A Study Comparing Zasocitinib (TAK-279) With Deucravacitinib in Adults With Plaque Psoriasis

Completed · Phase 3 · Has a placebo group

Conditions studied: Plaque Psoriasis

In brief

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.

Key facts

Study ID

NCT06973291

Run by

Takeda

People needed

606

Starts

2025-07-09

Expected to finish

2026-04-22

Last updated by the study team

2026-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Target Disease-Related Exclusions:
• 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.
• Recent/Concurrent Infectious Disease Exclusions:
• Tuberculosis (TB):
• 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.
• Participant has had any imaging trial during or 6 months prior to screening, including x-ray, chest computed tomography, Magnetic Resonance Imaging (MRI), or other chest imaging suggesting evidence of current active or a history of active TB. X-ray is required for all participants regardless of QFT results unless the participant has had normal chest imaging in the 6 months prior to screening.
• Herpes infections:
• Participant has active herpes virus infection, including herpes zoster or herpes simplex 1 and 2 (demonstrated on physical examination and/or medical history) at screening or Day 1.
• Participant has history of serious herpetic infection that includes any episode of disseminated disease, multidermatomal herpes zoster, herpes encephalitis, ophthalmic herpes, or recurrent herpes zoster (defined as 2 episodes within 2 years).
• Nonherpetic viral diseases:
• Participant has presence of Hepatitis C Virus (HCV) antibody and a positive confirmatory test result for HCV ribonucleic Acid (RNA) (nucleic acid test or Polymerase Chain Reaction [PCR]).
• Participant has presence of positive Hepatitis B Surface Antigen (HBsAg+), or indeterminate HBsAg, presence of HBV deoxyribonucleic Acid (DNA) (regardless of serology), or positive anti-hepatitis B core antibody without concurrent positive hepatitis B surface antibody (Hepatitis B Core Antibody [HBcAb] positive and Hepatitis B Surface Antibody [HBsAb] negative).
• Participant has positive results for Human Immunodeficiency Virus (HIV) by serology, regardless of viral load.
• Other infectious diseases:
• Participant has a history of active infection or febrile illness within 7 days prior to Day 1, as assessed by the investigator.
• Participant has history of symptoms suggestive of systemic or invasive infection within 30 days prior to Day 1.
• Participant has history of bacterial, viral, or fungal infection that required hospitalization or treatment with intravenous antimicrobial therapy within 8 weeks prior to Day 1 or oral antimicrobial therapy within 30 days prior to Day 1.
• Participant has a history of chronic or recurrent bacterial disease, including but not limited to chronic pyelonephritis or cystitis, chronic bronchitis/pneumonitis, osteomyelitis, or chronic skin ulcerations/infections or fungal infections (except superficial onychomycosis).
• Participant has a history of an infected joint prosthesis, unless that prosthesis has been removed or replaced at least 60 days prior to Day 1.
• Participant has a history of opportunistic infections (for example, Pneumocystis jirovecii pneumonia, histoplasmosis, coccidiomycosis).

Where it is running

• Burke Pharmaceutical Research — Hot Springs, Arkansas, United States
• Zenith Research, Inc. — Beverly Hills, California, United States
• First OC Dermatology Research Inc. — Fountain Valley, California, United States
• UNISON Clinical Trials (Shahram Jacobs md inc.) — Sherman Oaks, California, United States
• Central Connecticut Dermatology, PLLC — Cromwell, Connecticut, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Direct Helpers Research Center — Hialeah, Florida, United States
• San Marcus Research Clinic Inc — Miami Lakes, Florida, United States
• Advanced Clinical Research Institute — Tampa, Florida, United States
• Arlington Dermatology — Rolling Meadows, Illinois, United States
• Endeavor Health Clinical Trials — Skokie, Illinois, United States
• Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States
• Lawrence J Green, MD LLC — Rockville, Maryland, United States
• Henry Ford Health System — Detroit, Michigan, United States
• JDR Dermatology Research, LLC — Las Vegas, Nevada, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Markowitz Medical PLLC dba OptiSkin Medical — New York, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Bexley Dermatology Research - Probity - PPDS — Bexley, Ohio, United States
• Apex Clinical Research Center, LLC - Canton — Canton, Ohio, United States
• Apex Clinical Research Center, LLC - Mayfield Heights — Mayfield Heights, Ohio, United States
• UPMC Department of Dermatology — Pittsburgh, Pennsylvania, United States
• Goodlettsville Dermatology Research — Goodlettsville, Tennessee, United States
• Arlington Research Center — Arlington, Texas, United States
• Johnson Dermatology — Fort Smith, Arkansas, United States

Full record on ClinicalTrials.gov

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