A Phase 3, Randomized, Double-Blind, Study Comparing Risankizumab to Placebo in Subjects With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy (KEEPsAKE 1)
Phase: PHASE3
Conditions: Psoriatic Arthritis
Sponsor: AbbVie

NCT03675308

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
Sponsor emergency medical contact:
AbbVie
Avenida De Burgos 91,
Madrid, Spain 28050
Office/Mobile:
Email:
*The specific contact details of the AbbVie legal/regulatory entity (person) within the relevant country 
are provided within the clinical trial agreement with the Investigator/Institution and in the Clinical Trial 
Application with the Competent Authority.  Additional study contact information can be found in the 
Operations Manual (Appendix F).
EMERGENCY 24 hour Number:  +1 973-784-6402
Page 2 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
TABLE OF CONTENTS
1
SYNOPSIS
6
2
INTRODUCTION
9
2.1
BACKGROUND AND RATIONALE
9
2.2
BENEFITS AND RISKS TO PATIENTS
10
3
STUDY OBJECTIVES AND ENDPOINTS
12
3.1
OBJECTIVES
12
3.2
PRIMARY ENDPOINT
12
3.3
SECONDARY ENDPOINTS
12
3.4
ADDITIONAL ENDPOINTS
13
3.5
SAFETY ENDPOINTS
15
3.6
PHARMACOKINETIC ENDPOINTS
15
3.7
BIOMARKER SAMPLING
15
4
INVESTIGATIONAL PLAN
16
4.1
OVERALL STUDY DESIGN AND PLAN
16
4.2
DISCUSSION OF STUDY DESIGN
18
5
STUDY ACTIVITIES
20
5.1
ELIGIBILITY CRITERIA
20
5.2
CONTRACEPTION RECOMMENDATIONS
25
5.3
PROHIBITED MEDICATIONS AND THERAPY
26
5.4
PRIOR AND CONCOMITANT THERAPY
28
5.5
WITHDRAWAL OF SUBJECTS AND DISCONTINUATION OF STUDY
30
5.6
FOLLOW-UP FOR SUBJECT WITHDRAWAL FROM STUDY
32
5.7
STUDY DRUG
33
5.8
RANDOMIZATION/DRUG ASSIGNMENT
34
5.9
PROTOCOL DEVIATIONS
34
6
SAFETY CONSIDERATIONS
35
6.1
COMPLAINTS AND ADVERSE EVENTS
35
Page 3 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
6.2
TOXICITY MANAGEMENT
37
6.3
INDEPENDENT DATA MONITORING COMMITTEE
37
6.4
CARDIOVASCULAR ADJUDICATION COMMITTEE
37
6.5
ANAPHYLAXIS ADJUDICATION COMMITTEE
37
7
STATISTICAL METHODS & DETERMINATION OF SAMPLE SIZE
38
7.1
STATISTICAL AND ANALYTICAL PLANS
38
7.2
DEFINITION FOR ANALYSIS POPULATIONS
38
7.3
STATISTICAL ANALYSES FOR EFFICACY
38
7.4
STATISTICAL ANALYSES FOR SAFETY
40
7.5
ANALYSIS OF PK AND IMMUNOGENICITY
40
7.6
ANALYSIS OF EXPLORATORY VARIABLES
40
8
ETHICS
40
8.1
INDEPENDENT ETHICS COMMITTEE/INSTITUTIONAL REVIEW BOARD (IEC/IRB)
40
8.2
ETHICAL CONDUCT OF THE STUDY
40
8.3
SUBJECT CONFIDENTIALITY
41
9
SOURCE DOCUMENTS AND CASE REPORT FORM COMPLETION
41
10 DATA QUALITY ASSURANCE
41
11 COMPLETION OF THE STUDY
41
12 REFERENCES
42
LIST OF TABLES
TABLE 1.
DESCRIPTION OF STUDY DRUG AND PLACEBO
33
TABLE 2.
ADVERSE EVENTS THAT REQUIRE SUPPLEMENTAL REPORTS
36
LIST OF FIGURES
FIGURE 1.
STUDY SCHEMATIC
17
Page 4 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
LIST OF APPENDICES
APPENDIX A.
STUDY SPECIFIC ABBREVIATIONS AND TERMS
45
APPENDIX B.
RESPONSIBILITIES OF THE INVESTIGATOR
49
APPENDIX C.
LIST OF PROTOCOL SIGNATORIES
50
APPENDIX D.
ACTIVITY SCHEDULE
51
APPENDIX E.
PROTOCOL SUMMARY OF CHANGES
56
APPENDIX F.
OPERATIONS MANUAL
58
Page 5 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
2 INTRODUCTION
2.1 Background and Rationale
Why Is This Study Being Conducted
Psoriatic arthritis (PsA) is a chronic systemic inflammatory disease classified as a sub-type of 
spondyloarthritis (SpA) and characterized by the association of arthritis and psoriasis.  The course of PsA 
is usually characterized by flares and remissions.1  Left untreated, patients with PsA can have persistent 
inflammation, progressive joint damage, disability, and a reduced life expectancy.1,2  Patients with PsA 
experience varying combinations of disease manifestations affecting the synovium, tendons, entheses, 
skin, and bone.  These manifestations of disease range in prevalence, with peripheral arthritis and 
variable degrees of psoriasis observed in all patients at some point during their disease course, axial 
disease in 40% to 74% depending on the criteria used for diagnosis,3 enthesitis in 25% to 51%, dactylitis 
in 8% to 59%4-6 and anterior uveitis in 2% to 25%.7  Additionally, patients with PsA are more likely to 
experience the co-morbid conditions of cardiovascular disease, metabolic syndrome, obesity, diabetes, 
fatty liver disease, inflammatory bowel disease, kidney disease, osteoporosis, fibromyalgia,8 depression,
and anxiety than healthy subjects,9 and have decreased quality of life and functional impairment.10,11
Patients with PsA require treatment of the entire spectrum of disease manifestations.  The primary goal 
of treating patients with PsA is to maximize long-term health-related quality of life, through control of 
symptoms, prevention of structural damage, normalization of function and social participation and 
abrogation of inflammation.  Initial treatment of musculoskeletal symptoms consists of nonsteroidal 
anti-inflammatory drugs (NSAIDs) and local corticosteroid injections, while topical therapies are used for 
the initial treatment of psoriasis.  For patients who experience lack of efficacy or toxicity with these 
measures, for the treatment of peripheral arthritis, both the European League Against Rheumatism 
(EULAR)12 and Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)13
recommend systemic therapy with conventional synthetic disease modifying anti-rheumatic drugs 
(csDMARDs) (methotrexate [MTX], leflunomide [LEF], sulfasalazine [SSZ], or ciclosporin A), followed by 
anti-tumor necrosis factor (TNF) therapy in patients who do not respond adequately to csDMARDs.  
Other biologic therapies (e.g., Interleukin [IL]-12/23 or IL-17 inhibitors) are also recommended as 
alternatives to anti-TNF inhibitors in selected patients with PsA.  Janus kinase (JAK) inhibitors are also 
now available to treat PsA.  Additional specific recommendations differ slightly between EULAR and 
GRAPPA, however recommendations for therapeutic choice are made based on a patient's clinical 
presentation as some manifestations of PsA, such as enthesitis, dactylitis, and axial disease are either 
not responsive or poorly responsive to csDMARDs.  Specific therapeutic options are also recommended 
for treatment of skin disease.12,13
Despite the beneficial results achieved with currently available biologic agents, approximately 40% of 
patients do not achieve at least 20% improvement in American College of Rheumatology (ACR) 
scores12,14-20 and only 58%21 to 61%22 of patients with PsA are able to achieve clinical remission after 
1 year of treatment.  Only approximately 43% achieve sustained remission for at least 1 year as 
measured by minimal disease activity (MDA).23  Thus, there remains a clear medical need for additional 
therapeutic options in PsA for patients with inadequate response to or intolerance to currently available 
therapies.
Page 9 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
Risankizumab is a humanized immunoglobulin (Ig) G1 antagonistic monoclonal antibody (mAb) directed 
against the p19 subunit of the human cytokine IL-23.  IL-23 plays a critical role in the differentiation and 
function of T helper (Th)17 cells, which have emerged as an important T-cell subpopulation involved in 
the pathogenesis of immune mediated disorders.24
The therapeutic rationale for an IL-23 antagonist in inflammatory diseases such as psoriasis (PsO), 
Crohn's disease (CD), ulcerative colitis (UC), and PsA is supported by several lines of evidence.  IL-23 
knockout mice are resistant to experimental arthritis, experimental autoimmune encephalitis, and 
inflammatory bowel disease.25-27  Blocking IL-23 with an antagonistic antibody reduced the inflammatory 
response seen in mouse models of autoimmune encephalitis, colitis, and ovalbumin challenge.28-30
Genome-wide association studies have demonstrated associations between polymorphisms of the gene 
for IL-23, or the gene for its receptor, and the diseases PsO, CD, UC, and PsA.31-34  In addition, excessive 
expression of IL-23 has been reported in affected skin in PsO, in the gut mucosa in CD, and in the 
synovial tissue of subjects with PsA.35-37
This study is being conducted to evaluate the treatment of moderately to severely active PsA in subjects 
who have a demonstrated inadequate response (lack of efficacy after a minimum 12 week duration of 
therapy) or intolerance to at least 1 csDMARD therapy (csDMARD-IR).  A previous clinical study 
suggested that risankizumab dosed at 150 mg at Weeks 0, 4, and every 12 weeks (q12w) thereafter is 
effective in the treatment of PsA.
Clinical Hypothesis
Risankizumab will provide better efficacy compared to placebo and will be well tolerated in subjects 
with moderately to severely active PsA who have had inadequate response or intolerance to therapy 
with 1 or more csDMARDs.
2.2 Benefits and Risks to Patients
Despite the availability of various PsA therapies, many subjects still do not respond adequately to these 
treatments, or gradually lose response over time.  Risankizumab is an antagonist specific for IL-23 which 
has been implicated in the pathophysiology of immune-mediated inflammatory diseases.  Nonclinical 
studies have shown that risankizumab has minimal inhibitory effects on IL-12, the inhibition of which has 
been associated with increased risk of serious infections.38,39  Selective IL-23 inhibition may not increase 
risk of serious infection, including mycobacterial infections.40
Interleukin-23 inhibition is not known to increase the risk of tuberculosis (TB) infection or impair the 
response to TB infection in animal models.41-42  Thus, low risk subjects with positive QuantiFERON testing 
do not need to be treated with anti-TB therapy prior to receiving risankizumab, but should be carefully 
monitored for any sign of TB reactivation.  Absence of TB reactivation despite not receiving anti-TB 
prophylaxis will provide important information in humans as to whether TB testing is required prior to 
treatment with risankizumab.
Efficacy of risankizumab for the treatment of moderate to severe psoriasis was demonstrated in 
four Phase 3, randomized, placebo- and/or active-comparator (adalimumab or ustekinumab) controlled 
pivotal studies in > 2000 subjects.  Risankizumab response rates were consistent across all 4 studies:  
Page 10 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
72% to 75% of subjects achieved 90% reduction in Psoriasis Area and Severity Index score (PASI 90), and 
84% to 88% achieved sPGA clear or almost clear at Week 16.  In addition, nearly all subjects (85% to 
90%) achieved PASI 75 at Week 16.
As of 29 March 2018, 2,471 subjects in the psoriasis studies were exposed to ≥ 1 dose of risankizumab at 
any dosage level (including subjects who received placebo for Weeks 0 to 16 and then switched to 
risankizumab), representing 3,352 patient years (PYs) of exposure.  Of the 2,471 subjects, 1,671 have 
had exposure to risankizumab at any dosage for at least 1 year.  In the pivotal global Phase 3 plaque 
psoriasis studies, over the initial 16 weeks of exposure, the frequencies of adverse events (AEs) were 
similar in subjects treated with risankizumab (48.9%) compared to placebo (48.3%).  Through Week 52, 
the exposure-adjusted rate of AEs in subjects in the risankizumab group was comparable to the event 
rate in the ustekinumab group (228.0 E/100 PYs in the risankizumab group and 281.0 E/100 PYs in the 
ustekinumab group).  Likewise, serious adverse events per 100 subject-years were 9.4 for subjects 
treated with risankizumab and 10.9 for those treated with ustekinumab.  Approximately 2.0% of 
subjects discontinued due to AEs.  Few subjects had AEs in the following areas of safety interest:  major 
adverse cardiac events (MACE), infections, malignancies, hepatic events, injection site events, or 
hypersensitivity reactions.
The Phase 2 program in PsA with risankizumab demonstrated efficacy for improvement in signs and 
symptoms of PsA and the safety results were consistent with those known to be associated with IL-23 
antagonists.  Taken together, the safety and efficacy data from the Phase 2 program support further 
development of risankizumab in Phase 3 in subjects with PsA.
Although rare, a potential for hepatic AEs is under constant surveillance by sponsors and regulators.  
Therefore, this study requires timely detection, evaluation, and follow-up of laboratory alterations in 
selected liver laboratory parameters to ensure subjects' safety.
Increases in major adverse cardiovascular events (MACE), including myocardial infarction (MI), 
cerebrovascular accident, and cardiovascular death, reported initially with anti-IL-12/23 agents, such as 
ustekinumab, have not been observed in longer term studies.  While the likelihood of increased MACE is 
small, all suspected cardiovascular events (serious or nonserious) observed in this study will be 
adjudicated by an independent committee.  An independent Cardiovascular Adjudication Committee 
(CAC) will adjudicate all observed cardio- and cerebro-vascular events and will remain blinded to 
treatment allocation (Section 6.4).
Injection-site reactions to biologic therapies may be characterized by redness, swelling or induration at 
the injection site.  Manifestations of anaphylaxis may include pruritus, hypotension, swollen lips and 
tongue, abdominal pain, and respiratory distress.  Both local and systemic hypersensitivity reactions and 
anaphylaxis are readily detectable, transient in nature, and manageable with standard medical 
treatment.  Subjects will be closely monitored during study drug administration.  The duration of the 
post-drug-administration safety surveillance is of 2 hours post first dose and 1 hour post all other doses.  
An independent Anaphylaxis Adjudication Committee (AAC) will adjudicate suspected anaphylactic 
reactions.  The AAC will remain blinded to treatment allocation (Section 6.5).
An external Independent Data Monitoring Committee (IDMC) will review unblinded safety data on a 
periodic basis.
Page 11 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
For further details, please see findings from completed studies, including safety data, in the 
Risankizumab Investigator Brochure.43
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.  At this time, the effects of risankizumab 
on the course of COVID-19 are not well defined.
3 STUDY OBJECTIVES AND ENDPOINTS
3.1 Objectives
Primary
Period 1 Double-Blind
To compare the efficacy of risankizumab 150 mg versus placebo for the treatment of signs and 
symptoms of PsA in the study population (see Section 2.1 and Section 4.1).
Secondary
Period 1 Double-Blind
1.
To compare the efficacy of risankizumab 150 mg versus placebo for the inhibition of progression 
of structural damage as assessed by radiographs in the study population.
2.
To compare the safety and tolerability of risankizumab 150 mg versus placebo in the study 
population.
Period 2 Open-Label
To evaluate the long-term safety, tolerability and efficacy of risankizumab 150 mg in subjects with PsA 
who have completed Period 1.
3.2 Primary Endpoint
The primary endpoint is the proportion of subjects achieving American College of Rheumatology 
(ACR)20 Response (ACR20) at Week 24.
3.3 Secondary Endpoints
Ranked secondary endpoints with multiplicity adjustment:
1.
Change from Baseline in Health Assessment Questionnaire – Disability Index (HAQ-DI) at 
Week 24;
2.
Proportion of subjects achieving Psoriasis Area Severity Index (PASI) 90 response at Week 24 (in 
the subset of subjects with a body surface area (BSA) ≥ 3% at Baseline);
Page 12 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
3.
Proportion of subjects achieving ACR20 at Week 16;
4.
Proportion of subjects achieving Minimal Disease Activity (MDA) at Week 24;
5.
Change from Baseline in modified Nail Psoriasis Severity Index (mNAPSI) at Week 24 in the 
subset of subjects with nail psoriasis at Baseline; 
6.
Change from Baseline in Fingernail-Physician Global Assessment (PGA-F) at Week 24 in the 
subset of subjects with nail psoriasis at Baseline;
7.
Proportion of subjects with resolution of enthesitis (LEI = 0) at Week 24 in subjects with 
enthesitis at Baseline;
8.
Proportion of subjects with resolution of dactylitis (LDI = 0) at Week 24 in subjects with dactylitis 
at Baseline; 
9.
Change from Baseline in modified Total Sharp Score (PsA-mTSS) at Week 24;
10. Change from Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component 
Summary (PCS) at Week 24;
11. Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT 
Fatigue) Questionnaire at Week 24.
Other secondary endpoints without multiplicity adjustment are:
1.
Proportion of subjects achieving ACR50 response at Week 24;
2.
Proportion of subjects achieving ACR70 response at Week 24.
3.4 Additional Endpoints
Additional endpoints at the scheduled time points as indicated in Appendix D: 
!
Proportion of subjects achieving ACR20, ACR50, or ACR70 response;
!
Proportion of subjects with no radiographic progression (defined as change from Baseline in PsA 
mTSS ≤ 0) at Week 24, Week 52, and Week 100;
!
Change from Baseline in joint space narrowing score (JSN) and joint erosion score (JES), as 
assessed by radiographs at Week 24, Week 52, and Week 100;
!
Change from Baseline in individual components of ACR response;
!
Change from Baseline in LDI in subjects with dactylitis at Baseline;
!
Change from Baseline in dactylitis count in subjects with dactylitis at Baseline;
!
Proportion of subjects with resolution of dactylitis sites included in the LDI in subjects with 
dactylitis at Baseline;
!
Change from Baseline in LEI for subjects with enthesitis in the LEI at Baseline;
Page 13 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
!
Proportion of subjects with resolution of enthesitis sites included in the LEI for subjects with 
enthesitis in the LEI at Baseline;
!
Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis 
Index for subjects with enthesitis in the SPARCC at Baseline;
!
Proportion of subjects with resolution of enthesitis sites included in the SPARCC Enthesitis Index 
for subjects with enthesitis in the SPARCC at Baseline;
!
Change from Baseline in total enthesitis count for subjects with enthesitis in the LEI or SPARCC 
at Baseline;
!
Proportion of subjects with resolution of enthesitis in LEI and SPARCC for subjects with 
enthesitis in the LEI or SPARCC at Baseline;
!
Proportion of subjects achieving PASI 75 response (in the subset of subjects with a BSA ≥ 3% at 
Baseline);
!
Proportion of subjects achieving PASI 90 response (in the subset of subjects with a BSA ≥ 3% at 
Baseline);
!
Proportion of subjects achieving PASI 100 response (in the subset of subjects with a BSA ≥ 3% at 
Baseline);
!
Proportion of subjects with both ACR 50 and PASI 90 response (in the subset of subjects with a 
BSA ≥ 3% at Baseline)
!
Change from Baseline in BSA-PsO (in the subset of subjects with a BSA ≥ 3% at Baseline);
!
Proportion of subjects who achieve a Modified Psoriatic Arthritis Response Criteria (PsARC) 
response;
!
Change from Baseline in Disease Activity Score 28 using high sensitivity C-Reactive Protein 
(DAS28-hsCRP);
!
Change from Baseline in PsA Disease Activity Score (PASDAS);
!
Change from Baseline in Disease Activity In Psoriatic Arthritis (DAPSA) score;
!
Change from Baseline in the FACIT-Fatigue Questionnaire;
!
Change from Baseline in SF-36 Health Questionnaire;
!
Change from Baseline in EuroQol-5D-5L (EQ-5D-5L) Questionnaire; 
!
Change from Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire;
!
Proportion of subjects with health resource utilization (HRU) since the last study visit;
!
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI, in subjects 
with axial spondylitis at Baseline);
!
Proportion of subjects with BASDAI 50 response (in subjects with axial spondylitis at Baseline);
!
Change from Baseline in morning stiffness (mean of BASDAI Questions 5 and 6, in subjects with 
axial spondylitis at Baseline and all subjects);
Page 14 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
!
Change from Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS, in subjects with 
axial spondylitis at Baseline);
!
Proportion of subjects with ASDAS Inactive Disease (in subjects with axial spondylitis at 
Baseline);
!
Proportion of subjects with ASDAS Major Improvement (in subjects with axial spondylitis at 
Baseline);
!
Proportion of subjects with ASDAS Clinically Important Improvement (in subjects with axial 
spondylitis at Baseline);
!
Change from Baseline in PGA-F (in subjects with nail psoriasis at Baseline);
!
Change from Baseline in mNAPSI (in subjects with nail psoriasis at Baseline);
!
Proportion of subjects achieving a clinically meaningful improvement in HAQ-DI (change ≤ –0.35) 
in subjects with ≥ 0.35 HAQ-DI at Baseline.
3.5 Safety Endpoints
Safety evaluations include adverse event (AE) monitoring, physical examinations, vital sign 
measurements, and clinical laboratory testing (hematology, chemistry) as a measure of safety and 
tolerability for the entire study duration.
3.6 Pharmacokinetic Endpoints
Serum risankizumab concentrations, anti-drug antibodies (ADA), and neutralizing antibodies (nAb) will 
be determined at the visits indicated in the Activity Schedule (Appendix D).  Serum risankizumab 
concentrations will be summarized at the sampling time points using descriptive statistics.  Anti-drug 
antibody titers will be tabulated for each ADA positive subject at the respective study visits.  The 
number and percentage of subjects with ADA and nAb will be calculated. 
3.7 Biomarker Sampling
Optional whole blood and urine samples will be collected from subjects who provide consent to 
investigate prognostic, surrogate, predictive and pharmacodynamic biomarkers.  The samples may be 
analyzed as part of a multi-study assessment of factors influencing the subjects' response to the study 
drug (or drugs of the same or similar class) or the development and progression of PsA or related 
conditions.  The samples may also be used to develop new diagnostic tests, therapies, research methods 
or technologies.  Assessments may include but may not be limited to nucleic acids, proteins, 
metabolomic analytes, or lipids.  Research on samples collected in Germany will be restricted to PsA and 
risankizumab.
Page 15 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
4 INVESTIGATIONAL PLAN
4.1 Overall Study Design and Plan
This is a Phase 3, global, multicenter study that will evaluate subjects with moderately to severely active 
psoriatic arthritis who have had an inadequate response or intolerance to at least 1 csDMARD 
(csDMARD-IR). 
The study consists of a Screening Period (approximately 35 days), Period 1, Period 2, and a 20-week 
Follow-up Period (Figure 1).  Period 1 is a 24-week randomized, double-blind, placebo-controlled, 
parallel-group period.  Period 2 starts at Week 24.  To maintain the blind to the original treatment 
allocation, treatment at the Week 24 Visit will be blinded:  subjects randomized to placebo will receive 
blinded risankizumab 150 mg, and subjects randomized to risankizumab will receive blinded placebo.  At 
Week 28 and for the remaining dosing visits (to Week 208), all subjects will receive open-label 
risankizumab 150 mg q12w.  Subjects will remain blinded to the original randomization allocation for the 
duration of the study.  The total study duration is 228 weeks including a telephone call 140 days 
(20 weeks) after last dose of study drug. 
Screening Period
Subjects will be screened for eligibility to enroll in the study until approximately 880 subjects (440/arm) 
have been randomized.  Once 880 subjects have been randomized, subjects who have started screening 
but have not yet been randomized will be allowed to enroll in the study if eligible.  No further subjects 
will be screened once a sufficient number of subjects to fulfill the enrollment target have entered the 
screening process.
During the screening period, subjects will receive a full explanation of the study design and study 
procedures, provide a written informed consent, and undergo the screening procedures outlined in 
Appendix D.  Subjects who do not meet all the laboratory eligibility criteria, but whose values are within 
30% of the allowable laboratory value for any specific laboratory determination as defined in 
Section 5.1, at the principal investigator's discretion, may return for redraw of the specific laboratory 
test(s) that did not meet eligibility criteria.  Other laboratory parameters associated with the Screening 
Visit should not be re drawn. 
In addition, subjects not meeting eligibility criteria may undergo a second Screening Visit at the 
discretion of the Investigator.  The subject must meet all the eligibility criteria in order to qualify for the 
study.  There is no minimum period of time a subject must wait to re-screen for the study.  For 
consideration beyond two Screening Visits, AbbVie must be consulted.  Most screening procedures will 
be repeated during this second Screening Visit.  Possible exceptions are noted below.
If a subject has had an Interferon-Gamma Release Assay (IGRA; QuantiFERON Tuberculosis [TB] Gold 
test) and/or a purified protein derivative (PPD) test (or equivalent) (or both if required per local 
guidelines), and/or electrocardiogram (ECG) within the previous 90 days, these tests will not be required 
to be repeated for screening provided the conditions noted in the Operations Manual are met.  
If allowed by local regulation, radiographs of hands and feet may be repeated.
Page 16 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
Period 1:  Double-Blind Period
