PsoriasisPhase 3NCT02672852

BI 655066 / ABBV-066 (Risankizumab) in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment

A Phase 3 study testing Risankizumab in people with Psoriasis, run by AbbVie.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This was a multinational, multicenter, randomized, double-blind, placebo controlled study with randomized withdrawal and retreatment, evaluating the safety and efficacy of risankizumab 150 mg subcutaneous (SC) in participants with moderate to severe chronic plaque psoriasis. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Psoriasis
What is being tested?: Risankizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 507 participants
Where: No sites listed yet
Study dates: 29 Feb 2016to 26 Jul 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female participants. Woman of childbearing potential must be ready and willing to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1 percent per year when used consistently and correctly.
Age ≥18 years at screening
Have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) at least 6 months before the first administration of study drug. Duration of diagnosis may be reported by the participant.
Have stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline (Randomization); Have an involved body surface area (BSA) ≥ 10% and Have a Psoriasis Area and Severity Index (PASI) ≥ 12 and Have a static Physician Global Assessment (sPGA) score of ≥ 3.
Must be a candidate for systemic therapy or phototherapy for psoriasis treatment, as assessed by the investigator
Signed and dated written informed consent prior to admission to the study and performance of any study procedures in accordance with Good Clinical Practice (GCP) and local legislation

Who cannot join

Participants with nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular); current drug-induced psoriasis (including a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium); active ongoing inflammatory diseases other than psoriasis and psoriatic arthritis that might confound trial evaluations according to the investigators judgment.
Previous exposure to ABBV-066
Currently enrolled in another investigational study or less than 30 days (from screening) since completing another investigational study
Use of any restricted medication as noted or any drug considered likely to interfere with the safe conduct of the study.
Major surgery performed within 12 weeks prior to randomization or planned within 12 months after screening (e.g., hip replacement, removal aneurysm, stomach ligation).
Known chronic or relevant acute infections such as active tuberculosis, human immunodeficiency virus (HIV), or viral hepatitis

Show all 11Show fewer

Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix
Evidence of a current or previous disease (including chronic alcohol or drug abuse), medical condition other than psoriasis, surgical procedure (i.e., organ transplant), medical examination finding (including vital signs and electrocardiogram [ECG]), or laboratory value at the screening visit outside the reference range that in the opinion of the Investigator, is clinically significant and would make the study participant unable to adhere to the protocol or to complete the trial, compromise the safety of the patient, or compromise the quality of the data.
History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
Previous enrolment in this trial

About this study

Official title: BI 655066 / ABBV-066 (Risankizumab) Versus Placebo In a Multicenter Randomized Double-blind Study in Patients With Moderate to Severe Chronic Plaque Psoriasis Evaluating the Efficacy and Safety With Randomized Withdrawal and Re-treatment (IMMhance)

Read the detailed description

In Part A1, eligible participants were randomized at Baseline at a ratio of 4:1, stratified by weight and prior exposure to tumor necrosis factor antagonists to receive double-blind (DB) risankizumab 150 mg or placebo at Weeks 0 and 4. In Part A2, participants randomized at Baseline to receive DB placebo then received risankizumab 150 mg at Weeks 16 (Part A2) and at Week 28 and every 12 weeks up to 88 weeks (Part B); participants randomized to risankizumab 150 mg continued to receive risankizumab 150 mg at Week 16. Participants who received risankizumab in Part A and were nonresponders (sPGA >2) at Week 28 received risankizumab 150 mg at Week 28 and every 12 weeks up to 88 weeks (Part B). In Part B, participants who received risankizumab in Part A and were responders (sPGA ≤2) at Week 28, were rerandomized at a ratio of 1:2 to receive DB risankizumab 150 mg or placebo at Week 28 and every 12 weeks up to 88 weeks (Part B). Starting at Week 32, rerandomized participants who reached relapse (defined as sPGA ≥3) were switched to risankizumab 150 mg every 12 weeks.

Conditions: Psoriasis
Being tested: Risankizumab, Placebo
Keywords: ABBV-066, BI 655066, risankizumab
Medical subject headings: Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RisankizumabDrug
Also called BI 655066, ABBV-066, SKYRIZI
Risankizumab administered by subcutaneous injection
PlaceboDrug
Placebo for risankizumab administered by subcutaneous injection

Study groups in NCT02672852
Study group	Role	What they receive
Risankizumab	Experimental	Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg by subcutaneous injection at Weeks 0 and 4 (Part A1). Receives: Drug: Risankizumab
Placebo	Placebo comparator	Participants randomized at Baseline to receive double-blind (DB) placebo by subcutaneous injection at Weeks 0 and 4 (Part A1). Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) Score (PASI90) From Baseline to Week 16
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Non-responder imputation (NRI) was used for missing data.
Measured: Baseline, Week 16
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Measured: Week 16
Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Measured: Week 52

Secondary outcomes (8)

Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Measured: Week 16
Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 16
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Measured: Week 16
Percentage of Participants Achieving an sPGA Score of Clear at Week 16
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Measured: Week 16
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16
The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. NRI was used for missing data.
Measured: Week 16
Percentage of Participants Achieving an sPGA Score of Clear or Almost Clear at Week 104
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Measured: Week 104
Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 52
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Measured: Week 52
Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 52
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Measured: Week 52
Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 52
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Feb 201626 Jul 2018

First posted3 Feb 2016 (estimated)
Study start29 Feb 2016
Primary completion2 Aug 2017
Study completion26 Jul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for PsoriasisStudies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 507 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02672852
Sponsor's protocol ID: M15-992
Other IDs: 2014-005102-38, 1311.4, 2014
Status last verified: May 2019
First submitted: 1 Feb 2016
Last updated: 9 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Publications

Lebwohl MG, Soliman AM, Yang H, Wang J, Hagan K, Padilla B, Pinter A. Impact of Risankizumab on PASI90 and DLQI0/1 Duration in Moderate-to-Severe Psoriasis: A Post Hoc Analysis of Four Phase 3 Clinical Trials. Dermatol Ther (Heidelb). 2022 Feb;12(2):407-418. doi: 10.1007/s13555-021-00660-3. Epub 2021 Dec 18.
PubMed 34921669
Blauvelt A, Leonardi CL, Gooderham M, Papp KA, Philipp S, Wu JJ, Igarashi A, Flack M, Geng Z, Wu T, Camez A, Williams D, Langley RG. Efficacy and Safety of Continuous Risankizumab Therapy vs Treatment Withdrawal in Patients With Moderate to Severe Plaque Psoriasis: A Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2020 Jun 1;156(6):649-658. doi: 10.1001/jamadermatol.2020.0723.
PubMed 32267471
Suleiman AA, Khatri A, Oberoi RK, Othman AA. Exposure-Response Relationships for the Efficacy and Safety of Risankizumab in Japanese Subjects with Psoriasis. Clin Pharmacokinet. 2020 May;59(5):575-589. doi: 10.1007/s40262-019-00829-2.
PubMed 31667790
Suleiman AA, Minocha M, Khatri A, Pang Y, Othman AA. Population Pharmacokinetics of Risankizumab in Healthy Volunteers and Subjects with Moderate to Severe Plaque Psoriasis: Integrated Analyses of Phase I-III Clinical Trials. Clin Pharmacokinet. 2019 Oct;58(10):1309-1321. doi: 10.1007/s40262-019-00759-z.
PubMed 31054118

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: BI 655066 / ABBV-066 (Risankizumab) Versus Placebo In a Multicenter Randomized Double-blind Study in Patients With Moderate to Severe Chronic Plaque Psoriasis Evaluating the Efficacy and Safety With Randomized Withdrawal and Re-treatment (IMMhance)
ClinicalTrials.gov ID: NCT02672852
Acronym / sponsor ID: M15-992
Conditions: Psoriasis
Keywords: ABBV-066, BI 655066, risankizumab
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 507 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Collaborators: Boehringer Ingelheim
Study start: 29 Feb 2016 (actual)
Primary completion: 2 Aug 2017 (actual)
Study completion: 26 Jul 2018 (actual)
First posted: 3 Feb 2016 (estimated)
Results: Posted 28 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Risankizumab	Experimental	Drug: RisankizumabParticipants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg by subcutaneous injection at Weeks 0 and 4 (Part A1).
Placebo	Placebo comparator	Drug: PlaceboParticipants randomized at Baseline to receive double-blind (DB) placebo by subcutaneous injection at Weeks 0 and 4 (Part A1).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Male or female participants. Woman of childbearing potential must be ready and willing to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1 percent per year when used consistently and correctly.
Age ≥18 years at screening
Have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) at least 6 months before the first administration of study drug. Duration of diagnosis may be reported by the participant.
Have stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline (Randomization); Have an involved body surface area (BSA) ≥ 10% and Have a Psoriasis Area and Severity Index (PASI) ≥ 12 and Have a static Physician Global Assessment (sPGA) score of ≥ 3.
Must be a candidate for systemic therapy or phototherapy for psoriasis treatment, as assessed by the investigator

Key exclusion criteria (11 listed)

Participants with nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular); current drug-induced psoriasis (including a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium); active ongoing inflammatory diseases other than psoriasis and psoriatic arthritis that might confound trial evaluations according to the investigators judgment.
Previous exposure to ABBV-066
Currently enrolled in another investigational study or less than 30 days (from screening) since completing another investigational study
Use of any restricted medication as noted or any drug considered likely to interfere with the safe conduct of the study.
Major surgery performed within 12 weeks prior to randomization or planned within 12 months after screening (e.g., hip replacement, removal aneurysm, stomach ligation).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RisankizumabAlso: BI 655066, ABBV-066, SKYRIZIRisankizumab administered by subcutaneous injection	Drug	Risankizumab
PlaceboPlacebo for risankizumab administered by subcutaneous injection	Drug	Placebo

Primary outcome

Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) Score (PASI90) From Baseline to Week 16
Time frame: Baseline, Week 16
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Non-responder imputation (NRI) was used for missing data.
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16
Time frame: Week 16
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52
Time frame: Week 52
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.

8 secondary outcomes

Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16
Time frame: Week 16
Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 16
Time frame: Week 16
Percentage of Participants Achieving an sPGA Score of Clear at Week 16
Time frame: Week 16
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16
Time frame: Week 16
Percentage of Participants Achieving an sPGA Score of Clear or Almost Clear at Week 104
Time frame: Week 104
Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 52
Time frame: Week 52
Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 52
Time frame: Week 52
Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 52
Time frame: Week 52

Results and safety

Results posted to the registry on 28 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo (Part A1)	100	97
Risankizumab (Part A1)	407	403
Placebo/Risankizumab Part A2/Part B	0	0
Risankizumab/Risankizumab Part A2	0	0
Risankizumab/Placebo (Part B; Rerandomized Responders)	0	0
Risankizumab/Risankizumab (Part B; Rerandomized Responders)	0	0
Risankizumab/Risankizumab Part B (Nonresponders)	0	0

Primary outcome: Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) Score (PASI90) From Baseline to Week 16

Time frame: Baseline, Week 16. Number. Unit: percentage of participants

Measure	Placebo (Part A1) n = 100	Risankizumab (Part A1) n = 407
Value	2.0	73.2

Placebo (Part A1) vs Risankizumab (Part A1): Adjusted percentage difference: 70.8 (95% CI 65.7 to 76.0), p < 0.001, Cochran-Mantel-Haenszel

Population analysed: Intent to treat (ITT) Population in Part A1(ITT\_A1): all participants who were randomized at Baseline.

Primary outcome: Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16

Time frame: Week 16. Number. Unit: percentage of participants

Measure	Placebo (Part A1) n = 100	Risankizumab (Part A1) n = 407
Value	7.0	83.5

Placebo (Part A1) vs Risankizumab (Part A1): Adjusted percentage difference: 76.5 (95% CI 70.4 to 82.5), p < 0.001, Cochran-Mantel-Haenszel

Population analysed: ITT Population in Part A1(ITT\_A1)

Primary outcome: Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52

Time frame: Week 52. Number. Unit: percentage of participants

Measure	Risankizumab/Placebo (Part B; Rerandomized Responders) n = 225	Risankizumab/Risankizumab (Part B; Rerandomized Responders) n = 111
Value	61.3	87.4

Risankizumab/Placebo (Part B; Rerandomized Responders) vs Risankizumab/Risankizumab (Part B; Rerandomized Responders): Adjusted percentage difference: 25.9 (95% CI 17.3 to 34.6), p < 0.001, Cochran-Mantel-Haenszel

Population analysed: ITT Population in Part B for re-randomized participants (ITT\_B\_R): All participants who were randomized to Arm 1 at Baseline and re randomized at Week 28.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo (Part A1)	8 of 100 (8%)	17 of 100 (17%)	0 of 100
Risankizumab (Part A1)	8 of 407 (2%)	52 of 407 (12.8%)	0 of 407
Risankizumab/Placebo (Part B; Rerandomized Responders)	17 of 225 (7.6%)	92 of 225 (40.9%)	0 of 225
Risankizumab/Risankizumab (Part B; Rerandomized Responders)	13 of 111 (11.7%)	52 of 111 (46.8%)	2 of 111
Any Risankizumab	55 of 500 (11%)	242 of 500 (48.4%)	4 of 500

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34921669Lebwohl MG, Soliman AM, Yang H, Wang J, Hagan K, Padilla B, Pinter A. Impact of Risankizumab on PASI90 and DLQI0/1 Duration in Moderate-to-Severe Psoriasis: A Post Hoc Analysis of Four Phase 3 Clinical Trials. Dermatol Ther (Heidelb). 2022 Feb;12(2):407-418. doi: 10.1007/s13555-021-00660-3. Epub 2021 Dec 18.
Derived from this study: PubMed 32267471Blauvelt A, Leonardi CL, Gooderham M, Papp KA, Philipp S, Wu JJ, Igarashi A, Flack M, Geng Z, Wu T, Camez A, Williams D, Langley RG. Efficacy and Safety of Continuous Risankizumab Therapy vs Treatment Withdrawal in Patients With Moderate to Severe Plaque Psoriasis: A Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2020 Jun 1;156(6):649-658. doi: 10.1001/jamadermatol.2020.0723.
Derived from this study: PubMed 31667790Suleiman AA, Khatri A, Oberoi RK, Othman AA. Exposure-Response Relationships for the Efficacy and Safety of Risankizumab in Japanese Subjects with Psoriasis. Clin Pharmacokinet. 2020 May;59(5):575-589. doi: 10.1007/s40262-019-00829-2.
Derived from this study: PubMed 31054118Suleiman AA, Minocha M, Khatri A, Pang Y, Othman AA. Population Pharmacokinetics of Risankizumab in Healthy Volunteers and Subjects with Moderate to Severe Plaque Psoriasis: Integrated Analyses of Phase I-III Clinical Trials. Clin Pharmacokinet. 2019 Oct;58(10):1309-1321. doi: 10.1007/s40262-019-00759-z.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Risankizumab in people with Psoriasis, run by AbbVie.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) Score (PASI90) From Baseline to Week 16 (time frame: Baseline, Week 16). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02672852, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2019.