drugset / Trial / NCT03255382
A Study to Assess the Efficacy of Risankizumab Compared to FUMADERM® in Subjects With Moderate to Severe Plaque Psoriasis Who Are Naïve to and Candidates for Systemic Therapy
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to compare the efficacy and safety of subcutaneous (SC) risankizumab and oral FUMADERM provided as study medication in participants with moderate to severe plaque psoriasis who are naïve to and candidates for systemic therapy.
Timeline
- Start
- 2017-08-22
- Primary completion
- 2018-07-06
- Completion
- 2018-07-06
Outcome
Met primary endpoint
registry analysis (other test); Fumaderm vs Risankizumab; p < 0.001; Adjusted percentage difference 73.3 (95% CI 61.3 to 85.3); Cochran-Mantel-Haenszel NCT03255382 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fumaderm | Unknown | 240 mg | Oral |
| Subject | Risankizumab | Monoclonal antibody | 150 mg | Subcutaneous |