NCT03875508

A Study to Assess Usability of Risankizumab Autoinjector Combination Product in Participants With Moderate to Severe Plaque Psoriasis

Plaque Psoriasis: Usability of the Risankizumab Autoinjector Combination Product in Adults With Moderate to Severe Psoriasis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study were to evaluate the usability of the combination product of risankizumab in an autoinjector (AI), as well as to evaluate the efficacy, safety, and tolerability of risankizumab administered by AI for the treatment of adult participants with moderate to severe plaque psoriasis.

Detailed description

This was a Phase 3 multicenter, single-arm, open-label study that evaluated usability and efficacy of the risankizumab-AI combination product. The study included a 30-day screening period with study visits at Weeks 0, 4, 16, 28, and 40 with a subsequent follow-up telephone call at approximately 20 weeks after the last dose of study drug (Week 48). Study drug dosing consisted of 4 self-administered doses given subcutaneously on Weeks 0, 4, 16, and 28. Dosing on Weeks 4 and 16 was self-administered at home.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	Risankizumab	Risankizumab to be injected subcutaneously (SC)
DEVICE	Autoinjector	Single dose pre-filled autoinjector containing risankizumab for SC injection

Timeline

• Start date: 2019-06-04
• Primary completion: 2020-04-24
• Completion: 2020-08-25
• First posted: 2019-03-14
• Last updated: 2021-05-11
• Results posted: 2021-05-11

Locations

26 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study