants of nail
Nail Bed Psoriasis
The Nail Bed Psoriasis is the presence or absence of any of the following:  onycholysis, 
splinter hemorrhages, oil drop (salmon patch) discoloration, and nail bed hyperkeratosis.
Score for Nail Bed Psoriasis
0
=     none
1
=     present in 1 quadrant of nail
2
=    present in 2 quadrants of nail
3
=     present in 3 quadrants of nail
4
=     present in 4 quadrants of nail
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
96
The sum of the scores will be added resulting a range of 0 to 80.  If an individual finger 
assessment is missing (not done), the average of the remaining measured digits will be 
imputed and added to the sum.  If < 50% of the finger assessments are missing the 
imputation will be performed.  If more than 50% of the assessments are missing then the 
sum of the scores will be left as missing.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
97
Appendix H.
Palmoplantar Psoriasis Area and Severity Index (PPASI)
The PPASI provides a numeric scoring for psoriasis affecting the hands and feet with 
scores ranging from 0 to 72.  It is a linear combination of percent of surface area of hands 
and feet that are affected and the severity of erythema, induration, and desquamation.
If a subject has palmoplantar psoriasis, the physician will assess the psoriasis at each 
protocol defined time point.  Both palms and soles on each hand and foot will be 
individually assessed for erythema, induration, desquamation and percentage of area 
affected as follows:
●
Erythema, Induration and Desquamation:
0 = None
1 = Slight
2 = Moderate
3 = Severe
4 = Very Severe
●
Percent of Palm and Sole Area Covered:
0 = Clear
1 = < 10%
2 = 10 – 29%
3 = 30 – 49%
4 = 50 – 69%
5 = 70 – 89%
6 = 90 – 100%
The PPASI is a composite score and will be computed for each palm and sole, left and 
right and is derived from the sum of the scores for erythema (E), induration (I) and 
desquamation (D) multiplied by the score recorded for the extent of palm and sole area 
involved.  PPASI is calculated as follows:  (sum of scored for E+I+D)*Area 
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
98
*0.2(location:  right palm) + (sum of scored for E+I+D)*Area *0.2(location:  left palm) + 
(sum of scored for E+I+D)*Area *0.3(location:  right sole) +(sum of scores for 
E+I+D)*Area *0.3(location:  left sole).  The range is 0 to 72.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
99
Appendix I.
Psoriasis Scalp Severity Index (PSSI)
If a subject has scalp psoriasis, the physician will assess the erythema (redness), 
induration (hardness), desquamation (shedding of skin) and percent of scalp covered at 
each protocol defined time point.
Erythema, Induration and Desquamation:
0 = None
1 = Slight
2 = Moderate
3 = Severe
4 = Very Severe
Percent of Scalp Covered:
1 = < 10%
2 = 10 – 29%
3 = 30 – 49%
4 = 50 – 69%
5 = 70 – 89%
6 = 90 – 100%
The PSSI is a composite score derived from the sum of the scores for erythema, 
induration and desquamation multiplied by the score recorded for the extent of scalp area 
involved.  The range is 0 to 72.
 

Risankizumab/ABBV-066
M15-997 Protocol Amendment 8
EudraCT 2016-003046-87
100
Appendix J.
Dermatology Life Quality Index (DLQI)
The DLQI has been extensively used in clinical studies and has a large evidence base 
supporting reliability and validity.19  The DLQI is a self-administered, ten-question 
questionnaire used to assess the effect of different skin diseases on a subject's quality of 
life, overall health, and disability status.20  The questionnaire covers six domains 
including symptoms and feelings, daily activities, leisure, work and school, personal 
relationships and treatment and has a 1-week recall period.15
Each item is scored on a 4 point scale where a 0 score indicates "not relevant/not at all,"
and scores from 1 to 3 range from "a little," to "very much."  Question 7 is a 
"yes"/"no"question where "yes" is scored as 3.  If Question 7 is answered "no," scores 
range from 0 ("not at all") to 2 ("a lot").21
The DLQI total score is calculated by summing the scores of each question, resulting in a 
range of 0 to 30 where 0 – 1 = "no effect on subject's life," 2 – 5 = "small effect," 6 – 10 = 
"moderate effect," 11 – 20 = "very large effect," and 21 – 30 = "extremely large effect on 
subject's life."  The higher the score, the more the quality of life is impaired.  A 4-point 
change from baseline is considered a clinically important difference.20
The DLQI will be analyzed under six headings as follows:17
Domain
Question Number
Score
Symptoms and feelings 
Questions 1 and 2
Score maximum 6
Daily activities
Questions 3 and 4
Score maximum 6
Leisure
Questions 5 and 6
Score maximum 6
Work and school
Question 7
Score maximum 3
Personal relationship
Questions 8 and 9
Score maximum 6
Treatment
Question 10
Score maximum 3