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

PHASE4CompletedINTERVENTIONAL
Enrollment

190

Participants

Timeline

Start Date

September 4, 2019

Primary Completion Date

February 16, 2022

Study Completion Date

February 16, 2022

Conditions
Plaque Psoriasis
Interventions
DRUG

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.

DRUG

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.

DRUG

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.

Trial Locations (3)

Unknown

Investigator Site 3, Augsburg

Investigator Site 1, Bristol

Investigator Site 2, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Almirall, S.A.

INDUSTRY