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

• Status: Active, not recruiting
• Trial end date: 2022-02-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Almirall, S.A.
• Treatments: Antibodies, Monoclonal; Dimethyl Fumarate

Criteria

Inclusion Criteria:

• Provide signed written and dated informed consent given before any study related activity is performed

• Participants with at least 6 months history of chronic plaque psoriasis

• Participants diagnosed with moderate-to-severe plaque psoriasis at the Screening Visit

• Candidate for systemic treatment for plaque psoriasis at the Screening Visit

Exclusion Criteria:

• Women currently pregnant, or intend to become pregnant or breastfeeding. Unwillingness/inability for the participants (women or men) to use appropriate measures of contraception (if necessary)

• Other forms of psoriasis than chronic plaque-type

• Participants with drug-induced psoriasis at the Screening Visit

• Participants with history or evidence of skin disease or conditions other than chronic plaque-type psoriasis

• Participants with history of hypersensitivity or allergy to the study drugs

• Concurrent malignancy, current relevant autoimmune diseases other than psoriasis

• Participants with severe renal impairment, haematological abnormality and abnormal liver enzymes at the Screening visit

• Active infectious disease at the Screening Visit

• Participants positive test for human immunodeficiency virus or any other immunosuppressive disease

• Previous exposure to fumarate-based drug or a biologic systemic treatment

• Live vaccination within 4 weeks prior to the Baseline Visit

• Participant who intend to use any concomitant medication with immunomodulating or systemic corticosteroids

• Unable to comply with the requirements of the study or who in the opinion of the study physician should not participate in the study