NCT03875482

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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Risankizumab Using a New Formulation for the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 157 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	Risankizumab	Risankizumab 150 mg (150 mg/mL) in prefilled syringes, self-administered subcutaneously
DRUG	Placebo solution for risankizumab	Placebo solution in prefilled syringes, self-administered subcutaneously

Timeline

• Start date: 2019-05-13
• Primary completion: 2020-02-20
• Completion: 2020-07-15
• First posted: 2019-03-14
• Last updated: 2021-03-16
• Results posted: 2021-03-16

Locations

43 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study