Clinical trial NCT04263610: Efficacy and Safety of Tildrakizumab in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Who Are Non-Responders to Dimethyl Fumarate Therapy
Official title: An Open-Label, Randomised, Phase IV Study, to Assess the Efficacy and Safety of Tildrakizumab in Patients With Moderate-to-Severe Chronic Plaque Psoriasis Who Are Non-Responders to Dimethyl Fumarate Therapy (TRANSITION)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Plaque Psoriasis
Keywords: Dimethyl fumarate
Tildrakizumab
Moderate-to-severe plaque psoriasis
Chronic Plaque Psoriasis
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
First posted: 2020-02-11
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Part 2: Percentage of Participants Achieving a Psoriasis Area Severity Index 75 (PASI 75) after Tildrakizumab Treatment at Week 40
timeFrame: Week 40
Secondary outcomes:
measure: Part 1 and Part 2: Percentage of Participants Achieving PASI 50, PASI 75, PASI 90 and PASI 100 (Only for Part 2) Responses
timeFrame: Part 1: Weeks 8 and 16; Part 2: DMF: Weeks 24, 36 and 40, Tildrakizumab: Weeks 20, 32 and 40
measure: Part 1 and Part 2: Percentage of Participants Achieving an Absolute Psoriasis Area and Severity Index (PASI) Score Less Than or Equal to (<=) 5, 3 and 1
timeFrame: Part 1: Weeks 8 and 16; Part 2: DMF: Weeks 24, 36 and 40, Tildrakizumab: Weeks 20, 32 and 40
measure: Part 1 and Part 2: Absolute Psoriasis Area Severity Index (PASI) Score
timeFrame: Part 1: Weeks 8 and 16; Part 2: DMF: Weeks 24, 36 and 40, Tildrakizumab: Weeks 20, 32 and 40
measure: Part 1 and Part 2: Change from Baseline in Absolute Psoriasis Area and Severity Index (PASI) Score
timeFrame: Part 1: Baseline, Weeks 8 and 16; Part 2: DMF: Baseline, Weeks 24, 36 and 40, Tildrakizumab: Baseline, Weeks 20, 32 and 40
measure: Part 1 and Part 2: Absolute Body Surface Area (BSA) Score
timeFrame: Part 1: Weeks 8 and 16; Part 2: DMF: Weeks 24, 36 and 40, Tildrakizumab: Weeks 20, 32 and 40
measure: Part 1 and Part 2: Change from Baseline in Absolute Body Surface Area (BSA) Score
timeFrame: Part 1: Baseline, Weeks 8 and 16; Part 2: DMF: Baseline, Weeks 24, 36 and 40, Tildrakizumab: Baseline, Weeks 20, 32 and 40
measure: Part 1 and Part 2: Percentage of Participants Achieving Physician Global Assessment (PGA) Score of 0 or 1
timeFrame: Part 1: Weeks 8 and 16; Part 2: DMF: Weeks 24, 36 and 40, Tildrakizumab: Weeks 20, 32 and 40
measure: Part 1 and Part 2: Percentage of Participants Achieving Scalp Physician Global Assessment (scPGA) Score of 0 or 1
timeFrame: Part 1: Weeks 8 and 16; Part 2: DMF: Weeks 24, 36 and 40, Tildrakizumab: Weeks 20, 32 and 40
measure: Part 1 and Part 2: Percentage of Participants Achieving Palmoplantar Physician's Global Assessment (PPPGA) Score of 0 or 1
timeFrame: Part 1: Weeks 8 and 16; Part 2: DMF: Weeks 24, 36 and 40, Tildrakizumab: Weeks 20, 32 and 40
measure: Part 1 and Part 2: Absolute Physician Global Assessment (PGA) Score
timeFrame: Part 1: Weeks 8 and 16; Part 2: DMF: Weeks 24, 36 and 40, Tildrakizumab: Weeks 20, 32 and 40
measure: Part 1 and Part 2: Absolute Scalp Physician Global Assessment (scPGA) Score
timeFrame: Part 1: Weeks 8 and 16; Part 2: DMF: Weeks 24, 36 and 40, Tildrakizumab: Weeks 20, 32 and 40
measure: Part 1 and Part 2: Absolute Palmoplantar Physician's Global Assessment (PPPGA) Score
timeFrame: Part 1: Weeks 8 and 16; Part 2: DMF: Weeks 24, 36 and 40, Tildrakizumab: Weeks 20, 32 and 40
measure: Part 1 and Part 2: Change from Baseline in Absolute Physician Global Assessment (PGA) Score
timeFrame: Part 1: Baseline, Weeks 8 and 16; Part 2: DMF: Baseline, Weeks 24, 36 and 40, Tildrakizumab: Baseline, Weeks 20, 32 and 40
measure: Part 1 and Part 2: Change from Baseline in Absolute Scalp Physician Global Assessment (scPGA) Score
timeFrame: Part 1: Baseline, Weeks 8 and 16; Part 2: DMF: Baseline, Weeks 24, 36 and 40, Tildrakizumab: Baseline, Weeks 20, 32 and 40
