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

NCT02672852 | Completed Phase 3 Results DMC

• 3 other identifiers: M15-9922014-005102-381311.4
• Study Type: interventional
• Target: 507
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Psoriasis

Keywords

ABBV-066; BI 655066; risankizumab

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Week 52

Secondary Outcomes (8)

• Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16

  Week 16

• Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 16

  Week 16

• Percentage of Participants Achieving an sPGA Score of Clear at Week 16

  Week 16

• Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16

  Week 16

• Percentage of Participants Achieving an sPGA Score of Clear or Almost Clear at Week 104

  Week 104

Study Arms (2)

Risankizumab

EXPERIMENTAL

Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg by subcutaneous injection at Weeks 0 and 4 (Part A1).

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).

Drug: Placebo

Interventions

Risankizumab DRUG

Risankizumab administered by subcutaneous injection

Also known as: BI 655066, ABBV-066, SKYRIZI

Risankizumab

Placebo DRUG

Placebo for risankizumab administered by subcutaneous injection

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• AbbVie: lead
• Boehringer Ingelheim: collaborator

Related Publications (4)

• 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.

  PMID: 34921669 DERIVED

• 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.

  PMID: 32267471 DERIVED

• 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.

  PMID: 31667790 DERIVED

• 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.

  PMID: 31054118 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Psoriasis

Interventions

risankizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2016
• First Posted: February 3, 2016
• Study Start: February 29, 2016
• Primary Completion: August 2, 2017
• Study Completion: July 26, 2018
• Last Updated: October 9, 2019
• Results First Posted: May 28, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.