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

NCT06973291 | Completed Phase 3 DMC FDA Drug

• 3 other identifiers: TAK-279-PsO-30042024-512497-10-00jRCT2011250014
• Study Type: interventional
• Target: 606
• Locations: 8 countries
• Sites: 113

Brief 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.

Conditions

Plaque Psoriasis

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (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.

  At Week 16

Secondary Outcomes (8)

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

  At Weeks 4, 8, 12, and 16

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

  At Weeks 4, 8, 12, and 16

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

  At Weeks 4, 8, 12, and 16

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

  At Weeks 4, 8, and 12

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

  At Weeks 4, 8, 12, and 16

Study Arms (2)

Zasocitinib or Placebo

EXPERIMENTAL

Participants will receive zasocitinib or matching placebo tablet, orally, once daily (QD) up to Week 16.

Drug: Zasocitinib; Drug: Placebo to match zasocitinib

Deucravacitinib or Placebo

ACTIVE COMPARATOR

Participants will receive deucravacitinib 6 mg or matching placebo capsule, orally, QD up to Week 16.

Drug: Deucravacitinib; Drug: Placebo to match deucravacitinib

Interventions

Zasocitinib DRUG

Zasocitinib tablets.

Also known as: TAK-279, NDI-034858

Zasocitinib or Placebo

Deucravacitinib DRUG

Deucravacitinib capsules.

Deucravacitinib or Placebo

Placebo to match deucravacitinib DRUG

Deucravacitinib matching placebo capsules.

Deucravacitinib or Placebo

Placebo to match zasocitinib DRUG

Zasocitinib matching placebo tablets.

Zasocitinib or Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

• 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.
• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (113)

Johnson Dermatology

Fort Smith, Arkansas, 72916-6103, United States

Location

Burke Pharmaceutical Research

Hot Springs, Arkansas, 71913-6475, United States

Location

Zenith Research, Inc.

Beverly Hills, California, 90212, United States

Location

First OC Dermatology Research Inc.

Fountain Valley, California, 92708, United States

Location

UNISON Clinical Trials (Shahram Jacobs md inc.)

Sherman Oaks, California, 91403, United States

Location

Central Connecticut Dermatology, PLLC

Cromwell, Connecticut, 06416, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06511, United States

Location

Direct Helpers Research Center

Hialeah, Florida, 33012, United States

Location

San Marcus Research Clinic Inc

Miami Lakes, Florida, 33014, United States

Location

Advanced Clinical Research Institute

Tampa, Florida, 33607-6429, United States

Location

Arlington Dermatology

Rolling Meadows, Illinois, 60008-3811, United States

Location

Endeavor Health Clinical Trials

Skokie, Illinois, 60077, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

Location

Lawrence J Green, MD LLC

Rockville, Maryland, 20850, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

JDR Dermatology Research, LLC

Las Vegas, Nevada, 89145, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Markowitz Medical PLLC dba OptiSkin Medical

New York, New York, 10128, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27516, United States