Eligible subjects will be randomized to receive blinded risankizumab or placebo in 1:1 ratio through 
Week 24.  Study visits occur in Period 1 at Week 0, Week 4, Week 8, Week 12, Week 16, and dosing in 
Period 1 occurs at Week 0, Week 4, and Week 16 as outlined in Figure 1.
Period 2:  Open-Label Period
During Period 2, all subjects will receive risankizumab.  To maintain the blind to the original treatment 
allocation, treatment at the Week 24 Visit will be blinded:  subjects randomized to placebo will receive 
blinded risankizumab 150 mg, and subjects randomized to risankizumab will receive blinded placebo.  At 
Week 28 and for the remaining dosing visits all subjects will receive open-label risankizumab 150 mg 
q12w. 
Study dosing in Period 2 occur at Week 24, Week 28, and q12w thereafter until the final dosing time 
point at Week 208 as outlined in Figure 1.
Follow-up Period
The Follow-up Period consists of a completion visit 12 weeks after the last study drug dose.  An 
additional follow-up phone call will occur 8 weeks later, 20 weeks after last study drug dose, to 
determine the status of any ongoing AEs/serious adverse events (SAEs) or the occurrence of any new 
AEs/SAEs.
The schematic of the study is shown in Figure 1.  Further details regarding study procedures are located 
in the Operations Manual.
Figure 1.
Study Schematic
LEGEND:
BL = Baseline; RCT = randomized controlled trial; W = Week
*
At Week 24, subjects randomized to placebo in Period 1 will receive a blinded dose of risankizumab.  Subjects randomized 
to risankizumab treatment in Period 1 will receive a blinded dose of placebo. 
Page 17 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
**
At Week 28, subjects randomized to placebo in Period 1 will receive a 2nd dose of risankizumab.  Subjects randomized to 
risankizumab in Period 1 will receive risankizumab (scheduled dose). 
*** From Week 40 to Week 208 Visits, doses occur q12w. 
†
Follow-up phone call.
Dosing.
Bilateral radiographs.  Depending on response at Week 12 and Week 16, radiographs at Week 16 will not apply to all 
subjects.
a.
At Week 16, subjects classified as non-responders (defined as not achieving at least a 20% improvement in either or both 
tender joint count [TJC] and swollen joint count [SJC] at both Week 12 and Week 16 compared to Baseline) will have the 
option to add or modify rescue concomitant medications/therapy as described in Section 5.4.  Rescue therapy qualification 
occurs only at Week 16 Visit.
b.
Starting at Week 36, subjects classified as non-responders will be discontinued from study drug.  See Section 5.5 for 
details.
4.2 Discussion of Study Design
Choice of Control Group
Placebo control (with up to 2 background csDMARDs) will be used in this study to address potential 
confounding factors, such as placebo effect, potential investigator bias in safety and efficacy 
assessment, or regression to the mean in endpoint scoring.  At Week 24, all subjects assigned to placebo 
at Baseline will be switched to risankizumab treatment. 
Appropriateness of Measurements
Standard statistical, clinical, and laboratory procedures will be utilized in this study.  All efficacy 
measurements in this study are standard for assessing disease activity in subjects with PsA.  
Suitability of Subject Population
The intended study population is subjects with moderately to severely active PsA who have had an 
inadequate response or intolerance to prior csDMARD treatment.
Selection of Doses in the Study
Risankizumab dose of 150 mg subcutaneous (SC) administered at Weeks 0, 4, and q12w thereafter is 
selected for this study.  Subjects randomized to placebo will receive a risankizumab dose of 150 mg SC at 
the same dosing frequency starting Week 24 (at Week 24, 28, and q12w thereafter) as those 
randomized to risankizumab at Week 0.
The dose selection in this study was informed by analyses of safety and efficacy data from: 
!
Completed Phase 1 through 3 PsO studies (Studies 1311.1, 1311.2, M16-008, M15-995, 
M16-010);
!
Ongoing Phase 3 PsO Study M15-992
!
Phase 2 PsA Study M16-002 (1311.5)
Page 18 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
As well as:
!
Safety data from completed Phase 2 studies in subjects with ankylosing spondylitis (AS) 
(Study 1311.8) and CD (Study 1311.6)
!
Analyses of the exposure-response relationship of efficacy in PsA Phase 2 study 
In Phase 3 studies in subjects with PsO, a risankizumab dose of 150 mg SC administered at Weeks 0, 4, 
and q12w thereafter was evaluated.  In the Phase 2 study in subjects with PsA, risankizumab 150 mg SC 
was administered as frequently as every 4 weeks over a period of 16 weeks.  In Phase 2 studies in 
subjects with PsO, AS and CD, doses of risankizumab up to 180 mg SC were administered every 8 weeks 
or every 12 weeks for up to 24 weeks (Studies 1311.2, 1311.6, and 1311.8) and intravenous (IV) doses of 
up to 600 mg were administered every 4 weeks for 12 to 24 weeks (Study 1311.6 in subjects with CD).
In the Phase 2 study of risankizumab in subjects with PsA (Study M16-002), 4 risankizumab dosing 
regimens were evaluated:  single dose of 75 mg at Week 0 (N = 20); 150 mg at Week 0 and 12 (N = 39); 
150 mg at Week 0, 4, and 16 (N = 42); and 150 mg at Week 0, 4, 8, 12, and 16 (N = 42).  In this study, 
risankizumab-treated subjects demonstrated significant improvement compared to placebo in key 
rheumatology endpoints (ACR20/50/70 and DAS28-CRP) and skin-related endpoints (PASI 75/90/100).  
At Week 16, ACR20/50/70 responses were 62%/24%/7% in subjects who received risankizumab doses of 
150 mg SC at Weeks 0, 4, and 16 compared to 36%/12%/0% in subjects on placebo.  The Week 16 PASI 
75/90/100 responses, in subjects with baseline body surface area of skin symptoms ≥ 3%, were 
70%/67%/50% in subjects who received risankizumab doses of 150 mg SC at Weeks 0, 4, and 
16 compared to 10%/10%/10% in subjects on placebo.  No further improvements in ACR or PASI 
responses were noted in subjects who received risankizumab doses of 150 mg at Weeks 0, 4, 8, 12, and 
16.
Risankizumab exposures in subjects with PsA in the Phase 2 study (Study M16-002) were comparable to 
those in subjects with PsO in Phase 1 through 3 studies at similar dose and dosing frequency.  The ADA 
incidence (approximately 12% [17/140] over 32 weeks) in risankizumab-treated subjects with PsA 
(Study M16-002) was comparable to that in subjects with PsO or CD, and presence of ADA did not affect 
risankizumab plasma exposures. 
Exposure-response analyses were conducted to explore the relationship between risankizumab Cavg (the 
average plasma concentration from Week 0 – 16) and ACR20/50/70 and PASI 75/90/100 responses at 
Week 16 in subjects with PsA (Study M16-002).  For this analysis, Cavg from Weeks 0 to 16 was used as an 
exposure metric, as it accounts for the differences in risankizumab dosing frequency across different 
arms in the study.  A shallow trend for exposure-response relationship was observed for ACR20, PASI 75, 
and PASI 90 across the risankizumab regimens evaluated in the Phase 2 study.  
Only 20 subjects received the risankizumab 75 mg dose in Study M16-002 and among these, PASI 
assessments were performed only in subjects with skin symptoms on BSA ≥ 3%, and only 9 subjects met 
that criterion.  Since very limited data were available at the 75 mg dose, these subjects were excluded 
from the exposure-responses analyses.  Excluding these subjects showed a clear exposure-response 
relationship for ACR20 and PASI 75/90/100 responses, with plateau of efficacy at Cavg associated with 
the risankizumab dosing regimen of 150 mg at Weeks 0, 4, and 16.  These results support that a 
Page 19 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
risankizumab dosing regimen of 150 mg at Week 0, 4, and 16 is optimal for efficacy for subjects with 
PsA.
Risankizumab was well tolerated in the Phase 2 study in subjects with PsA, with no discernible 
differences in treatment-emergent AEs and laboratory abnormalities between risankizumab-treated and 
placebo-treated subjects and no dose-related trends in risankizumab-treated subjects across all dosing 
regimens with doses up to 150 mg SC every 4 weeks.  Additionally, safety data from ongoing Phase 3 
study (Study M15-992) and completed Phase 2 and 3 studies (Studies 1311.2, M15-995, M16-008, and 
M16-010) in subjects with PsO, and final safety data from completed Phase 2 studies (Studies 1311.6 
and 1311.8) in subjects with CD (Study 1311.6) and AS (Study 1311.8) indicate that risankizumab 
administration was safe and generally well tolerated by study participants, with no dose limiting 
toxicities.  It is noteworthy that approximately 2120 PsO subjects have been enrolled in Phase 3 studies 
at a dose of 150 mg SC administered at Week 0, 4, and q12w thereafter, for up to 2 years in duration.  
Risankizumab doses of up to 600 mg IV were administered every 4 weeks for 12 to 24 weeks and up to 
180 mg SC were administered every 8 weeks or every 12 weeks for up to 24 weeks in Phase 2 studies in 
subjects with CD, PsO, or AS.
In addition, single doses of risankizumab up to 300 mg SC and 1200 mg intravenous (IV) have been 
administered to healthy subjects in a Phase 1 study (Study M16-513), and safety data indicate that 
risankizumab administration was safe and generally well tolerated by study participants with no dose-
limiting toxicities.  In addition, a single dose of risankizumab 1800 mg has been administered to healthy 
subjects in another Phase 1 study (Study M16-533), and preliminary safety data indicate that 
risankizumab administration was safe and generally well tolerated by study participants.  Details of the 
safety findings from completed or ongoing Phase 1 through 3 studies in healthy subjects or subjects with 
PsA, PsO, CD, and AS are provided in the Investigator's Brochure.
In summary, the risankizumab dose selected for evaluation in this Phase 3 study is expected to be 
efficacious based on data from Phase 2 PsA study (Study M16-002) with an acceptable safety profile 
based on data from completed and ongoing Phase 2 and 3 studies in subjects with PsO, CD and AS.
Treatment Duration Rationale
Period 1 is a 24-week randomized, double-blind, placebo-controlled parallel-group period.  It is designed 
to compare the efficacy, safety, and tolerability of risankizumab versus placebo in subjects with 
moderately to severely active PsA.  The treatment duration of Period 1 is designed to test the superiority 
of risankizumab versus placebo for achieving the primary efficacy endpoint (ACR20 at Week 24) and 
several secondary endpoints.  Period 2 begins at Week 24.  It is designed to assess long-term safety and 
maintenance of treatment response to risankizumab for subjects who have completed Period 1.
5 STUDY ACTIVITIES
5.1 Eligibility Criteria
Subjects must meet all of the following criteria in order to be included in the study.  Anything other than 
a positive response to the questions below will result in exclusion from study participation.
Page 20 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
Consent
1. Subject must be functionally able to read and understand a written informed consent form, 
study-related instructions, and study questionnaires.
2. Subjects must voluntarily sign and date an informed consent, approved by an Independent 
Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening 
or study-specific procedures.  The use of Legally Authorized Representatives (LARs) is prohibited 
for this protocol.
3. Employees of the sponsor and/or study sites and their family members may not be enrolled in 
this study.
Demographic and Laboratory Assessments
4. Adult male or female, at least 18 years old (subjects must also meet the legal age of majority 
per local law).
5. Laboratory values meeting the following criteria within the Screening period prior to the 
first dose of study drug:
!
Serum aspartate transaminase (AST) < 2 × upper limit of normal (ULN);
!
Serum alanine transaminase (ALT) < 2 × ULN;
!
Serum total bilirubin ≤ 2.0 mg/dL; except for subjects with isolated elevation of indirect 
bilirubin relating to Gilbert syndrome;
!
Total white blood cell (WBC) count > 3,000/μL;
!
Absolute neutrophil count (ANC) > 1,500/μL;
!
Platelet count > 100,000/μL;
!
Hemoglobin > 8.0 g/dL;
6. Subject is willing and able to comply with procedures required in this protocol.
Disease Activity
7. Subject has a clinical diagnosis of PsA with symptom onset at least 6 months prior to the 
Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) at Screening Visit.
8. Subject has active disease defined as ≥ 5 tender joints (based on 68 joint counts) and 
≥5 swollen joints (based on 66 joint counts) at both the Screening Visit and Baseline.
9. Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of ≥ 2 cm diameter or 
nail changes consistent with psoriasis at the Screening Visit.
10. Presence of either at Screening:
!
≥ 1 erosion on radiograph as determined by central imaging review or;
!
hs-CRP ≥ 3.0 mg/L
Page 21 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
Subject History
11. To be considered csDMARD-IR:
!
Subject must have demonstrated an inadequate response (lack of efficacy after minimum 
12 week duration of therapy) to previous or current treatment with at least 1 of the 
following csDMARD at maximally tolerated dose:  MTX, sulfasalazine (SSZ), leflunomide
(LEF), apremilast, bucillamine and iguratimod, or ciclosporin A.  
!
MTX-IR is defined as an inadequate response (lack of efficacy after minimum 12 weeks 
duration of therapy) at the following doses ranges:  ≥ 15 mg/week, or ≥ 10 mg/week in 
subjects who are intolerant of MTX at doses ≥ 12.5 mg/week after complete titration 
(for subjects in some countries, such as China, Korea, Malaysia, Singapore, Hong Kong, 
Taiwan, and Japan inadequate response to MTX is defined as ≥ 7.5 mg/week or as 
required per local authorities). 
!
Alternatively, subject must have an intolerance to or contraindication for csDMARDs as 
determined by the investigator. 
12. No evidence of hepatitis B (HBV), hepatitis C (HCV) infection, human immunodeficiency 
virus (HIV) infection, or TB defined as: 
!
HBV:  Hepatitis B surface antigen (HBs Ag) positive (+) test or detected sensitivity on the HBV 
DNA polymerase chain reaction (PCR) qualitative test for subjects who are hepatitis B core 
antibody (HBc Ab) positive (+) (and for hepatitis B surface antibody [HBs Ab] positive [+] 
subjects where mandated by local requirements). 
!
HCV:  HCV RNA detectable in any subject with anti-HCV antibody (HCV Ab).
!
HIV:  Confirmed positive anti-HIV antibody (HIV Ab) test.  Ineligibility due to a positive HIV 
test should be documented in the CRF as a screen failure due to criterion 16 to keep this test 
result private.
!
TB:  Subjects with a positive QuantiFERON® TB /PPD 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.  If presence of latent TB is established, subjects are not 
required to be treated with prophylactic anti-TB therapy prior to or during the study, if the 
subject is considered low risk for reactivation per the investigator judgment.
13. No active systemic infection during the last 2 weeks prior to Baseline Visit (exception:  
common cold), as assessed by the investigator.
14. No documented active or suspected malignancy or history of any malignancy within the last 
5 years except for successfully treated non-melanoma skin cancer (NMSC) or localized 
carcinoma in situ of the cervix.
15. No history of organ transplantation requiring continued immunosuppression.
16. No major surgery performed within 12 weeks prior to randomization or planned during the 
conduct of the trial (e.g., hip replacement, aneurysm removal, stomach ligation).
Page 22 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
17. No history of clinically significant medical conditions or any other reason, including any 
physical, psychological, or psychiatric condition that in the opinion of the Investigator would 
compromise the safety or interfere with the subject's participation in this study, including a 
positive HIV test, or would make the subject an unsuitable candidate to receive study drug or 
would put the subject at risk by participating in the protocol; or permanently wheelchair-bound 
or bedridden or very poor functional status which prevents the ability to perform self-care.
18. No active skin disease other than psoriasis which could interfere with the assessment of 
psoriasis.
19. No history of extra-articular manifestations of PsA (e.g., PsO, uveitis, or inflammatory bowel 
disease [IBD]) that is not clinically stable for at least 30 days prior to Screening.
20. No prior joint surgery at joints to be assessed within this study in the 8 weeks prior to the 
Baseline Visit or treatment with intra-articular, intramuscular, intravenous, trigger point or 
tender point, intra-bursa, or intra-tendon sheath corticosteroids in the 8 weeks prior to the 
Baseline Visit.  
21. No history of fibromyalgia, any arthritis with onset prior to age 17 years or current diagnosis 
of inflammatory joint disease other than PsA (including, but not limited to rheumatoid arthritis, 
gout, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, systemic 
lupus erythematosus.) 
!
Prior history of reactive arthritis or axial spondyloarthritis including ankylosing spondylitis 
and non-radiographic axial spondyloarthritis is permitted if documentation of change in 
diagnosis to PsA or additional diagnosis of PsA is made. 
!
Prior history of fibromyalgia is permitted if documentation of change in diagnosis to PsA or 
documentation that the diagnosis of fibromyalgia was made incorrectly.
22. No history of clinically significant (per investigator's judgment) drug or alcohol abuse within 
the last 6 months.
23. No history of an allergic reaction or significant sensitivity to constituents of the study drug 
(and its excipients) and/or other products in the same class.
Contraception
24. A negative serum pregnancy test is required at the Screening Visit for all female subjects of 
childbearing potential.  In addition a negative urine pregnancy test is required at Baseline prior 
to the first dose of study drug for all female subjects of childbearing potential.  Subjects with a 
borderline serum pregnancy test at Screening must have a negative serum pregnancy test 
≥3 days later to document continued lack of a positive result. 
25. If female, subject must be of non-childbearing potential (as defined in Section 5.2) OR a 
female of childbearing potential practicing at least 1 protocol-specified method of birth control, 
that is effective from Study Day 1 through at least 140 days (20 weeks) after the last dose of 
study drug (local practices may require 2 methods of birth control).
26. Female subject may not be pregnant, breastfeeding, or considering becoming pregnant
during the study and for at least 140 days (20 weeks) after the last dose of study drug.
Page 23 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
Concomitant Medications
27. Subjects are not required to be receiving csDMARD therapy to participate in the clinical trial.  
However, subjects on current treatment with concomitant csDMARDs at study entry must be on 
≤ 2 of only the following csDMARDs for ≥ 12 weeks and at stable dose for ≥ 4 weeks prior to the 
Baseline Visit at the following doses:  
!
MTX (≤ 25 mg/week); 
!
SSZ (≤ 3000 mg/day); 
!
LEF (≤ 20 mg/day); 
!
apremilast (≤ 60 mg/day); 
!
hydroxychloroquine (HCQ) (≤ 400 mg/day); 
!
bucillamine (≤ 300 mg/day); 
!
iguratimod (≤ 50 mg/day) 
!
ciclosporin A (≤ 5 mg/kg/day)
No other csDMARDs are permitted.  The combination of MTX and LEF is exclusionary.
Where mandated by local requirements only, treatment with at least one of the following 
medications is required:  non-biologic csDMARDs, NSAIDs, acetaminophen low potency opioids 
(tramadol, codeine, or hydrocodone, alone or in combination with acetaminophen), or oral 
corticosteroids at dose equivalent to prednisone ≤ 10 mg/day.
28. Subjects who need to discontinue or modify dose or dosing interval of their csDMARD 
therapy prior to the Baseline Visit in order to comply with Eligibility Criterion 27 must follow the 
procedure specified below:
!
LEF must be discontinued ≥ 8 weeks prior to baseline if no elimination procedure was 
followed, or adhere to an elimination procedure (i.e., 11 days with cholestyramine or 
activated charcoal or as per local label);
!
Discontinuation or modification of all other csDMARDS must occur ≥ 4 weeks prior to 
Baseline or at least five times the mean terminal elimination half-life of the drug before 
undergoing the Baseline Visit, whichever is longer.
29. Subjects are permitted to take stable doses of NSAIDs, acetaminophen/paracetamol, low-
potency opiates (tramadol, codeine, or hydrocodone, alone or in combination with 
acetaminophen), oral corticosteroids (equivalent to prednisone ≤ 10 mg/day), or inhaled 
corticosteroids for stable medical conditions.  However, these medications must have been at a 
stable dose for ≥ 1 week prior to the Baseline Visit without an anticipated dose adjustment 
during study duration.
30. Subjects must have discontinued all opiates (except for tramadol, codeine, or hydrocodone, 
alone or in combination with acetaminophen) for ≥ 1 week prior to the first dose of study drug 
(refer to Section 5.3).
31. No prior exposure to any biologic immunomodulation agents including risankizumab.
Page 24 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
32. No use of the following concomitant psoriasis treatments within the specified timeframe 
prior to Baseline Visit:
!
Oral retinoids within 4 weeks;
!
Fumarates within 1 week;
!
Psoralens and Ultraviolet A (PUVA) within 4 weeks;
!
Ultraviolet A (UVA) and Ultraviolet B (UVB) within 2 weeks;
!
Topical treatments, including medicated shampoos, within 2 weeks, with the exception of 
the following:  
!
Bland (without beta or alpha hydroxy acids) emollients
!
Low potency (Class VI or VII) topical corticosteroids on the palms, soles, face, 
inframammary area and groin only.
!
Topical anti-itch treatment with no expected effect on psoriatic skin lesions
33. Subject must not have received any live vaccine within 6 weeks prior to the first dose of 
study drug, or expected need of live vaccination during study participation including at least 
140 days (20 weeks) after the last dose of study drug (refer to Section 5.3).
34. Subject must not have been treated with any investigational drug within 30 days or 
5 half-lives of the drug (whichever is longer) prior to the first dose of study drug or is currently 
enrolled in another interventional clinical study.
5.2 Contraception Recommendations
If female, subject must be either postmenopausal or practicing birth control methods outlined below.  
Postmenopausal is defined as: 
!
Age > 55 years with no menses for 12 or more months without an alternative medical cause;
!
Age ≤55 years with no menses for 12 or more months without an alternative medical cause 
AND an follicle stimulating hormone (FSH) level > 40 international units (IU)/L;
OR
!
Permanently surgically sterile (bilateral oophorectomy, bilateral salpingectomy or 
hysterectomy).
Women of childbearing potential are defined as having experienced menarche and are: 
!
Not postmenopausal (as defined above);
!
Not permanently sterilized (e.g., hysterectomy, bilateral oophorectomy or bilateral 
salpingectomy).  
Page 25 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
Women of childbearing potential must practice at least one of the following methods of birth control 
throughout the study, including 140 days (20 weeks) after the last study drug dose is given.
!
Combined (estrogen and progestogen containing) hormonal birth control (oral, intravaginal, 
transdermal, injectable) associated with inhibition of ovulation initiated at least 1 month prior to 
study Baseline (Day 1);
!
Progestogen-only hormonal birth control (oral, injectable, implantable) associated with 
inhibition of ovulation initiated at least 1 month prior to study Baseline (Day 1);
!
Bilateral tubal occlusion/ligation (can be via hysteroscopy, provided a hysterosalpingogram 
confirms success for the procedure);
!
Intrauterine device (IUD);
!
Intrauterine hormone-releasing system (IUS);
!
Vasectomized sexual partner(s) (provided the vasectomized partner has received medical 
assessment of the surgical success and is the sole sexual partner of the trial participant);
!
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).
If required per local guidelines, male or female condom with or without spermicide OR cap, diaphragm 
or sponge with spermicide should be used in addition to one of the birth control methods listed above 
(excluding true abstinence).
Contraception recommendations related to use of concomitant therapies prescribed per standard of 
care should be based on the local label.
5.3 Prohibited Medications and Therapy
During the study all other investigational drugs are prohibited.  In addition, the following drugs are 
prohibited.
JAK Inhibitors
Concomitant use of JAK inhibitors (including but not limited to ruxolitinib [Jakafi®], tofacitinib [Xeljanz®], 
baricitinib, upadacitinib, and filgotinib).
Corticosteroids
!
Intravenous (IV), intramuscular (IM) and epidural corticosteroids 
!
Intra-articular, trigger point or tender point, intra-bursa, and intra-tendon sheath corticosteroids 
are exclusionary and NOT allowed in Period 1 up to Week 36 unless a subject qualifies for rescue 
