A Study to Assess Safety and Efficacy of Risankizumab Using a New Formulation in Participants With Moderate to Severe Plaque Psoriasis

AbbVie

Status and phase: Completed; Phase 3

Conditions: Psoriasis

Treatments: Drug: Placebo solution for risankizumab; Drug: Risankizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03875482

M15-999

Details and patient eligibility

About

The primary objective of this study was to evaluate the safety and efficacy of risankizumab (150 mg/mL) administered by prefilled syringe (PFS) for the treatment of adult participants with moderate to severe plaque psoriasis.

Full description

This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of risankizumab 150 mg/mL formulation in PFS in adult participants with moderate to severe plaque psoriasis. The study included a 30-day screening period, a 28-week treatment period with study visits at Weeks 0, 4, 16 and 28, and a subsequent follow-up telephone call at approximately 20 weeks after the last dose of study drug. Study drug dosing consisted of 3 self-administered, subcutaneous (SC) doses on Weeks 0, 4, and 16. Dosing on Week 4 was self-administered at home.

Enrollment: 157 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant has diagnosis of chronic plaque psoriasis for at least 6 months before the baseline visit.
• Participant meets following disease activity criteria:
• Stable moderate to severe chronic plaque psoriasis, defined as greater than or equal to 10% body surface area (BSA) psoriasis involvement, static physician global assessment (sPGA) score of greater than or equal to 3, and Psoriasis Area Severity Index (PASI) greater than or equal to 12 at Screening and baseline visit.
• Candidate for systemic therapy as assessed by the investigator.

Exclusion criteria

• Participant has history of active skin disease other than psoriasis that could interfere with the assessment of psoriasis.
• Participant has history of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis.
• Participant has previous exposure to risankizumab.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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157 participants in 2 patient groups, including a placebo group

Risankizumab

Experimental group

Description:

Subcutaneous (SC), self-administered 150 mg doses of risankizumab at Weeks 0, 4, and 16

Treatment:

Drug: Risankizumab

Placebo

Placebo Comparator group

Description:

Subcutaneous (SC), self-administered doses of placebo solution at Weeks 0, 4, and 16

Treatment:

Drug: Placebo solution for risankizumab