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

Almirall

Status and phase: Completed; Phase 4

Conditions: Plaque Psoriasis

Treatments: Drug: Dimethyl fumarate (DMF) standard scheme; Drug: Tildrakizumab; Drug: Dimethyl fumarate (DMF) simplified scheme

Study type: Interventional

Funder types: Industry

Identifiers

NCT04263610

M-14745-41

2019-000817-35 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 190 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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190 participants in 3 patient groups

Non-Germany: Dimethyl fumarate standard scheme

Experimental group

Description:

Part 1: Participants will receive Dimethyl fumarate (DMF) standard scheme from baseline to Week 16. Part 2: Participants achieving a Psoriasis Area and Severity Index (PASI) 75 response (responders) and participants failing to achieve a PASI 75 response but having achieved a PASI 50 response (partial responders) at Week 16 will continue with DMF treatment until Week 40. Participants failing to achieve a PASI 50 response (non-responders) at Week 16 will be treated with Tildrakizumab until Week 40.

Treatment:

Drug: Tildrakizumab

Drug: Dimethyl fumarate (DMF) standard scheme

Germany: Dimethyl fumarate standard scheme

Experimental group

Description:

Part 1: Participants will receive DMF standard scheme from Baseline to Week 16. Part 2: Participants achieving a PASI 75 response (responders) and participants failing to achieve a PASI 75 response but having achieved a PASI 50 response (partial responders) at Week 16 will continue with DMF treatment until Week 40. Participants failing to achieve a PASI 50 response (non-responders) at Week 16 will be treated with Tildrakizumab until Week 40.

Treatment:

Drug: Tildrakizumab

Drug: Dimethyl fumarate (DMF) standard scheme

Germany: Dimethyl fumarate simplified scheme

Experimental group

Description:

Part 1: Participants will receive DMF simplified scheme from Baseline to Week 16. Part 2: Participants achieving a PASI 75 response (responders) and participants failing to achieve a PASI 75 response but having achieved a PASI 50 response (partial responders) at Week 16 will continue with DMF treatment until Week 40. Participants failing to achieve a PASI 50 response (non-responders) at Week 16 will be treated with Tildrakizumab until Week 40.

Treatment:

Drug: Tildrakizumab

Drug: Dimethyl fumarate (DMF) simplified scheme