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Plaque PsoriasisPhase 3NCT06973291

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

A Phase 3 study testing Zasocitinib and Deucravacitinib in people with Plaque Psoriasis, run by Takeda at 113 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Plaque Psoriasis
What is being tested?
Zasocitinib and Deucravacitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
606 participants
Where
113 sitesin 8 countries
Study dates
9 Jul 2025to 22 Apr 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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:
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  • 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).
  • Participant had a bacterial infection within 60 days prior to Day 1 for which he or she did not receive treatment.
  • Noninfectious Disorders Exclusions:
  • Participant has any clinically significant medical condition, evidence of an unstable clinical condition (for example, cardiovascular, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, or immunologic), or vital signs/physical/laboratory/Electrocardiogram (ECG) abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of trial results. These include but are not limited to:
  • Participant has a history of known or suspected condition/illness that is consistent with compromised immunity, including but not limited to any identified congenital or acquired immunodeficiency, splenectomy.
  • Participant had a major surgery within 60 days prior to Day 1 or has a major surgery planned during the trial.
  • Participant has unstable, poorly controlled, or severe hypertension at screening, confirmed by 2 repeat assessments.
  • Participant has a history of Class III or IV congestive heart failure as defined by New York Heart Association criteria.
  • Participant has a history of cancer or lymphoproliferative disease, with the exception of successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix.
  • For participants with asthma, chronic obstructive pulmonary disease, or other pulmonary illnesses, participant has been hospitalized in the past 3 months, has ever required intubation for treatment, currently requires oral corticosteroids, or has required more than 1 course of oral corticosteroids within 6 months prior to Day 1.
  • Participant has any of the following cardiovascular disease history:
  • A new diagnosis of atrial fibrillation or an episode of atrial fibrillation with rapid ventricular response or other dysrhythmia, nonacute cardiac hospitalization (for example, pacemaker implantation), pulmonary embolism, or deep venous thrombosis within the past 6 months prior to screening.
  • Any history of cerebrovascular event, myocardial infarction, coronary stenting, or aorto-coronary bypass surgery. If, however, the investigator determines there are no suitable treatment alternatives available for the participant and it has been at least 6 months since the occurrence of any such event, the participant may enroll.
  • Participant has ECG abnormalities that are considered clinically significant and would pose an unacceptable risk to the participant if he or she participated in the trial, in the opinion of the investigator.
  • Participant has significant/uncontrolled psychiatric illness, in the opinion of the investigator.
  • Participant has a history of clinically significant drug or alcohol abuse within 12 months prior to Day 1.
  • Prohibited Psoriasis Treatments Exclusions:
  • For the below prohibited psoriasis treatments, the washout period prior to Day 1 is within the time frame indicated or 5 half-lives, whichever is longer, regardless of whether they are prescribed for psoriasis or another condition:
  • Participant has received any of the following biologics or biosimilar versions within the time frame indicated:
  • Antibodies to interleukin (IL)-12/-23, IL-17, or IL-23 (for example, ustekinumab, secukinumab, tildrakizumab, ixekizumab, or guselkumab) within 6 months prior to Day 1.
  • Tumor Necrosis Factor (TNF) inhibitor(s) (for example, etanercept, adalimumab, infliximab, or certolizumab) within 2 months prior to Day 1.
  • Agents that modulate integrin pathways to impact lymphocyte trafficking (for example, natalizumab) or agents that modulate B cells or T cells (for example, alemtuzumab, abatacept, or visilizumab) within 3 months prior to Day 1.
  • Rituximab or other immune cell-depleting therapy within 6 months prior to Day 1.
  • Participant has used medicated shampoo and/or body wash, including formulations containing but not limited to salicylic acid, corticosteroids, coal tar, vitamin D3 analogues, or other compounds used for the management of psoriasis within 2 weeks prior to Day 1.
  • Participant has used any topical medication that could affect psoriasis presentation (including but not limited to corticosteroids, salicylic acid, urea, alpha- or beta-hydroxy acids, anthralin, retinoids, vitamin D analogues [such as calcipotriol], methoxsalen, trimethylpsoralen, calcineurin inhibitors [for example, tacrolimus], tapinarof, roflumilast, Janus kinase (JAK) inhibitors, or tar) within 2 weeks prior to Day 1.
  • Participant has used any systemic nonbiologic treatment that could affect psoriasis presentation (including oral, intravenous, intramuscular, intra-articular, intrathecal, or intralesional corticosteroids; oral retinoids; immunosuppressive/immunomodulating medication; methotrexate; azathioprine; 6-thioguanidine; mercaptopurine; mycophenolate mofetil; hydroxyurea; cyclosporine; 1,25-dihydroxyvitamin D3 analogues; psoralens; sulfasalazine; fumaric acid derivatives; JAK inhibitors; apremilast) within 4 weeks prior to Day 1, or 5 half-lives, whichever is longer. Note: Intranasal corticosteroids, inhaled corticosteroids, and eye and ear drops containing corticosteroids are permitted.
  • Participant has used leflunomide within 6 months prior to Day 1.
  • Participant has received phototherapy (including Ultraviolet B [UV B], Psoralen plus Ultraviolet A [PUVA], tanning beds, therapeutic sunbathing) or excimer laser within 4 weeks prior to Day 1.
  • Participant has used botanical preparations (for example, herbal supplements or traditional medicines, including traditional Chinese medicines derived from plants, minerals, or animals) intended to treat psoriasis or other immunological diseases within 4 weeks prior to Day 1.
  • Participant is currently being treated with oral antihistamines for any reason, with the exception of oral antihistamines that are administered at a stable dose for at least 4 weeks prior to Day 1. Note: Additional treatment with oral antihistamines may be permitted after discussion with the medical monitor.
  • Participant has any previous exposure to zasocitinib (also known as TAK-279 or NDI 034858) or other Tyrosine Kinase 2 (TYK2) inhibitors (including deucravacitinib), or participated in any trial that included a TYK2 inhibitor (for example, deucravacitinib, VTX958, GLPG3667, et cetera), unless participant has documentation of posttrial unblinding that confirms the participant did not receive a TYK2 inhibitor.
  • Other Prohibited Concomitant Medications Exclusions: For the below prohibited concomitant medications, where applicable, the washout period prior to Day 1 is within the time frame indicated or 5 half-lives, whichever is longer.
  • Participant has received lithium, antimalarials, or intramuscular gold therapy within 4 weeks prior to Day 1.
  • Participant is currently being treated with strong or moderate Cytochrome P450 3A4 (CYP3A4) inhibitors (such as itraconazole) or strong or moderate CYP3A4 inducers (such as rifampin, carbamazepine, or phenytoin), or has received strong or moderate CYP3A4 inhibitors or strong or moderate CYP3A4 inducers within 4 weeks or 5 half-lives of the inducer or inhibitor, whichever is longer, prior to Day 1, or is anticipated to require treatment with strong or moderate CYP3A4 inducers or inhibitors during the trial period.
  • Note: This includes consumption of food or beverages containing grapefruit and/or Seville oranges within 1 week of Day 1. Participants must be counseled to avoid food or beverages containing grapefruit and/or Seville oranges for the duration of the trial.
  • Participant has received any live-attenuated vaccine within 60 days prior to Day 1 or plans to receive a live-attenuated vaccine during the trial and up to 4 weeks after the last trial intervention administration.
  • Note: Non-live-attenuated vaccines or boosters for Coronavirus Disease 2019 (COVID-19) or influenza are permitted during the trial.
  • Participant received an investigational antibody or biologic therapy within 6 months prior to Day 1.
  • Participant received an investigational oral therapy within 3 months prior to Day 1.
  • Participant is currently receiving a nonbiological trial intervention or device or has received one within 4 weeks prior to Day 1.
  • Participant is currently enrolled in a clinical trial or anticipates enrollment in a clinical trial during the course of the trial.
  • Laboratory/Physical Exclusions:
  • Participant has any of the following laboratory values at the screening visit:
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values greater than (˃)3*upper limit of normal (ULN).
  • Total Bilirubin (Tbili) (unconjugated and/or conjugated) ˃1.5*ULN.
  • Hemoglobin less than (<) 9.0 grams per deciliter (g/dL) (<90.0 grams per liter [g/L]).
  • Absolute white blood cell (WBC) count <3.0*109/liters (L) (<3000 per cubic millimeter [/mm3]).
  • Absolute neutrophil count of <1.0*109/L (<1000/mm3).
  • Absolute lymphocytes count of <0.5*109/L (<500/mm3).
  • Platelet count <100*109/L (<100,000/mm3).
  • Thyroid-stimulating hormone outside the normal reference range AND free T4 or T3 outside the normal reference range.
  • Estimated creatinine clearance <45 milliliters per minute (mL/min) based on the Cockcroft-Gault calculation.
  • Creatine phosphokinase (CPK) > ULN. CPK may be repeated once; if repeat value is Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or lower (or <=2.5*ULN) and no higher than the initial value, participant remains eligible. Investigators should assess the participant for modulating factors, including concomitant medications or vigorous exercise, that may affect CPK levels.
  • Participant has any other significant laboratory abnormalities that, in the opinion of the investigator, might place the participant at unacceptable risk for participation in this trial.
  • Participant does not tolerate venipuncture or inability to be venipunctured.
  • Allergies and Adverse Drug Reactions Exclusions:
  • Participant has history of significant drug allergy (such as anaphylaxis).
  • Participant has a known or suspected allergy to zasocitinib or deucravacitinib or any of their components.

