BI 655066 (Risankizumab) Compared to Placebo in Japanese Patients With Moderate to Severe Chronic Plaque Psoriasis

NCT ID: NCT03000075

Last Updated: 2019-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-02
• Study Completion Date: 2018-06-20

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.

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo (Part A)

Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).

Group Type: PLACEBO_COMPARATOR

placebo for risankizumab

Intervention Type: DRUG

Placebo for risankizumab pre-filled syringe, administered by subcutaneous (SC) injection

Risankizumab 75 mg (Part A)

Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).

Group Type: EXPERIMENTAL

risankizumab

Intervention Type: DRUG

Risankizumab pre-filled syringe, administered by subcutaneous (SC) injection

placebo for risankizumab

Intervention Type: DRUG

Placebo for risankizumab pre-filled syringe, administered by subcutaneous (SC) injection

Risankizumab 150 mg (Part A)

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

Group Type: EXPERIMENTAL

risankizumab

Intervention Type: DRUG

Risankizumab pre-filled syringe, administered by subcutaneous (SC) injection

Interventions

risankizumab

Risankizumab pre-filled syringe, administered by subcutaneous (SC) injection

Intervention Type: DRUG

placebo for risankizumab

Placebo for risankizumab pre-filled syringe, administered by subcutaneous (SC) injection

Intervention Type: DRUG

Other Intervention Names

ABBV-066; BI 655066

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: collaborator

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

References

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.

Reference Type: DERIVED

PMID: 31667790 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31237727 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

1311.38

Identifier Type: OTHER

Identifier Source: secondary_id

M16-004

Identifier Type: -

Identifier Source: org_study_id