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

AbbVie

Status and phase: Completed; Phase 2

Conditions: Psoriasis

Treatments: Drug: placebo for risankizumab; Drug: risankizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03000075

M16-004

1311.38 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 182 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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182 participants in 3 patient groups, including a placebo group

Placebo (Part A)

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo for risankizumab

Risankizumab 75 mg (Part A)

Experimental group

Description:

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

Treatment:

Drug: risankizumab

Drug: placebo for risankizumab

Risankizumab 150 mg (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