Trial locations and contacts

113 sites in 8 countries.

113 sites in 8 countries

United States31 sites

  • Arlington Research Center

    Arlington, Texas, 76011-3800

  • Bellaire Dermatology Associates

    Bellaire, Texas, 77401-3505

  • The University of Texas Health Science Center at Houston (UTHSC-H)

    Bellaire, Texas, 77401

  • Zenith Research, Inc.

    Beverly Hills, California, 90212

  • Bexley Dermatology Research - Probity - PPDS

    Bexley, Ohio, 43209

  • Apex Clinical Research Center, LLC - Canton

    Canton, Ohio, 44718

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27516

  • Central Connecticut Dermatology, PLLC

    Cromwell, Connecticut, 06416

  • Reveal Research Institute

    Dallas, Texas, 75235

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Johnson Dermatology

    Fort Smith, Arkansas, 72916-6103

  • First OC Dermatology Research Inc.

    Fountain Valley, California, 92708

  • Goodlettsville Dermatology Research

    Goodlettsville, Tennessee, 37072

  • Direct Helpers Research Center

    Hialeah, Florida, 33012

  • Burke Pharmaceutical Research

    Hot Springs, Arkansas, 71913-6475

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46250

  • JDR Dermatology Research, LLC

    Las Vegas, Nevada, 89145

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Apex Clinical Research Center, LLC - Mayfield Heights

    Mayfield Heights, Ohio, 44124-4005

  • San Marcus Research Clinic Inc

    Miami Lakes, Florida, 33014

  • Yale University School of Medicine

    New Haven, Connecticut, 06511

  • Markowitz Medical PLLC dba OptiSkin Medical

    New York, New York, 10128

  • UPMC Department of Dermatology

    Pittsburgh, Pennsylvania, 15213-3403

  • Lawrence J Green, MD LLC

    Rockville, Maryland, 20850

  • Arlington Dermatology

    Rolling Meadows, Illinois, 60008-3811

  • San Antonio

    San Antonio, Texas, 78213-2250

  • Texas Dermatology and Laser Specialists-San Antonio

    San Antonio, Texas, 78218-3128

  • UNISON Clinical Trials (Shahram Jacobs md inc.)

    Sherman Oaks, California, 91403

  • Endeavor Health Clinical Trials

    Skokie, Illinois, 60077

  • Houston Center for Clinical Research, LLC

    Sugar Land, Texas, 77479-1001

  • Advanced Clinical Research Institute

    Tampa, Florida, 33607-6429

Other trials in United States

Poland20 sites

  • ClinicMed Daniluk, Nowak Spolka Komandytowa

    Bialystok, Podlaskie Voivodeship, 15-879

  • Ambulatorium Sp. z o.o. | Elblag, Poland

    Elblag, Warmian-Masurian Voivodeship, 20-573

  • Centrum Badan Klinicznych Pi-house Sp. Z O. O.

    Gdansk, Pomeranian Voivodeship, 80-546

  • NZOZ Holsamed-Oddział Libero

    Katowice, 229 40-600

  • Krakowskie Centrum Medyczne Sp. z o.o.

    Krakow, Lesser Poland Voivodeship, 31-501

  • Centrum Terapii Współczesnej J.M. Jasnorzewska S.K.A.