therapy at the Week 16 Visit;
!
Oral corticosteroids (refer to Section 5.1 Eligibility Criterion 29 for more information).
Page 26 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
Biologic Therapies
All prior and concomitant biologic therapies and biosimilar versions of biologic drugs for the treatment 
of PsA are prohibited during the study (Period 1 and Period 2).  Examples of biologic therapies include 
but are not limited to the following: 
!
Humira® (adalimumab) 
!
Enbrel® (etanercept) 
!
Remicade® (infliximab) 
!
Orencia® (abatacept) 
!
Cimzia® (certolizumab pegol) 
!
Simponi® (golimumab) 
!
Stelara® (ustekinumab) 
!
Taltz® (ixekizumab) 
!
Cosentyx® (secukinumab) 
!
Tremfya® (guselkumab)
Opiates
Opiates, with the exception of tramadol, codeine, or hydrocodone, alone or in combination with 
acetaminophen, are not permitted during the study and subjects must have discontinued at least 
1 week prior to the first dose of study drug. 
Opiates including (but not limited to):
!
buprenorphine
!
fentanyl
!
hydromorphone
!
levophanol
!
meperidine
!
methadone
!
morphine
!
oxycodone
!
oxymorphone
!
propoxyphene 
Page 27 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
Vaccines
Live vaccines are not permitted during the study participation including up to 140 days (20 weeks) after 
the last dose of study drug.  Although not mandated by the protocol, it is recommended that subjects be 
up to date on vaccines recommended by local guidelines.  If the subject and investigator choose to 
administer live vaccines, these vaccinations must be completed at least 6 weeks before first dose of 
study drug. 
Examples of live vaccines include, but are not limited to, the following:
!
Monovalent live attenuated influenza A (H1N1) (intranasal)
!
Seasonal trivalent live attenuated influenza (intranasal)
!
Herpes zoster (Zostavax®)
!
Rotavirus
!
Varicella (chicken pox)
!
Measles-mumps-rubella or measles mumps rubella varicella
!
Oral polio vaccine
!
Smallpox
!
Yellow fever
!
Bacille Calmette-Guérin (BCG)
!
Oral Typhoid
Vaccines that are inactivated, toxoid, or biosynthetic may be administered at any time without 
restrictions.  Examples of common vaccines that meet these criteria include but are not limited to:  
injectable influenza vaccine, pneumococcal, pertussis (Tdap), and Shingrix®. 
5.4 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 reasons for use; dates of administration, including start and end dates; and dosage 
information including dose, route, and frequency on the appropriate electronic case report form (eCRF) 
through the last follow-up telephone call (up to Week 228).
All prior drug therapies for PsA, since initial diagnosis, must be recorded in the eCRF along with the 
dates of first and last dose, maximum dosage taken, route of administration and reason for 
discontinuation, if known.  Additionally, the investigator will record response to csDMARDs (e.g., no 
response, inadequate response, loss of response), intolerance to csDMARDs, and/or contraindication for 
csDMARDs.
Page 28 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
Any questions regarding concomitant or prior therapy should be raised to the AbbVie emergency 
medical contact.  Information regarding potential drug interactions with risankizumab can be located in 
the Risankizumab Investigator's Brochure.
Subjects must be able to safely discontinue any prohibited medications prior to initial study drug 
administration as specified in the Eligibility Criteria (Section 5.1); where not specified, discontinuation 
must occur 5 half-lives or 4 weeks, whichever is longer, prior to initial study drug administration.  
Subjects must be consented for the study prior to discontinuing any prohibited medications for the 
purpose of meeting study eligibility.
Allowed Concomitant Medications/Therapy
Subjects are allowed to be on 0, 1, or 2 background csDMARDs.  They must continue on their stable 
background csDMARD treatment through Week 36, unless the subject qualifies for rescue therapy at the 
Week 16 Visit.  Background csDMARDs should have been started ≥ 12 weeks prior to the Baseline Visit 
and without dosing or administration changes ≤ 4 weeks prior to the Baseline Visit.  Subjects taking MTX 
should take a dietary supplement of oral folic acid (or equivalent) throughout study participation.
At any time, the background csDMARD dose may be decreased for safety reasons. 
Additionally subjects must also continue on their stable doses of the following, starting 4 weeks prior to 
Baseline through the Week 36 assessments: 
!
NSAIDs
!
Acetaminophen/paracetamol
!
Low-potency opiates (tramadol, codeine, or hydrocodone, alone or in combination with 
acetaminophen)
!
Oral corticosteroids (equivalent to prednisone ≤ 10 mg/day)
If an enrolled subject is not taking any of the above at Baseline Visit, these concomitant medications 
must not be initiated except where permitted by protocol (specific time period or protocol-defined 
rescue).  If taking any of the above at Baseline on an as-needed basis (PRN), a subject should continue to 
use them for the same reason and same dose each time but they should not be taken within the 
24 hours prior to any study visit to avoid bias in outcome measurements.  
In the event of tolerability (or other safety) issues, these medications may be decreased, or discontinued 
with substitution of another permitted medication from that class.  
In Period 2, at Week 24 (after Week 24 assessments have been performed) and thereafter, subjects may 
use any topical therapy for PsO per investigator judgment.
In Period 2, starting at Week 36 (after Week 36 assessments have been performed) and thereafter, 
1 intra-articular, trigger point or tender point, intra-bursa, or intra-tendon sheath injection of 
corticosteroids, dosage and frequency per standard of care, is allowed every 12 weeks.  However, 
corticosteroid injections should be avoided within 21 days prior to the next scheduled study visit to 
avoid confounding effects of systemic absorption of corticosteroids.
Page 29 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
At Week 36 (after Week 36 assessments have been performed) and thereafter, initiation of or change in 
corticosteroids, NSAIDs, acetaminophen/paracetamol, low potency opiates (tramadol, codeine, or 
hydrocodone, alone or in combination with acetaminophen) or adding or changing doses of csDMARDs 
(MTX, LEF, SSZ, apremilast, HCQ, bucillamine, iguratimod or ciclosporin A) is allowed as per eligibility 
criterion # 27 or local label, whichever dose is lower.  The combination of MTX and LEF is not allowed at 
any time during study conduct.  
Allowed topical corticosteroids by World Health Organization classification44 are listed below:
Potency
Class
Topical Corticosteroid
Formulation
Low
VI
Betamethasone valerate
Lotion, 0.05%
Desonide
Cream, 0.05%
Fluocinolone acetonide
Solution, 0.01%
VII
Dexamethasone sodium phosphate
Cream, 0.1%
Hydrocortisone acetate
Cream, 1%
Methyprednisolone acetate
Cream, 0.25%
Rescue Concomitant Medications/Therapy 
At Week 16, subjects classified as non-responders (defined as not achieving at least a 20% improvement 
in either or both tender joint count [TJC] and swollen joint count [SJC] compared to Baseline at both 
Week 12 and Week 16), will: 
!
Add or modify doses of NSAIDs, acetaminophen/paracetamol, low potency opioid medications 
(tramadol, codeine, or hydrocodone, alone or in combination with acetaminophen); OR
!
Receive 1 intra articular, trigger point or tender point, intra-bursa, or intra-tendon sheath 
corticosteroid injection for 1 peripheral joint or 1 enthesis.  Corticosteroid injections should be 
avoided within 21 days prior to the next scheduled study visit.  For the analysis of the TJC, SJC, 
and enthesitis sites, injected joints or enthesitis sites will be considered "not assessable" for 
90 days from the time of the injection; OR
!
Titrate current background csDMARD or add an additional csDMARD, as allowed by eligibility 
criteria (Section 5.1).  Doses of csDMARDs may not exceed maximums defined in eligibility 
criteria.  Addition of a biologic therapy is not permitted.  No more than 2 csDMARDs may be 
used.
5.5 Withdrawal of Subjects and Discontinuation of Study
Lack of response within the context of this study is defined as not achieving at least a 20% improvement 
in either or both TJC and SJC, compared to Baseline, on 2 consecutive visits.  This evaluation begins at 
Week 32; therefore, Week 36 is the first possible time point a subject might be discontinued for lack of 
response.  From Week 36 onward, study subjects will continue to be evaluated for lack of response on 
two consecutive visits.  Discontinued subjects will be followed through the remainder of the study.
Page 30 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
A subject may voluntarily withdraw or be withdrawn from the study or study treatment at any time for 
reasons including, but not limited to, the following:
!
Clinically significant abnormal laboratory result(s) or AEs, which rule out continuation of the 
study drug, as determined by the Investigator or the AbbVie Therapeutic Area Medical Director 
(TA MD) (as applicable).
!
The Investigator believes withdrawal from the study treatment or study is in the best interest of 
the subject.
!
The subject requests withdrawal from the study treatment or study.
!
Eligibility criteria violation(s) are noted after the subject started study drug, if continuation of 
the study drug would place the subject at risk as determined by the AbbVie TA MD, after 
consultation with the investigator.
!
Subject needs to initiate prohibited medication(s) or dosages, and continuation of the study 
drug would place the subject at risk as determined by the AbbVie TA MD.
!
The subject becomes pregnant while on study drug.
!
Subject is non-compliant with TB prophylaxis (if applicable) or develops active TB at any time 
during the study (see Operations Manual, Section 3.12).
!
Subject is diagnosed with a malignancy (Exception: localized non-melanoma skin cancer or 
carcinoma in-situ of the cervix, where continuation of the subject is at the discretion of the 
investigator).
!
Subject is significantly non-compliant with study procedures which would put the subject at risk 
for continued participation in the trial as determined by the Investigator or AbbVie TA MD.
!
Occurrence of following hepatic test abnormalities that is confirmed on a separate sample 
following a repeated blood draw:
!
ALT or AST > 8 × Upper Limit of Normal (ULN);
!
ALT or AST > 5 × ULN for more than 2 weeks;
!
ALT or AST > 3 × ULN and (Total Bilirubin > 2 × ULN or international normalized ratio [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%).
Positive TB Screen
!
If subject has a positive QuantiFERON®-TB Gold Test (or other Interferon-Gamma Release Assay 
[IGRA]) or TB Skin Test (Purified Protein Derivative [PPD] test) at Screening or prior documented 
positive test within 90 days prior to Screening Visit, the test should not be repeated. 
!
If subject has a positive QuantiFERON®-TB Gold Test (or IGRA equivalent) and/or positive PPD 
test, or if there is a repeat indeterminate QuantiFERON®-TB Gold test (or IGRA equivalent) upon 
retesting, subjects may participate or continue in the study if further work up (according to local 
practice/guidelines) establishes conclusively that the subject has no evidence of active TB.  
Page 31 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
!
If presence of latent TB is established, subjects who are at low risk of reactivation, defined by 
local guidelines and investigator judgment, do not need to be treated with prophylactic anti-TB 
therapy prior to or during the trial.  
!
If a decision is made to treat based on the clinical judgment of the investigator, TB prophylaxis 
should be initiated according to local country guidelines.  Subjects do not need to be 
discontinued from study participation if prophylaxis for latent TB is initiated.  
!
It is also necessary to report new diagnoses of latent or active TB as an AE in the source 
documents and eCRFs.  In the case of a TB-related AE, a TB Supplemental Form that collects 
additional information will be completed by the investigator.
!
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.
!
TB assessment and treatment must be considered in regards to the local practice guidelines of 
any concomitant csDMARDs in use.  
For subjects to be considered lost to follow-up, reasonable attempts must be made to obtain 
information on the final status of the subject.  At a minimum, 2 telephone calls must be made and 
1 certified letter must be sent and documented in the subject's source documentation.
AbbVie may terminate this study prematurely, either in its entirety or at any site.  The Investigator may 
also stop the study at his/her site if he/she has safety concerns.  If AbbVie terminates the study for 
safety reasons, AbbVie will promptly notify the Investigator.
COVID-19 Pandemic-Related Acceptable Protocol Modification
During the COVID-19 pandemic, it may be necessary to ensure subject safety and continuity of care.  
Acceptable mitigation strategies are identified and included in the Operations Manual in Appendix F.
The investigator should contact the sponsor before discontinuing a subject from the study for a reason 
other than "planned per protocol," to ensure all acceptable mitigation steps have been explored.
Refer to the Operations Manual in Appendix F for details on how to handle study activities/procedures.
5.6 Follow-Up for Subject Withdrawal from Study
To minimize missing data for efficacy and safety assessments, subjects who prematurely discontinue 
study drug treatment should continue to be followed for all regularly scheduled visits, unless subjects 
have decided to discontinue the study participation entirely (withdrawal of informed consent).  Subjects 
should be advised on the continued scientific importance of their data even if they discontinue 
treatment with study drug early.
Subjects who prematurely discontinue study drug should complete a Premature Discontinuation Visit 
(PD Visit) as soon as possible.  Afterwards, subjects should follow the regular visit schedule as outlined in 
the Activity Schedule (Appendix D) and adhere to all study procedures except for dispensing study drug, 
pharmacokinetic (PK) sample collection and blood sample collection for optional exploratory research.  
Once the subject has discontinued study drug, all rescue- and efficacy-driven discontinuation criteria no 
Page 32 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
longer apply.  If at any point a subject no longer wants to provide assessments (withdrawal of informed 
consent) following discontinuation of study drug, a second PD Visit is not required.
If a subject prematurely discontinues study participation but is willing to receive a 140-day (20-week) 
follow-up phone call after the last dose of study drug, the phone call should be completed to ensure all 
treatment-emergent AEs/serious AEs (SAEs) have been resolved.  The follow-up phone call will not be 
conducted for subjects who withdraw study consent.
All attempts must be made to determine the primary reason for discontinuation of study drug or study 
participation.  The information will be recorded on the appropriate eCRF page.  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.  Following discontinuation of study 
drug, the subject will be treated in accordance with the Investigator's best clinical judgment, irrespective 
of whether or not the subject decides to continue participation in the study.  Subjects who prematurely 
discontinue from the study will not be replaced.
5.7 Study Drug
Information about the study drug and placebo used in this study is presented in Table 1.
Table 1.
Description of Study Drug and Placebo
Study Drug
Dosage Form
Strength
Route of 
Administration
Manufacturer
Risankizumab 
(ABBV-066) 
Solution for injection 
in pre-filled syringe
75 mg/0.83 mL 
(90 mg/mL)
SC injection
Boehringer-Ingelheim 
Pharma GmbH & Co. 
KG
Placebo for 
Risankizumab 
(ABBV-066) 
Solution for injection 
in pre-filled syringe
N/A
SC injection
Boehringer-Ingelheim 
Pharma GmbH & Co. 
KG
N/A = not applicable; SC = subcutaneous
AbbVie will not supply drug other than risankizumab and matching placebo.  If a subject is unable to 
come to the study site for a study visit due to the COVID-19 pandemic, study drug can be taken to the 
subject's residence and administered by trained site personnel under appropriate conditions.
Open-label and blinded risankizumab and placebo will be packaged in quantities sufficient to 
accommodate study design.  Each kit will be labeled per local requirements and this label must remain 
affixed to the kit.  Upon receipt, study drug should be kept in the original packaging and stored as 
specified on the label in a secure, limited-access storage area.  Each kit will contain a unique kit number.  
This kit number is assigned to a subject via interactive response technology (IRT) and encodes the 
appropriate study drug to be dispensed at the subject's corresponding study visit.  All blank spaces on 
the label will be completed by the site staff prior to dispensing to subjects.  Study drug will only be used 
for the conduct of this study.
Page 33 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
Interruption/Discontinuation of Study Drug Due to COVID-19 
Delays in study drug dosing due to a subject with COVID-19 must be discussed with the AbbVie medical 
contact, along with the possibility of premature discontinuation from study drug.  Follow Section 5.6 for 
subjects who discontinue study drug.
5.8 Randomization/Drug Assignment
All subjects will be assigned a unique identification number by the IRT at the Screening Visit.  For 
subjects who rescreen, the screening number assigned by the IRT at the initial Screening Visit should be 
used.  Subjects will be randomized in a 1:1 ratio to one of two treatment groups:
!
Group 1:  Risankizumab 150 mg (N = 440)
!
Group 2:  Placebo (N = 440)
Randomization will be stratified by extent of psoriasis (≥ 3% BSA vs < 3% BSA), current use of at least 
1 csDMARD (0 vs ≥ 1), presence of dactylitis (yes vs no), and presence of enthesitis (yes vs no) at 
Baseline.
The Investigator, study site personnel, and the subject will remain blinded to each subject's treatment in 
Period 1 throughout the study.  AbbVie will carry out an analysis of the primary endpoint at Week 24.  
To maintain the blind during the blinded portion of the study, the risankizumab pre-filled syringe (PFS) 
and placebo PFS provided for the study will be identical in appearance.
In the event of a medical emergency in which the Investigator believes that knowledge of study drug 
treatment is required, reasonable efforts must be made to contact the AbbVie Emergency Contact prior 
to breaking the blind, as long as it does not compromise subject safety.  However, if an urgent 
therapeutic intervention is necessary which warrants breaking the blind prior to contacting AbbVie 
Emergency Contact, the Investigator can directly access the IRT system to break the blind without 
AbbVie agreement.
The date and reason that the blind was broken must be recorded in the source documentation and 
eCRF, as applicable.
5.9 Protocol Deviations
The Investigator is responsible for complying with all protocol requirements, written instructions, and 
applicable laws regarding protocol deviations.  Protocol deviations are prohibited except when 
necessary to eliminate an immediate hazard to study subjects.  If a protocol deviation occurs (or is 
identified, including those that may be due to the COVID-19 pandemic), the Investigator is responsible 
for notifying the Independent Ethics Committee/Institutional Review Board (IEC/IRB), regulatory 
authorities (as applicable) and AbbVie.
Page 34 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
6 SAFETY CONSIDERATIONS
6.1 Complaints and Adverse Events
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.  Complaints associated with any component of this investigational 
product must be reported to AbbVie.
Product Complaint
A product complaint is any complaint related to the biologic or drug component of the product or to the 
medical device component(s).
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 (e.g., printing illegible), missing components/product, device not working properly, 
or packaging issues.
Product complaints concerning the investigational product and/or device must be reported to AbbVie 
within 1 business day of the study site's knowledge of the event.  Product complaints occurring during 
the study will be followed up to a satisfactory conclusion.
Medical Complaints/Adverse Events and Serious Adverse Events
An AE is defined as any untoward medical occurrence in a subject 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.
The investigators will monitor each subject for clinical and laboratory evidence of AEs on a routine basis 
throughout the study.  All AEs will be followed to a satisfactory conclusion.
If any of the following events are reported, then the following applicable supplemental report must be 
completed (Table 2).
Page 35 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
The investigators will assess the relationship of the adverse events to the use of study drug as 
Reasonable Possibility or No Reasonable Possibility.
Pregnancy
While not an adverse events, 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 from study drug.  Information regarding a pregnancy occurrence in a study subject and the 
outcome of the pregnancy will be collected.  The pregnancy outcome of an elective or spontaneous 
abortion, stillbirth, or congenital anomaly is considered an SAE and must be reported to AbbVie within 
24 hours of the site becoming aware of the event. 
6.2 Toxicity Management
Monitoring of toxicity related to stable background csDMARDs, titration of csDMARDs, or addition of 
csDMARDs should comply with the country level requirements.
6.3 Independent Data Monitoring Committee
An external Independent Data Monitoring Committee (IDMC) will review unblinded safety data at 
approximate 6 month intervals throughout the course of the study.  
!
A separate IDMC charter will be prepared outside of the protocol and will describe the roles and 
responsibilities of the IDMC members, frequency and triggers of data reviews, and relevant 
safety data to be assessed.  Unblinded adjudicated cardio-cerebrovascular and anaphylaxis 
events will be presented to the IDMC for review on a periodic basis.
!
Communications from the IDMC to the Study Teams will not contain information that could 
potentially unblind the team to subject treatment assignments.
6.4 Cardiovascular Adjudication Committee 
An independent adjudication committee will adjudicate all observed cardio- and cerebro-vascular events 
and will remain blinded to treatment allocation.  The events that are adjudicated and the adjudication 
process will be detailed in the CAC Adjudication Committee Charter (CAC).  Dedicated eCRFs will be used 
as outlined in Table 2.
In addition, the site may be contacted for additional source documentation for relevant events.
6.5 Anaphylaxis Adjudication Committee
While systemic hypersensitivity reactions and anaphylaxis are not identified risks for risankizumab, the 
Sponsor has established an independent, blinded, expert committee to adjudicate events of anaphylaxis 
based on a pre-specified definition.  An independent external AAC will adjudicate suspected 
anaphylactic reactions and will remain blinded to treatment allocation.  The events that are adjudicated 
Page 37 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
and the adjudication process will be detailed in the AAC Charter.  A supplemental Hypersensitivity 
Reaction Signs and Symptoms 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.
7 STATISTICAL METHODS & DETERMINATION OF SAMPLE SIZE
7.1 Statistical and Analytical Plans
An unblinded analysis will be conducted after all subjects have completed Week 24 or have prematurely 
discontinued for the purpose of initial regulatory submission.  Complete and specific details of the 
statistical analysis will be described and fully documented in the Statistical Analysis Plan (SAP).  The 
statistical analyses will be performed using SAS (SAS Institute Inc., Cary, North Carolina, USA).
7.2 Definition for Analysis Populations
The Full Analysis Set (FAS) includes all randomized subjects who received at least 1 dose of study drug.  
The FAS will be used for all efficacy and Baseline analyses.  Subjects will be grouped according to 
treatment as randomized.
The Safety Analysis Set consists of all subjects who received at least 1 dose of study drug.  For the Safety 
Analysis Set, subjects are assigned to a treatment group based on the treatment actually received, 
regardless of the treatment randomized.
7.3 Statistical Analyses for Efficacy
Imputation Methods
Non-Responder Imputation incorporating multiple imputation to handle missing data due to COVID-19 
(NRI-C):  Subjects with a missed scheduled assessment visit due to reasons other than the COVID-19 
pandemic will be handled by non-responder imputation. In addition, subjects will be considered as non-
responders after the initiation of concomitant medications for PsA that could meaningfully impact
efficacy assessment or initiation of rescue therapy.  Missing data due to a COVID-19 infection or 
logistical restrictions related to the COVID-19 pandemic will be handled through multiple imputation 
(MI).  
As Observed (AO):  The AO analysis will not impute values for missing evaluations; therefore, a subject 
who does not have an evaluation on a scheduled visit will be excluded from the AO analysis for that visit.  
Regardless of premature discontinuation of study drug, initiation of concomitant medications for PsA 
that could meaningfully impact efficacy assessments, or initiation of rescue therapy, all observed data 
will be used in the AO analysis.
Linear Extrapolation for Radiographic Data:  For radiographic data (i.e., mTSS-based endpoints), if a 
subject prematurely discontinued before Week 24/52, their Week 24/52 data will be imputed assuming 
a linear relationship between Baseline and the time point when the data should be collected.
Page 38 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
Statistical Analyses for Efficacy
The comparisons between the risankizumab and placebo treatment groups for the primary efficacy 
endpoint (ACR20 at Week 24) will be performed using the Cochran-Mantel-Haenszel (CMH) test 
stratified by stratification factors. 
For continuous efficacy endpoints, the treatment comparison will be conducted using a Mixed-Effect 
Model Repeated Measures (MMRM) method as primary inference purpose.  
MMRM analysis will be conducted using mixed-effect model with observed measurements at all visits
prior to initiation of any concomitant medications for PsA that could meaningfully impact efficacy 
assessments or rescue medications.  The mixed model includes the categorical fixed effects of 
treatment, visit and treatment-by-visit interaction, main stratification factors, and the continuous fixed 
covariate of baseline measurement.  An unstructured variance covariance matrix will be used.  The 
parameter estimations are based on the assumption of data being missing at random and using the 
method of restricted maximum likelihood (REML).
Categorical efficacy variables will be analyzed using the CMH test controlling for stratification variables. 
NRI-C imputation will be used for missing data imputation. 
For radiographic data, the analysis for mTSS change from Baseline at Week 24 will be conducted with 
ANCOVA model to compare risankizumab vs placebo.  Linear Extrapolation imputation method will serve
as the primary missing data imputation approach.  Analysis for Week 24 radiographic endpoints will also 
be repeated using AO imputation method as sensitivity analysis.  
The primary and ranked secondary efficacy endpoints will be tested with multiplicity adjustment to 
ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).  The 
details of the testing procedure will be specified in SAP.  
Long-term efficacy by time point will be summarized using descriptive statistics.  For binary endpoints, 
frequencies and percentages will be summarized.  For continuous endpoints, the mean, standard 
deviation, median, minimum, and maximum will be reported.
Additional subgroup analysis and sensitivity analysis will be specified in the SAP.
Sample Size Estimation
Approximately 880 subjects will be randomized to risankizumab 150 mg or placebo in a ratio of 1:1 
(440 subjects/treatment group).  This sample size provides at least 90% power to detect at least 25% 
difference in ACR20 response rate at Week 24 (assuming a placebo ACR20 response rate of 35%).  The 
same sample size provides approximately 80% power to detect a standardized effect size of 0.20 for 
mTSS change from Baseline for risankizumab versus placebo group at Week 24.  All power and sample 
size were calculated based on at two-sided significance level of 0.05 and accounting for a 10% dropout 
rate. 
Page 39 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
7.4 Statistical Analyses for Safety
Safety analyses will be carried out using the Safety Analysis Set.  There will be two sets of planned safety 
analysis:  safety analysis by Week 24, and long-term safety analysis.  Safety will be assessed by AEs, 
physical examinations, laboratory assessments, and vital signs.  Frequency tables and lists of subjects 
with treatment emergent AEs by preferred term as in the Medical Dictionary for Regulatory Activities 
(MedDRA), by system organ class and preferred term, by severity, and by relationship to the study drug 
as assessed by the Investigator will be provided.  The changes from Baseline in vital signs, physical 
examination results, and clinical laboratory values will be analyzed in a descriptive manner.  Shift of 
laboratory values from Baseline to defined time points will be tabulated.
7.5 Analysis of PK and Immunogenicity 
Serum risankizumab concentrations will be summarized at the sampling time point using descriptive 
statistics.  In addition, ADA titers will be tabulated for each ADA positive subject at the respective study 
visits.  The number and percentage of subjects with ADA and nAb will be calculated.  Additional analyses 
may be conducted if appropriate. 
7.6 Analysis of Exploratory Variables
Data from exploratory research samples will be tabulated for each subject with a breakdown by dose 
group.  Exploratory analyses will be performed on the data from exploratory research samples.  These 
exploratory analyses are separate from the study statistical analysis plan and may not be reported in 
study report.
8 ETHICS
8.1 Independent Ethics Committee/Institutional Review Board 
(IEC/IRB)
The protocol, informed consent form(s), recruitment materials, and all participant materials will be 
submitted to the IEC/IRB for review and approval.  Approval of both the protocol and the informed 
consent form(s) must be obtained before any participant is enrolled.  Any amendment to the protocol 
will require review and approval by the IEC/IRB before the changes are implemented to the study.  In 
addition, all changes to the consent form(s) will be IEC/IRB approved. 
8.2 Ethical Conduct of the Study
The study will be conducted in accordance with the protocol, Operations Manual, International Council 
for Harmonisation (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 Investigator are specified in Appendix B.
Page 40 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
In the event of a state of emergency due to the COVID-19 pandemic leading to difficulties in performing 
protocol-specified procedures, AbbVie will engage with study site personnel in efforts to ensure the 
safety of subjects, maintain protocol compliance, and minimize risks to the integrity of the study while 
trying to best manage subject continuity of care.  This may include alternative methods for assessments 
(e.g., phone contacts or virtual study visits), alternative locations for data collection (e.g., use of a local 
laboratory instead of a central laboratory), study visit schedule modification, and home study drug 
administration by trained site personnel to ensure continuity of treatment, where allowed.  Refer to the 
Operations Manual in Appendix F for additional details.  In all cases, these alternative measures must be 
allowed by local regulations and permitted by IRB/IEC.  Investigators should notify AbbVie if any urgent 
safety measures are taken to protect the subjects against any immediate hazard.
8.3 Subject Confidentiality
To protect subjects' confidentiality, all subjects and their associated samples will be assigned numerical 
study identifiers or "codes."  No identifiable information will be provided to AbbVie.
9 SOURCE DOCUMENTS AND CASE REPORT FORM 
COMPLETION
The Investigator is responsible for ensuring the accuracy, completeness, legibility, and timeliness of the 
data reported.  All source documents should be attributable, legible, contemporaneous, original, 
accurate, and complete to ensure accurate interpretation of data.  Clinical site monitoring is conducted 
to ensure that the rights and well-being of human subjects are protected, that the reported trial data 
are accurate, complete, and verifiable, and that the conduct of the trial is in compliance with the 
currently approved protocol, ICH Good Clinical Practice (GCP), and applicable local regulatory 
requirement(s).  
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.
10 DATA QUALITY ASSURANCE
AbbVie will ensure that the clinical trial is conducted and data are generated, documented and reported 
in compliance with the protocol, ICH GCP and applicable regulatory requirements. 
11 COMPLETION OF THE STUDY
The investigator will conduct the study in compliance with the 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.
Page 41 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
The investigator must submit, maintain, and archive any records related to the study according to ICH 
GCP and all other applicable regulatory 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 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 last protocol contact or last protocol follow-up, whichever is longer.
12 REFERENCES
1.
Duarte GV, Faillace C, Freire de Carvalho J.  Psoriatic arthritis.  Best Pract Res Clin Rheumatol.  
2012;(1):147-56.
2.
Gladman DD, Chandran V.  Observational cohort studies:  lessons learnt from the University of 
Toronto Psoriatic Arthritis Program.  Rheumatology (Oxford).  2011;50(1):25-31.
3.
Kavanaugh AF, Ritchlin CT; GRAPPA Treatment Guideline Committee.  Systematic review of 
treatments for psoriatic arthritis:  an evidence based approach and basis for treatment 
guidelines.  J Rheumatol.  2006;33(7):1417-21.
4.
Bruce IN, Ho PYP.  Clinical features of psoriatic arthritis.  Rheumatology, 6th Edition.  Editors 
Hochberg MC, Silman AJ, Smolen JS, Weinblatt ME, Weisman MH.  Publisher:  Elsevier, 
pp. 989-97, 2015. 
5.
Nash P. Therapies for axial disease in psoriatic arthritis.  A systematic review.  J Rheumatol.  
2006;33(7):1431-4.
6.
Kalyoncu U, Ogdie A, Campbell W, et al.  Systematic literature review of domains assessed in 
psoriatic arthritis to inform the update of the psoriatic arthritis core domain set.  RMD Open.  
2016;2(1):e000217.
7.
Cantini F, Nannini C, Cassarà E, et al.  Uveitis in spondyloarthritis:  an overview.  J Rheumatol 
Suppl.  2015;93:27-9.
8.
Magrey MN, Antonelli M, James N, et al.  High frequency of fibromyalgia in patients with 
psoriatic arthritis:  a pilot study.  Arthritis.  2013;2013:762921.
9.
Husni ME.  Comorbidities in psoriatic arthritis.  Rheum Dis Clin North Am.  2015;41(4):677-98.
10. Lee S, Mendelsohn A, Sarnes E.  The burden of psoriatic arthritis:  a literature review from a 
global health systems perspective.  PT.  2010;35(12):680-9.
11. Gladman DD, Shuckett R, Russell ML, et al.  Psoriatic arthritis (PSA)-an analysis of 220 patients.  
Q J Med.  1987;62(238):127-41.
12. Gossec L, Smolen JS, Ramiro S, et al.  European League Against Rheumatism (EULAR) 
recommendations for the management of psoriatic arthritis with pharmacological therapies:  
2015 update.  Ann Rheum Dis.  2016;75(3):499-510.  
Page 42 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
13. Coates LC, Kavanaugh A, Mease PJ, et al.  Group for research and assessment of psoriasis and 
psoriatic arthritis 2015 treatment recommendations for psoriatic arthritis.  Arthritis Rheumatol.  
2016;68(5):1060-71.
14. Alamanos Y, Papadopoulos NG, Voulgari PV, et al.  Epidemiology of psoriatic arthritis in 
northwest Greece, 1982-2001.  J Rheumatol.  2003;30(12):2641-4.
15. Savolainen E, Kaipiainen-Seppänen O, Kröger L, et al.  Total incidence and distribution of 
inflammatory joint diseases in a defined population:  results from the Kuopio 2000 arthritis 
survey.  J Rheumatol.  2003;30(11):2460-8.
16. Sandborn WJ.  State-of-the-art:  immunosuppression and biologic therapy.  Dig Dis.  
2010;28(3):536-42.
17. Cosentyx (secukinumab injection) [package insert].  East Hanover, New Jersey; Novartis 
Pharmaceuticals Corporation, 2016.
18. Stelara (ustekinumab injection) [package insert].  Horsham, Pennsylvania; Janssen Biotech, Inc., 
2014.
19. Enbrel (etanercept) [package insert].  Thousand Oaks, California; Amgen, 2015.
20. Remicade (infliximab) [package insert].  Horsham, Pennsylvania; Janssen Biotech, Inc., 2015.
21. Saber TP, Ng CT, Renard G, et al.  Remission in psoriatic arthritis:  is it possible and how can it be 
predicted?  Arthritis Res Ther.  2010;12(3):R94.
22. Perrotta FM, Marchesoni A, Lubrano E.  Minimal disease activity and remission in psoriatic 
arthritis patients treated with anti-TNF-α drugs.  J Rheumatol.  2016;43(2):350-5.
23. Perrotta FM, Lubrano E.  Subcutaneous anti-TNF alfa induced sustained minimal disease activity 
and remission in psoriatic arthritis patients:  a retrospective study.  Postgrad Med.  
2016;128(7):693-6.
24. Iwakura Y, Nakae S, Saijo S, et al.  The roles of IL-17A in inflammatory immune responses and 
host defense against pathogens.  Immunol Rev.  2008;226:57-79.
25. Murphy CA, Langrish CL, Chen Y, et al.  Divergent pro- and antiinflammatory roles for IL-23 and
IL-12 in joint autoimmune inflammation.  J Exp Med.  2003;198(12):1951-7.
26. Cua DJ, Sherlock J, Chen Y, et al.  Interleukin-23 rather than interleukin-12 is the critical cytokine 
for autoimmune inflammation of the brain.  Nature.  2003;421(6924):744-8.
27. McGovern D, Powrie F.  The IL23 axis plays a key role in the pathogenesis of IBD.  Gut.  
2007;56(10):1333-6.
28. Chen Y, Langrish CL, Mckenzie B, et al.  Anti-IL-23 therapy inhibits multiple inflammatory 
pathways and ameliorates autoimmune encephalomyelitis.  J Clin Invest.  2006;116(5):1317-26.
29. Elson CO, Cong Y, Weaver CT, et al.  Monoclonal anti-interleukin 23 reverses active colitis in a T 
cell-mediated model in mice.  Gastroenterology.  2007;132(7):2359-70.
30. Wakashin H, Hirose K, Maezawa Y, et al.  IL-23 and Th17 cells enhance Th2-cell-mediated 
eosinophilic airway inflammation in mice.  Am J Respir Crit Care Med.  2008;178(10):1023-32.
Page 43 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
31. 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(5):1325-7.
32. Duerr RH, Taylor KD, Brant SR, et al.  A genome-wide association study identifies IL23R as an 
inflammatory bowel disease gene.  Science.  2006;314(5804):1461-3.
33. Bowes J, Barton A.  The genetics of psoriatic arthritis:  lessons from genome-wide association 
studies.  Discov Med.  2010;10(52):177-83.
34. Liu M, Zhu W, Wang J, et al.  Interleukin-23 receptor genetic polymorphisms and ulcerative 
colitis susceptibility:  a meta-analysis.  Clin Res Hepatol Gastroenterol.  2015;39(4):516-25.
35. Lee E, Trepicchio WL, Oestreicher JL, et al.  Increased expression of interleukin 23 p19 and p40 in 
lesional skin of patients with psoriasis vulgaris.  J Exp Med.  2004;199(1):125-30.
36. Liu Z, Yadav PK, Xu X, et al.  The increased expression of IL-23 in inflammatory bowel disease 
promotes intraepithelial and lamina propria lymphocyte inflammatory responses and 
cytotoxicity.  J Leukoc Biol.  2011;89(4):597-606.
37. Celis R, Planell N, Fernández-Sueiro JL, et al.  Synovial cytokine expression in psoriatic arthritis 
and associations with lymphoid neogenesis and clinical features.  Arthritis Res Ther.  
2012;14(2):R93.
38. Filipe-Santos O, Bustamante J, Chapgier A, et al.  Inborn errors of IL-12/23 and IFN-γ-mediated 
immunity:  molecular, cellular, and clinical features.  Semin Immunol.  2006;18(6):347-61.
39. Meeran SM, Mantena S, Meleth S, et al.  Interleukin-12deficient mice are at greater risk of UV 
radiation-induced skin tumors and malignant transformation of papillomas to carcinomas.  Mol 
Cancer Ther.  2006;5(4):825-32.
40. Chackerian AA, Chen SJ, Brodie SJ, et al.  Neutralization or absence of the interleukin-23 
pathway does not compromise immunity to mycobacterial infection.  Infect Imun.  
2006;74(11):6092-9.
41. O'Garra A, Redford PS, McNab FW, et al.  The immune response in tuberculosis.  Annu Rev 
Immunol.  2013;31:475-527.
42. Qian X.  Increased Th17 cells in the tumor microenvironment is mediated by IL-23 via tumor-
secreted prostaglandin E2.  J Immunol.  2013;190(11):5894-902.
43. AbbVie.  Risankizumab Investigator's Brochure Edition 3.  10 May 2018.
44. WHO Model Prescribing Information:  Drugs Used in Skin Diseases.  1997.  Available at 
http://apps.who.int/medicinedocs/en/d/Jh2918e/32.html.  Accessed 09 July 2018.
Page 44 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
APPENDIX A. STUDY SPECIFIC ABBREVIATIONS AND TERMS
Abbreviation
Definition
AAC
Anaphylaxis Adjudication Committee
ACR
American College of Rheumatology
ADA
Anti-drug antibody
AE
Adverse Event
ALT
Alanine transaminase
ANC
Absolute neutrophil count
AO
As observed
AS
Ankylosing spondylitis
ASDAS
Ankylosing Spondylitis Disease Activity Score
AST
Aspartate transaminase
BASDAI
Bath Ankylosing Spondylitis Disease Activity Index
BCG
Bacille Calmette-Guérin
BSA
Body surface area
CAC
Cardiovascular Adjudication Committee
Cavg
Average plasma concentrations
CASPAR
Classification Criteria for PsA
CCP
Cyclic-citrullinated peptide
CD
Crohn's disease
CL/F
Apparent Clearance
CMH 
Cochran-Mantel-Haenszel
COVID-19
Coronavirus disease of 2019
CRO
Contract research organization
csDMARD
Conventional synthetic disease modifying anti-rheumatic drug
DAPSA
Disease Activity In Psoriatic Arthritis
DAS28
Disease Activity Score 28
DMARD
Disease modifying anti-rheumatic drug
ECG
Electrocardiogram
eCRF
Electronic case report form
EMA
European Medicines Agency
EQ-5D-5L
EuroQol-5D-5L
Page 45 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
EULAR
European League Against Rheumatism
FACIT-Fatigue
Functional Assessment of Chronic Illness Therapy
FAS
Full Analysis Set
FSH
Follicle stimulating hormone
GCP
Good Clinical Practice
GRAPPA
Group for Research and Assessment of Psoriasis and Psoriatic Arthritis
HAQ-DI
Health Assessment Questionnaire-Disability Index
HBc-Ab
Hepatitis B core antibody
HBs Ag
Hepatitis B surface antigen
HBV
Hepatitis b virus
HCV
Hepatitis c virus
HCQ
Hydroxychloroquine
HIV
Human immunodeficiency virus
hsCRP
High sensitivity C-Reactive Protein
IBD
Inflammatory bowel disease
ICH
International Council for Harmonisation
IDMC
Independent Data Monitoring Committee
IEC
Independent Ethics Committee
Ig
Immunoglobulin
IGRA
Interferon-Gamma Release Assay
IL
Interleukin
IM
Intramuscular
IMP
Investigational Medicinal Product
INR
International normalized ratio
IRB
Institutional Review Board
IRT
Interactive Response Technology
IUD
Intrauterine device
IUS
Intrauterine hormone-releasing system
IV
Intravenous
JAK
Janus kinase
LDI
Leeds Dactylitis Index
LEF
Leflunomide
LEI
Leeds Enthesitis Index
mAb
Monoclonal antibody
Page 46 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
MACE
Major adverse cardiac event
MDA
Minimal Disease Activity
MedDRA
Medical Dictionary for Regulatory Activities
MI
Multiple imputation
MMRM 
Mixed Effect Model Repeated Measures
MTX
Methotrexate
nAb
Neutralizing antibody
NMSC
Non-melanoma skin cancer
NRI-C
Non-responder imputation while incorporating multiple imputation to 
handle missing data due to COVID-19
NSAID
Nonsteroidal anti-inflammatory drug
OC
Observed cases
PASDAS
PsA Disease Activity Score
PASI
Psoriasis Area Severity Index
PCR
Polymerase chain reaction
PCS
Physical Component Summary
PD
Premature Discontinuation
PFS
Pre-filled syringe
PK
Pharmacokinetic(s)
PPD
Purified protein derivative
PRN
Pro re nata (as-needed basis)
PsA
Psoriatic arthritis
PsARC
Psoriatic Arthritis Response Criteria
PsO
Psoriasis
PUVA
Psoralens and Ultraviolet A
PY 
Patient years
q12w
Every 12 weeks
REML
Restricted maximum likelihood
RNA
Ribonucleic acid
SAE
Serious Adverse Event
SAP
Statistical Analysis Plan
SC
Subcutaneous
SF-36
36-Item Short Form Health Survey
SJC
Swollen joint count
Page 47 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
SpA
Spondyloarthritis
SPARCC
Spondyloarthritis Research Consortium of Canada
SSZ
Sulfasalazine
SUSAR
Suspected Unexpected Serious Adverse Reactions
TB
Tuberculosis
Th
T helper
TJC
Tender joint count
TNF
Tumor necrosis factor
UC
Ulcerative colitis
ULN
Upper limit of normal
UVA
Ultraviolet A
UVB
Ultraviolet B
VAS
Visual analog scale
WBC
White blood cell
WPAI
Work Productivity and Activity Impairment
Page 48 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
APPENDIX B. RESPONSIBILITIES OF THE INVESTIGATOR
Protocol M16-011:  Psoriatic Arthritis:  Risankizumab Therapy Vs Placebo in DMARD-IR Subjects
Protocol Date:  10 September 2020
Clinical research studies sponsored by AbbVie are subject to the International Council for Harmonisation 
(ICH) Good Clinical Practices (GCP) and local regulations and guidelines governing the study at the site 
location.  In signing the Investigator Agreement, the investigator is agreeing to the following:
1.
Conducting the study in accordance with ICH GCP, the applicable regulatory requirements, 
current protocol and operations manual, and making changes to a protocol only after notifying 
AbbVie and the appropriate Institutional Review Board (IRB)/Independent Ethics Committee 
(IEC), except when necessary to protect the subject from immediate harm.
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., IEC or IRB) review and approval of the protocol and its amendments.
4.
Reporting complaints that occur in the course of the investigation(s) to AbbVie.
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 protocol and all of its amendments.
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. Providing direct access to source data documents for study-related monitoring, audits, IEC/IRB 
review, and regulatory inspection(s).
Signature of Principal Investigator
Date
Name of Principal Investigator (printed or typed)
Page 49 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
APPENDIX C. LIST OF PROTOCOL SIGNATORIES
Name
Title
Functional Area
Protocol Author
Immunology Clinical Development
Immunology Clinical Development
Clinical Program Development
Data Statistical Sciences
Clinical Pharmacology and 
Pharmacometrics
Page 50 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
APPENDIX D. ACTIVITY SCHEDULE
The following table shows the required activities across the Screening and subsequent study visits.  The 
individual activities and allowed modifications due to COVID-19 are described in detail in the Operations 
Manual (Appendix F).
Page 51 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
APPENDIX E. PROTOCOL SUMMARY OF CHANGES
Previous Protocol Versions
Protocol
Date
Version 1.0
26 July 2018
Version 2.0
14 February 2019
Version 3.0
17 March 2020
The purpose of this version is to incorporate necessary protocol modifications due to the COVID-19 
pandemic as follows:
!
Section 2.2 – included information on the re-evaluation of the benefit and risk to subjects 
participating in the study.  
!
Section 5.5 – added instructions to refer to Operations Manual for necessary changes to 
activities or procedures.
!
Section 5.7 – provided instructions in the event of temporary study drug interruption/halt due 
to COVID-19 and that in the event the subject cannot complete an onsite visit, administration of 
study drug at the subject's house is to be performed by study staff if feasible and permitted by 
local regulations.
!
Section 5.9 – clarified that protocol deviations may include modifications due to COVID-19.
!
Section 7.3 – replaced NRI with NRI-C to incorporate handling of missing data due to COVID-19. 
!
Section 8.2 – noted that AbbVie will modify the study protocol as necessary due to the 
pandemic, referring to the Operations Manual in Appendix F for additional details.  Investigators 
must also notify AbbVie if any urgent safety measures are taken.
!
Section 9 – noted that remote monitoring may be employed as needed.
!
Appendix D – added reference to Operations Manual for allowed modification.
!
Appendix F – Operations Manual updated to include details on how to perform specific 
activities/procedures that may be impacted by changes in global/local regulations due to the 
pandemic.
Rationale for all of the above changes: To make modifications to the protocol related to the 
COVID-19 pandemic that ensures subject safety, continuity of care for subjects, and data 
integrity within the study.
The following changes not related to the COVID-19 pandemic were also made:
!
Section 3.3 – Added the ranked secondary endpoint ACR20 at Week 16.
Rationale: As a clinically meaningful measure of efficacy, ACR20 with multiplicity control at 
an earlier timepoint will provide additional data on treatment effect.
Page 56 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
!
Section 3.3 – Separated the endpoint of mNAPSI and PGA-F into 2 individual endpoints.
Rationale:  To clarify that these are separate study endpoints.
!
Section 3.3 – Adjusted ranking of the mTSS endpoint in the secondary ranked endpoints.
Rationale: Ranking of this endpoint was modified based upon analysis of recently published 
data.  No data from this study or any other ongoing study was used to make this 
determination.
!
Section 3.4 – Corrected the description of the endpoint "Change from Baseline in Modified 
Psoriatic Arthritis Response Criteria (PsARC)" to "Proportion of subjects who achieve a Modified 
Psoriatic Arthritis Response Criteria (PsARC) response."
Rationale: Change from baseline is not the correct method to evaluate a binary endpoint.
!
Section 7.3 – Modified wording on the NRI-C and AO imputation methods.
Rationale: To clarify differences between the NRI-C and AO methods.
!
Section 7.3 – Modified wording on MMRM analysis for continuous variables.
Rationale: To clarify which data will be used in the MMRM analysis.
Page 57 of 131

