IMMprint: A Phase 3b Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating Safety and Efficacy of Risankizumab Compared to Placebo in Adult Subjects With Moderate to Severe Plaque Psoriasis With Palmoplantar (Non-Pustular) Involvement (PPPsO)
Phase: PHASE3
Conditions: Psoriasis
Sponsor: AbbVie



  
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TABLE OF CONTENTS
1
SYNOPSIS
5
2
INTRODUCTION
8
2.1
BACKGROUND AND RATIONALE
8
2.2
BENEFITS AND RISKS TO SUBJECTS
9
3
OBJECTIVES AND ENDPOINTS
10
3.1
OBJECTIVES, HYPOTHESES, AND ESTIMANDS
10
3.2
PRIMARY ENDPOINT
12
3.3
SECONDARY ENDPOINTS
12
3.4
ADDITIONAL EFFICACY ENDPOINTS
13
3.5
SAFETY ENDPOINTS
13
3.6
PHARMACOKINETIC EVALUATION
14
3.7
BIOMARKER RESEARCH
14
4
INVESTIGATIONAL PLAN
14
4.1
OVERALL STUDY DESIGN AND PLAN
14
4.2
DISCUSSION OF STUDY DESIGN
15
5
STUDY ACTIVITIES
16
5.1
ELIGIBILITY CRITERIA
16
5.2
CONTRACEPTION RECOMMENDATIONS
20
5.3
PROHIBITED MEDICATIONS AND THERAPY
21
5.4
PRIOR AND CONCOMITANT THERAPY
22
5.5
WITHDRAWAL OF SUBJECTS AND DISCONTINUATION OF STUDY
23
5.6
FOLLOW-UP AFTER SUBJECT DISCONTINUATION OF STUDY DRUG OR FROM STUDY
24
5.7
STUDY DRUG
25
5.8
RANDOMIZATION/DRUG ASSIGNMENT
26
5.9
PROTOCOL DEVIATIONS
27
6
SAFETY CONSIDERATIONS
27
6.1
COMPLAINTS AND ADVERSE EVENTS
27
6.2
CARDIOVASCULAR ADJUDICATION COMMITTEE
31
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6.3
ANAPHYLAXIS ADJUDICATION COMMITTEE
31
7
STATISTICAL METHODS & DETERMINATION OF SAMPLE SIZE
32
7.1
STATISTICAL AND ANALYTICAL PLANS
32
7.2
DEFINITION FOR ANALYSIS POPULATIONS
32
7.3
HANDLING POTENTIAL INTERCURRENT EVENTS FOR THE PRIMARY AND KEY SECONDARY ENDPOINTS
32
7.4
STATISTICAL ANALYSES FOR EFFICACY
33
7.5
STATISTICAL ANALYSES FOR SAFETY
34
7.6
INTERIM ANALYSIS
35
7.7
OVERALL TYPE I ERROR CONTROL
35
7.8
SAMPLE SIZE DETERMINATION
35
7.9
STATISTICAL ANALYSIS OF OPTIONAL BIOMARKER DATA
35
8
ETHICS
35
8.1
INDEPENDENT ETHICS COMMITTEE/INSTITUTIONAL REVIEW BOARD
35
8.2
ETHICAL CONDUCT OF THE STUDY
36
8.3
SUBJECT CONFIDENTIALITY
36
9
SOURCE DOCUMENTS AND CASE REPORT FORM COMPLETION
36
10 DATA QUALITY ASSURANCE
37
11 COMPLETION OF THE STUDY
37
12 REFERENCES
37
LIST OF TABLES
TABLE 1.
HYPOTHESES AND ESTIMANDS CORRESPONDING TO THE RANKED SECONDARY ENDPOINTS
12
TABLE 2.
DESCRIPTION OF STUDY DRUG AND PLACEBO
25
TABLE 3.
SUPPLEMENTAL ADVERSE EVENTS ECRFS
30
LIST OF FIGURES
FIGURE 1.
STUDY SCHEMATIC
15
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LIST OF APPENDICES
APPENDIX A.
STUDY-SPECIFIC ABBREVIATIONS AND TERMS
40
APPENDIX B.
RESPONSIBILITIES OF THE INVESTIGATOR
44
APPENDIX C.
LIST OF PROTOCOL SIGNATORIES
45
APPENDIX D.
ACTIVITY SCHEDULE
46
APPENDIX E.
SUMMARY OF CHANGES
50
APPENDIX F.
OPERATIONS MANUAL
52
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2 INTRODUCTION
2.1 Background and Rationale
Why Is This Study Being Conducted?
This study will provide essential data for risankizumab in the treatment of adult patients with moderate 
to severe plaque psoriasis (PsO) with palmoplantar (non-pustular) involvement.
Psoriasis is a chronic debilitating immunologic disease characterized by marked inflammation and 
thickening of the epidermis that result in thick, scaly skin plaques.  In most developed countries, the 
prevalence in adults is between approximately 1.5 and 5%.1  About 20% of patients have moderate to 
severe disease with a considerable negative impact on psychosocial and economic status.2,3  It is 
increasingly recognized that PsO is more than a superficial disease, with 30% of patients having joint 
involvement and a high correlation between PsO and obesity, diabetes, depression, metabolic 
syndrome, and cardiovascular risk exits.4,5
Palmoplantar (non-pustular) plaque psoriasis (PPPsO) represents a localized form of PsO.  Approximately 
3 to 17% of all patients with PsO have palmoplantar involvement,6-8 presenting with well-defined 
erythematous, hyperkeratotic desquamative plaques (often with fissures) located on the palms and 
soles that can occur in isolation or in combination with generalized PsO.9  Palmoplantar (non-pustular) 
plaque psoriasis is considered by healthcare professionals as a difficult-to-treat disease manifestation of 
PsO.9  The thicker stratum corneum of the palms and soles represents a barrier to topical treatment 
agents.  Systemic treatments, such as methotrexate, cyclosporine, and some biologics, have shown 
limited efficacy in dedicated studies, compared with the results seen in patients who have PsO without 
palmoplantar involvement, indicating a medical need for increased treatment efficacy in the 
palmoplantar patient population.9-11
Typically, less than 5% of the body surface area (BSA) is affected by PsO in patients with palmoplantar 
involvement, precluding these patients from entering clinical research studies with biologics, which 
usually require a BSA involvement of ≥ 10%.11  This creates challenges in understanding if results of PsO 
clinical trials are applicable to patients with palmoplantar disease.  Assessing treatment options to 
address the unmet needs of patients with PPPsO is important, since palmoplantar involvement has a 
significantly greater impact on patients' quality of life compared to that of patients who have moderate 
to severe PsO without palmoplantar involvement.12  One reason for this is because PsO lesions of the 
dominant hand and/or feet impair patients' ability to work or perform daily activities.6,13  Therefore, in 
addition to the BSA involved, other factors such as location of the lesions and impact of PsO on patients'
quality of life, have been proposed to more accurately assess PsO severity in PPPsO patients.14
Positive results in PsO patients treated with risankizumab were reported in 4 pivotal Phase 3 clinical 
trials that evaluated risankizumab compared with ustekinumab, placebo, and adalimumab for the 
treatment of adult patients with moderate to severe PsO.  Results from these pivotal studies 
demonstrated that risankizumab is highly effective for the treatment of PsO, meeting co-primary 
endpoints of achieving PASI 90 (defined as at least a 90% improvement from Baseline in the Psoriasis 
Area and Severity Index [PASI]) and static Physician's Global Assessment (sPGA) score of "clear" or 
"almost clear" (0 or 1) versus comparator or placebo at Week 16 across all 4 studies.15-17  These Phase 3 
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PsO studies (M15-995 [Study 1311.28]; M16-008 [Study 1311.3]; and M15-992 [Study 1311.4]) enrolled 
moderate to severe psoriatic subjects with an affected BSA ≥10%, an sPGA of "moderate" or "severe"
(≥3).  A subset of subjects in these trials had documented palmoplantar involvement of their PsO, 
defined as a Palmoplantar Psoriasis Area and Severity Index (PPASI) > 0.  Efficacy data from this subject
subgroup showed significant improvement from Baseline PPASI in the risankizumab treatment group 
compared to subjects who received placebo (P < 0.01 in all 3 trials) at Week 16.  The response was 
sustained in the risankizumab-treated subjects until Week 52.18
Risankizumab (Skyrizi™) has been approved for the treatment of moderate to severe PsO and is 
currently being developed for Crohn's disease, ulcerative colitis, psoriatic arthritis (Phase 3 studies), and 
the treatment of atopic dermatitis and hidradentitis suppurativa (in Phase 2 studies).  Risankizumab is a 
humanized monoclonal antibody (mAb) of the immunoglobin (Ig)G1 subclass directed towards the p19 
subunit of interleukin-23 (IL-23).  The antibody (Ab) has been engineered to reduce Fcγ receptor and 
complement binding and potential charge heterogeneity.  Risankizumab binds with high affinity to 
human IL-23.
The current study compares the safety and efficacy of risankizumab versus placebo in adult subjects 
with moderate to severe PPPsO.  For a more detailed description of the risankizumab drug profile, refer 
to the latest version of the Investigator's Brochure (IB).17
Clinical Hypothesis
Risankizumab will provide superior efficacy compared to placebo with respect to Palmoplantar 
Investigator's Global Assessment (ppIGA) of "clear" or "almost clear" (0 or 1) with at least a 2-point
reduction from Baseline at Week 16, and will be well tolerated in adult subjects with PPPsO.
2.2 Benefits and Risks to Subjects
In Phase 1, Phase 2, and Phase 3 studies of risankizumab in patients with PsO, the majority of subjects
receiving risankizumab achieved 90% improvement of their disease and risankizumab was well 
tolerated.  As with many immune-modulating agents, risankizumab may impair immune function, 
resulting in a risk of infection.  This will be monitored by collection of all adverse events (AEs) during the 
treatment and observation periods.  In addition, subjects with active systemic infection or clinically 
important infection will not be included in the study.
Subjects with a positive QuantiFERON®-TB (or interferon gamma release assay [IGRA] 
equivalent)/tuberculosis (TB) skin test result for TB must fulfill entry criteria as specified in Section 5.1 of 
this protocol.  Interleukin-23 inhibition is not known to increase the risk of TB infection or impair the 
response to TB infection in animal models.19,20  Subjects with positive QuantiFERON-TB testing (or IGRA 
equivalent)/TB skin test who have latent TB (defined by local guidelines) are not required to be treated 
(unless recommended by local guidelines or by investigator judgement) with TB prophylaxis prior to 
receiving risankizumab, but should be carefully monitored for any sign of TB reactivation.
Published literature indicates that inhibition of IL-23 is unlikely to increase the risk for cancer.  
Expression of IL-23 is increased in human tumors.21-23  Moreover, preclinical data have demonstrated a 
beneficial effect of IL-23 p19 inhibition in animal models, both for pre-existing and tumor-induction 
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models.24  While there is not enough clinical information at this time to rule out a risk of cancer with 
risankizumab, this risk is considered small.
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, 
cerebrovascular accident, and cardiovascular death, reported initially with anti-IL-12/23 agents such as 
ustekinumab, have not been observed in longer-term studies with risankizumab.  While the likelihood of 
increased MACE is small, all suspected cardiovascular or cerebrovascular events (serious or nonserious) 
observed in this study will be adjudicated by an independent Cardiovascular Adjudication Committee 
(CAC).  The committee will remain blinded to treatment allocation (Section 6.2).
Local reactions to subcutaneously (SC) administered biologic therapies are usually limited to redness, 
swelling, or induration at the injection site.  Manifestations of systemic hypersensitivity reactions include 
anaphylaxis, pruritus, hypotension, and respiratory distress.  Both local and systemic hypersensitivity 
reactions are readily detectable, transient in nature, and manageable with standard medical treatment.  
Subjects will be closely monitored during study drug administration while at the site and be given 
instructions regarding management of signs and symptoms of anaphylaxis to be followed during home 
dosing visits.  An independent Anaphylaxis Adjudication Committee (AAC) will adjudicate observed 
systemic hypersensitivity and anaphylactic events.  The AAC will remain blinded to treatment allocation
(Section 6.3).
In conclusion, the benefit-risk profile of risankizumab is considered appropriate for this stage of clinical 
development.25  Based on data from the integrated safety analyses, risankizumab is safe and well 
tolerated and demonstrates a favorable benefit-risk profile.
For further details, please see findings from completed studies, including safety data, in the current 
risankizumab Investigator Brochure.17
In view of the coronavirus disease of 2019 (COVID-19) pandemic, the benefit-risk profile of various 
immunomodulatory therapies on COVID-19 is being evaluated based on real world data and clinical trial 
data.  At this time, the effects of risankizumab on the course of COVID-19 are not well defined.
3 OBJECTIVES AND ENDPOINTS
3.1 Objectives, Hypotheses, and Estimands
Primary
The primary objective of this study is to assess the safety and efficacy of risankizumab (150 mg) versus 
placebo for the treatment of signs and symptoms of moderate to severe plaque PsO in patients with 
palmoplantar (non-pustular) involvement.
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The primary efficacy objective is to demonstrate a higher rate of ppIGA of "clear" or "almost clear" (0 or 
1) with at least a 2-point reduction from Baseline at Week 16 with risankizumab treatment compared to 
placebo in the Intent-to-Treat (ITT) Population, which consists of all randomized subjects (Section 7.2).
The hypothesis corresponding to the primary endpoint (Section 3.2) is:

