A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 60 Weeks of Treatment With a Withdrawal and Retreatment Period
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Takeda
- Study ID
- NCT06108544
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- TAK-279 — DRUGSpecified drug on specified days.
- Placebo — DRUGSpecified drug on specified days.
- Apremilast — DRUGSpecified drug on specified days.
Study Details
The main aim of this study is to show how well TAK-279 reduces the skin plaques compared to placebo, in participants with moderate-to-severe plaque psoriasis. Participants will be assigned to one of the 3 study treatments (TAK-279, apremilast (an approved treatment), or a placebo). Participants will be in the study for up to 69 weeks.
Key Dates
- Start date
- Nov 6, 2023
- Status verified
- Nov 2025
- Primary completion
- Dec 6, 2024
- Completion
- Nov 7, 2025
Study Design
- Enrollment
- 1,108 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: TAK-279
- Placebo Comparator: Placebo
- Active Comparator: Apremilast
Primary Outcome Measure
Percentage of Participants Achieving a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 16 Comparing TAK-279 Against Placebo [ Time Frame: Baseline, Week 16 ]
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