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

NCT03000075 | Completed Phase 2 Results DMC

• 2 other identifiers: M16-0041311.38
• Study Type: interventional
• Target: 182
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Psoriasis

Keywords

BI 655066; ABBV-066; risankizumab

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A)

  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. Nonresponder imputation (NRI) was used for missing data.

  Week 16

Secondary Outcomes (9)

• Percentage of Participants Achieving PASI90 at Week 52 (Part B)

  Week 52

• Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Part A)

  Week 16

• Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52 (Part B)

  Week 52

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

  Week 16

• Percentage of Participants Achieving PASI75 at Week 52 (Part B)

  Week 52

Study Arms (3)

Placebo (Part A)

PLACEBO COMPARATOR

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

Drug: placebo for risankizumab

Risankizumab 75 mg (Part A)

EXPERIMENTAL

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

Drug: risankizumab; Drug: placebo for risankizumab

Risankizumab 150 mg (Part A)

EXPERIMENTAL

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

Drug: risankizumab

Interventions

risankizumab DRUG

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

Also known as: ABBV-066, BI 655066

Risankizumab 150 mg (Part A); Risankizumab 75 mg (Part A)

placebo for risankizumab DRUG

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

Placebo (Part A); Risankizumab 75 mg (Part A)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with
• non-plaque forms of psoriasis (including guttate, erythrodermic, or pustular)
• current drug-induced psoriasis (including 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 investigator's judgment
• Previous exposure to BI 655066

Sponsors & Collaborators

• AbbVie: lead
• Boehringer Ingelheim: collaborator

Related Publications (2)

• 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

• 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.

  PMID: 31237727 DERIVED

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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: December 21, 2016
• Study Start: December 2, 2016
• Primary Completion: September 21, 2017
• Study Completion: June 20, 2018
• Last Updated: May 21, 2019
• Results First Posted: February 6, 2019

Record last verified: 2019-05