The proportion of subjects achieving ppIGA of 0 or 1 with at least a 2-point reduction from 
Baseline with risankizumab is greater than that with placebo at Week 16.
The estimand corresponding to the primary endpoint is defined using composite variable strategy:

Difference in the proportion of subjects achieving ppIGA of 0 or 1 with at least a 2-point 
reduction from Baseline at Week 16 without premature discontinuation of study drug due to
lack of efficacy prior to Week 16, in the risankizumab group in comparison with the placebo 
group in the ITT population.
Secondary
The secondary efficacy objectives are based on the ranked secondary endpoints as defined in 
Section 3.3.  The hypotheses and estimands corresponding to these ranked secondary endpoints are 
summarized in Table 1.
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Table 1.
Hypotheses and Estimands Corresponding to the Ranked Secondary Endpoints
Hypothesis
Estimand
1.
The proportion of subjects achieving PPASI 75 
with risankizumab is greater than that with 
placebo at Week 16.
Difference in the proportion of subjects achieving
PPASI 75 at Week 16 without premature 
discontinuation of study drug due to lack of efficacy 
prior to Week 16 in the risankizumab group in 
comparison with the placebo group in the ITT 
population.
2.
The proportion of subjects achieving PPASI 90 
with risankizumab is greater than that with 
placebo at Week 16.
Difference in the proportion of subjects achieving
PPASI 90 at Week 16 without premature 
discontinuation of study drug due to lack of efficacy 
prior to Week 16 in the risankizumab group in 
comparison with the placebo group in the ITT 
population.
3.
The proportion of subjects achieving sPGA of 
0 or 1 with at least a 2-point reduction from 
Baseline with risankizumab is greater than that 
with placebo at Week 16.
Difference in proportion of subjects achieving sPGA of 
0 or 1 with at least a 2-point reduction from Baseline 
at Week 16 without premature discontinuation of 
study drug due to lack of efficacy prior to Week 16 in 
the risankizumab group in comparison with the 
placebo group in the ITT population.
4.
The proportion of subjects achieving PPASI 100 
with risankizumab is greater than that with 
placebo at Week 16.
Difference in the proportion of subjects achieving
PPASI 100 at Week 16 without premature 
discontinuation of study drug due to lack of efficacy 
prior to Week 16 in the risankizumab group in 
comparison with the placebo group in the ITT 
population.
ITT = intent-to-treat; PPASI = Palmoplantar Psoriasis Area and Severity Index; sPGA = static Physician's Global Assessment
3.2 Primary Endpoint
The primary endpoint is the achievement of ppIGA of "clear" or "almost clear" (0 or 1) with at least a 
2-point reduction from Baseline at Week 16.
3.3 Secondary Endpoints
Secondary Endpoints (Ranked)
The following ranked secondary endpoints will be tested in a hierarchical order, only if the null 
hypothesis for the primary endpoint has been rejected:
1.
Achievement of ≥75% improvement from Baseline in Palmoplantar Psoriasis Area and Severity 
Index (PPASI 75) response at Week 16
2.
Achievement of ≥90% improvement from Baseline in Palmoplantar Psoriasis Area and Severity 
Index (PPASI 90) response at Week 16
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3.
Achievement of sPGA of "clear" or "almost clear" (0 or 1) with at least a 2-point reduction from 
Baseline at Week 16
4.
Achievement of 100% improvement from Baseline in Palmoplantar Psoriasis Area and Severity 
Index (PPASI 100) response at Week 16
3.4 Additional Efficacy Endpoints
All primary and ranked secondary endpoints will be analyzed at all other visits collected.  In addition, the 
following endpoints will be analyzed at all visits collected:

Achievement of ppIGA of "clear" (0)

Achievement of sPGA of "clear" (0)

Change from Baseline in PPASI

Percent change from Baseline in PPASI

Change from Baseline in PASI

Percent change from Baseline in PASI among subjects with Baseline PASI ≥12

Change from Baseline in Patient Global Assessment of Skin Pain (PGA-SP), among subjects with 
Baseline Numerical Rating Scale (NRS) ≥4

Percentage change from Baseline in PGA-SP, among subjects with Baseline NRS ≥4

Change from Baseline in Psoriasis Symptom Scale (PSS)

Achievement of PSS 0 or 1

Change from Baseline in Dermatology Life Quality Index (DLQI)

Achievement of DLQI 0 or 1

Achievement of DLQI improvement (reduction) of ≥ 4 points, among subjects with Baseline 
DLQI ≥4
In addition, the achievement of ppIGA of "clear" (0), ppIGA of "clear" or "almost clear" (0 or 1) with at 
least a 2-point reduction from Baseline, and PPASI 75/90/100 response will also be summarized at later 
visits in Period B, among subjects who are randomized to risankizumab in Period A and have achieved 
the corresponding response status at the entry of Period B.
3.5 Safety Endpoints
The following safety evaluations will be performed throughout the study as measures of safety and 
tolerability:

Adverse event (AE) monitoring

Vital sign measurements
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
Physical examinations

Clinical laboratory testing
3.6 Pharmacokinetic Evaluation
The pharmacokinetics (PK) and immunogenicity of risankizumab have been well characterized in 
subjects with plaque PsO.  No samples will be collected for the purpose of PK and immunogenicity in this 
study, except in cases of hypersensitivity reactions.
3.7 Biomarker Research
For subjects who consent, optional blood samples (whole blood, serum, and plasma) will be collected as 
described in the Activity Schedule (Appendix D) to evaluate known and/or novel disease-related or 
drug-related biomarkers.  Types of biomarkers may include nucleic acids, proteins, lipids, and/or 
metabolites.  The objective of this research is to analyze samples for biomarkers that will help to 
understand PsO, related conditions, or response to treatment with risankizumab or similar compounds.  
Research may also include changes in epigenetics, gene expression, and proteomics that may associate 
with PsO, related conditions, or the subject's response to treatment.  This research is exploratory in 
nature and the results may not be included with the clinical study report.
4 INVESTIGATIONAL PLAN
4.1 Overall Study Design and Plan
This is a Phase 3b multicenter, randomized, double-blind, parallel-group, placebo-controlled study to 
evaluate the safety and efficacy of risankizumab (150 mg) compared to placebo in adult subjects with 
moderate to severe plaque PsO with palmoplantar involvement.
The study is designed to enroll 168 subjects.  See Section 5 for information regarding eligibility criteria.
The study duration will be up to approximately 65 weeks.  The study is comprised of a Screening period 
of up to 35 days, a 52-week treatment period, and a follow-up phone call for safety.
The 52-week treatment duration includes Period A and Period B.

Period A, Double-Blind Period (Baseline [Day 1] to Week 16):  Eligible subjects will be centrally 
randomized at the Baseline visit in a 1:1 ratio to receive either risankizumab 150 mg as a single 
SC injection, or matching placebo.  Study drug administration will occur at Baseline and Week 4.  
Randomization will be stratified by Baseline ppIGA ("moderate" [3] versus "severe" [4]) and 
Baseline BSA (< 10% versus ≥10%).  The final efficacy evaluation of Period A will be at Week 16.

Period B, Open-label Period (Week 16 to Week 52):  Starting at Week 16, all subjects will receive 
open-label risankizumab 150 mg once every 12 weeks (q12w) at Weeks 16, 28, and 40.  The final 
efficacy evaluation will take place at Week 52.
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A follow-up phone call for safety will be conducted approximately 20 weeks after administration of the 
last dose of risankizumab.
A subgroup of approximately 15 subjects at prospectively selected sites will be asked to have skin 
photographs taken of their palms and soles to document disease response during the study.  Subjects 
who consent will have photographs taken at Baseline and Weeks 4, 16, 28, 40, and 52.  No efficacy 
analysis will be made from the obtained material.
The schematic of the study is shown in Figure 1.  Further details regarding study procedures are located 
in the Operations Manual (Appendix F).
Figure 1.
Study Schematic
N = number of subjects; Wk = week
Solid arrows indicate administration of study drug at study visits.
4.2 Discussion of Study Design
Choice of Control Group
Placebo control 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.
Appropriateness of Measurements
Standard statistical, clinical, and laboratory procedures will be utilized in this study.  All efficacy 
measurements in this study for assessing disease activity in adult subjects with moderate to severe 
PPPsO have been used in other studies assessing this subset of patients.11,15,16,26,27  All clinical and 
laboratory procedures in this study are standard and generally accepted.  Patient-reported outcome 
(PRO) measures in this study were included to assess patient symptoms and quality of life.
Suitability of Subject Population
Female or male adults with chronic PPPsO with or without psoriatic arthritis for at least 6 months prior 
to Baseline and a ppIGA of "moderate" or "severe" (≥3, at Screening and Baseline) and who are 
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candidates for systemic therapy are eligible for this study.  Eligible subjects must also have ≥1% BSA PsO
involvement, sPGA score of "moderate" or "severe" (≥ 3), PPASI ≥ 8 (moderate or severe disease),28 and 
at least 1 additional PsO plaque outside of the palms and soles at Screening and the Baseline visit.  At 
least 50% of the overall study population will be comprised of subjects with Baseline BSA ≥10%.  The 
selection criteria relating to safety ensure that enrolled subjects can safely be treated with risankizumab 
based on the current knowledge of this drug.
Selection of Doses in the Study
The risankizumab dosing regimen selected for the current study (i.e., 150 mg SC at Weeks 0, 4, and 
q12w thereafter up to Week 40) is the same as used in the risankizumab pivotal Phase 3 studies in 
subjects with moderate to severe chronic plaque PsO.  The risankizumab 150 mg SC dose has been 
shown to be efficacious with an acceptable safety profile and is considered appropriate for the 
treatment of subjects with plaque PsO.
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.
Consent
1. Subjects or their legally authorized representative 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.
2. Employees of the Sponsor and/or study sites and their family members may not be enrolled in 
this study.
3. Subjects must be willing and able to comply with procedures required in this protocol.
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 aminotransaminase (AST) ≤2 × upper limit of normal (ULN);

Serum alanine aminotransaminase (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;
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
Platelet count ≥100,000/µL;

Hemoglobin ≥10 g/dL (100 g/L).
Disease Activity
6. Female or male adults with chronic PPPsO (with or without psoriatic arthritis) for at least 
6 months prior to Baseline and a ppIGA of "moderate" or "severe" (≥3), at Screening and 
Baseline.
7. Subjects must have at Screening and Baseline:

Plaque PsO BSA involvement of ≥1%,

sPGA score of "moderate" or "severe" (≥ 3),

PPASI ≥ 8 (moderate or severe disease), and

At least 1 additional PsO plaque outside of the palms and soles.
At least 50% of the overall study population will be comprised of subjects with Baseline BSA 
≥10%.
8. Previously inadequately controlled disease by topicals, phototherapy, and/or systemic 
treatments.
9. Subject must be a candidate for systemic therapy as assessed by the investigator.
Subject History
10. Subject is judged to be in good general health, as determined by the investigator based upon 
the results of a medical history, physical examination, laboratory profile, and a 12-lead 
electrocardiogram (ECG) performed during the Screening period.
11. No forms of PsO other than chronic plaque-type PsO (e.g., pustular PsO, palmoplantar 
pustulosis, acrodermatitis of Hallopeau, erythrodermic, or guttate PsO).
12. No current drug-induced PsO or a drug-induced exacerbation of pre-existing psoriasis.
13. No active ongoing inflammatory skin diseases other than PsO and psoriatic arthritis that 
could interfere with the assessment of PsO (e.g., hyperkeratotic eczema).
14. Subjects must not have a history of clinically significant (per investigator's judgment) drug or 
alcohol abuse within the last 6 months.
15. Subjects must not have a 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.
16. Subjects must not have had major surgery performed within 12 weeks prior to 
randomization or planned during the conduct of the study (e.g., hip replacement, aneurysm 
removal, stomach ligation).
17. Subjects must not have evidence of:

Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, defined as:
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
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).

Human immunodeficiency virus (HIV), defined as confirmed positive anti-HIV Ab test.  Note:
In case a screened subject has a confirmed positive HIV Ab test, Eligibility Criterion 10 
(Subject is judged to be in good general health criteria…) should be selected in electronic 
case report form (eCRF) for documentation of screening failure.

Active TB.  For subjects with latent TB, please see Section 3.16 of the Operations Manual.

Active systemic infection/Clinically important infection during the last 2 weeks prior to 
Baseline visit as assessed by the investigator.
18. Subject must not have any of the following medical diseases or disorders: 

Recent (within past 6 months) cerebrovascular accident or myocardial infarction; 

History of an organ transplant which requires continued immunosuppression; 

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.
19. Subject must not have concurrent clinically significant medical conditions other than the 
indication being studied or any other reason that the investigator determines would interfere 
with the subject's participation in this study, would make the subject an unsuitable candidate 
to receive study drug, or would put the subject at risk by participating in the study.
20. No known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.  If 
a subject has signs/symptoms suggestive of SARS-CoV-2 infection, they should undergo 
molecular (e.g., PCR) testing to rule out SARS-CoV-2 infection.  In addition, if based on the 
answers to the SARS-CoV-2 Infection Risk Assessment Tool the site considers the subject 
currently at risk for developing SARS-CoV-2 infection, then the subject should either be tested or 
advised to come back for study screening after 14 days.
Subjects who do not meet SARS-CoV-2 infection eligibility criteria must be screen failed and may 
only rescreen after they meet the following SARS-CoV-2 infection viral clearance criteria:

At least 14 days since first PCR test result have passed in asymptomatic patients or 14 days 
since recovery, defined as resolution of fever without use of antipyretics and improvement 
in symptoms.
Contraception
21. For all females of child-bearing potential; a negative serum pregnancy test at the Screening 
visit and a negative urine pregnancy test at Baseline prior to the first dose of study drug is 
required.
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22. Female subjects of childbearing potential must practice at least 1 protocol-specified method 
of birth control, that is effective from Study Day 1 through at least 140 days (20 weeks or as 
guided by the local risankizumab label [if approved], whichever is longer) after the last dose of 
study drug (local practices may require 2 methods of birth control).  Female subjects of 
non-childbearing potential do not need to use birth control.
23. Female subjects may not be pregnant, breastfeeding, or considering becoming pregnant
during the study or for approximately 140 days (20 weeks or as guided by the local risankizumab 
label [if approved], whichever is longer) after the last dose of study drug.
Concomitant Medications (Prior Medication Restrictions)
24. No prior exposure to risankizumab.
25. Subject must not have received any live viral or bacterial vaccine within 4 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 or as guided by the local risankizumab label [if approved], whichever 
is longer) after the last dose of study drug.
26. 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 clinical study or was previously enrolled in this study.
27. Subject did not receive any systemic biologics to treat PsO for the following timeframes prior 
to the Baseline visit: 

Etanercept (Enbrel®) and biosimilar versions within 3 weeks;

Certolizumab (Cimzia®), adalimumab (Humira®), ixekizumab (Taltz®), brodalumab 
(Siliq®/Kyntheum®), infliximab (Remicade®), and biosimilar versions within 10 weeks;

Ustekinumab (Stelara®) and guselkumab (Tremfya®) within 15 weeks;

Tildrakizumab (Ilumya™) and secukinumab (Cosentyx®) within 20 weeks.
28. Subject did not receive for at least 30 days prior to randomization any: 

Other systemic immunomodulating treatments (including, but not limited to:  e.g., 
methotrexate, cyclosporine A, corticosteroids, cyclophosphamide, tofacitinib [Xeljanz®], 
apremilast [Otezla®]);

Other systemic PsO treatments (e.g., retinoids, fumarates, any other drug known to possibly 
benefit PsO);

Photochemotherapy (e.g., psoralen and ultraviolet A radiation [PUVA]), phototherapy (e.g., 
ultraviolet B rays [UVB]).
29. Subject did not receive for at least 14 days prior to randomization any topical treatment for 
PsO or any other skin condition (including, but not limited to: e.g., corticosteroids, vitamin D 
analogues, vitamin A analogues, pimecrolimus, retinoids, salicyl vaseline, salicylic acid, lactic 
acid, tacrolimus, tar, urea, or anthralin).
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5.2 Contraception Recommendations
Contraception Requirements for Females
Subjects must follow the following contraceptive guidelines as specified:

Females, Non-Childbearing Potential
Females do not need to use birth control during or following study drug treatment if considered
of non-childbearing potential due to meeting any of the following criteria:

Premenopausal female with permanent sterility or permanent infertility due to one of the 
following:

Permanent sterility due to a hysterectomy, bilateral salpingectomy, bilateral 
oophorectomy.

Non-surgical permanent infertility due to Mullerian agenesis, androgen insensitivity, or 
gonadal dysgenesis; investigator discretion should be applied to determining study entry 
for these individuals.

Postmenopausal, female:

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 a follicle-stimulation hormone (FSH) level > 30 IU/L.

Females, of Childbearing Potential

Females of childbearing potential must avoid pregnancy while taking study drug(s) and for 
at least 140 days (20 weeks or as guided by the local risankizumab label [if approved], 
whichever is longer) after the last dose of study drug.

Females must commit to one of the following methods of birth control:

Combined (estrogen- and progestogen- containing) hormonal birth control (oral, 
intravaginal, transdermal, injectable) associated with inhibition of ovulation initiated at 
least 30 days prior to study Baseline.

Progestogen-only hormonal birth control (oral, injectable, implantable) associated with 
inhibition of ovulation initiated at least 30 days prior to study Baseline.

Bilateral tubal occlusion/ligation (can be via hysteroscopy, provided a 
hysterosalpingogram confirms success of the procedure).

Intrauterine device (IUD).

Intrauterine hormone-releasing system (IUS).

Vasectomized partner (provided the partner has received medical confirmation of the 
surgical success of the vasectomy and is the sole sexual partner of the trial subject).

Practice true abstinence, defined as:  Refraining from heterosexual intercourse when 
this is in line with the preferred and usual lifestyle of the subject (periodic abstinence 
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[e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are 
not acceptable).
If required per local practices, 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 should be based on 
the local label.
5.3 Prohibited Medications and Therapy
1.
During the study, no biologic treatment is allowed.  Exception:  Treatment with commercially 
available risankizumab after the Week 52/Premature Discontinuation (PD) assessments if this 
has been determined as an appropriate subsequent treatment by the investigator in discussion 
with the subject.
2.
Systemic (including oral or injectable administrations) non-biologic therapy that can be used to 
treat PsO, including but not limited to cyclosporine, corticosteroids, methotrexate, retinoids, 
apremilast, and fumaric acid derivatives.
3.
Phototherapy treatment (UVB or ultraviolet A [UVA] phototherapy, including PUVA), laser 
therapy, tanning booth, or extended sun exposure that could affect disease severity or interfere 
with disease assessments.
4.
Topical PsO treatments, including but not limited to corticosteroids, anthralin, calcipotriene, 
topical vitamin D derivatives, retinoids, urea, α- or β-hydroxyl acids, and medicated shampoos 
(for example those that contain corticosteroids, coal tar, or vitamin D3 analogues).
5.
All other investigational drugs and enrollment in another clinical study are prohibited.
6.
Live attenuated vaccines are not permitted during study participation and including up to 
140 days (20 weeks or as guided by the local risankizumab label [if approved], whichever is 
longer) after the last dose of study drug.  Examples of live attenuated vaccines include, but are 
not limited to, the following:

Bacille Calmette-Guérin (BCG)

Zoster vaccine live (Zostavax®)

Measles mumps rubella or measles mumps rubella varicella

Monovalent live attenuated influenza A (intranasal)

Oral polio vaccine

Rotavirus

Seasonal trivalent live attenuated influenza (intranasal)

Smallpox

Oral typhoid vaccine
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
Varicella (chicken pox)

Yellow fever

Dengue (Dengvaxia®)
5.4 Prior and Concomitant Therapy
Stable doses of concomitant therapies for chronic conditions, for which neither the condition nor the 
treatment are judged to exclude the patient from participation are permissible.  All concomitant 
medications should be carefully evaluated by the investigator.
Any medication or vaccine (including over-the-counter or prescription medicines, vitamins, and/or 
herbal supplements) that the subject has received from 4 weeks prior to Screening or receives during 
the study must be recorded along with the reason for use; date(s) of administration, including start and 
end dates; and dosage information including dose, route, and frequency on the appropriate eCRF.
A detailed history of all prior biologic use will be obtained in the electronic data capture (EDC).
Any questions regarding concomitant or prior therapy should be raised to the AbbVie emergency 
contact.  Information regarding potential drug interactions with risankizumab can be located in the 
risankizumab Investigator's Brochure.17
Subjects must be able to safely discontinue any prohibited medications (including biologics) 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.
Non-live vaccines may be administered during screening or treatment period, if not contraindicated or 
medically inappropriate.
When possible, first dose of study drug should be given at least ± 7 days from non-live SARS-CoV-2 
vaccine administration. The potential impact of risankizumab on SARS-CoV-2 vaccination is unknown.  
The decision to receive a locally available non-live vaccine should be based on local guidance and an 
individual discussion between the treating physician and the subject and/or guardian.
Allowed Concomitant Medications/Therapy
Allowed concomitant medications and therapies include the following:

Moisturizers:  Provided that moisturizers (without active ingredients) have been used for at least 
2 weeks prior to Baseline and are anticipated to be continuously used at least until the Week 16 
visit.  Subjects should not apply emollients within 8 hours prior to study assessments.

Only inhaled, topical ophthalmic, or intranasal corticosteroids are permitted during the study.
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COVID-19 Pandemic-Related Vaccination Guidance
Any SARS-CoV-2 vaccine information must be documented on the COVID-19 vaccine eCRF.  Refer to the 
Operations Manual (Appendix F)for instructions on reporting any AEs associated with the COVID-19 
vaccine.
5.5 Withdrawal of Subjects and Discontinuation of Study
A subject may voluntarily withdraw from the study drug and/or study at any time.  Subjects must be 
withdrawn from the study drug and/or study for reasons including, but not limited to, the following:

The subject requests withdrawal from the study.

The investigator believes it is in the best interest of the subject.

Clinically significant abnormal laboratory results or AEs, which rule out continuation of the study 
drug, as determined by the investigator or the AbbVie Therapeutic Area (TA) Medical Director 
(MD).

Subject is non-compliant with TB prophylaxis (if applicable) or develops active TB at any time 
during the study.

Malignancy, except for localized NMSC or carcinoma in-situ of the cervix where discontinuation 
is at the discretion of the investigator.

The subject becomes pregnant while on study drug.

Eligibility criteria violation was noted after the subject started study drug and continuation of 
the study drug would place the subject at risk.