STUDY M16-011  |  Version 4.0  |  EudraCT 2017-002465-22
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
APPENDIX F. OPERATIONS MANUAL
Page 58 of 131

p. 2 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
1 CONTACTS
Sponsor Non-
Emergency 
Contact
AbbVie
1 North Waukegan Road
North Chicago, IL 60064
Office:
Mobile:
Email:
Sponsor/
Emergency 
Contact
AbbVie
Avenida De Burgos 91,
Madrid, Spain 28050
EMERGENCY 24 hour Number:  
+1 (973) 784-6402
Office/Mobile:
Email:
Safety Concerns
Immunology Safety Team
Dept. R48S, Bldg. AP31-2
1 North Waukegan Road 
North Chicago, IL 60064
Phone:
(847) 938-8737
Email:
GPRD_SafetyManagement_Immunology@abbvie.com
SAE Reporting 
outside of RAVE
Email:
PPDINDPharmacovigilance@abbvie.com
Fax:
(847) 938-0660
Protocol 
Deviations
AbbVie
1 North Waukegan Road
North Chicago, IL 60064
Office:
Mobile:
Email:
Certified Clinical 
Lab
Covance Central Laboratory Services SA
8211 Scicor Drive
Indianapolis, IN 46214
Phone:
+001 866-762-6209 (Toll free)
+001 317-271-1200 (Local calls)
Fax:  +001 317-616-2362
For country specific toll free numbers please refer to 
Covance Lab Manual.
Pharmacokinetic 
Lab
AbbVie Deutschland GmbH & Co. KG
Bioanalysis Large Molecules
Knollstrasse
67061 Ludwigshafen, Germany
Phone:
+49 621-589-4847
Fax:
+49 621-589-3184
Exploratory 
Sample Lab
BioStorage Technologies, Inc.
2910 Fortune Circle West, Suite E
Indianapolis, IN 46241
Page 60 of 131

p. 3 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
TABLE OF CONTENTS
1
CONTACTS
2
2
INVESTIGATION PLAN
6
2.1
INDIVIDUAL TREATMENT PERIOD VISIT ACTIVITIES
6
2.2
COVID-19 PANDEMIC-RELATED ACCEPTABLE PROTOCOL MODIFICATIONS
16
3
STUDY PROCEDURES
18
3.1
SUBJECT INFORMATION AND INFORMED CONSENT
18
3.2
MEDICAL HISTORY
19
3.3
ADVERSE EVENT ASSESSMENT
19
3.4
PATIENT-REPORTED OUTCOMES
19
3.5
INVESTIGATOR ASSESSMENTS
21
3.6
BIOMARKER SAMPLING
25
3.7
12-LEAD ELECTROCARDIOGRAM
25
3.8
HEIGHT AND WEIGHT
26
3.9
VITAL SIGNS
26
3.10 PHYSICAL EXAMINATION
26
3.11 ADMINISTER STUDY DRUG
26
3.12 CLINICAL LABORATORY TESTS
27
3.13 DRUG CONCENTRATION AND ANTI-DRUG ANTIBODY MEASUREMENTS
32
3.14 RADIOGRAPHS OF THE HANDS AND FEET
33
3.15 OUT OF WINDOW VISITS DUE TO COVID-19 PANDEMIC
34
4
SAFETY MANUAL
34
4.1
METHODS AND TIMING OF SAFETY ASSESSMENT
34
4.2
DEFINITION OF ADVERSE EVENT
35
4.3
SERIOUS ADVERSE EVENTS
35
4.4
ADVERSE EVENT DEFINITION OF SEVERITY GRADE
36
4.5
DEFINITION OF RELATIONSHIP TO STUDY DRUG
36
4.6
RECORDING DATA AND ANALYSES OF SAFETY FINDINGS
37
4.7
REPORTING ADVERSE EVENTS AND INTERCURRENT ILLNESSES
37
Page 61 of 131

p. 4 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
4.8
REPORTING PRODUCT COMPLAINTS
38
5
COUNTRY-SPECIFIC REQUIREMENTS
39
5.1
SUSAR REPORTING
39
5.2
ADDITIONAL ELIGIBILITY CRITERIA
39
5.3
ADDITIONAL REQUIREMENTS-FRANCE
39
5.4
ADDITIONAL LABORATORY REQUIREMENTS
39
6
STUDY DRUG
39
6.1
TREATMENTS ADMINISTERED
39
6.2
PACKAGING AND LABELING
40
6.3
METHOD OF ASSIGNING SUBJECTS TO TREATMENT GROUPS
40
6.4
SELECTION AND TIMING OF DOSE FOR EACH SUBJECT
41
6.5
DRUG ACCOUNTABILITY
41
7
REFERENCES:
41
8
APPENDICES
44
8.1
STUDY SPECIFIC ABBREVIATIONS AND TERMS
44
8.2
CASPAR CRITERIA
47
8.3
CLINICAL CRITERIA FOR DIAGNOSING ANAPHYLAXIS
48
8.4
JOINT ASSESSMENT
49
8.5
AMERICAN COLLEGE OF RHEUMATOLOGY 20 RESPONSE (ACR20)
50
8.6
DAS28 – HSCRP
52
8.7
MODIFIED TOTAL SHARP SCORE (MTSS)
53
8.8
PASI SCORE DEFINITIONS AND USE
54
8.9
LEEDS DACTYLITIS INDEX
55
8.10 LEEDS ENTHESITIS INDEX (LEI)
56
8.11 SPONDYLOARTHRITIS RESEARCH CONSORTIUM OF CANADA (SPARCC) ENTHESITIS INDEX
57
8.12 PSORIATIC ARTHRITIS RESPONSE CRITERIA (PSARC) RESPONSE
58
8.13
MNAPSI – MODIFIED NAIL PSORIASIS SEVERITY INDEX
59
8.14 PHYSICIAN GLOBAL ASSESSMENT – FINGERNAILS (PGA-F)
61
8.15 MINIMAL DISEASE ACTIVITY
62
8.16 PSA DISEASE ACTIVITY SCORE (PASDAS)
63
Page 62 of 131

p. 5 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
8.17 DISEASE ACTIVITY IN PSORIATIC ARTHRITIS (DAPSA)
64
8.18 ANKYLOSING SPONDYLITIS DISEASE ACTIVITY (ASDAS)
65
8.19 HEALTH RESOURCE UTILIZATION QUESTIONNAIRE (HRU)
66
8.20 PATIENT-REPORTED OUTCOMES
67
LIST OF TABLES
TABLE 1.
MODIFICATIONS TO STUDY VISITS DUE TO COVID-19 PANDEMIC
17
LIST OF FIGURES
FIGURE 1.
INTERPRETATION AND MANAGEMENT OF HBV SEROLOGIC TEST RESULTS
30
Page 63 of 131

p. 6 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
2 INVESTIGATION PLAN
2.1 Individual Treatment Period Visit Activities
This section presents a list of activities performed during each visit, organized by visit.  The dot pattern 
on the upper right indicates the place of the visit in the overall Treatment Period Activity Schedule.
Any of the procedures, excluding study drug administration and patient reported outcomes, may be 
performed at an unscheduled visit at the discretion of the investigator.
Activities are grouped by category (Interview, Exam, etc.).  Further information about activities is 
provided in Section 3.
Page 64 of 131

p. 19 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
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.
3.2 Medical History
A complete medical history including subtype of PsA, cardiovascular history and cardiovascular risk 
factors, history of hepatitis B vaccination, and tobacco (including e-cigarettes) and alcohol use will be 
taken at Screening.  A detailed history of prior csDMARD(s) and reasons for discontinuing will also be 
collected.  The subject's medical history will be updated at the Study Day 1 visit.  This updated medical 
history will serve as the Baseline for clinical assessment.
The subject's demographic data, including year of birth, gender, race, and ethnicity will be collected 
when allowed by local regulatory guidelines.
3.3 Adverse Event Assessment
Please refer to Section 4.2.
3.4 Patient-Reported Outcomes
Subjects will complete the self-administered patient-reported outcome (PRO) instruments.  Subjects 
should be instructed to follow the instructions provided with the instrument and to provide the best 
possible response to each item.  Site personnel shall not provide interpretation or assistance to subjects 
other than encouragement to complete the tasks.  Site personnel will encourage completion of the 
instrument at all specified visits and will ensure that a response is entered for all items.
All PROs are collected electronically.  The subject should complete the questionnaires before site 
personnel perform any clinical assessments and preferably before any interaction with site personnel 
has occurred to avoid biasing the subject's response.  Data stored on the central server will be 
considered source.  The investigator and delegated staff will be able to access uploaded subject-entered 
data via a password protected website until the generation, receipt, and confirmation of the study 
archive.  Data from the ePRO system will be archived and provided to the investigator at that time as a 
durable record of the site's ePRO data.
Subjects will complete the following questionnaires as specified in the Study Activities Table (Appendix D 
of protocol).  A validated translation will be provided in their local language, as applicable:
BASDAI
The BASDAI is composed of 6 items investigating 5 domains (fatigue, spinal pain, joint pain/swelling, 
areas of localized tenderness, morning stiffness), with 1 item for each of the first 4 domains and 2 items 
for the last domain (morning stiffness).  A lower score indicates less disease activity.
Page 77 of 131

p. 20 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
EQ-5D-5L Health Questionnaire
The EQ-5D-5L is a health state utility instrument that evaluates preference for health status (utility).  The 
5 items in the EQ-5D-5L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and 
anxiety/depression) each of which are rated on 5 levels of severity.  Responses to the 5 items encode a 
discrete health state which is mapped to a preference (utility) specific for different societies.  Subjects 
also rate their perception of their overall health on a separate visual analogue scale.
FACIT-Fatigue
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue is a 13-item questionnaire that 
evaluates fatigue/tiredness and its impact on daily activities and functioning in chronic diseases.  This 
instrument includes items such as tiredness, weakness, listlessness, lack of energy, and the impact of 
these feelings on daily functioning (e.g., sleeping, and social activities).  A lower score indicates less 
negative impact on daily activities.
HAQ-DI
Health Assessment Questionnaire Disability Index (HAQ-DI) is a self-reported assessment of how the 
patient's illness affects their ability to function in their daily life over the past week.  The HAQ-DI for a 
patient is calculated as the mean of the following 8 category scores:  Dressing and Grooming, Rising, 
Eating, Walking, Hygiene, Reach, Grip, and Activities.  A lower score demonstrates less disability.
Patient's Assessment of Pain (VAS)
The Patient's Assessment of Pain (VAS) allows patients score on a 100 mm horizontal scale (0 being no 
pain and 100 being severe pain) to assess the patient's overall assessment of pain due to the disease 
condition during the past 24 hours.
PtGA of Disease Activity (VAS)
Patient's Global Assessment (PtGA) of Disease Activity (VAS) allows patients to score on a 100 mm 
horizontal scale (0 being very well and 100 being very poorly) to assess the patient's overall functionality 
assessment considering the disease activity within the past 24 hours.  
SF-36 Health Questionnaire
The SF-36 Health Questionnaire is a 36-item survey of patient health consisted of 8 scaled scores, which 
are weighted sums of the questions in their section.  The 8 sections are physical functioning, bodily pain, 
role limitations due to physical health problems, role limitations due to personal or emotional problems, 
emotional well-being, social functioning, energy/fatigue, and general health perceptions.  It also 
includes a single item that provides an indication of perceived change in health.  A higher score indicates 
a more favorable health state.
WPAI
The WPAI Questionnaire is a well-validated instrument to measure impairments in work and activities.  
The questionnaire includes 6 questions to assess the effect of psoriatic arthritis (PsA) on the patient's 
ability to work and perform regular activities in the past 7 days.
Patient reported outcome assessments are provided in 8.20.
Page 78 of 131

p. 21 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
COVID-19 Pandemic-Related Acceptable Protocol Modifications
If electronic PRO instruments (ePROs) cannot be completed on the tablet, they are permitted to be 
completed via phone or video interview.
Site staff will record the subject's responses on the screen shot of the PRO in the subject's language. 
The date, time and interviewer name should be recorded in the source document.  The investigator or 
study coordinator must transcribe the PRO responses into the TrialManager website.  No other site roles 
will receive access to enter data into TrialManager.  Training will be required for investigator data entry 
into TrialManager and will be provided upon request of the sponsor. 
If appropriate site personnel can travel to the subject's home, the tablet can be taken to the subject's 
home for ePRO completion.  All ePROs should be completed for the assigned visit.
3.5 Investigator Assessments
The investigator assessments will be conducted at the study visits specified in the Study Activities Table.  
The results of the assessments, with the exception of the Physician Global Assessment (PGA) of Disease 
Activity (VAS), will be recorded on paper forms and entered into the electronic case report form (eCRF).  
The PGA will be entered into the ePRO device.  If possible, the investigator assessments should be 
performed by an independent and blinded assessor who should not perform any other study related 
procedures. 
In order to minimize variability, the same assessor should evaluate the subject at each visit for the 
duration of the trial.  A back-up assessor should be identified.  The assessor should be an independent 
qualified medical professional (i.e., nurse, physician's assistant, physician, or other qualified person).  It 
is the responsibility of the Investigator to ensure that all assessors are qualified and trained to perform 
assessments and that all training is documented.  If the assessor is not available, the pre-identified back-
up assessor should perform such assessments.
Assessors must complete the following training modules provided by the Group for Research and 
Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA):
!
Assessment of Enthesitis and Dactylitis in Psoriatic Arthritis 
!
PASI/BSA – Psoriasis Area and Severity Index (PASI) 
!
Assessment of Synovitis in Psoriatic Arthritis – Joint Count
!
mNAPSI
Assessors must also complete the following training module provided by AbbVie:
!
PGA-F
The training modules will be provided via web portals.  The trainings for PASI/BSA, NAPSI, mNAPSI, and 
PGA-F are to be completed at 3 time points and the PASI/BSA training may be completed in either 
Study M16-011 or Study M15-998.  The NAPSI training module should be completed prior to the mNAPSI 
Page 79 of 131

p. 22 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
training module as the mNAPSI focuses on the modifications to the NAPSI that are needed to complete 
the mNAPSI subject assessments.  The time points are as follows for each assessor at the site:
1.
Prior to the first subject screened
2.
Between randomization and the first Week 4 visit
3.
Between Week 12 and the first Week 24 visit.
If an assessor has been certified for any of the above GRAPPA trainings in the previous 6 months, the 
respective GRAPPA training module(s) required prior to screening the first subject may be waived upon 
providing the training certificate.  The PASI/BSA, NAPSI, and mNAPSI training required at the second and 
third time points described above may not be waived.
mNAPSI
Each fingernail will be assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails will be 
combined.  Investigators will assess each nail abnormality for each of a participant's nails by grading 
3 features or groups of features (pitting, onycholysis and oil-drop dyschromia, and crumbling) and 
noting the presence or absence of 4 features (leukonychia, splinter hemorrhages, hyperkeratosis, and 
red spots in the lunula).  The range of possible scores is 0 to 130, with a score of 0 indicating absence of 
nail psoriasis and a score of 130 indicating the most severe nail psoriasis.  A decrease in mNAPSI score 
indicates improvement.
The assessor should be an independent qualified medical professional
Physician Global Assessment – Fingernails (PGA-F)
The PGA-F is a clinician-rated outcomes assessment used to measure the severity of signs and symptoms 
associated with fingernail psoriasis.  The instrument instructs clinicians to assess signs and symptoms 
associated with the nail bed and nail matrix separately for each of the ten fingernails.  
The assessor should be an independent qualified medical professional
HRU Questionnaire
Sites will complete a HRU questionnaire at the study visits specified in the Study Activities Table.  The 
questionnaire will be an interview administered by the site.  The answers will be completed on the 
source worksheet provided by the sponsor and entered in the eCRF.
The assessor is not required to be independent and should be a qualified medical professional or a study 
coordinator. 
Psoriasis Assessments
PASI
The PASI is a measure of psoriasis severity.  Four anatomic sites – head, upper extremities, trunk, and
lower extremities – are assessed for erythema, induration and desquamation using a 5-point scale.  
Based on the extent of lesions in a given anatomic site, the area affected is assigned a numerical value.  
Since the head, upper extremities, trunk and lower extremities correspond to approximately 10, 20, 30 
and 40% of body surface area, respectively; the PASI score will be calculated in the eCRF.
Page 80 of 131

