NCT04102007

A Study of the Safety and Efficacy of Risankizumab in Adult Participants With Plaque Psoriasis Who Have Had a Suboptimal Response to Secukinumab or Ixekizumab

A Phase 3b, Multicenter, Interventional, Open-label Study of Adult Subjects With Moderate to Severe Plaque Psoriasis Who Have a Suboptimal Response to Secukinumab or Ixekizumab and Are Switched to Risankizumab

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 244 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate whether adult participants with moderate to severe plaque psoriasis who have been treated with secukinumab or ixekizumab for at least 6 months and are experiencing a suboptimal response may benefit from switching to risankizumab with regard to skin symptoms, quality of life symptoms and psoriasis symptoms. Study duration will last for up to 64 weeks with risankizumab given by subcutaneous injection at Week 0, Week 4, and then every 12 weeks for 52 Weeks (With the last dose being administered at Week 40). An additional visit will occur at Week 8 for a physical exam and questionnaire collection. A final follow-up phone call will occur at Week 60.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	Risankizumab	Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS).

Timeline

• Start date: 2019-11-12
• Primary completion: 2022-01-17
• Completion: 2022-11-07
• First posted: 2019-09-25
• Last updated: 2023-11-27
• Results posted: 2023-03-21

Locations

57 sites across 8 countries: United States, Australia, Germany, Israel, Italy, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study