Introduction of prohibited medications or dosages and continuation of the study drug would 
place the subject at risk.

Subject is significantly noncompliant with study procedures, which would put the subject at risk 
for continued participation in the trial.

Post-Baseline occurrence of one or more of the following hepatic test abnormalities (confirmed 
on a second separate sample at least 48 hours apart):

ALT or AST > 8 × ULN;

ALT or AST > 5 × ULN for more than 2 weeks;

ALT or AST > 3 × ULN and 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%).

Subjects who meet any of the above criteria should be evaluated for an alternative etiology 
of the ALT or AST elevation and managed as medically appropriate.  If applicable, the 
alternative etiology should be documented (in the eCRF if reported as an AE).  If ALT or AST 
values return to the normal reference range or its Baseline value, study drug may be 
restarted.  If restarting study drug, documentation should include reason that rechallenge is 
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expected to be safe.  If after clinically appropriate evaluation, no alternative etiology for ALT 
or AST elevation is found or the ALT or AST elevation has not resolved or is not trending 
down toward normal, the subject should be discontinued from study drug.
For subjects to be considered lost to follow-up, reasonable attempts must be made to obtain 
information on the subject's final status.  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 employ mitigation strategies to enable the 
investigator 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 medical contact before discontinuing a subject from the 
study for a reason other than described in 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.
Interruption/Discontinuation of Study Drug Due to COVID-19 Infection
For subjects with documented COVID-19, the timing of next administration of study drug or possibility of 
premature discontinuation from study drug should be discussed with the AbbVie Medical Contact.  
Follow subsequent protocol Section 5.6 for subjects who discontinued study drug.
5.6 Follow-Up After Subject Discontinuation of Study Drug or from 
Study
To minimize missing data for safety and efficacy 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.
If a subject prematurely discontinues study participation, the procedures outlined for the PD visit should 
be completed as soon as possible, preferably within 2 weeks.  In addition, if subject is willing, a 
follow-up phone call 140 days after the last dose of study drug may be completed to ensure all 
treatment-emergent AEs/serious adverse events (SAEs) have been resolved.  The 140-day follow-up 
phone call following the last dose administration of risankizumab study drug during the trial will not be 
required for any subject who initiates commercially available risankizumab after completion of the 
Week 52 visit or premature discontinuation visit.
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If a subject withdraws from study follow-up or withdraws permission for the collection of their personal 
data, the study staff may still use available public records to obtain information about survival status 
only, as appropriate per local regulations.
In the event a subject withdraws consent from the clinical study, biomarker research will continue 
unless the subject explicitly requests analysis to be stopped.  When AbbVie is informed the subject has 
withdrawn and no longer wishes biomarker sample research to continue, samples will not be analyzed, 
and no new biomarker analysis data will be collected for the withdrawn subject or added to the existing 
data or database(s).  A subject may withdraw consent for optional biomarker research at any time and 
remain in the clinical study.  Data generated from clinical study and/or optional biomarker research, 
before subject withdrawal of consent, will remain part of the study results.
5.7 Study Drug
AbbVie will provide study drug for risankizumab or matching placebo.  AbbVie-provided study drug 
should not be substituted or alternately sourced unless otherwise directed by AbbVie.  Information 
about the study drug and placebo used in this study is presented in Table 2.
During Period A (Double-Blind Period), study site staff will administer study drug subcutaneously 
(risankizumab 150 mg or matching placebo in a pre-filled syringe [PFS]) at Baseline and Week 4 visits.  
Subjects will be trained by site staff on self-injection at the Baseline visit to proactively be prepared for 
at-home dosing by the subject or caregiver at Weeks 4, 28, and 40, should the need for a virtual visit 
arise due to COVID-19-related restrictions. Subjects may be retrained on self-injection at the Week 16 
visit.
During Period B (Open-Label Period), study site staff will administer risankizumab as a 150 mg SC dose 
(1 × 150 mg PFS) at Week 16, Week 28, and Week 40 visits.
Only subjects who self-administer study drug at home due to COVID-related visit modifications (e.g., 
virtual visit) will record the self-administered dosing in a subject dosing diary.
Table 2.
Description of Study Drug and Placebo
Study Drug
Dosage Form
Strength
Route of 
Administration
Manufacturer
Risankizumab (ABBV-066) 
Solution for 
injection in PFS
150 mg Active, 
150 mg/mL
SC injection
AbbVie Biotechnology 
Ltd., Barceloneta, 
Puerto Rico
Placebo for Risankizumab 
(ABBV-066) 
Solution for 
injection in PFS
Not applicable
SC injection
AbbVie Deutschland 
GmbH & Co. KG, 
Ludwigshafen, Germany
PFS = pre-filled syringe; SC = subcutaneous
Blinded risankizumab or placebo and open-label risankizumab 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 must be kept protected from light in the original packaging, 
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in a refrigerator between 2°C to 8°C (36°F to 46°F).  A temperature log must be maintained for
documentation.  Study drug must be kept in a secure location and must not be frozen at any time.  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.  Upon receipt of the study drugs, the site will acknowledge receipt within the IRT system.  All 
blank spaces on the label will be completed by the site staff prior to dispensing to subjects.
AbbVie will not supply drug other than risankizumab and matching placebo, and study drug will only be 
used for the conduct of this study.  AbbVie-provided study drug should not be substituted or alternately 
sourced unless otherwise directed by AbbVie.  If a subject is unable to come to the study site to pick up 
their study drug due to COVID-19, a direct-to-patient (DTP) study drug shipment can be made from the 
study site to the subject if allowed by local regulations.  AbbVie will submit any required notifications to 
the regulatory authority as applicable.  Refer to the Operations Manual in Appendix F for details on DTP 
shipment of 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.  The IRT will assign a randomization number that will encode the subject's treatment group 
assignment according to the randomization schedule generated by Data and Statistical Sciences (DSS) at 
AbbVie.
Eligible subjects will be centrally randomized in a 1:1 ratio to risankizumab 150 mg or placebo groups 
during Treatment Period A. The randomization will be stratified by Baseline ppIGA ("moderate" [3]
versus "severe" [4]) and Baseline BSA (< 10% versus ≥10%).  All subjects will receive risankizumab 
150 mg during Treatment Period B.
All AbbVie personnel with direct oversight of the conduct and management of the study (with the 
exception of AbbVie Drug Supply Management Team) will remain blinded until the Primary Analysis at 
Week 16 is available.  The investigator, study site personnel, and the subject will remain blinded to each 
subject's treatment throughout the study.  To maintain the blind, the risankizumab PFS and placebo PFS 
provided for the study will be identical in appearance.  The IRT will provide access to unblinded subject 
treatment information in the case of a medical emergency.
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 the 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.
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5.9 Protocol Deviations
AbbVie does not allow intentional/prospective deviations from the protocol except when necessary to 
eliminate an immediate hazard to study subjects.  The investigator is responsible for complying with all 
protocol requirements, written instructions, and applicable laws regarding protocol deviations.  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 IEC/IRB, regulatory authorities (as applicable), and 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 24 hours 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.
Such an event can result from use of the drug as stipulated in the protocol or labeling, as well as from 
"special situations" such as accidental or intentional overdose, medication error, occupational or 
accidental exposure, off-label use, drug abuse, drug misuse, or drug withdrawal, all which must be 
reported whether associated with an AE or not.  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 
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abnormalities and changes in vital signs are considered to be AEs only if they result in discontinuation 
from the study, necessitate therapeutic medical intervention, and/or if the investigator considers them 
to be AEs.
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.
An elective surgery/procedure scheduled to occur during a study will not be considered an AE if the 
surgery/procedure is being performed for a pre-existing condition and/or the surgery/procedure has 
been pre-planned prior to study entry.  However, if the pre-existing condition deteriorates unexpectedly 
during the study (e.g., surgery performed earlier than planned), then the deterioration of the condition 
for which the elective surgery/procedure is being done will be considered an AE.
If an AE, whether associated with study drug or not, meets any of the following criteria, it is to be 
reported to AbbVie clinical pharmacovigilance or contract research organization (CRO) (as appropriate) 
as an SAE within 24 hours of the site being made aware of the serious SAE (refer to Section 4.3 of the 
Operations Manual for reporting details and contact information):
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).
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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, along with any suspected transmission of an 
infectious agent via a medicinal product if no other serious criterion 
is applicable.  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.
All AEs reported from the time of study drug administration until 140 days (20 weeks) after 
discontinuation of study drug administration will be collected, whether solicited or spontaneously 
reported by the subject.  In addition, study procedure-related serious and nonserious AEs will be 
collected from the time the subject signs the study-specific informed consent.
The following definitions will be used for Serious Adverse Reaction (SAR) and Suspected Unexpected 
Serious Adverse Reaction (SUSAR):
SAR
Defined as all noxious and unintended responses to an Investigational Medicinal 
Product (IMP) related to any dose administered that result in an SAE as defined 
above.
SUSAR
Refers to individual SAE case reports from clinical trials where a causal 
relationship between the SAE and the IMP was suspected by either the sponsor 
or the investigator, is not listed in the applicable Reference Safety Information
(RSI), and meets one of the above serious criteria.  All individually reported SARs 
are considered suspected.
AbbVie will be responsible for SUSAR reporting for the IMP in accordance with global and local 
requirements.
Adverse events will be monitored throughout the study to identify any of special interest that may 
indicate a trend or risk to subjects.
Areas of Safety Interest/Safety Topics of Interest
Infections, especially opportunistic infections, are a potential risk with immunomodulators.  Subjects will 
be screened and monitored throughout the study for Areas of Safety Interest (ASI)/Safety Topics of 
Interest.  Screening procedures are outlined in the Activity Schedule (Appendix D).  In consideration of 
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
Grade 4 (Severe); Life-threatening consequences; urgent intervention indicated.

Grade 5 (Severe); Death related to AE.
If no specific criteria per CTCAE Version 5 guidelines are available for the reported event, the event 
should be graded per the investigator's judgment according to the definitions outlined above.
The investigator will use the following definitions to assess the relationship of the AE to the use of study 
drug:
Reasonable 
Possibility
After consideration of factors including timing of the event, biologic 
plausibility, clinical judgment, and potential alternative causes, there is 
sufficient evidence (information) to suggest a causal relationship.
No Reasonable 
Possibility
After consideration of factors including timing of the event, biologic 
plausibility, clinical judgment, and potential alternative causes, there is 
insufficient evidence (information) to suggest a causal relationship.
Pregnancy
While not an AE, pregnancy in a study subject must be reported to AbbVie within 24 hours after the site 
becomes aware of the pregnancy.  Subjects who become pregnant during the study must be 
discontinued (Section 5.5).  If a pregnancy occurs in a study subject, information regarding the 
pregnancy and the outcome 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 after the site becomes aware of the 
event.
6.2 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 Charter.  Dedicated eCRFs will be used as outlined in Table 3.
In addition, the site may be contacted for additional source documentation for relevant events.
6.3 Anaphylaxis Adjudication Committee
While no concerns with anaphylaxis/systemic hypersensitivity have been identified with the use of 
risankizumab, the Sponsor has established an independent, blinded, expert committee to adjudicate 
events of anaphylaxis based on prespecified definitions.  This independent external AAC will adjudicate 
suspected anaphylactic reactions and will remain blinded to each subject's initial treatment allocation.  
The event terms to be adjudicated and the adjudication process are detailed in the AAC Charter.  A 
supplemental Hypersensitivity Reactions 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.
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If a suspected systemic hypersensitivity reaction occurs at the investigative site, in addition to testing 
tryptase and histamine levels, drug (serum risankizumab concentration) and antidrug antibody 
(ADA)/neutralizing antibody (Nab) samples should also be collected.  If a systemic hypersensitivity 
reaction such as anaphylaxis is observed or reported while the subject is not at the investigative site, 
every effort should be made to obtain tryptase and histamine levels from the treating facility to help 
better characterize the diagnosis.
7 STATISTICAL METHODS & DETERMINATION OF SAMPLE SIZE
7.1 Statistical and Analytical Plans
The statistical methods provided in this protocol will be focused on primary and ranked secondary 
analyses.  Complete and specific details of the statistical analysis will be described in the Statistical 
Analysis Plan (SAP).
The Primary Analysis will be conducted after all continuing subjects complete Week 16 and all data 
pertaining to Period A are cleaned.  This will be the only and final analysis for efficacy in Period A.  Study 
sites and subjects will remain blinded to their initial treatment assignment for the duration of the entire 
study.
7.2 Definition for Analysis Populations
The Intent-to-Treat (ITT) Population includes all randomized subjects. The ITT Population will be used 
for all efficacy analyses.  Subjects who are randomized to placebo in Period A and do not continue into 
Period B will not be included in the analysis in Period B.
The following populations will be used for the safety analysis:

The Safety Population in Period A (Safety_A) is defined as all subjects who are randomized and 
received at least 1 dose of study drug in Period A.

The Safety Population in Period B (Safety_B) is defined as all subjects who received at least 
1 dose of study drug in Period B.

The All Risankizumab Treated (ALL_RZB) Population is defined as subjects who received at least 
1 dose of risankizumab as the study drug.  This population will be used to provide a 
comprehensive summary of safety.
7.3 Handling Potential Intercurrent Events for the Primary and Key 
Secondary Endpoints
The primary endpoint (Section 3.2) and the ranked secondary endpoints (Section 3.3) will be analyzed in 
the ITT Population and the following method will be used to address potential intercurrent events:
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
Subjects discontinuing study drug due to lack of efficacy before Week 16 are considered as not 
achieving the response.
7.4 Statistical Analyses for Efficacy
Analysis of all efficacy endpoints will be conducted on the ITT Population based on treatment as 
randomized.
All statistical tests will be performed at a 2-sided alpha level of 0.05 in Period A. The 95% confidence 
interval (CI) of the treatment effect will be provided.

For categorical variables, comparison will be made between risankizumab and placebo using the 
Cochran-Mantel-Haenszel (CMH) test, adjusting for the actual values of stratification factors 
(Baseline ppIGA and Baseline BSA).  Non-Responder Imputation incorporating multiple 
imputation to handle missing data due to COVID-19 (NRI-C) will be the primary approach to 
handle missing values.

For continuous variables, comparison will be made between risankizumab and placebo based on 
the fixed term of treatment from a Mixed-effect Model Repeat Measurement (MMRM), 
adjusting for treatment, actual values of stratification factors (Baseline ppIGA and Baseline BSA), 
and baseline value if applicable (if not duplicating the stratification factors).  The MMRM will be 
the primary approach to handle missing values.
Summary statistics will be provided in Period B by treatment groups.  Categorical endpoints will be 
summarized by the number and proportion of subjects who achieved the endpoint, as well as the 95% 
confidence interval of that proportion.  Continuous endpoints will be summarized by descriptive 
statistics including the mean, standard error, and the 95% confidence interval of the mean.
Analysis of the Primary Endpoints
Analysis of the primary endpoint, as described in Section 3.2, will be conducted on the ITT population 
based on treatment as randomized.
Comparison of the primary endpoint will be made between risankizumab and placebo using the CMH 
test adjusting for the actual values of stratification factors (Baseline ppIGA and Baseline BSA) with a 
2-sided significance level of 0.05.
NRI-C will be the primary approach to handle missing values.  A sensitivity analysis will also be 
performed for the primary efficacy endpoint, using multiple imputation (MI) to handle missing values.  
Analysis details for NRI-C, MI, and other sensitivity analyses (if applicable) will be provided in the SAP.
Analysis of the Secondary Endpoints
Analysis of all ranked secondary efficacy endpoints will be conducted on the ITT population based on 
treatment as randomized.
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To control the overall type I error rate, the null hypotheses for all ranked secondary endpoints will be 
tested in a hierarchical order as described in Section 3.3, with a 2-sided significance level of 0.05, only if 
the null hypothesis for the primary endpoint has been rejected.
Analysis of Additional Efficacy Endpoints
Additional endpoints, as described in Section 3.4, will also be analyzed.  Analysis details about additional 
efficacy endpoints will be provided in the SAP.
Subgroup Analysis for Efficacy
To evaluate the consistency of the efficacy across demographic and other baseline characteristics, 
summaries and analyses will be performed for selected subgroups for the primary efficacy endpoint.
Subgroup analysis will be performed on the primary endpoint using the following subgroups:

Age group (< 40 years, ≥40);

Sex (male, female);

Race (white, non-white);

Smoking (current, ex-, or never);

Body mass index (BMI) (normal:  < 25, overweight:  ≥25 to < 30, obese:  ≥30);

Baseline ppIGA ("moderate" [3], "severe" [4]);

Baseline BSA (< 10% versus ≥10%);