p. 23 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
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, respectively.  PASI scores range from 
0.0 to 72.0 with the highest score representing complete erythroderma of the severest possible degree.
Typically scores of 3 or less represent mild disease, scores over 3 and up and including 15 represent 
moderate disease and scores over 15 are considered to be associated with severe disease.
The assessor should be an independent qualified medical professional.
BSA – PsO
The subject's right or left hand should be selected as the measuring device.  For purposes of clinical 
estimation, the total surface of the palm plus five digits will be assumed to be approximately equivalent 
to 1%.  Measurement of the total area of involvement by the assessor is aided by imagining if scattered 
plaques were moved so that they were next to each other and then estimating the total area involved.
The assessor should be an independent qualified medical professional. 
TJC and SJC Assessment
TJC Assessment
An assessment of 68 joints will be done for tenderness by pressure manipulation on physical 
examination.  Joint pain/tenderness will be classified as:  present, absent, replaced or no assessment.  
Joints injected with corticosteroid will be considered non-evaluable for 90 days from the time of the 
injection.
The assessor should be an independent qualified medical professional. 
SJC Assessment
An assessment of 66 joints will be done by directed physical examination.  The hip joints are not 
assessed for swelling; all other joints that are assessed for tenderness will also be examined for swelling.  
Joint swelling will be classified as present, absent, replaced or no assessment.  Joints injected with 
corticosteroid will be considered non-evaluable for 90 days from the time of the injection.
The assessor should be an independent qualified medical professional.
Dactylitis
LDI
This evaluation will be conducted to assess the presence or absence of dactylitis in all 20 of the subject's 
digits.  The assessment should begin with visual inspection of the hands and feet.  For each pair of digits 
in which one or both digits appear dactylitic, the circumference of the affected digits (both right and left 
side) will be assessed using a dactylometer.  Additionally, the affected digit pairs will be assessed for
tenderness by squeezing the digital shaft mid-way between the metacarpophalangeal and proximal 
interphalangeal joints and will be recorded as tenderness, yes or no.  Tenderness should not be assessed 
by squeezing the joint lines.  Digits injected with corticosteroid will be considered non-evaluable for 
90 days from the time of the injection.  If a digit is missing and its contralateral digit is dactylitic, "digit 
absent" will be recorded for the missing digit.  For any digit without an available dactylometer 
Page 81 of 131

p. 24 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
measurement the standard reference value will be utilized in calculation of the LDI.  The standard 
reference values will not be entered into the eCRF.  A dactylometer will be provided to sites for use.  If 
dactylitis is present with any of the digits, the subject is counted as a subject with dactylitis for purposes 
of stratification.
The assessor should be an independent qualified medical professional.
Enthesitis
LEI
LEI is a validated enthesitis index that uses 6 sites for evaluation of enthesitis:  lateral epicondyle 
humerus left and right, Achilles tendon insertion left and right, and medial condyle femur left and right.  
Tenderness on examination is recorded as either present, absent, or not assessed for each of the 6 sites, 
for an overall score range of 0 – 6.  If enthesitis is present with any of the 6 sites, the subject is counted 
as a subject with enthesitis for purposes of stratification.
Enthesitis sites injected with corticosteroid will be considered non-evaluable for 90 days from the time 
of the injection.
The assessor should be an independent qualified medical professional.
SPARCC Enthesitis Index
This evaluation will be conducted to assess the presence or absence of enthesitis at 8 bilateral sites:  
medial epicondyle, lateral epicondyle, supraspinatus insertion to the greater tuberosity of the humerus, 
greater trochanter, quadriceps insertion into the superior border of the patella, patellar ligament 
insertion into the inferior pole of the patella or tibial tubercle, Achilles tendon insertion into calcaneum, 
and plantar fascia insertion into calcaneum.  Tenderness on examination is recorded as either present, 
absent, or not assessed for each of the 16 sites.  For scoring purposes, the inferior patella and tibial 
tuberosity are considered to be one site due to their anatomical proximity.  The overall score range is 0 
to 16.  Enthesitis sites injected with corticosteroid will be considered non-evaluable for 90 days from the 
time of the injection.  The lateral epicondyle and Achilles tendon insertion will only need to be assessed 
once since the 2 bilateral sites overlap between the LEI and SPARCC.  
The assessor should be an independent qualified medical professional.
Psoriatic Spondylitis
This evaluation will be conducted at Baseline only as part of assessing PsA subtype.  If the investigator 
determines that a subject has psoriatic spondylitis, how the diagnosis was made should be recorded 
(i.e., clinical evaluation, radiography and/or MRI).
Where possible, this evaluation should be assessed by a rheumatologist.
CASPAR
This is a validated set of criteria used for the classification of PsA based on the presence of inflammatory 
arthritis (joints, spine, or entheses) with ≥ 3 points from 5 categories as specified in 8.2.
Page 82 of 131

p. 25 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
Subjects will receive bilateral radiographs of the hands and feet.  Radiographs will be locally read for 
CASPAR criteria and centrally read for erosion determination (8.2). 
PGA
Physician Global Assessment (PGA) of Disease Activity (VAS) allows physicians to score on a 100 mm 
horizontal scale (0 being very well and 100 being very poorly) to assess the patient's overall functionality 
assessment considering the disease activity within the past 24 hours.
The assessor is not required to be independent but should be a qualified medical professional, 
preferably a physician. 
Investigator assessments are shown in 8.4 through 8.19. 
3.6 Biomarker Sampling
Optional whole blood and urine samples will be collected for exploratory research throughout the study 
as outlined in Section 2.1.  All biomarker samples should be labeled and shipped as outlined in the 
study-specific laboratory manual.  AbbVie (or people or companies working with AbbVie) will store the 
samples and data in a secure storage space with adequate measures to protect confidentiality.  The 
samples may be retained while research on risankizumab (or drugs of this class) or psoriatic arthritis and 
related conditions continues, but for no longer than 20 years after study completion, or per local 
requirement.
3.7 12-Lead Electrocardiogram
A 12-lead ECG will be performed at Screening using local equipment, as specified in Section 2.1.  If a 
subject has had an ECG within the previous 90 days, it will not be required to be repeated for screening 
provided the conditions noted in this section are met.  The ECG should be performed prior to blood 
collection.  
The ECGs will be evaluated by an appropriately trained physician at the site ("local reader").  The local 
reader from the site will sign and date all ECG tracings and will provide his/her global interpretation as a 
written comment on the tracing using the following categories:
!
Normal ECG
!
Abnormal ECG – not clinically significant
!
Abnormal ECG – clinically significant
In case of an abnormal ECG, the abnormal finding will be documented.  Clinically significant ECG findings 
noted at screening will be captured in Medical History.
Only the local reader's evaluation of the ECG will be collected and documented in the subject's source 
folder.  The automatic machine reading (i.e., machine-generated measurements and interpretation that 
are automatically printed on the ECG tracing) will not be collected but will be retained in subject's 
source records.
Page 83 of 131

p. 26 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
3.8 Height and Weight
Height and weight will be measured without shoes.  The subject will wear lightweight clothing and no 
shoes during weighing.  Weight should be measured at screening, Week 24 and Week 52.  After 
Week 52, weight should be measured every 24 weeks (at Week 76, Week 100, Week 124, Week 148, 
Week 172, Week 196, and the Week 220/PD visit).
3.9 Vital Signs
Vital sign determinations of systolic and diastolic blood pressure (BP) and pulse rate will be obtained at 
visits as specified in Section 2.1 before blood draws are performed.  Blood pressure and pulse rate 
should be measured after the subject has been sitting for at least 3 minutes.  Any significant abnormal 
vital signs findings will be reported as AEs.
3.10 Physical Examination
A complete physical examination will be performed at the designated study visits as specified in 
Section 2.1.  The physical examination performed on Study Day 1 will serve as the Baseline physical 
examination for the entire study.  Any significant physical examination findings after the first dose will 
be recorded as AEs.  All findings, whether related to an AE or part of each subject's medical history, will 
be captured on the appropriate eCRF page.
At any visits that do not require a full physical examination, a symptom-directed physical examination 
can be performed as deemed necessary by the Investigator.
3.11 Administer Study Drug
Study drug will be administered to subjects beginning at Baseline (Study Day 1) and as specified in 
Section 2.1.  All SC doses of risankizumab and placebo will be administered by study site personnel 
under the direction of the Investigator.  The date and time (to the nearest minute) of onset of study 
drug administration will be recorded in the subject's medical record.  The first dose of study drug will be 
administered after all other Baseline (Study Day 1) procedures are completed.
COVID-19 Pandemic-Related Acceptable Protocol Modifications
If a subject cannot travel to the site for a visit when study drug administration is planned, site personnel 
may travel to the subject's home to conduct an at-home visit.  Study drug may be transported under 
appropriate storage conditions and administered by trained site personnel.  The site must contact the 
Sponsor to obtain instructions on how to dispense drug in the IRT system for at-home visits or for visits 
when a joint count assessment cannot be made.
If an at-home visit is scheduled, site staff should also bring the ePRO tablet to the home for the subject 
to complete those assessments, see Section 3.4 for more details.
Page 84 of 131

p. 27 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
Monitoring for Hypersensitivity Reactions
Therapeutic protein products, such as biologics, may elicit a range of acute effects, from symptomatic 
discomfort to sudden, fatal reactions that have often been grouped as 'infusion reactions' in the past.  
Although the term implies a certain temporal relationship, infusion reactions are otherwise not well 
defined and may encompass a wide range of clinical events, including anaphylaxis and other events that 
may not be directly related to antibody responses, such as cytokine release syndrome.
All appropriate medical support measures (e.g., diphenhydramine, steroids, epinephrine, oxygen) for the 
treatment of suspected hypersensitivity reactions should be available for immediate use in the event 
that a suspected hypersensitivity reaction occurs.  Subjects who manifest any new signs or symptoms 
during the injection should be monitored for appropriate resolution prior to leaving the site.  Subjects 
are encouraged to report any symptoms related to a possible injection-related reactions or local 
injection site reaction or late phase reactions to the site any time during the study.  A patient 
information card listing the symptoms of these reactions will be provided to the participants.
In the event of a suspected anaphylactic reaction, in addition to the standard AE eCRF, the supplemental 
Hypersensitivity Reaction Signs and Symptoms eCRF should also be completed by the site.  The clinical 
criterion for diagnosing anaphylaxis is provided in 8.3 for reference; symptoms of anaphylactic reaction 
usually occur within 24 hours after exposure to an allergen.  These are guidelines that are used to help 
diagnose anaphylaxis.  The investigator is encouraged to report any suspected reactions.
Subjects will be monitored throughout the study for signs and symptoms suggestive of hypersensitivity 
reactions, including allergic reactions and anaphylaxis.  A medical person qualified in the treatment of 
acute hypersensitivity reactions must be present during the injections.  Subjects will be closely 
monitored for approximately 2 hours after the first dose administration (Study Day 1) and Week 24 
(first dose of risankizumab for subjects randomized to placebo) and 1 hour after all other dose 
administrations.  
Anaphylaxis Testing
In the event of a suspected anaphylactic reaction, a blood sample for risankizumab drug level, ADA, and 
nAb should be collected once within 24 hours of the reaction.  In addition to risankizumab drug level, 
ADA, and nAb assays, blood tests to be conducted in the event of a suspected anaphylactic reaction are: 
!
Serum tryptase:  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:  5 to 15 minutes of symptom onset, and no later than 1 hour.
3.12 Clinical Laboratory Tests
A certified laboratory will be utilized to process and provide results for the clinical laboratory tests.  
Laboratory reference ranges will be obtained prior to the initiation of the study.  The Baseline (Day 1) 
laboratory test results for clinical assessment for a particular test will be defined as the last 
measurement prior to the initial dose of study drug.
Page 85 of 131

p. 28 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
Instructions regarding the collection, processing, and shipping of these samples will be provided by the 
central laboratory.
If a laboratory test value is outside the reference range and the investigator considers the laboratory 
result to be clinically significant, the investigator will:
!
repeat the test to verify the out-of-range value;
!
follow the out-of-range value to a satisfactory clinical resolution; or
!
discontinue the subject from the study or require the subject to receive treatment; in this case, 
the laboratory result will be recorded as an adverse event.
Clinical Laboratory Tests
Hematology
Clinical Chemistry
Other Tests
Hematocrit
Hemoglobin
Red Blood Cell (RBC) count
White Blood Cell (WBC) count
Neutrophils
Bands, if detected
Lymphocytes
Monocytes
Basophils
Eosinophils
Platelet count
Coagulation:
International Normalized Ratio 
(INR)a
Blood Urea Nitrogen (BUN)
Creatinine
Total bilirubin
Direct and indirect bilirubinc
Alanine transaminase (SGPT/ALT) 
Aspartate transaminase (SGOT/AST)
Gamma glutamyl transferase (GGT)
Alkaline phosphatase
Sodium
Potassium
Calcium
Cholesterold
Total protein
Glucose
Triglyceridesd
LDLd
HDLd
Albumin
Chloride
Bicarbonate/CO2
Estimated glomerular filtration rate 
(eGFR)
(Chronic Kidney Disease Epidemiology 
Collaboration [CKD-EPI])
Hepatitis B surface antigen 
(HBsAg, qualitative)b
Hepatitis B core antibody 
(HBcAb)/anti-HBcb (qualitative)
HBsAb/anti-HBsb (qualitative)
Hepatitis B Virus DNA (reflex, 
quantitative)b
Hepatitis C Antibodies 
(qualitative)b
Hepatitis C Virus RNA (reflex, 
quantitative)b
HIV-1 and HIV-2 Antibody 
(qualitative)b
Human Chorionic Gonadotropin 
(hCG) for females 
(quantitative)b,e
Rheumatoid Factorb
Anti-CCP antibodiesb
hsCRP
FSHb,f
TB screen (QuantiFERON-TB 
Gold Test)
Anaphylaxis Testingg
Tryptaseg
Histamineg
Serum risankizumab 
concentrationsg
ADA/nAb sampleg
Local Labs
TB screen (PPD Skin Test) (if 
needed)
Urine hCG for femalese
Urinalysisb
Specific gravity
Ketones
pH
Protein
Blood
Glucose 
Urobilinogen
Bilirubin
Leukocyte esterase
Nitrite
Microscopic (reflex)
a.
INR test only performed if ALT or AST > 3 × ULN (upper limit of normal).
Page 86 of 131

p. 29 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
b.
Performed only at Screening.
c.
Direct and indirect bilirubin is reflex if total bilirubin ≥ ULN.
d.
Performed only at Baseline.
e.
Pregnancy testing is required only for females of childbearing potential.
f.
FSH testing is to be done at Screening in all women aged ≤ 55 years with no menses for 12 or more months without an 
alternative medical cause.
g.
Only performed in case of a suspected anaphylactic reaction.  A blood sample for risankizumab drug level, ADA, and nAb 
should be collected once within 24 hours of the reaction.  In addition, blood tests to be conducted in the event of a 
suspected anaphylactic reaction are: 
!
Serum tryptase:  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:  5 to 15 minutes of symptom onset, and no later than 1 hour. 
In the event that a suspected anaphylactic reaction occurs while the subject is not on site at the study clinic, please advise 
the treating facility to perform serum tryptase and histamine. 
Serum Pregnancy Test
A serum pregnancy test will be performed for all female subjects of childbearing potential (defined in 
the protocol) at Screening.  The serum pregnancy test will be sent to and performed by the central 
laboratory.  If the serum pregnancy test is positive the subject is considered a screen failure.  If the 
serum pregnancy test is borderline, it should be repeated to determine eligibility.
If the repeat serum pregnancy test is:
!
Positive, the subject is considered a screen failure;
!
Negative, the subject can be enrolled into the trial;
!
Still borderline ≥ 3 days later:  If no clinical suspicion of pregnancy and there are other 
pathological causes of borderline results, the borderline results will be considered 
documentation of continued lack of a positive result and the subject can be enrolled into the 
study.
Determination of postmenopausal status will be made during the Screening period based on the 
subject's history and confirmed by FSH if appropriate.
A pregnant or breastfeeding female will not be eligible for participation or continuation in this study.
Urine Pregnancy Test
Additional urine pregnancy tests for female subjects of childbearing potential will be performed at visits 
indicated in Section 2.1.  More frequent pregnancy tests will be performed throughout the study if 
required per local/country requirements.
If the urine pregnancy test (which is performed at the site) is negative, begin or continue dosing.  If urine 
pregnancy test is positive, withhold dosing and perform a serum pregnancy test.  Pregnant subjects 
must discontinue from the study.
Page 87 of 131

p. 30 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
Chemistry
Blood samples at Baseline will be collected following a minimum 8-hour fast.  If a subject is not able to 
fast due to unforeseen circumstances, the nonfasting status will be recorded in study source 
documentation and lab requisition.  Subjects are not required to fast before laboratory assessments at 
other time points.
Urinalysis
Dipstick urinalysis will be completed by the central laboratory at the Screening Visit.  Specified abnormal 
macroscopic urinalyses dipstick results will be followed up with a microscopic analysis at the central 
laboratory.
Hepatitis B and C Testing
All subjects will be tested for the presence of the hepatitis B virus (HBV) and hepatitis C virus (HCV) at 
Screening.  Subjects with hepatitis B (HBs Ag positive [+] or detected sensitivity on the HBV DNA PCR 
qualitative test) or hepatitis C (HCV RNA detectable in any subject with anti-HCV Ab) will be excluded. 
Subjects who have been vaccinated against hepatitis B and are HBs Ab positive may be enrolled.  If 
Hepatitis B Surface Antigen is negative but Hepatitis B Core Antibodies total is positive, Hepatitis B Virus 
DNA will be quantified.  If Hepatitis B Virus DNA level is undetectable at Screening, the subject can 
participate in this trial.  If Hepatitis C Virus Antibodies is positive, Hepatitis C Virus RNA will be 
quantified.  If Hepatitis C RNA level is undetectable at Screening, the subject can participate in this trial.
Figure 1.
Interpretation and Management of HBV Serologic Test Results
*
A positive test result for HBs Ab is expected for subjects who have had a HBV vaccination.  For subjects without a history of
HBV vaccination (and where mandated by local requirements), a positive result for HBs Ab requires HBV DNA PCR testing.
**
Where mandated by local requirements; subjects with HBs Ab+ and/or HBc Ab+ and negative HBV DNA at screening should 
have HBV DNA PCR testing performed q12w.  HBV DNA PCR testing q12w is not necessary when the subject has a history 
of HBV vaccine and is HBs Ab+ and HBc Ab–.
Page 88 of 131

p. 31 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
HIV Testing
HIV testing will be performed at Screening.  The Investigator must discuss any local reporting 
requirements to local health agencies with the subject.  The site will report confirmed positive results to 
their health agency per local regulations, if necessary.  If a subject has a confirmed positive result, the 
Investigator must discuss with the subject the potential implications to the subject's health and subject 
should receive or be referred for clinical care promptly.  A subject will not be eligible for study 
participation if test results indicate a positive HIV infection.  AbbVie will not receive results from the 
testing and will not be made aware of any positive result.  Ineligibility due to a positive HIV test should 
be documented in the CRF as a screen failure due to criterion 17 to keep this test result private.
TB Screen
Subjects will be tested for TB by either the QuantiFERON-TB Gold Test (or IGRA equivalent) or a TB Skin 
Test (PPD) at the Screening visit.  Subjects who have had a TB test performed within 90 days of the 
Screening Visit will not need to have the test repeated, provided all of the protocol required 
documentation is available at the site, and no new TB risk factors have been identified.
At Screening, all subjects will be assessed for evidence of TB, and if positive, additional risk factors will 
be assessed.  At Week 52, subjects with no prior positive TB test will be tested for TB by either the 
QuantiFERON-TB Gold Test (or IGRA equivalent) or a TB Skin Test (PPD).
The QuantiFERON®-TB Gold assay test will be supplied and analyzed by the central laboratory.  
(QuantiFERON-TB test is preferred over TB Skin Test.)  Details on the collection, shipment of samples 
and reporting of results by the central laboratory are provided to investigators in the laboratory manual.
!
If the QuantiFERON-TB Gold Test (or IGRA equivalent) is NOT possible, or if both the 
QuantiFERON-TB Gold Test (or IGRA equivalent) 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 subject had a positive QuantiFERON-TB Gold (or IGRA equivalent) or PPD test at Screening, the 
test should not be repeated.  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.
!
If the TB screening test (either PPD 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 participate in the study if further work-up (according to local 
practice/guidelines) establishes conclusively that the patient has no evidence of active TB.
!
If the subject is diagnosed with active TB, the subject should not be randomized in the study and 
should not receive study drug.  Subject will be considered as a screening failure.
Page 89 of 131

p. 32 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
!
If presence of latent TB is established, subjects who are considered at low risk for reactivation 
defined by local guidelines and investigator judgment are not required to be treated with 
prophylactic anti-TB therapy prior to or during the study.
!
If the subject is diagnosed with active TB after being randomized, the subject should not receive 
any further study drug and PD Visit procedures should be followed (Section 2.1).
!
If TB (latent or active) is diagnosed during the study, it is also necessary to report it as an AE in 
the source documents and eCRFs.  In the case of a TB-related AE, a TB supplemental form that 
provides additional information will be completed by the investigator or designee.
FSH
FSH should be tested at Screening if the female subject is ≤ 55 years of age AND has had no menses for 
≥12 months AND has no history of permanent surgical sterilization.
Anaphylaxis Testing 
In the event of a suspected anaphylactic reaction or other systemic post-dose reaction, blood samples 
should be collected as stated in Section 3.11.
COVID-19 Pandemic-Related Acceptable Protocol Modifications
If travel 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 laboratory, hospital, or other facility.  Local laboratory results 
should be obtained along with reference ranges.  Local laboratory results and reference ranges need to 
be entered into the EDC system and also kept with the subjects' source documentation.  Local 
laboratory 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.  In addition, the Investigator must review and 
confirm the subject has no additional issues that would impact the ability of the subject to safely 
continue use of the study drug in the absence of current labs.  The subject should be scheduled for 
laboratory draws as soon as feasible.
3.13 Drug Concentration and Anti-Drug Antibody Measurements
Pharmacokinetic, ADA, and nAb samples should be collected within 60 minutes prior to the dose at 
dosing visits.  
Collection of Blood Samples for Risankizumab Analysis, ADA Assay, and nAb Assay
Blood samples for analysis of risankizumab serum concentrations, ADA assay, and nAb assay will be 
collected during the treatment period on the study days and time points specified in the protocol.  
Samples will be collected by venipuncture into appropriately labeled, evacuated serum collection tubes.  
The time that each blood sample (PK and ADA/nAb) is collected will be recorded to the nearest minute.
Page 90 of 131