    Lodz, Łódź Voivodeship, 90-338

  • Dermoklinika-Centrum Medyczne s.c

    Lodz, Łódź Voivodeship, 90-436

  • Luxderm Specjalistyczny Gabinet Dermatologiczny Dorota Krasowska

    Lublin, Lublin Voivodeship, 20-573

  • ETYKA Osrodek Badan Klinicznych

    Olsztyn, 10-117

  • DermoDent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski, s.c.

    Osielsko, Kuyavian-Pomeranian Voivodeship, 86-031

  • Dermedic Jacek Zdybski

    Ostrowiec Swietokrzyski, Lower Silesian Voivodeship, 27-400

  • Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie

    Rzeszów, Podkarpackie Voivodeship, 35-055

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, 71-500

  • MICS Centrum Medyczne Warszawa

    Warsaw, Masovian Voivodeship, 00-874

  • Klinika Reuma Park Sp. z o.o. sp. k. | Centrum Medyczne Reuma Park

    Warsaw, Masovian Voivodeship, 02-665

  • ETG Warszawa - PPDS

    Warsaw, Masovian Voivodeship, 02-677

  • Klinika Ambroziak Dermatologia

    Warsaw, Masovian Voivodeship, 02-953

  • Royalderm Agnieszka Nawrocka

    Warsaw, 02 962

  • Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p

    Wroclaw, Lower Silesian Voivodeship, 50-566

  • Centrum Columbus

    Wroclaw, Lower Silesian Voivodeship, 51-503

Other trials in Poland

Canada18 sites

  • Beacon Dermatology - Probity

    Calgary, Alberta, T3E 0B2

  • VIDA Dermatology - Probity

    Edmonton, Alberta, T6H 4J8

  • Brunswick Dermatology Centre - Probity

    Fredericton, New Brunswick, E3B 1G9

  • Lima's Excellence In Allergy And Dermatology Research (Leader) Inc. - Probity

    Hamilton, Ontario, L8L 3C3

  • Dermatrials Research

    Hamilton, Ontario, L8N 1Y2

  • Lynderm Research Inc - Probity

    Markham, Ontario, L3P 1X3

  • Siena Medical Research Corporation

    Montreal, Quebec, H3Z 2S6

  • North Bay Dermatology Center - Probity

    North Bay, Ontario, P1B 3Z7

  • The Centre for Clinical Trials Inc.

    Oakville, Ontario, L6J 7W5

  • Skin Centre for Dermatology

    Peterborough, Ontario, K9J 5K2

  • Centre de Recherche Dermatologique du Quebec Metropolitain

    Québec, G1V 4X7

  • The Centre For Dermatology

    Richmond Hill, Ontario, L4B 1A5

  • Skinsense Medical Research

    Saskatoon, Saskatchewan, S7K 2C1

  • Enverus Medical Research - Probity

    Surrey, British Columbia, V3V 0C6

  • Dr Chih-Ho Hong Medical Inc

    Surrey, British Columbia, V3V 6A7

  • Alliance Clinical Trials

    Waterloo, Ontario, N2J 1C4

  • XLR8 Medical Research

    Windsor, Ontario, N8T1E6

  • Wiseman Dermatology Research Inc.