Psoriatic arthritis (yes, no); and

Body weight (≤100 kg, > 100 kg).
7.5 Statistical Analyses for Safety
All safety analyses will be performed on the Safety Population in each period.  Subjects will be analyzed 
based on the actual treatment received, defined as the first dose of treatment received after 
randomization. Treatment-emergent adverse events (TEAEs), laboratory assessments, and vital signs 
will be summarized.  Key safety variables will also be summarized on the ALL_RZB Population.  Details 
will be described in the SAP.
A TEAE for the Safety Population is defined as an AE newly occurred or worsened after the first dose of 
study drug and within 20 weeks (140 days) after the last dose of study drug.  The number and 
percentage of subjects experiencing TEAEs will be tabulated using the Medical Dictionary for Regulatory 
Activities (MedDRA) system organ class (SOC) and preferred term (PT), by severity, and by relationship 
to the study drug as assessed by the investigator.  Summaries (including percentages and events per 
100 patient years [PY]) of SAEs, deaths, and AEs leading to discontinuation will be provided as well.  Pre-
treatment AEs will be summarized separately.
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For selected laboratory parameters, a listing of all subjects with any laboratory value that is above 
Grade 3 of Common Toxicity Criteria will be provided.  Mean change in laboratory and vital signs 
variables will be summarized.
Additional details for the safety analysis are provided in the SAP.Interim Analysis
No interim analysis is planned for this study.
7.7 Overall Type I Error Control
Overall type I error rate will be controlled at a 2-sided significance level of 0.05 by testing the primary 
endpoint, followed by the ranked secondary endpoints, in a hierarchical order as described in 
Section 3.2 and Section 3.3.
7.8 Sample Size Determination
The ppIGA is an endpoint that has been used in another clinical trial in the palmoplantar psoriasis 
population and which is based on the modified Investigator's Global Assessment version of 2011.11,30  
Given the lack of historical ppIGA data from risankizumab trials, the assumption of response rates in the 
current study are based on the relevant endpoints of PPASI 75 and PPASI 90 from risankizumab PsO
Studies M15-992 (NCT02672852, Study 1311.4), M15-995 (NCT02684357, Study 1311.28), and M16-008 
(NCT02684370, Study 1311.3), among subjects who had Baseline PPASI of at least 8.  Among these 
subjects, approximately 80% and 75% of subjects from the risankizumab (RZB) group achieved PPASI 75 
and PPASI 90, respectively; compared to 50% and 40% in the placebo (PBO) group.
Assuming that 75% of subjects from the RZB group and 45% of subjects from the PBO group would
achieve the primary endpoint of ppIGA of "clear" or "almost clear" (0 or 1) with at least a 2-point
reduction from Baseline at Week 16, the sample size of 168 subjects (84 subjects per group) will provide
more than 90% power to detect the treatment difference between RZB and PBO, under a 2-sided 
significance level of 0.05.
7.9 Statistical Analysis of Optional Biomarker Data
Analysis may be conducted on optional biomarker data for the purpose of identification of prognostic, 
predictive, surrogate, and pharmacodynamic biomarkers associated with safety or efficacy.  The 
association of biomarkers to the efficacy or safety endpoints may be explored for each biomarker one at 
a time, and also for combinations of biomarkers via some multivariate predictive modeling approaches.
8 ETHICS
8.1 Independent Ethics Committee/Institutional Review Board
The protocol, informed consent form(s), recruitment materials, and all subject materials will be 
submitted to the IEC/IRB for review and approval.  Approval of both the protocol and the informed 
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consent form(s) must be obtained before any subject 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.
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 site visits), alternative locations for data collection (e.g., use of a local lab 
instead of a central lab), and shipping investigational product and/or supplies direct to subjects 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.
Supplemental study case report forms should be completed in the event of COVID-19 related 
missed/virtual visits, study drug interruptions or discontinuations, or AEs (including capture of specific 
signs/symptoms of infection and testing results).
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10
DATA QUALITY ASSURANCE
AbbVie will ensure that the clinical trial is conducted with a quality management system that will define 
quality tolerance limits in order to ensure human subject protection and reliability of study results.  Data 
will be 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.
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 Agency for the Evaluation of 
Medicinal Products Guidance on Investigator's Signature for Study Reports.
The end-of-study is defined as the date of the last subject's last contact, which will be a follow-up phone 
call for safety approximately 20 weeks after administration of the last dose of study drug (risankizumab).
12
REFERENCES
1.
World Health Organization. Global report on psoriasis. 2016. Available from: 
http://apps.who.int/iris/handle/10665/204417. Accessed on: 30 October 2017.
2.
Menter A, Griffiths CE. Current and future management of psoriasis. Lancet. 2007;370(9583):272-84.
3.
Helmick CG, Lee-Han H, Hirsch SC, et al. Prevalence of psoriasis among adults in the U.S.: 2003-2006 
and 2009-2010 National Health and Nutrition Examination Surveys. Am J Prev Med. 2014;47(1):37-
45.
4.
Mease PJ, Gladman DD, Papp KA, et al. Prevalence of rheumatologist-diagnosed psoriatic arthritis in 
patients with psoriasis in European/North American dermatology clinics. J Am Acad Dermatol. 
2013;69(5):729-35.
5.
Davidovici BB, Sattar N, Prinz J, et al. Psoriasis and systemic inflammatory diseases: potential 
mechanistic links between skin disease and co-morbid conditions. J Invest Dermatol. 
2010;130(7):1785-96.
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6.
Engin B, Askin O, Tuzun Y. Palmoplantar psoriasis. Clin Dermatol. 2017;35(1):19-27.
7.
Kumar B, Saraswat A, Kaur I. Palmoplantar lesions in psoriasis: a study of 3065 patients. Acta Derm 
Venereol. 2002;82(3):192-5.
8.
Yan D, Afifi L, Jeon C, et al. A cross-sectional study of the distribution of psoriasis subtypes in 
different ethno-racial groups. Dermatol Online J. 2018;24(7).
9.
Raposo I, Torres T. Palmoplantar psoriasis and palmoplantar pustulosis: current treatment and 
future prospects. Am J Clin Dermatol. 2016;17(4):349-58.
10. Janagond AB, Kanwar AJ, Handa S. Efficacy and safety of systemic methotrexate vs. acitretin in 
psoriasis patients with significant palmoplantar involvement: a prospective, randomized study. J Eur 
Acad Dermatol Venereol. 2013;27(3):e384-9.
11. Gottlieb A, Sullivan J, van Doorn M, et al. Secukinumab shows significant efficacy in palmoplantar 
psoriasis: Results from GESTURE, a randomized controlled trial. J Am Acad Dermatol. 2017;76(1):70-
80.
12. Chung J, Callis Duffin K, Takeshita J, et al. Palmoplantar psoriasis is associated with greater 
impairment of health-related quality of life compared with moderate to severe plaque psoriasis. J 
Am Acad Dermatol. 2014;71(4):623-32.
13. Farley E, Masrour S, McKey J, et al. Palmoplantar psoriasis: a phenotypical and clinical review with 
introduction of a new quality-of-life assessment tool. J Am Acad Dermatol. 2009;60(6):1024-31.
14. Strober B, Ryan C, van de Kerkhof P, et al. Recategorization of psoriasis severity: Delphi consensus 
from the International Psoriasis Council. J Am Acad Dermatol. 2020;82(1):117-22.
15. Gordon KB, Strober B, Lebwohl M, et al. Efficacy and safety of risankizumab in moderate-to-severe 
plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-
controlled and ustekinumab-controlled phase 3 trials. Lancet. 2018;392(10148):650-61.
16. Reich K, Gooderham M, Thaci D, et al. Risankizumab compared with adalimumab in patients with 
moderate-to-severe plaque psoriasis (IMMvent): a randomised, double-blind, active-comparator-
controlled phase 3 trial. Lancet. 2019;394(10198):576-86.
17. AbbVie. Risankizumab Investigator's Brochure Edition 5. 13 May 2019.
18. Agency EM. Skyrizi (risankizumab) [SmPC]. Ludwigshafen, Germany: AbbVie Deutschland GmbH & 
Co. KG.; 2019.
19. Khader SA, Pearl JE, Sakamoto K, et al. IL-23 compensates for the absence of IL-12p70 and is 
essential for the IL-17 response during tuberculosis but is dispensable for protection and antigen-
specific IFN-gamma responses if IL-12p70 is available. J Immunol. 2005;175(2):788-95.
20. O'Garra A, Redford PS, McNab FW, et al. The immune response in tuberculosis. Annu Rev Immunol. 
2013;31:475-527.
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No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.
21. Qian X, Gu L, Ning H, et al. Increased Th17 cells in the tumor microenvironment is mediated by IL-23 
via tumor-secreted prostaglandin E2. J Immunol. 2013;190(11):5894-902.
22. Baird AM, Leonard J, Naicker KM, et al. IL-23 is pro-proliferative, epigenetically regulated and 
modulated by chemotherapy in non-small cell lung cancer. Lung Cancer. 2013;79(1):83-90.
23. Hu WH, Chen HH, Yen SL, et al. Increased expression of interleukin-23 associated with progression of 
colorectal cancer. J Surg Oncol. 2017;115(2):208-12.
24. Langowski JL, Zhang X, Wu L, et al. IL-23 promotes tumour incidence and growth. Nature. 
2006;442(7101):461-5.
25. AbbVie. Data on File, RRT165055.
26. Armstrong AW, Vender R, Kircik L. Secukinumab in the Treatment of Palmoplantar, Nail, Scalp, and 
Pustular Psoriasis. J Clin Aesthet Dermatol. 2016;9(6 Suppl 1):S12-S6.
27. Gottlieb AB, Kubanov A, van Doorn M, et al. Sustained efficacy of secukinumab in patients with 
moderate-to-severe palmoplantar psoriasis: 2.5-year results from GESTURE, a randomized, double-
blind, placebo-controlled trial. Br J Dermatol. 2020;182(4):889-99.
28. Menter A, Warren RB, Langley RG, et al. Efficacy of ixekizumab compared to etanercept and placebo 
in patients with moderate-to-severe plaque psoriasis and non-pustular palmoplantar involvement: 
results from three phase 3 trials (UNCOVER-1, UNCOVER-2 and UNCOVER-3). J Eur Acad Dermatol 
Venereol. 2017;31(10):1686-92.
29. US Department of Health and Human Services. Common Terminology Criteria for Adverse Events 
(CTCAE) Version 5.0 27 November 2017 [Available from: 
https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/CTCAE_v5_Quick_Refer
ence_8.5x11.pdf.
30. Langley RG, 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 Dermatolog Treat. 
2015;26(1):23-31.
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APPENDIX A. STUDY-SPECIFIC ABBREVIATIONS AND TERMS
Abbreviation
Definition
AAC
Anaphylaxis Adjudication Committee
Ab
Antibody
ADA
Antidrug antibody
AE
Adverse event
ALT
Alanine aminotransaminase/aminotransferase
ANC
Absolute neutrophil count
AP
Alkaline phosphatase
ASI
Areas of safety interest
AST
Aspartate aminotransaminase/aminotransferase
BCG
Bacille Calmette-Guérin
BMI
Body-mass index
BSA
Body surface area
BUN
Blood urea nitrogen
CAC
Cardiovascular Adjudication Committee
CBC
Complete blood count
CI
Confidence interval
CK
Creatine kinase
CKD-EPI
Creatinine with eGFR
CMH
Cochran-Mantel-Haenszel
CS
Clinically significant
COVID-19
Coronavirus disease of 2019
CRO
Contract research organization
CTCAE
Common Terminology Criteria for Adverse Events
D
Desquamation
DFP
Direct-from-patient
DLQI
Dermatology Life Quality Index
DSS
Data and Statistical Sciences
DSUR
Development safety update report
DTP
Direct-to-patient
E
Erythema
ECG
Electrocardiogram
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eCRF
Electronic case report form
EDC
Electronic data capture
eGFR
Estimated glomerular filtration rate
FDA
Food and Drug Administration
FSH
Follicle-stimulating hormone
GCP
Good clinical practice
GGT/γ-GT
Gamma-glutamyl transferase
h
Head
HBc Ab
Hepatitis B core antibody
HBs Ab
Hepatitis B surface antibody
HBs Ag
Hepatitis B surface antigen
HBV
Hepatitis B virus
HBV Ab
Hepatitis B virus antibody
HCV
Hepatitis C virus
HCV Ab
Hepatitis C virus antibody
HDL-C
High-density lipoprotein cholesterol
HIV
Human immunodeficiency virus
HIV Ab
Human immunodeficiency virus antibody
hsCRP
High-sensitivity C-reactive protein
I
Induration
IB
Investigator's Brochure
ICH
International Council for Harmonisation of Technical Requirements for Pharmaceuticals 
for Human Use
IEC
Independent ethics committee
Ig
Immunoglobin
IGRA
interferon gamma release assay
IL
Interleukin
IMP
Investigational medicinal product
INR
International normalized ratio
IRB
Institutional review board
IRT
Interactive response technology
ITT
Intent-to-treat
IUD
Intrauterine device
IUS
Intrauterine hormone-releasing system
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l
Lower extremities
LDL-C
Low-density lipoprotein cholesterol
mAb
Monoclonal antibody
MACE
Major adverse cardiovascular events
MCV
Mean corpuscular volume
MD
Medical Director
MedDRA
Medical Dictionary for Regulatory Activities
MI
Multiple imputation
MMRM
Mixed-effect Model Repeat Measurement
NAb
Neutralizing antibody
NCI
National Cancer Institute
NCS
Not clinically significant
NMSC
Non-melanoma skin cancer
NRI
Non-responder imputation
NRI-C
Non-Responder Imputation incorporating multiple imputation to handle missing data 
due to COVID-19
NRS
Numerical Rating Scale
PASI
Psoriasis Area and Severity Index
PASI 90
Achievement of ≥90% improvement from Baseline in Psoriasis Area and Severity Index
PBO
Placebo
PCR
Polymerase chain reaction
PD
Premature Discontinuation
PFS
Pre-filled syringe
PGA-SP
Patient Global Assessment of Skin Pain
PK
Pharmacokinetics
PPASI
Palmoplantar Psoriasis Area and Severity Index
PPASI 75
Achievement of ≥75% improvement from Baseline in Palmoplantar Psoriasis Area and 
Severity Index
PPASI 90
Achievement of ≥90% improvement from Baseline in Palmoplantar Psoriasis Area and 
Severity Index
PPASI 100
Achievement of ≥100% improvement from Baseline in Palmoplantar Psoriasis Area and 
Severity Index
PPD
Purified protein derivative
ppIGA
Palmoplantar Investigator's Global Assessment
PPPsO
Palmoplantar plaque psoriasis
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PRO
Patient-reported outcome
PSD
Psoriasis Symptom Diary
PSI
Psoriasis Symptom Inventory
PsO
Psoriasis
PSS
Psoriasis Symptom Scale
PT
Preferred term
PUVA
Psoralen and ultraviolet A radiation
PY
Patient years
q12w
Once every 12 weeks
QTcF
QT interval corrected for heart rate using Fridericia's formula
RBC
Red blood cell
RSI
Reference Safety Information
RZB
Risankizumab
SAE
Serious adverse event
SAP
Statistical Analysis Plan
SAR
Serious adverse reaction
SARS-CoV-2
Severe acute respiratory syndrome coronavirus 2
SC
Subcutaneous
SOC
System organ class
sPGA
Static Physician's Global Assessment
SUSAR
Suspected unexpected serious adverse reactions
t
Trunk
TA
Therapeutic Area
TB
Tuberculosis
TEAE
Treatment-emergent adverse event
u
Upper extremities
UACR
Urine albumin-to-creatinine ratio
ULN
Upper limit of normal
UVA
Ultraviolet A rays
UVB
Ultraviolet B rays
WBC
White blood cell
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APPENDIX B. RESPONSIBILITIES OF THE INVESTIGATOR
Protocol M15-994:  IMMprint:  A Phase 3b Multicenter, Randomized, Double-Blind, Parallel-Group, 
Placebo-Controlled Study Evaluating Safety and Efficacy of Risankizumab Compared to Placebo in Adult 
Subjects with Moderate to Severe Plaque Psoriasis with Palmoplantar (Non-Pustular) Involvement
(PPPsO)
Protocol Date: 10 June 2021
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)
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APPENDIX C. LIST OF PROTOCOL SIGNATORIES
Name
Title
Functional Area
Medical Monitor/Medical Director
Medical Affairs, Immunology
Associate Director
Clinical Program Development
Associate Director, Statistics
Data and Statistical Sciences
Director, Statistics
Data and Statistical Sciences
Senior Director/Statistics Therapeutic Area Head
Data and Statistical Sciences
Associate Director
Medical Writing (Protocol Author)
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APPENDIX D. ACTIVITY SCHEDULE
The following table shows the required activities across the subject encounters.  The individual activities 
and allowed modifications due to COVID-19 are described in detail in the Operations Manual
(Appendix F).
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APPENDIX E. SUMMARY OF CHANGES
Previous Protocol Versions
Protocol
Date
Version 1.0
11 December 2020
Administrative Change 1
24 March 2021
The purpose of this version is to update the following sections and incorporate necessary protocol 
modifications due to the COVID-19 pandemic and changes due to new safety information available as 
follows:
Modifications to the Protocol and Operations Manual due to State-of-Emergency or Pandemic 
Situations

Vaccine language was updated.  A COVID-19 vaccine eCRF is being implemented in the study.

Sections affected include: Protocol Section 5.4, Operations Manual Section 4.3
Rationale:  To ensure subject safety during state-of-emergency or pandemic situations.

In Section 2.1 of the Operations Manual, the activities list was updated to indicate that Week 16 
labs may be processed at a local lab, if needed.
Rationale: Vendor kit shortages due to the COVID-19 pandemic may necessitate the use of local 
labs.

In Section 3.12 of the Operations Manual, language was provided regarding acceptable 
modifications to ECG collection.
Rationale: Due to protocol modifications in state of emergency or pandemic situations, 
acceptable alternatives may need to be employed.
Protocol

Text was updated throughout the Protocol to align with revisions in the protocol template and 
changes due to new safety information available.

Sections include:  Section 5.1, Section 5.2, Section 5.4, Section 5.5, Section 6.1 (Table 3), 
Appendix D (Activity Schedule)
Rationale: Updated language to provide align with new safety information available and 
provide additional clarity.

Throughout the Protocol, made typographical, stylistic, and administrative updates.
Rationale:  To correct known typographical, stylistic, and administrative inconsistencies.
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Operations Manual

Text was updated throughout the Operations Manual to align with revisions in the Operations 
Manual template and changes due to new safety information available.

Sections include:  Section 3.12, Section 3.16, Section 4.1
Rationale:  Updated language to provide align with new safety information available and 
provide additional clarity.

Protocol Section 2.1 was updated to clarify that vital signs, height, weight, and PASI would not 
be collected at virtual visits, if utilized (Week 4, Week 28, Week 40, and Week 52).  Hematology 
and clinical chemistry labs at Week 16 were updated with a "+" to indicate that these labs could 
be performed locally, if needed.
Rationale:  To provide clarity and correct the discrepancy between the text and visit activities 
lists.  Vendor kit shortages may result in the need to use local laboratories.

Throughout the Operations manual, made typographical, stylistic, and administrative updates.
Rationale:  To correct known typographical, stylistic, and administrative inconsistencies.
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