p. 33 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
Measurement Methods
Serum concentrations of risankizumab and ADA and nAb assessments will be done using validated 
methods at or under the supervision of the Bioanalysis Department at AbbVie.  The presence of ADA to 
risankizumab will be assessed via a tiered approach with an electrochemiluminescence assay using 
screening, confirmatory, and titration analyses.  Samples that are confirmed positive may be further 
characterized in a validated nAb assay.  Any additional analytes may be analyzed using nonvalidated 
methods.  Serum samples collected for risankizumab PK and ADA analysis may be used for future assay 
development or validation activities.  Risankizumab nAb samples upon request may be used for the 
analysis of neutralizing ADAs.
Disposition of Samples
The frozen serum samples for risankizumab analysis, ADA and nAb assays will be packed in dry ice 
sufficient to last during transportation and shipped from the study site to the central lab according to 
instructions from AbbVie.
3.14 Radiographs of the Hands and Feet
Each subject will undergo 4 scheduled radiographic examinations of the hands and feet:  at Screening, 
Week 24, Week 52, and Week 100.  In addition, subjects who are nonresponders at Week 16 will 
undergo an unscheduled radiographic examination at the Week 16 Visit.  Repeat imagining at any of 
these time points may be needed due to failure to meet the quality requirements.  Radiographs will be 
centrally read.
Randomization is permitted prior to results of the central reading of hand and foot radiographs for 
eligibility if a subject has an elevated hs-CRP available from the central laboratory and all other criteria 
are met.
The Investigator or their qualified delegate may read the Screening visit radiographs of the hands and 
feet to determine if the subject fulfills item 5 of the CASPAR criteria (8.2).  However, for eligibility criteria 
of erosion, a central read is required.  The Investigator, or qualified delegate, should review the images 
to assess for clinically significant findings.  The central reader will not assess the radiographs for any 
clinically significant findings that may impact a subject's health.
For subjects who re-screen:  Provided the conditions outlined in the imaging manual are met, if the 
subject had radiographs of hands and feet performed within 12 weeks of re-screening these tests will 
not be required for re-screening.  Radiographs will be sent to the designated central imaging vendor and 
will be interpreted by an experienced reader selected for the study, who will make the final 
determination as to whether a subject has at least 1 erosion.  The imaging vendor will return an 
eligibility notification report to the site as outlined in the central imaging documents.
All subjects who fail to attain at least a 20% improvement in either or both TJC and SJC at Week 12 and 
Week 16 will have a radiographic examination at Week 16.  At Week 16, subjects classified as non-
responders (defined as not achieving at least 20% improvement in either or both tender joint count 
(TJC) and swollen joint count (SJC) at both Week 12 and Week 16) may add or modify background 
therapy for PsA.
Page 91 of 131

p. 34 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
All subjects will receive radiographs of hands and feet if they discontinue from the study or from study 
drug at or after Week 12 and if it has been at least 12 weeks from when radiographs were last obtained 
during Period 1 or at least 24 weeks during Period 2.  In such subjects, radiographs should be obtained 
as close as possible to the date of study drug discontinuation.
Further details regarding the specific imaging techniques to be used will be provided in an imaging 
manual from AbbVie or designee.
3.15 Out of Window Visits Due to COVID-19 Pandemic
If a visit can be performed onsite but OOW, consult with the sponsor to determine if the OOW visit is 
permitted.  
Regardless of whether an onsite OOW visit can occur, a phone call from the site to the enrolled subject 
should be conducted as close to the date of the study visit as possible to query for any AEs and to review 
concomitant medications.  
4 SAFETY MANUAL
4.1 Methods and Timing of Safety Assessment
All serious adverse events (SAEs) as well as protocol-related nonserious AEs (e.g., bruising related to 
blood draw) will be collected from the time the subject signed the study-specific informed consent until 
study drug administration.  From the time of study drug administration until 140 days (20 weeks) 
following discontinuation of study treatment has elapsed, all AEs and SAEs will be collected, whether 
solicited or spontaneously reported by the subject. 
Page 92 of 131

p. 35 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
4.2 Definition of Adverse Event
An AE can result from use of the drug as stipulated in the 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, meets protocol specific 
criteria (see Section 6.2 in the Protocol regarding toxicity management), 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 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.
4.3 Serious Adverse Events
Classification of Serious Adverse Events is defined as follows: 
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).
Page 93 of 131

p. 36 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
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.
4.4 Adverse Event Definition of Severity Grade
When criteria are available, events should be graded to the 5 criteria as described in the National Cancer 
Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0,1 which can be accessed 
at: 
https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/CTCAE_v5_Quick_Referenc
e_8.5x11.pdf.
If no grading criteria are provided for the reported event, the event should be graded as mild, moderate, 
or severe per the Investigator's judgment.
Mild
Asymptomatic or mild symptoms; clinical or diagnostic observations only; 
intervention not indicated.
Moderate
Minimal, local or noninvasive intervention indicated; limiting age-appropriate 
instrumental activities of daily living (ADL).
Severe
Severe or medically significant but not immediately life threatening; hospitalization or 
prolongation of hospitalization indicated; disabling; limiting self-care ADL.
Life-threatening consequences; urgent intervention indicated. 
Death related to AE.
4.5 Definition of Relationship to Study Drug
Relationship to study drug is defined as follows: 
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
Page 94 of 131

p. 39 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
5 COUNTRY-SPECIFIC REQUIREMENTS
5.1 SUSAR Reporting
AbbVie will be responsible for SUSAR reporting for the IMP in accordance with global and local 
guidelines, and Appendix A of the Investigator's Brochure will serve as the Reference Safety Information 
(RSI).  The RSI in effect at the start of a Development Safety Update Report (DSUR) reporting period 
serves as the RSI during the reporting period.  For follow-up reports, the RSI in place at the time of 
occurrence of the 'suspected' Serious Adverse Reaction will be used to assess expectedness.
5.2 Additional Eligibility Criteria 
For subjects in some countries, such as China, Korea, Malaysia, Singapore, Hong Kong, Taiwan, and 
Japan, inadequate response to MTX is defined as lack of efficacy after minimum 12 weeks duration of 
therapy at MTX dose ≥ 7.5 mg/week or as required per local authorities.
5.3 Additional Requirements-France
Collection of race and ethnicity information is not required. 
5.4 Additional Laboratory Requirements
If required by country regulatory authorities, subjects who initiate or increase dose of MTX during the 
study should undergo ALT, AST, creatinine and complete blood count (CBC) testing every 4 weeks for a 
12 week period.
6 STUDY DRUG
6.1 Treatments Administered
The study drug (risankizumab or placebo) will be administered by a healthcare professional in the form 
of 2 subcutaneous injections of 75 mg per injection at the visits listed in Section 2.1.  For additional 
details on dispensing study drug in the event of home administration due to the COVID-19 pandemic, 
see Section 3.11.
Risankizumab will be provided by AbbVie as solution for injection in pre-filled syringes (PFS).
Risankizumab will be administered as an initial dose, a second dose 4 weeks later, and q12w thereafter.
Study drug administration instructions will be provided separately.
Page 97 of 131

p. 40 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
6.2 Packaging and Labeling
Study drug packaged in 75 mg PFS will be provided in both open-label and blinded fashion and packaged 
in cartons containing 1 syringe per carton.  Each kit will be labeled as required per local requirements.  
Each kit label will contain a unique kit number.  This kit number is assigned to a subject via Interactive 
Response Technology (IRT) and encodes the appropriate study drug to be administered at the subjects 
corresponding study visit.
All labels must remain affixed to the study drug at all times and should never be removed for any 
reason.  All blank spaces should be completed by site staff prior to dispensing to subject. 
Storage and Disposition of Study Drug
Risankizumab or placebo PFS must be kept protected from light in the original packaging, in a 
refrigerator between 2° to 8°C (36° to 46°F).  Study drug must not be frozen at any time.  The 
investigational products are for investigational use only and are to be used only within the context of 
this study.  The study drug supplied for this study must be maintained under adequate security and 
stored under the conditions specified on the label until dispensed for subject use or destroyed on site as 
appropriate.  A temperature log must be maintained for documentation.
The refrigerator temperature must be recorded each business day.  Malfunctions or temperature 
excursions must be reported to the Sponsor immediately upon notice.  Study drug should be 
quarantined and not dispensed until AbbVie or AbbVie Temperature Excursion Management System 
(ATEMS) deems the drug as acceptable.
6.3 Method of Assigning Subjects to Treatment Groups
This is a Phase 3, global, multi-center study that will evaluate subjects with moderately to severely 
active psoriatic arthritis.  Period 1 is a 24-week randomized, double-blind, placebo-controlled, parallel-
group period.  Eligible subjects will be randomized to risankizumab or placebo in a 1:1 ratio for Period 1.  
After the Week 24 assessments are performed, Period 2 begins.  During Period 2, all subjects will receive 
risankizumab.  To maintain the blind to the original treatment allocation, treatment at the Week 24 Visit 
will be blinded:  subjects who were randomized to placebo will receive blinded risankizumab, and those 
randomized to risankizumab will receive 1 dose of blinded placebo.  At Week 28 and for the remaining 
dosing visits, all subjects will receive open-label risankizumab 150 mg q12w.
At the Screening Visit, all subjects will be assigned a unique subject number through the use of the IRT.  
Randomization will be stratified by extent of psoriasis (≥ 3% BSA vs < 3% BSA), current use of csDMARD 
(0 vs ≥ 1), presence of dactylitis (yes vs no), and presence of enthesitis (yes vs no) at Baseline. 
For subjects who do not meet the study selection criteria, the site personnel must login to the IRT 
system and identify the subject as a screen failure.  
Subjects who are enrolled will retain their subject number assigned at the Screening Visit throughout 
the study.  Upon receipt of study drug, the site will acknowledge receipt in the IRT system.
Contact information and user guidelines for IRT use will be provided to each site.
Page 98 of 131

p. 41 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
6.4 Selection and Timing of Dose for Each Subject
Risankizumab 150 mg or matching placebo dose subcutaneously (SC, 2 × 75 mg PFS) administered at 
Week 0, 4, 16, 24, 28, and q12w thereafter is selected for this study.
6.5 Drug Accountability
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.
An overall accountability of the study drug will be performed and verified by the AbbVie monitor 
throughout the treatment period.  The monitor will review study drug accountability on an ongoing 
basis.  Final accountability will be verified by the monitor at the end of study drug treatment at the site.
Stand-alone investigational product administration guidelines for sites will be provided by the sponsor.
The study drug start date and the last dose of the regimen will be documented in the subject's source 
documents and recorded on the appropriate eCRF.  The status of each kit and the date of reconciliation 
will be documented in the IRT system.  The monitor will review study drug accountability on an ongoing 
basis.
Upon completion of or discontinuation from the treatment, all study drug will be returned to AbbVie (or 
designee) or destroyed on site.  All destruction procedures will be according to instructions from the 
Sponsor and according to local regulations following completion of drug accountability procedures.
7 References: 
1.
US Dept. of Health and Human Services.  Common Terminology Criteria for Adverse Events 
(CTCAE) Version 5.0.  November 27, 2017.  Available from:  
https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/CTCAE_v5_Quick_R
eference_8.5x11.pdf.
2.
Sampson HA, Muñoz-Furlong A, Campbell RL, et al. Second symposium on the definition and 
management of anaphylaxis:  summary report - Second National Institute of Allergy and 
Infectious Disease/Food Allergy and Anaphylaxis Network symposium.  J Allergy Clin Immunol.  
2006;117(2):391-7. 
3.
Felson DT, Anderson JJ, Boers M, et al.  American College of Rheumatology.  Preliminary 
definition of improvement in rheumatoid arthritis.  Arthritis Rheum.  1995;38(6):727-35. 
4.
Langley RGB, Feldman SR, Nyirady J, et al.  The 5-point Investigator's Global Assessment (IGA) 
scale:  a modified tool for evaluating plaque psoriasis severity in clinical trials.  J Dermatol Treat.  
2015;26(1):23-31. 
5.
Gestel AM van, Haagsma CJ, Riel PLCM van.  Validation of rheumatoid arthritis improvement 
criteria that include simplified joint counts.  Arthritis Rheum.  1998;41(10):1845-50.
Page 99 of 131

p. 42 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
6.
van der Heijde D.  How to read radiographs according to the Sharp/van der Heijde method.  
J Rheumatol.  2000;27(1):261-3.
7.
Fredriksson T, Pettersson U.  Severe psoriasis--oral therapy with a new retinoid.  Dermatologica.  
1978;157(4):238-44.
8.
Helliwell PS, Firth J, Ibrahim GH, et al.  Development of an assessment tool for dactylitis in 
patients with psoriatic arthritis.  J Rheumatol.  2005;32(9):1745-50.  
9.
Healy PJ, Helliwell PS.  Measuring dactylitis in clinical trials:  which is the best instrument to use?  
J Rheumatol.  2007;34(6):1302-6.
10. Healy PJ, Helliwell PS.  Measuring clinical enthesitis in psoriatic arthritis:  assessment of existing 
measures and development of an instrument specific to psoriatic arthritis.  Arthritis Care Res.  
2008;59(5):686-91.  
11. Maksymowych WP, Mallon C, Morrow S, et al.  Development and validation of the 
Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index.  Ann Rheum Dis.  
2009;68(6):948-53.  
12. Mease PJ, Gladman DD, Ritchlin CT, et al.  Adalimumab Effectiveness in Psoriatic Arthritis Trial 
Study Group.  Adalimumab for the treatment of patients with moderately to severely active 
psoriatic arthritis:  results of a double-blind, randomized, placebo-controlled trial.  Arthritis 
Rhem.  2005;52(10):3279-89.
13. Cassell SE, Bieber JD, Rich P, et al.  The modified nail psoriasis severity index:  validation of an 
instrument to assess psoriatic nail involvement in patients with psoriatic arthritis.  J Rheumatol.  
2007;34(1):123-9. 
14. Hudgens S, Sundaram M, Williams DA.  Evaluation of a novel clinician reported outcome in nail 
psoriasis [abstract].  Value Health.  2016;19:A127. 
15. Elewski BE, Okun MM, Papp K, et al.  Adalimumab for nail psoriasis:  Efficacy and safety from the 
first 26 weeks of a phase 3, randomized, placebo-controlled trial.  J Am Acad Dermatol.  
2018;78(1):90-9.
16. Coates LC, Fransen J, Helliwell PS.  Defining minimal disease activity in psoriatic arthritis:  a 
proposed objective target for treatment.  Ann Rheum Dis.  2010;69(1):48-53. 
17. Helliwell PS, FitzGerald O, Fransen J, et al.  The development of candidate composite disease 
activity and responder indices for psoriatic arthritis (GRACE project).  Ann Rheum Dis.  
2013;72(6):986-91.
18. Eberl G, Studnicka-Benke A, Hitzelhammer H, et al.  Development of a disease activity index for 
the assessment of reactive arthritis (DAREA).  Rheumatology (Oxford).  2000;39(2):148-55. 
19. Machado P, Landewé R, Lie E, et al.  Ankylosing Spondylitis Disease Activity Score (ASDAS):  
defining cut-off values for disease activity states and improvement scores.  Ann Rheum Dis.  
2011;70(1):47-53.
20. Garrett S, Jenkinson T, Kennedy LG, et al.  A new approach to defining disease status in 
ankylosing spondylitis:  the Bath Ankylosing Spondylitis Disease Activity Index.  J Rheumatol.  
1994;21(12):2286-91. 
Page 100 of 131

p. 43 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
21. Felson DT, Anderson JJ, Boers M, et al.  The American College of Rheumatology preliminary core 
set of disease activity measures for rheumatoid arthritis clinical trials.  Arthritis Rheum.  
1993;36(6):729-40.
22. The Health Assessment Questionnaire (HAQ) and the improved HAQ (formerly called the 
PROMIS HAQ) (revised June 2009).  Stanford:  Stanford University School of Medicine, Division 
of Immunology & Rheumatology.  2009.  Available from:  
http://aramis.stanford.edu/downloads/HAQ%20Instructions%20(ARAMIS)%206-30-09.pdf.  
Accessed on:  09 July 2018.
23. Webster K, Cella D, Yost K.  The Functional Assessment of Chronic Illness Therapy (FACIT) 
Measurement System:  properties, applications, and interpretation.  Health Qual Life Outcomes.  
2003;1:79. 
24. Chandran V, Bhella S, Schentag C, et al.  Functional assessment of chronic illness therapy-fatigue 
scale is valid in patients with psoriatic arthritis.  Ann Rheum Dis.  2007;66(7):936-9.
25. Ware JE, editor.  SF-36 Health Survey:  Manual and Interpretation Guide.  Boston:  The Health 
Institute, New England Medical Center (1993).
26. Ware JE, Kosinski M, Keller SD, editors.  SF-36 Physical and Mental Health Summary Scales:  A 
User's Manual.  3rd, revised ed.  Boston:  The Health Institute, New England Medical Center 
(1994).
27. Herdman M, Gudex C, Lloyd A, et al.  Development and preliminary testing of the new five-level 
version of EQ-5D (EQ-5D-5L).  Qual Life Res.  2011;20(10):1727-36.
28. Hawker GA, Mian S, Kendzerska T, et al.  Measures of Adult Pain.  Arthritis Care & Research.  
November 2011;63(S11):S240-52.
29. Reilly MC, Zbrozek AS, Dukes EM.  The validity and reproducibility of a work productivity and 
activity impairment instrument.  Pharmacoeconomics.  1993;4(5):353-65.
Page 101 of 131

p. 44 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
8 Appendices
8.1 STUDY SPECIFIC ABBREVIATIONS AND TERMS
Abbreviation
Definition
Ab
Antibody
ADA
Anti-drug antibody
AE
Adverse event
Ag
Antigen
ALT
Alanine aminotransferase
AST
Aspartate aminotransferase
BASDAI
Bath Ankylosing Spondylitis Disease Activity Index
BP
Blood pressure
BSA-PsO
Body surface area-psoriasis
BUN
Blood urea nitrogen
CASPAR
Classification Criteria for PsA
CBC
Complete blood count
CCP
Cyclic-citrullinated peptide
CKD-EPI
Chronic Kidney Disease Epidemiology Collaboration
csDMARD
Conventional synthetic disease modifying anti-rheumatic drug
DAS28
Disease Activity Score 28
ECG
Electrocardiogram
eCRF
Electronic case report form
EDC
Electronic data capture
eGFR
Estimated glomerular filtration rate
EQ-5D-5L
EuroQol-5D-5L
FACIT-Fatigue
Functional Assessment of Chronic Illness Therapy-Fatigue
FSH
Follicle-stimulating hormone
GGT
Gamma-glutamyl transferase
GRAPPA
Group for Research and Assessment of Psoriasis and Psoriatic Arthritis
HAQ-DI
Health Assessment Questionnaire-Disability Index
HBc
Hepatitis B core
HBs
Hepatitis B surface
hCG
Human Chorionic Gonadotropin
Page 102 of 131

p. 45 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
HCV
Hepatitis C virus
HDL-C
High-density lipoprotein-cholesterol
HIV
Human immunodeficiency virus
HRU
Health Resource Utilization
hsCRP
High sensitivity C-Reactive Protein
IMP
Investigational Medical Product
IRT
Interactive Response Technology
LDI
Leeds Dactylitis Index
LDL-C
Low-density lipoprotein-cholesterol
LEI
Leeds Enthesitis Index
MedDRA
Medical Dictionary for Regulatory Activities
nAb
Neutralizing antibody
OOW
Out of window
PASI
Psoriasis Area Severity Index
PD
Premature Discontinuation
PFS
Pre-filled syringe
PGA
Physician's Global Assessment
PK
Pharmacokinetic(s)
PPD
Purified Protein Derivative
PRO
Patient-reported outcome
PsA
Psoriatic Arthritis
PsARC
Psoriatic Arthritis Response Criteria
PT
Preferred term
PtGA
Patient's Global Assessment
RBC
Red blood cell
SAE
Serious adverse event
SC
Subcutaneous(ly)
SF-36
36-Item Short Form Health Survey
SJC
Swollen joint count
SOC
System Organ Class
SPARCC
Spondyloarthritis Research Consortium of Canada
SUSAR
Suspected Unexpected Serious Adverse Reaction
TA MD
Therapeutic Area Medical Director
TB
Tuberculosis
Page 103 of 131

p. 46 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
TJC
Tender joint count
ULN
Upper limit of normal
VAS
Visual analogue scale
WBC
White blood cell
WPAI
Work Productivity and Activity Impairment
Page 104 of 131

p. 47 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
8.2 CASPAR CRITERIA
Page 105 of 131

p. 48 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
8.3 CLINICAL CRITERIA FOR DIAGNOSING ANAPHYLAXIS 
Anaphylaxis2 is highly likely when any one of the following 3 criteria is fulfilled:
1.
Acute onset of an illness (minutes to several hours) with involvement of the skin, mucosal tissue, 
or both (e.g., generalized hives, pruritus or flushing, swollen lips tongue-uvula) AND AT LEAST 
ONE OF THE FOLLOWING:
!
Respiratory compromise (e.g., dyspnea, wheeze-bronchospasm, stridor, reduced peak 
expiratory flow, hypoxemia)
!
Reduced BP or associated symptoms or end-organ dysfunction (e.g., hypotonia [collapse], 
syncope, incontinence)
2.
Two or more of the following that occur rapidly after exposure to a likely allergen (study drug) 
for a subject within minutes to several hours:
!
Involvement of the skin-mucosal tissue (e.g., generalized hives, itch-flush, swollen lips-
tongue-uvula)
!
Respiratory compromise (e.g., dyspnea, wheeze-bronchospasm, stridor, reduced PEF, 
hypoxemia)
!
Reduced BP or associated symptoms (e.g., hypotonia [collapse], syncope, incontinence)
!
Persistent gastrointestinal symptoms (e.g., crampy abdominal pain, vomiting)
3.
Reduced BP after exposure to known allergen (study drug) for that subject (within minutes to 
several hours), with systolic BP of less than 90 mmHg or greater than 30% decrease from that 
subject's baseline BP (Day 1).
Page 106 of 131

p. 49 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
8.4 JOINT ASSESSMENT
Joint counts will be performed by assessor(s) who must be well trained and part of the site personnel.  
Whenever possible, the same evaluator should perform these assessments at all visits.
Number of Tender Joints:
The 68 joints assessed for tenderness include the 2 temporomandibular, 2 sternoclavicular, 
2 acromioclavicular joints, 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal, 10 proximal 
interphalangeal, 8 distal interphalangeal joints of the hands, the 2 hips, 2 knees, 2 ankles 2 mid-tarsal, 
10 metatarsophalangeal, and 10 proximal interphalangeal joints of the feet. 
Joints are to be scored as either tender (1) or not tender (0), replaced (9) or not assessed (99).
Number of Swollen Joints:
The 66 joints to be examined for swelling are the same as those examined for tenderness, however 
excluding both hip joints.
Joints are to be scored as either swollen (1) or not swollen (0), replaced (9) or not assessed (99).
Synovial fluid and/or soft tissue swelling but not bony overgrowth represents a positive result for 
swollen joint count. 
Page 107 of 131

