A Study Comparing Zasocitinib (TAK-279) With Deucravacitinib in Adults With Plaque Psoriasis (NCT06973291) | Clinical Trial Compass
CompletedPhase 3
A Study Comparing Zasocitinib (TAK-279) With Deucravacitinib in Adults With Plaque Psoriasis
United States606 participantsStarted 2025-07-09
Plain-language summary
The main aim of this study is to assess whether zasocitinib works better than deucravacitinib in treating participants with moderate-to-severe plaque psoriasis.
Participants will take one tablet daily of either zasocitinib or a matching placebo, along with one capsule daily of either over-encapsulated deucravacitinib or a matching placebo, for a duration of 16 weeks.
Participants will be in the study for up to 25 weeks, which includes screening period of up to 35 days, a 16-week treatment period, and a 4-week safety follow-up period.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Participant has a diagnosis of chronic plaque psoriasis for \>=6 months prior to the screening visit.
✓. Participant has stable plaque psoriasis, defined as no significant flare or change in morphology (as assessed by the investigator) in psoriasis, for \>=6 months before screening.
✓. Participant has moderate-to-severe plaque psoriasis, as defined by a PASI score \>=12 and an sPGA score \>=3, at screening and Day 1.
✓. Participant has plaque psoriasis covering \>=10 percent (%) of his or her total body surface area (BSA) at screening and Day 1.
✓. Participant must be a candidate for phototherapy or systemic therapy.
Exclusion criteria
✕. Participant has evidence of nonplaque psoriasis (erythrodermic, pustular, predominantly guttate psoriasis, predominantly inverse, or drug-induced psoriasis). If a participant meets criteria for inclusion based on typical plaque psoriasis presentation, a limited amount of inverse psoriasis is not exclusionary.
✕. Participant requires systemic treatment, other than nonsteroidal anti-inflammatory drugs, during the trial period for an immune related disease (for example, inflammatory bowel disease).
✕. Participant has a history of excessive sun exposure, has used tanning booths within 4 weeks prior to Day 1, or is not willing to minimize natural and artificial sunlight exposure during the trial period. Use of sunscreen products and protective apparel is recommended when sun exposure cannot be avoided.
✕. Participant has concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the trial assessments.
What they're measuring
1
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI)-100 at Week 16
✕. Participant has history of active TB infection, regardless of treatment status.
✕. Participant has signs or symptoms of active TB (including, but not limited to, chronic fever, chronic productive cough, night sweats, or weight loss) as judged by the investigator.
✕. Participant has evidence of latent TB infection (LTBI) as evidenced by a positive QuantiFERON-TB Gold (QFT) result OR 2 indeterminate QFT results, and participant does not have documentation of appropriate LTBI prophylaxis or is not able or not willing to initiate appropriate LTBI prophylaxis.