190
Participants
Start Date
September 4, 2019
Primary Completion Date
February 16, 2022
Study Completion Date
February 16, 2022
Dimethyl fumarate (DMF) standard scheme
Participants will receive DMF gastro-resistant tablet orally from baseline to Week 16, at a dose of 30 milligrams (mg) once daily, twice daily, thrice daily in Week 1, Week 2, Week 3 respectively, 120 mg only once in Week 4. Participants will increase DMF dose by 120 mg tablet per week for the subsequent 5 weeks. Participants achieving Psoriasis area and severity Index (PASI) 50-75 (partial responder) or 75 (responder) will continue the DMF treatment until Week 40. The maximum daily dose taken by a participant will be 720 mg.
Dimethyl fumarate (DMF) simplified scheme
Participants will receive DMF gastro-resistant tablet orally at a dose of 60, 120, 180, 240, 360 mg daily in Week 1, Week 2, Week 3, Week 4, Week 5 respectively, and 480 mg daily from Week 6 to Week 8. If a PASI is greater than or equal to (\>=) 30% at Week 8, no dose increase will be done and if PASI is less than (\<) 30% at Week 8, participants will receive 600 mg daily in Week 9 and 720 mg from the Week 10 onwards.
Tildrakizumab
Participants who achieve PASI less than (\<) 50 (non-responders) at Week 16 will receive Tildrakizumab subcutaneous injection at a dose of either 100 or 200 mg \[(as per the Summary of Product Characteristics (SmPC)\] at Weeks 16, 20 and 32 up to Week 40.
Investigator Site 3, Augsburg
Investigator Site 1, Bristol
Investigator Site 2, London
Lead Sponsor
Almirall, S.A.
INDUSTRY