    Winnipeg, Manitoba, R3M 3Z4

Other trials in Canada

Japan15 sites

  • St. Luke's International Hospital

    Chuo-ku, Tokyo, 104-8560

  • Fukuoka University Hospital

    Fukuoka, Fukuoka, 814-0180

  • Hino Dermatology Clinic

    Fukutsu-shi, Fukuoka, 811-3217

  • Ohyama Dermatology Clinic

    Kumamoto, 861-4101

  • Seikoukai Omi Medical Center

    Kusatsu-shi, Shiga, 525-8585

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602

  • Nippon Life Hospital

    Osaka, Osaka, 550-0006

  • Investigational Product department Dermatology and Ophthalmology Kume Clinic

    Sakai-shi, Osaka, 593-8324

  • JR Sapporo Hospital

    Sapporo, Hokkaido, 060-0033

  • Investigational Product department

    Sapporo, Hokkaido, 060-0063

  • Jichi Medical University Hospital

    Shimotsuke-shi, Tochigi, 329-0498

  • JCHO Tokyo Yamate Medical Center

    Shinjuku-ku, Tokyo-to, 169-0073

  • Tokyo Medical University Hospital

    Shinjuku-Ku, Tokyo, 160-0023

  • Medical Corporation Jitai-kai Tachikawa Dermatology Clinic

    Tachikawa-shi, Tokyo, 190-0023

  • Shirasaki Dermatology Clinic

    Takaoka-shi, Toyama, 933-0871

Other trials in Japan

Bulgaria10 sites

  • Medical Center Asklepii OOD

    Dupnitsa, Kyustendil, 2600

  • Multiprofile Hospital For Active Treatment Dr Tota Venkova

    Gabrovo, 5300

  • Diagnostic Consultative Center Sveti Georgi EOOD

    Haskovo, 6300

  • Medical Center Medconsult Pleven - Lovech Branch

    Lovech, 5500

  • Medical Center Unimed EOOD-Sevlievo

    Sevlievo, Gabrovo, 5400

  • Medical Centre Femiclinic EOOD

    Sofia, Dianabad District, 1113

  • Diagnostic and Consulting Center Aleksandrovska EOOD

    Sofia, Sofia-Grad, 1431

  • Medical Center Hera EOOD-Sofia

    Sofia, Sofia-Grad, 1510

  • Diagnostic Consultative Center XXVIII - Sofia - EOOD

    Sofia, Sofia-Grad, 1592

  • Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia

    Sofia, Sofia-Grad, 1606

Other trials in Bulgaria

Czechia8 sites

  • Pratia Brno s.r.o. - PRATIA - PPDS

    Brno, South Moravian, 602 00

  • Nemocnice AGEL Novy Jicin a.s

    Nový Jičín, Moravian-Silesian Region, 741 01

  • Dermskin s.r.o

    Olomouc, Olomouc Region, 779 00

  • CCR Ostrava s.r.o.

    Ostrava, Moravian-Silesian Region, 702 00

  • Pratia Pardubice

    Pardubice, 53002

  • CLINTRIAL s.r.o.

    Prague, 100 00

  • Prof. MUDr. Petr Arenberger, DrSc. - CRC - PPDS

    Prague, 110 00

  • Praglandia s.r.o.

    Prague, 150 00

Other trials in Czechia

Latvia7 sites

  • Semigallia

    Kuldīga, LV-3301

  • Health Center 4, Center of Diagnostics

    Riga, 1003

  • Health Center 4, Clinic of Dermatology

    Riga, 1013

  • Riga 1st Hospital

    Riga, LV-1001

  • Aesthetic dermatology clinic of prof. J. Kisis

    Riga, LV-1003

  • Veseliba un estetika Ltd.

    Riga, LV-1009

  • Outpatient Clinic Adoria

    Riga, LV-1011

Other trials in Latvia

France4 sites

  • Centre Hospitalier Le Mans

    Le Mans, Sarthe, 72037

  • Office of Mireille Ruer-Mulard, MD

    Martigues, Paca, 13500

  • Hopital Charles Nicolle-1 Rue de Germont

    Rouen, 76031

  • Centre Hospitalier Universitaire de Saint Etienne

    Saint-Etienne, 42270

Other trials in France

About this study

Official title: A Phase 3, Randomized, Multicenter, Double-Blind Trial to Evaluate the Efficacy, Safety, and Tolerability of Zasocitinib (TAK-279) Compared to Deucravacitinib in Participants With Moderate-to-Severe Plaque Psoriasis

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.

Being tested
Zasocitinib, Deucravacitinib, Placebo to match zasocitinib, Placebo to match deucravacitinib
Keywords
Drug Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZasocitinibDrug

    Also called TAK-279, NDI-034858

    Zasocitinib tablets.

  • DeucravacitinibDrug

    Deucravacitinib capsules.

  • Placebo to match zasocitinibDrug

    Zasocitinib matching placebo tablets.

  • Placebo to match deucravacitinibDrug

    Deucravacitinib matching placebo capsules.

Study groups in NCT06973291
Study groupRoleWhat they receive
Zasocitinib or PlaceboExperimentalParticipants will receive zasocitinib or matching placebo tablet, orally, once daily (QD) up to Week 16.
Receives: Drug: Zasocitinib; Drug: Placebo to match zasocitinib
Deucravacitinib or PlaceboActive comparatorParticipants will receive deucravacitinib 6 mg or matching placebo capsule, orally, QD up to Week 16.
Receives: Drug: Deucravacitinib; Drug: Placebo to match deucravacitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI)-100 at Week 16

    PASI is a measure of the average erythema, induration/infiltration, and desquamation/scaling of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72 (less than or equal to [<=] 3 representing mild disease, greater than or equal to [>=3] to 15 representing moderate disease, and >=15 indicating severe disease) with higher PASI scores denoting more severe disease activity. Percentage of participants showing 100 percentage (%) improvement in PASI score relative to baseline PASI score will be reported.

    Measured: At Week 16

Secondary outcomes (8)

  1. Percentage of Participants Achieving PASI-90 at Weeks 4, 8, 12, and 16

    PASI is a measure of the average erythema, induration/infiltration, and desquamation/scaling of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72 (<= 3 representing mild disease, >=3 to 15 representing moderate disease, and >=15 indicating severe disease) with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 90% improvement in PASI score relative to baseline PASI score will be reported.

    Measured: At Weeks 4, 8, 12, and 16

  2. Percentage of Participants Achieving PASI <=2 Response at Weeks 4, 8, 12, and 16

    PASI is a measure of the average erythema, induration/infiltration, and desquamation/scaling (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72 (<= 3 representing mild disease, >=3 to 15 representing moderate disease, and >=15 indicating severe disease) with higher PASI scores denoting more severe disease activity. Percentage of participants achieving PASI <=2 at Weeks 4, 8, 12, and 16 will be reported.

    Measured: At Weeks 4, 8, 12, and 16

  3. Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear (0) at Weeks 4, 8, 12, and 16

    The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity. 'Clear' will include all participants who score a 0.

    Measured: At Weeks 4, 8, 12, and 16

  4. Percentage of Participants Achieving PASI-100 at Weeks 4, 8, and 12

    PASI is a measure of the average erythema, induration/infiltration, and desquamation/scaling of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72 (<= 3 representing mild disease, >=3 to 15 representing moderate disease, and >=15 indicating severe disease) with higher PASI scores denoting more severe disease activity. Percentage of participants showing 100% improvement in PASI score relative to baseline PASI score will be reported.

    Measured: At Weeks 4, 8, and 12

  5. Percentage of Participants Achieving PASI-75 at Weeks 4, 8, 12, and 16

    PASI is a measure of the average erythema, induration/infiltration, and desquamation/scaling of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 75% improvement in PASI score relative to baseline PASI score will be reported.

    Measured: At Weeks 4, 8, 12, and 16

  6. Percentage of Participants Achieving sPGA of Clear (0) or Almost Clear (1) at Weeks 4, 8, 12, and 16

    The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity. 'Clear' and 'Almost clear' will include all participants who score a 0 or 1.

    Measured: At Weeks 4, 8, 12, and 16

  7. Change From Baseline in PASI Score at Weeks 4, 8, 12, and 16

    PASI is a measure of the average erythema, induration/infiltration, and desquamation/scaling of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72 (<= 3 representing mild disease, >=3 to 15 representing moderate disease, and >=15 indicating severe disease) with higher PASI scores denoting more severe disease activity. Change from baseline will be calculated as post-baseline value minus baseline value.

    Measured: Baseline, Weeks 4, 8, 12, and 16

  8. Percent Change From Baseline in PASI score at Weeks 4, 8, 12, and 16

    PASI is a measure of the average erythema, induration/infiltration, and desquamation/scaling of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72 (<= 3 representing mild disease, >=3 to 15 representing moderate disease, and >=15 indicating severe disease) with higher PASI scores denoting more severe disease activity. Percent change from baseline will be calculated as post-baseline value minus baseline value multiplied by 100.

    Measured: Baseline, Weeks 4, 8, 12, and 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2025
  2. Study start9 Jul 2025
  3. Primary completion22 Apr 2026
  4. Study completion22 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
606 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06973291
Sponsor's protocol ID
TAK-279-PsO-3004
Other IDs
2024-512497-10-00, jRCT2011250014
Status last verified
Apr 2026
First submitted
8 May 2025
Last updated
1 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Zasocitinib and Deucravacitinib in people with Plaque Psoriasis, run by Takeda at 113 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 82 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 113 sites in United States, Poland, Canada, Japan, Bulgaria and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI)-100 at Week 16 (time frame: At Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06973291.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.

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