p. 50 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
8.5 AMERICAN COLLEGE OF RHEUMATOLOGY 20 RESPONSE (ACR20) 
ACR RESPONSE CRITERIA3,4
ACR 20:
!
At least 20% improvement in SJC* compared to baseline AND
!
At least 20% improvement in TJC* compared to baseline AND
!
At least 20% improvement in at least 3 out of the following 5 variables
1.
Patient's assessment of pain on VAS
2.
Patient's global assessment of the disease on VAS
3.
Investigator's global assessment of the disease on VAS
4.
Patient's assessment of disability on HAQ
5.
Acute phase reactant (serum CRP)
ACR 50:
!
At least 50% improvement in SJC* compared to baseline AND
!
At least 50% improvement in TJC* compared to baseline AND
!
At least 50% improvement in at least 3 out of the following 5 variables
1.
Patient's assessment of pain on VAS
2.
Patient's global assessment of the disease on VAS
3.
Investigator's global assessment of the disease on VAS
4.
Patient's assessment of disability on HAQ
5.
Acute phase reactant (serum CRP)
ACR 70:
!
At least 70% improvement in SJC* compared to baseline AND
!
At least 70% improvement in TJC* compared to baseline AND
!
At least 70% improvement in at least 3 out of the following 5 variables:
1.
Patient's assessment of pain on VAS
2.
Patient's global assessment of the disease on VAS
3.
Investigator's global assessment of the disease on VAS
4.
Patient's assessment of disability on HAQ
5.
Acute phase reactant (serum CRP)
Page 108 of 131

p. 51 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
*
SJC and TJC are evaluated according to the complete joint count (see 8.4).
Page 109 of 131

p. 52 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
8.6 DAS28 – hsCRP
DAS28-hsCRP5 will be calculated taking the following variables into account: 
!
TJC (on 28 joints)
!
SJC (on 28 joints)
!
Patient's global assessment of the disease on VAS (0 – 100)
!
Serum hsCRP level (mg/L)
Page 110 of 131

p. 53 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
8.7 MODIFIED TOTAL SHARP SCORE (mTSS) 
The modified Total Sharp Score (mTSS) method, including distal interphalangeal joints, will be used to 
evaluate radiographic evidence of damage.6
Page 111 of 131

p. 54 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
8.8 PASI SCORE DEFINITIONS AND USE 
The PASI score is an established measure of clinical efficacy for psoriasis medications.7
The PASI is a tool which provides a numeric scoring for patients overall psoriasis disease state, ranging 
from 0 to 72.  It is a linear combination of percent of surface area of skin that is affected and the severity 
of erythema, induration, and desquamation over four body regions.
The endpoints used are based on the percent reduction from baseline, generally summarized as a 
dichotomous outcome based on achieving over an X% reduction (or PASIX), where X is 50, 75, 90, and 
100.
To calculate the PASI score, the four main body areas are assessed:  head (h), trunk (t), upper 
extremities (u) and lower extremities (l).  These correspond to 10, 30, 20 and 40% of the total body 
area respectively.
The area of psoriatic involvement of these four areas (Ah, At, Au, and Al) is given a numerical value:  
0 = no involvement, 1 = < 10%, 2 = 10 to < 30%, 3 = 30 to < 50%, 4 = 50 to < 70%, 5 = 70 to < 90%, and 
6 = 90 to 100% involvement.
The signs of severity, erythema (E), induration (I) and desquamation (D) of lesions are assessed using a 
numeric scale 0 – 4 where 0 is a complete lack of cutaneous involvement and 4 is the severest possible 
involvement; scores are made independently for each of the areas, h, t, u and l and represents a 
composite score for each area.  An illustration of judging erythema follows:  0 = no erythema, 1 = slight 
erythema, 2 = moderate erythema, 3 = marked erythema, and 4 = very marked erythema.
The PASI score is calculated according to the following formula:
PASI = 0.1(Eh+Ih+Dh)Ah + 0.3(Et+It+Dt)At + 0.2(Eu+Iu+Du)Au + 0.4(El+Il+Dl)Al
Page 112 of 131

p. 55 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
8.9 LEEDS DACTYLITIS INDEX
The LDI basic measures the ratio of the circumference of the affected digit to the circumference of the 
digit on the opposite hand or foot, using a minimum difference of 10% to define a dactylitic digit.8,9  The 
ratio of circumference is multiplied by a tenderness score, using a modification of LDI which is a binary 
score (1 for tender, 0 for non-tender).  If both sides are considered involved, or the circumference of the 
contralateral digit cannot be obtained, AbbVie will input and utilize a circumference provided in the 
standard reference tables.  This modification is referred to as LDI basic and will be applied in this study.  
The LDI requires a finger circumference gauge or a tape measure to measure digital circumference. 
Dactylitis Count
The dactylitis count is the number of fingers and toes with dactylitis, with a range of 0 – 20.
Presence of Dactylitis
If dactylitis is present with any finger or toe, the subject is counted as a subject with dactylitis.
Page 113 of 131

p. 56 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
8.10 LEEDS ENTHESITIS INDEX (LEI) 
LEI is a validated enthesitis index that uses 6 sites for evaluation of enthesitis:  lateral epicondyle 
humerus left and right, Achilles tendon insertion left and right and medial condyle femur left and right.  
The LEI demonstrated substantial to excellent agreement with other scores in the indication of psoriatic 
arthritis.10
Enthesitis Count
Tenderness on examination is recorded as either present (1) or absent (0) for each of the 6 sites, for an 
overall score range of 0 – 6.
Presence of Enthesitis
If enthesitis is present with any of the 6 sites (lateral epicondyle humerus left and right, Achilles tendon 
insertion left and right and medial condyle femur left and right), the subject is counted as a subject with 
enthesitis.
Page 114 of 131

p. 57 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
8.11 SPONDYLOARTHRITIS RESEARCH CONSORTIUM OF CANADA 
(SPARCC) ENTHESITIS INDEX
SPARCC:11  Enthesial sites examined include medial epicondyle (left and right), lateral epicondyle (left 
and right), supraspinatus insertion into greater tuberosity of humerus (left and right), greater trochanter 
(left and right), quadriceps insertion into superior border of patella (left and right), patellar ligament 
insertion into inferior pole of patella or tibial tubercle (left and right), Achilles tendon insertion into 
calcaneum (left and right), plantar fascia insertion into calcaneum (left and right). 
Enthesitis Count
Tenderness on examination is recorded as either present (1) or absent (0) for each of the 16 sites, for an 
overall score range of 0 – 16.
Page 115 of 131

p. 58 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
8.12 PSORIATIC ARTHRITIS RESPONSE CRITERIA (PsARC) RESPONSE
A subject is defined as a PsARC responder if, and only if, they have an improvement in two of the 
following four factors (with at least one factor being a joint count) and no worsening in the remaining 
factors:12
!
Patient global assessment of disease activity (0 – 100 mm VAS scale, improvement defined as 
decrease of ≥ 20 mm) 
!
Physician global assessment of disease activity (0 – 100 mm VAS scale, improvement defined as 
decrease ≥ 20 mm)
!
Tender 68-joint count (improvement defined as decrease of ≥ 30%)
!
Swollen 66-joint count (improvement defined as decrease of ≥ 30%)
Page 116 of 131

p. 59 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
8.13 mNAPSI – MODIFIED NAIL PSORIASIS SEVERITY INDEX
Modified NAPSI Instructions13
This tool will ask you to assess each abnormality for each of a subject's fingernails.  If you question which 
grade to give, your answer should be the lower of the grades.  Three features or groups of features 
(pitting, onycholysis and oil-drop dyschromia, and crumbling) of each fingernail will be graded on a scale 
from 0 to 3, according to the directions below.  Four features (leukonychia, splinter hemorrhages, 
hyperkeratosis, and red spots in the lunula) will be graded as either present or absent for each 
fingernail.  
1.
Onycholysis:  Separation of the nail plate from the nail bed.  The separated part of the nail is 
opaque and can have white, yellow, or greenish tinge.  If there is a piece of nail missing, 
estimate where the nail normally would have ended at the end of the nail bed, and count that 
missing part as involved in onycholysis.
Oil-drop (salmon patch) dyschromia:  Reddish-brown discoloration under the nail plate.
Onycholysis and oil-drop dyschromia are considered together.  When looking at the nail, 
combine the total percentage area of the nail that is affected by either and use that combined 
total to score the nail.
Score
Percent of Nail with Onycholysis or Oil-Drop Dyschromia Present
0
No onycholysis or oil drop dyschromia present
1
1 – 10% of the nail has onycholysis or oil-drop dyschromia
2
11 – 30% of the nail has onycholysis or oil-drop dyschromia
3
> 30% of the nail has onycholysis or oil-drop dyschromia
2.
Pitting:  Small, sharply defined depressions in the nail surface.  Pits are discrete abnormalities 
("ice-pick-like").  If there is nail plate crumbling that is confluent with pits, do not score for pits.  
If the pits are separate from crumbling, they may be scored regardless of whether crumbling is 
present or not.
Score
Number of Pits
0
0
1
1 – 10
2
11 – 49
3
> 50
3.
Nail plate crumbling:  Crumbling or fragmentation of friable nail plate which may be associated 
with confluent pitting.  Crumbling involves alteration of the nail plate surface.  Horizontal ridging 
of the nail, "wave-like" appearance, and horizontal lines are all features of crumbling.
Page 117 of 131

p. 60 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
Score
Percent of Nail with Crumbling Present
0
No crumbling
1
1 – 25% of the nail has crumbling
2
26 – 50% of the nail has crumbling
3
> 50% of the nail has crumbling
The next 4 abnormalities are scored only by their presence or absence.  A score of 1 indicates present 
and a score of zero indicates not present.
4.
Leukonychia:  White spots in the nail plate due to psoriasis in the mid matrix.  Leukonychia are 
just color changes.  If it appears that there is depression or irregularity to the nail surface, this 
may be pitting or crumbling, not leukonychia.  If the leukonychia is adjacent to, or confluent 
with crumbling or pits, it is counted as part of the crumbling or pitting and not as a separate 
abnormality.
5.
Splinter hemorrhages:  Small, longitudinal, linear, dark brown hemorrhage under the fingernail.
6.
Nail bed hyperkeratosis: Thickened keratin in the nail bed.
7.
Red spots in the lunula:  Small pink or red macules in the lunula.
Page 118 of 131

p. 61 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
8.14 PHYSICIAN GLOBAL ASSESSMENT – FINGERNAILS (PGA-F) 
The PGA-F is a clinician-rated outcomes assessment used to measure the severity of signs and symptoms 
associated with fingernail psoriasis.14,15  
Scoring Instructions
!
Subject's fingernails need to be globally assessed separately for nail bed signs and nail matrix 
signs of disease, following the criteria specified below.  A global score between '0' (clear) and '4' 
(severe) should be separately assigned for nail bed involvement and nail matrix involvement.  A 
subject's overall global score is the worse of the nail bed score and nail matrix score.  For 
example, if a subject has a nail bed score '2' and a nail matrix score of '4,' this subject's overall 
score is '4.'
!
If a subject has signs of nail bed (or nail matrix) disease intermediate between two grades, then 
the subject's nail bed (or nail matrix score) should be assigned the higher of the two grades.  For 
example, if a subject's nail bed hyperkeratosis is considered to be worse than 'mild' but less than 
'moderate,' and all other nail bed signs are mild or less, the subject's nail bed score should be 
considered 'moderate.'
Page 119 of 131

p. 62 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
8.15 MINIMAL DISEASE ACTIVITY
The proportion of subjects achieving minimal disease activity (MDA) will be analysed.16  A patient is 
classified as achieving MDA when at least 5 of the 7 following criteria are met.
!
Tender joint count ≤ 1
!
Swollen joint count ≤ 1
!
PASI ≤ 1 or BSA ≤ 3%
!
Patient Assessment of Pain-VAS ≤ 15
!
Patient Global Assessment of Disease Activity VAS ≤ 20
!
HAQ-DI ≤ 0.5
!
Tender entheseal points ≤ 1
Page 120 of 131

p. 63 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
8.16 PSA DISEASE ACTIVITY SCORE (PASDAS) 
The PASDAS is a weighted index incorporating patient and physician global VAS scores, TJC68 and SJC66, 
dactylitis and enthesitis, health-related quality of life, and CRP levels.17  The following formula is used:
(((0.18*√PGA) + (0.159 x √PtGA) – (0.253*√SF36/PCS) + (0.101 x LN (SJC66 + 1)) + (0.048*LN(TJC68 +1)) + 
(0.23 x LN (LEI + 1)) + (0.377 LN (TDC +1)) + (0.102 x LN (CRPmg/dl +))+2)*1.5
LN = natural logarithm; TDC = tender dactylitis count
Page 121 of 131

p. 64 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
8.17 DISEASE ACTIVITY IN PSORIATIC ARTHRITIS (DAPSA) 
DAPSA is an assessment of disease activity in PsA based on the following variables:  TJC68, SJC66, PtGA 
of Disease Activity (VAS), Patient's Assessment of Pain (VAS), and CRP.18  Minor, moderate, and major 
response in DAPSA are defined as 50%, 75%, and 85% improvement from baseline (Day 1) respectively.  
Calculation:  SJC + TJC + PtGA + PP + CRP [mg/dl]
Page 122 of 131

p. 65 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
8.18 ANKYLOSING SPONDYLITIS DISEASE ACTIVITY (ASDAS) 
ASDAS will be calculated taking the following variables into account:
!
Back pain (question 2 from BASDAI)
!
Duration of morning stiffness (question 6 from BASDAI)
!
Patient's global assessment of the disease on VAS (0 - 10 cm)
!
Peripheral joint pain/swelling (question 3 from the BASDAI)
!
Serum CRP level (mg/L)
ASDAS calculation19
The ASDAS formulas are as follows:
ASDAS-CRP (the preferred version):
0.12 × Back Pain + 0.06 × Duration of Morning Stiffness + 0.11 × Patient Global + 0.07 × 
Peripheral Pain/Swelling + 0.58×Ln(CRP+1)
CRP is in mg/litre; the range of other variables is from 0 to 10; Ln represents the natural logarithm; √ 
represents the square root.
Page 123 of 131

p. 66 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
8.19 HEALTH RESOURCE UTILIZATION QUESTIONNAIRE (HRU)
Since the last study visit has the subject had any visits for their psoriatic arthritis other than the protocol 
required visit?
YES:        ____
NO:        ____
If YES, please provide the following:
1.    Since the last protocol required visit, has the subject been seen by a health care professional for 
their psoriatic arthritis?
                YES:        ____
                NO:        ____
                If YES, how many times:  ____
2.    Since the last protocol required visit, has the subject been seen in the Emergency Room for their 
psoriatic arthritis?
                YES:        ____
                NO:        ____
                If YES, how many times:  ____
3.    Since the last protocol required visit, has the subject been admitted to the hospital due to their 
psoriatic arthritis?
                YES:        ____
                NO:        ____
If YES, please list the ADMISSION DATE:  __ __/___ ___ ___/ ___ ___ ___ __
DD
MMM
YYYY
DISCHARGE DATE:  __ __/___ ___ ___/ ___ ___ ___ __
DD
MMM
YYYY
Page 124 of 131

p. 67 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
8.20 PATIENT-REPORTED OUTCOMES
BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)20
Each question is answered on a 0 to 10 scale.  For Questions 1 – 5, 0 means none and 10 means very 
severe; for Question 6, 0 means 0 hours and 10 means 2 or more hours.  All questions refer to last week.
1.
How would you describe the overall level of fatigue/tiredness you have experienced?
2.
How would you describe the overall level of AS neck, back or hip pain you have had?
3.
How would you describe the overall level of pain/swelling in joints other than neck, back or hips 
you have had? 
4.
How would you describe the overall level of discomfort you have had from any areas tender to 
touch or pressure? 
5.
How would you describe the overall level of morning stiffness you have had from the time you 
wake up?
6.
How long does your morning stiffness last from the time you wake up?
Calculation of BASDAI:  compute the mean of Questions 5 and 6.  Calculate the sum of the values of 
Questions 1 – 4 and add the result to the mean of Questions 5 and 6.  Divide the result by 5.
Patient's Global Assessment of Disease Activity21
The patient global assessment VAS will be self-administered by the patient.
The patient's global assessment of disease activity will be performed using a horizontal 100 mm VAS, 
ranging from 0 (very well) to 100 (very poor) after the question:
"Considering all the ways psoriatic arthritis affects you, please indicate with a vertical mark ( | ) through 
the horizontal line how well you are doing today."
Health Assessment Questionnaire Disability Index (HAQ-DI)22
HAQ-DI is a self-reported patient outcome measurement tool commonly used in RA clinical trials to 
measure physical functioning in RA patients.  The HAQ-DI composite score is calculated as the mean of 
the scores from the 8 following categories with a range of 0 – 3 (0 = no disability; 3 = worst disability):  
Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities.  The higher the 
score, the more likely to associate with morbidity and mortality for the RA patient.  Under each category 
there are 2 - 3 items on the amount of difficulty they have in performing specific activities with 
four response options from 0 (no difficulty) to 3 (unable to do).  In addition to these eight categories, 
there is an AIDS OR DEVICES/HELP FROM OTHER PERSON section ("companion items") that is used to 
record the type of assistance, if any, a subject uses for his/her usual activities in each of the eight 
categories.
Page 125 of 131

p. 68 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)23,24
Response options/scale:  Answers are based on a 5-point Likert scale.  Responses of "not at all," "a 
little," "somewhat," "quite a bit," and "very much" are available for each question, and correspond to 
scores of 0, 1, 2, 3, and 4, respectively.  Recall period for items:  7 days.
1.
I feel fatigued.
2.
I feel weak all over.
3.
I feel listless ("washed out").
4.
I feel tired.
5.
I have trouble starting things because I am tired.
6.
I have trouble finishing things because I am tired.
7.
I have energy.
8.
I am able to do my usual activities.
9.
I need to sleep during the day.
10. I am too tired to eat.
11. I need help doing my usual activities.
12. I am frustrated by being too tired to do the things I want to do.
13. I have to limit my social activity because I am tired
Short Form-3625,26
The Short Form-36 (SF-36) is a 36-item patient reported measure of overall health.  The SF-36 consists of 
eight domains: 
!
vitality
!
physical functioning
!
bodily pain
!
general health perceptions
!
physical role functioning
!
emotional role functioning
!
social role functioning
!
mental health
A scaled score is calculated for each domain as the weighted sum of the questions in the domain.  The 
score for each domain ranges from 0 to 100.  The higher the score the less disability; a score of 100 is 
equivalent to no disability and a score of 0 is equivalent to maximum disability. 
Page 126 of 131

p. 69 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
EQ-5D-5L27
Under each heading, please check the ONE box that best describes your health TODAY:
Mobility
I have no problems walking
☐
I have slight problems walking
☐
I have moderate problems walking
☐
I have severe problems walking
☐
I am unable to walk
☐
Self-Care
I have no problems washing or dressing myself
☐
I have slight problems washing or dressing myself
☐
I have moderate problems washing or dressing myself
☐
I have severe problems washing or dressing myself
☐
I am unable to wash or dress myself
☐
Usual Activities (e.g., work, study, housework, family, or leisure activities)
I have no problems with doing my usual activities
☐
I have slight problems with doing my usual activities
☐
I have moderate problems with doing my usual activities
☐
I have severe problems with doing my usual activities
☐
I am unable to do my usual activities
☐
Pain/Discomfort
I have no pain or discomfort
☐
I have slight pain or discomfort
☐
I have moderate pain or discomfort
☐
I have severe pain or discomfort
☐
I have extreme pain or discomfort
☐
Page 127 of 131

p. 70 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
Anxiety/Depression
I am not anxious or depressed
☐
I am slightly anxious or depressed
☐
I am moderately anxious or depressed
☐
I am severely anxious or depressed
☐
I am extremely anxious or depressed
☐
The patient's assessment of health will be performed using a horizontal 100 mm visual analog scale 
(VAS), ranging from 0 (worst health patient can imagine) to 100 (best health patient can imagine) after 
the question:
"Please indicate with a vertical mark ( | ) through the horizontal line how your health is today."
Patient's Assessment of PsA Pain Intensity28
The patient's assessment of PsA pain intensity will be performed using a horizontal 100 mm visual 
analog scale (VAS), ranging from 0 (no pain) to 100 (severe pain) after the question:
"Please indicate with a vertical mark ( | ) through the horizontal line the most pain you had from your 
psoriatic arthritis today."
Work Productivity and Activity Impairment (WPAI) Questionnaire29
The following questions ask about the effect of your psoriatic arthritis on your ability to work and 
perform regular activities.  Please fill in the blanks or circle a number, as indicated.
1.
Are you currently employed (working for pay)? _____ No ___ Yes
If NO, check "NO" and skip to question 6.
The next questions are about the past seven days, not including today.
2.
During the past seven days, how many hours did you miss from work because of problems 
associated with your psoriatic arthritis?  Include hours you missed on sick days, times you went 
in late, left early, etc., because of your psoriatic arthritis.  Do not include time you missed to 
participate in this study.
_____ HOURS
3.
During the past seven days, how many hours did you miss from work because of any other 
reason, such as vacation, holidays, time off to participate in this study?
_____ HOURS
4.
During the past seven days, how many hours did you actually work?
_____ HOURS (If "0," skip to question 6.)
Page 128 of 131

p. 71 of 71
OPERATIONS MANUAL FOR CLINICAL STUDY PROTOCOL M16-011 Version 4.0
CONFIDENTIAL INFORMATION
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
5.
During the past seven days, how much did your psoriatic arthritis affect your productivity while 
you were working? 
Think about days you were limited in the amount or kind of work you could do, days you 
accomplished less than you would like, or days you could not do your work as carefully as usual.  
If psoriatic arthritis affected your work only a little, choose a low number.  Choose a high number 
if psoriatic arthritis affected your work a great deal. 
Consider only how much psoriatic arthritis affected 
productivity while you were working.
Psoriatic arthritis had no 
effect on my work
Psoriatic arthritis 
completely prevented 
me from working
0
1
2
3
4
5
6
7
8
9
10
CIRCLE A NUMBER
6.
During the past seven days, how much did your psoriatic arthritis affect your ability to do your 
regular daily activities, other than work at a job? 
By regular activities, we mean the usual activities you do, such as work around the house, 
shopping, childcare, exercising, studying, etc.  Think about times you were limited in the amount 
or kind of activities you could do and times you accomplished less than you would like.  If 
psoriatic arthritis affected your activities only a little, choose a low number.  Choose a high 
number if psoriatic arthritis affected your activities a great deal. 
Consider only how much psoriatic arthritis affected your ability 
to do your regular daily activities, other than work at a job.
Psoriatic arthritis had no 
effect on my daily 
activities
Psoriatic arthritis 
completely prevented 
me from doing my daily 
activities
0
1
2
3
4
5
6
7
8
9
10
CIRCLE A NUMBER
Page 129 of 131