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Clinical trial

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

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Last updated:6th Oct 2019
Identifier: NCT04102007

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. An additional visit will occur at Week 8 for a physical exam and questionnaire collection. A follow-up phone call will occur at Week 60.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 250 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date: October 7, 2019
Estimated Primary Completion Date: December 13, 2020
Estimated Study Completion Date: August 22, 2021

Arm:
- Risankizumab

Category Value
Date last updated at source 2019-09-25
Study type(s) Interventional
Expected enrolment 250
Study start date 2019-10-07
Estimated primary completion date 2020-12-13

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