CompletedPhase 3

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

United States1,108 participantsStarted 2023-11-06

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Plaque psoriasis for at least 6 months.
✓. Moderate to severe disease.
✓. Candidate for phototherapy or systemic therapy.

Exclusion criteria

✕. Other forms of psoriasis.
✕. History of recent infection.
✕. Prior exposure to TAK-279 or active comparator.

What they're measuring

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

Timeframe: Baseline, Week 16

Percentage of Participants Achieving ≥75% Improvement from Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 16 Comparing TAK-279 Against Placebo

Timeframe: Baseline, Week 16

Trial details

NCT IDNCT06108544

SponsorTakeda

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-06

View on ClinicalTrials.gov More Plaque Psoriasis trials