BI 655066 (Risankizumab) Compared to Placebo and Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

560 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-09-30

Brief Summary

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The purpose of this study is to assess the safety and efficacy of BI 655066/ABBV-066 (risankizumab) for the treatment of moderate to severe chronic plaque psoriasis in adult patients.

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Detailed Description

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Participants were randomized to receive either placebo, ustekinumab, or risankizumab in Part A. All participants received 2 sets of injections to maintain the blind: the placebo arm received placebo for risankizumab and placebo for ustekinumab), the risankizumab arm received risankizumab and placebo for ustekinumab, and the ustekinumab arm received ustekinumab and placebo for risankizumab. Participants who received placebo in Part A switched to risankizumab in Part B; participants who received ustekinumab or risankizumab in Part A continued to receive the same treatment (ustekinumab or risankizumab) in Part B.

Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo (Part A)

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

Group Type PLACEBO_COMPARATOR

placebo for risankizumab

Intervention Type DRUG

Placebo for risankizumab administered by subcutaneous (SC) injection

placebo for ustekinumab

Intervention Type DRUG

Placebo for ustekinumab administered by subcutaneous (SC) injection

Ustekinumab (Part A)

Participants randomized to receive double-blind (DB) ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).

Group Type ACTIVE_COMPARATOR

placebo for risankizumab

Intervention Type DRUG

Placebo for risankizumab administered by subcutaneous (SC) injection

ustekinumab

Intervention Type DRUG

Ustekinumab administered by subcutaneous (SC) injection

Risankizumab (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 administered by subcutaneous (SC) injection

placebo for ustekinumab

Intervention Type DRUG

Placebo for ustekinumab administered by subcutaneous (SC) injection

Interventions

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risankizumab

Risankizumab administered by subcutaneous (SC) injection

Intervention Type DRUG

placebo for risankizumab

Placebo for risankizumab administered by subcutaneous (SC) injection

Intervention Type DRUG

ustekinumab

Ustekinumab administered by subcutaneous (SC) injection

Intervention Type DRUG

placebo for ustekinumab

Placebo for ustekinumab administered by subcutaneous (SC) injection

Intervention Type DRUG

Other Intervention Names

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ABBV-066 BI 655066 SKYRIZI

Eligibility Criteria

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Inclusion Criteria

* Male or female patients with age ≥18 years at screening.
* Have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of study drug.
* 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.
* Must be candidates for systemic therapy or phototherapy for psoriasis treatment, as assessed by the investigator.
* Must be a candidate for treatment with Stelara® (ustekinumab) according to local label.

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.
* Previous exposure to ustekinumab (Stelara®).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No