Clinical trial NCT03000075: BI 655066 (Risankizumab) Compared to Placebo in Japanese Patients With Moderate to Severe Chronic Plaque Psoriasis
Official title: A Phase II/III, Randomized, Double-blind Study to Evaluate Efficacy and Safety of Two Different Dose Regimens of BI 655066 (Risankizumab) and Placebo and Maintenance of Response of BI 655066 (Risankizumab) Administered Subcutaneously in Japanese Patients With Moderate to Severe Chronic Plaque Type Psoriasis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Keywords: BI 655066
ABBV-066
risankizumab
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Boehringer Ingelheim
First posted: 2016-12-21
Enrollment: 182
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized double blind, double dummy, placebo controlled, parallel design study that is being performed to assess the safety and efficacy of BI 655066 (risankizumab).

Detailed description: Participants were randomized to receive either placebo, risankizumab 75 mg, or risankizumab 150 mg in Part A. All participants received 2 injections to maintain the blind: the placebo arm received 2 injections of placebo, the risankizumab 75 mg arm received one injection of risankizumab 75 mg and one injection of placebo, and the risankizumab 150 mg arm received 2 injections of risankizumab 75 mg. Participants who received placebo in Part A switched to risankizumab in Part B; participants who received risankizumab (75 mg or 150 mg) in Part A continued to receive the same treatment (risankizumab 75 mg or 150 mg) in Part B.

Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of study drug. Duration of diagnosis may be reported by the patient.
* Have stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline (Randomisation):

  1. Have an involved body surface area (BSA) ≥10% and
  2. Have a Psoriasis Area and Severity Index (PASI) score ≥12 and
  3. Have a Static Physician Global Assessment (sPGA) score of ≥3.

Exclusion Criteria:

* Patients with

  1. non-plaque forms of psoriasis (including guttate, erythrodermic, or pustular)
  2. current drug-induced psoriasis (including an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
  3. active ongoing inflammatory diseases other than psoriasis and psoriatic arthritis that might confound trial evaluations according to investigator's judgment
* Previous exposure to BI 655066

Primary outcomes:
measure: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A)
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of Participants Achieving PASI90 at Week 52 (Part B)
timeFrame: Week 52
measure: Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Part A)
timeFrame: Week 16
measure: Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52 (Part B)
timeFrame: Week 52
measure: Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16 (Part A)
timeFrame: Week 16
measure: Percentage of Participants Achieving PASI75 at Week 52 (Part B)
timeFrame: Week 52
measure: Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 16 (Part A)
timeFrame: Week 16
measure: Percentage of Participants Achieving PASI100 at Week 52 (Part B)
timeFrame: Week 52
measure: Percentage of Participants (ITT Participants in Select Study Sites With Confirmed Diagnosis of Psoriatic Arthritis and Baseline Total Tender and Swollen Joint Count ≥ 3) Achieving an American College of Rheumatology 20 Response (ACR20) at Week 16 (Part A)
timeFrame: Week 16
measure: Percentage of Participants (ITT Participants in Select Study Sites With Confirmed Diagnosis of Psoriatic Arthritis and Baseline Total Tender and Swollen Joint Count ≥ 3) Achieving an ACR20 at Week 52 (Part B)
timeFrame: Week 52
Other outcomes:
Locations:
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.
citation: Ohtsuki M, Fujita H, Watanabe M, Suzaki K, Flack M, Huang X, Kitamura S, Valdes J, Igarashi A. Efficacy and safety of risankizumab in Japanese patients with moderate to severe plaque psoriasis: Results from the SustaIMM phase 2/3 trial. J Dermatol. 2019 Aug;46(8):686-694. doi: 10.1111/1346-8138.14941. Epub 2019 Jun 25.