measure: Part 1 and Part 2: Change from Baseline in Absolute Palmoplantar Physician's Global Assessment (PPPGA) Score
timeFrame: Part 1: Baseline, Weeks 8 and 16; Part 2: DMF: Baseline, Weeks 24, 36 and 40, Tildrakizumab: Baseline, Weeks 20, 32 and 40
measure: Part 1 and Part 2: Percentage of Participants Achieving Dermatology Quality of Life Index (DLQI) Score of 0 or 1
timeFrame: Part 1: Weeks 8 and 16; Part 2: Weeks 32 and 40
measure: Part 1 and Part 2: Absolute Dermatology Quality of Life Index (DLQI) Score
timeFrame: Part 1: Weeks 8 and 16; Part 2: Weeks 32 and 40
measure: Part 1 and Part 2: Change from Baseline in Absolute Dermatology Quality of Life Index (DLQI) Score
timeFrame: Part 1: Baseline, Weeks 8 and 16; Part 2: Baseline, Weeks 32 and 40
measure: Part 1 and Part 2: Absolute Skindex-16 Score
timeFrame: Part 1: Weeks 8 and 16; Part 2: Weeks 32 and 40
measure: Part 1 and Part 2: Change from Baseline in Absolute Skindex-16 Score
timeFrame: Part 1: Baseline, Weeks 8 and 16; Part 2: Baseline, Weeks 32 and 40
measure: Part 1 and Part 2: Absolute Pruritus-Visual Analogue Scale (VAS) Score
timeFrame: Part 1: Weeks 8 and 16; Part 2: DMF: Weeks 24, 36 and 40, Tildrakizumab: Weeks 20, 32 and 40
measure: Part 1 and Part 2: Change from Baseline in Absolute Pruritus-Visual Analogue Scale (VAS) Score
timeFrame: Part 1: Baseline, Weeks 8 and 16; Part 2: Baseline, DMF: Weeks 24, 36 and 40, Tildrakizumab: Baseline, Weeks 20, 32 and 40
measure: Part 1 and Part 2: Absolute Medical Outcomes Study (MOS) Score
timeFrame: Part 1: Week 16; Part 2: Week 40
measure: Part 1 and Part 2: Change from Baseline in Absolute Medical Outcomes Study (MOS) Score
timeFrame: Part 1: Baseline, Week 16; Part 2: Baseline, Week 40
measure: Part 2: Percent Change from Baseline in Absolute Psoriasis Area Severity Index (PASI) Score
timeFrame: DMF: Baseline, Weeks 24, 36 and 40, Tildrakizumab: Baseline, Weeks 20, 32 and 40
measure: Part 2: Percent Change from Baseline in Absolute Physician Global Assessment (PGA) Score
timeFrame: DMF: Baseline, Weeks 24, 36 and 40, Tildrakizumab: Baseline, Weeks 20, 32 and 40
measure: Part 2: Percent Change from Baseline in Absolute Scalp Physician Global Assessment (scPGA) Score
timeFrame: DMF: Baseline, Weeks 24, 36 and 40, Tildrakizumab: Baseline, Weeks 20, 32 and 40
measure: Part 2: Percent Change from Baseline in Absolute Palmoplantar Physician's Global Assessment (PPPGA) Score
timeFrame: DMF: Baseline, Weeks 24, 36 and 40, Tildrakizumab: Baseline, Weeks 20, 32 and 40
measure: Part 2: Percent Change from Baseline in Absolute Dermatology Quality of Life Index (DLQI) Score
timeFrame: Baseline, Weeks 32 and 40
measure: Part 2: Percent Change from Baseline in Absolute Skindex-16 Score
timeFrame: Baseline, Weeks 32 and 40
measure: Part 2: Percent Change from Baseline in Absolute Pruritus-Visual Analogue Scale (VAS) Score
timeFrame: DMF: Baseline, Weeks 24, 36 and 40, Tildrakizumab: Baseline, Weeks 20, 32 and 40
measure: Part 2: Percent Change from Baseline in Absolute Medical Outcomes Study (MOS) Score
timeFrame: Baseline, Week 40
measure: Part 2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From start of study drug administration up to Week 49
measure: Percentage of Participants Withdrawing from Trial
timeFrame: From start of study drug administration up to Week 49
measure: Number of Participants with Treatment Compliance
timeFrame: From start of study drug administration up to Week 49
measure: Percentage of Participants Using Topical Corticosteroids (TCS)
timeFrame: Part 1: Baseline up to Week 14; Part 2: Week 20 to Week 40
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Investigator Site 3
city: Bristol
country: United Kingdom
facility: Investigator Site 1
city: London
country: United Kingdom
facility: Investigator Site 2
Study officials:
affiliation: Almirall, SAS
name: Study Director
role: STUDY_DIRECTOR
References: