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

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.

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).

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: placebo for risankizumab; Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo (Part A); 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; Placebo for risankizumab pre-filled syringe, administered by subcutaneous (SC) injection
EXPERIMENTAL: 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).	Drug: placebo for risankizumab; Placebo for risankizumab pre-filled syringe, administered by subcutaneous (SC) injection; Drug: risankizumab; Risankizumab pre-filled syringe, administered by subcutaneous (SC) injection; Other Names: BI 655066; ABBV-066
EXPERIMENTAL: 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).	Drug: risankizumab; Risankizumab pre-filled syringe, administered by subcutaneous (SC) injection; Other Names: BI 655066; ABBV-066

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving PASI90 at Week 52 (Part B)	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 52
Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Part A)	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. Nonresponder imputation (NRI) was used for missing data.	Week 16
Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52 (Part B)	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. Nonresponder imputation (NRI) was used for missing data.	Week 52
Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) 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. 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. Nonresponder imputation (NRI) was used for missing data.	Week 16
Percentage of Participants Achieving PASI75 at Week 52 (Part B)	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. Nonresponder imputation (NRI) was used for missing data.	Week 52
Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) 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. 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. Nonresponder imputation (NRI) was used for missing data.	Week 16
Percentage of Participants Achieving PASI100 at Week 52 (Part B)	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. Nonresponder imputation (NRI) was used for missing data.	Week 52
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)	Response defined by ACR20 criteria (improvement from baseline): ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: Patient assessment of pain; Patient global assessment of disease activity; Investigator's global assessment of disease activity; Health Assessment Questionnaire Disability Index (HAQ-DI); and Acute phase reactant value (C-reactive protein). Nonresponder imputation (NRI) was used for missing data.	Week 16
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)	Response defined by ACR20 criteria (improvement from baseline): ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: Patient assessment of pain; Patient global assessment of disease activity; Investigator's global assessment of disease activity; Health Assessment Questionnaire Disability Index (HAQ-DI); and Acute phase reactant value (C-reactive protein). Nonresponder imputation (NRI) was used for missing data.	Week 52

Collaborators and Investigators

• Sponsor: AbbVie
• Collaborators: Boehringer Ingelheim

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 2, 2016
• Primary Completion (ACTUAL): September 21, 2017
• Study Completion (ACTUAL): June 20, 2018

Study Registration Dates

• First Submitted: December 19, 2016
• First Submitted That Met QC Criteria: December 19, 2016
• First Posted (ESTIMATE): December 21, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 21, 2019
• Last Update Submitted That Met QC Criteria: May 7, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: ABBV-066; BI 655066; risankizumab
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Immunologic Factors; Antibodies, Monoclonal
• Other Study ID Numbers: M16-004; 1311.38 (OTHER: Boehringer Ingelheim)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No