drugset
drugset / Trial / NCT04263610

Efficacy and Safety of Tildrakizumab in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Who Are Non-Responders to Dimethyl Fumarate Therapy

NCT04263610 ↗

Phase 4 Completed 190 enrolled Almirall, S.A.
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the efficacy, safety and tolerability of Tildrakizumab in moderate-to-severe plaque psoriasis participants who are non-responder to Dimethyl fumarate (DMF) at Week 16. The study consists of two parts. Part 1 will include the first 16 weeks of the Treatment Period and Part 2 will include the last 24 weeks of the Treatment Period.

Timeline

Start
2019-09-04
Primary completion
2022-02-16
Completion
2022-02-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Tildrakizumab Monoclonal antibody 100 mg Subcutaneous
Subject Tildrakizumab Monoclonal antibody 200 mg Subcutaneous
Subject dimethyl fumarate Unknown 480 mg Oral
Subject dimethyl fumarate Unknown 720 mg Oral

Indications

psoriasis