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
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- AbbVie
- Study ID
- NCT04102007
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Risankizumab — DRUGRisankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS).
Study Details
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.
Key Dates
- Start date
- Nov 12, 2019
- Status verified
- Nov 2023
- Primary completion
- Jan 17, 2022
- Completion
- Nov 7, 2022
Study Design
- Enrollment
- 244 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Other: RisankizumabParticipants receive Risankizumab following suboptimal response to secukinumab or ixekizumab
Primary Outcome Measure
Proportion of Participants Achieving Static Physician Global Assessment (sPGA) 0/1 [ Time Frame: At Week 16 ]
Locations (20)
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