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

AbbVie

Status and phase: Completed; Phase 3

Conditions: Psoriasis

Treatments: Drug: placebo for ustekinumab; Drug: risankizumab; Drug: placebo for risankizumab; Drug: ustekinumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02684370

2014-005117-23 (EudraCT Number)

1311.3 (Other Identifier)

M16-008

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 560 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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®).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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560 participants in 3 patient groups, including a placebo group

Placebo (Part A)

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo for risankizumab

Drug: placebo for ustekinumab

Ustekinumab (Part A)

Active Comparator group

Description:

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).

Treatment:

Drug: ustekinumab

Drug: placebo for risankizumab

Risankizumab (Part A)

Experimental group

Description:

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

Treatment:

Drug: risankizumab

Drug: placebo for ustekinumab