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

NCT03255382 ↗

Phase 3 Completed 120 enrolled AbbVie
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

EvaluationDrugModalityDoseRoute
Comparator Fumaderm Unknown 240 mg Oral
Subject Risankizumab Monoclonal antibody 150 mg Subcutaneous

Indications