Location

Bexley Dermatology Research - Probity - PPDS

Bexley, Ohio, 43209, United States

Location

Apex Clinical Research Center, LLC - Canton

Canton, Ohio, 44718, United States

Location

Apex Clinical Research Center, LLC - Mayfield Heights

Mayfield Heights, Ohio, 44124-4005, United States

Location

UPMC Department of Dermatology

Pittsburgh, Pennsylvania, 15213-3403, United States

Location

Goodlettsville Dermatology Research

Goodlettsville, Tennessee, 37072, United States

Location

Arlington Research Center

Arlington, Texas, 76011-3800, United States

Location

Bellaire Dermatology Associates

Bellaire, Texas, 77401-3505, United States

Location

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

Bellaire, Texas, 77401, United States

Location

Reveal Research Institute

Dallas, Texas, 75235, United States

Location

San Antonio

San Antonio, Texas, 78213-2250, United States

Location

Texas Dermatology and Laser Specialists-San Antonio

San Antonio, Texas, 78218-3128, United States

Location

Houston Center for Clinical Research, LLC

Sugar Land, Texas, 77479-1001, United States

Location

Medical Centre Femiclinic EOOD

Sofia, Dianabad District, 1113, Bulgaria

Location

Medical Center Unimed EOOD-Sevlievo

Sevlievo, Gabrovo, 5400, Bulgaria

Location

Medical Center Asklepii OOD

Dupnitsa, Kyustendil, 2600, Bulgaria

Location

Diagnostic and Consulting Center Aleksandrovska EOOD

Sofia, Sofia-Grad, 1431, Bulgaria

Location

Medical Center Hera EOOD-Sofia

Sofia, Sofia-Grad, 1510, Bulgaria

Location

Diagnostic Consultative Center XXVIII - Sofia - EOOD

Sofia, Sofia-Grad, 1592, Bulgaria

Location

Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia

Sofia, Sofia-Grad, 1606, Bulgaria

Location

Multiprofile Hospital For Active Treatment Dr Tota Venkova

Gabrovo, 5300, Bulgaria

Location

Diagnostic Consultative Center Sveti Georgi EOOD

Haskovo, 6300, Bulgaria

Location

Medical Center Medconsult Pleven - Lovech Branch

Lovech, 5500, Bulgaria

Location

Beacon Dermatology - Probity

Calgary, Alberta, T3E 0B2, Canada

Location

VIDA Dermatology - Probity

Edmonton, Alberta, T6H 4J8, Canada

Location

Enverus Medical Research - Probity

Surrey, British Columbia, V3V 0C6, Canada

Location

Dr Chih-Ho Hong Medical Inc

Surrey, British Columbia, V3V 6A7, Canada

Location

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

Brunswick Dermatology Centre - Probity

Fredericton, New Brunswick, E3B 1G9, Canada

Location

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

Hamilton, Ontario, L8L 3C3, Canada

Location

Dermatrials Research

Hamilton, Ontario, L8N 1Y2, Canada

Location

Lynderm Research Inc - Probity

Markham, Ontario, L3P 1X3, Canada

Location

North Bay Dermatology Center - Probity

North Bay, Ontario, P1B 3Z7, Canada

Location

The Centre for Clinical Trials Inc.

Oakville, Ontario, L6J 7W5, Canada

Location

Skin Centre for Dermatology

Peterborough, Ontario, K9J 5K2, Canada

Location

The Centre For Dermatology

Richmond Hill, Ontario, L4B 1A5, Canada

Location

Alliance Clinical Trials

Waterloo, Ontario, N2J 1C4, Canada

Location

XLR8 Medical Research

Windsor, Ontario, N8T1E6, Canada

Location

Siena Medical Research Corporation

Montreal, Quebec, H3Z 2S6, Canada

Location

Skinsense Medical Research

Saskatoon, Saskatchewan, S7K 2C1, Canada

Location

Centre de Recherche Dermatologique du Quebec Metropolitain

Québec, G1V 4X7, Canada

Location

Nemocnice AGEL Novy Jicin a.s

Nový Jičín, Moravian-Silesian Region, 741 01, Czechia

Location

CCR Ostrava s.r.o.

Ostrava, Moravian-Silesian Region, 702 00, Czechia

Location

Dermskin s.r.o

Olomouc, Olomouc Region, 779 00, Czechia

Location

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

Brno, South Moravian, 602 00, Czechia

Location

Pratia Pardubice

Pardubice, 53002, Czechia

Location

CLINTRIAL s.r.o.

Prague, 100 00, Czechia

Location

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

Prague, 110 00, Czechia

Location

Praglandia s.r.o.

Prague, 150 00, Czechia

Location

Office of Mireille Ruer-Mulard, MD

Martigues, Paca, 13500, France

Location

Centre Hospitalier Le Mans

Le Mans, Sarthe, 72037, France

Location

Hopital Charles Nicolle-1 Rue de Germont

Rouen, 76031, France

Location

Centre Hospitalier Universitaire de Saint Etienne

Saint-Etienne, 42270, France

Location

Nagoya City University Hospital

Nagoya, Aichi-ken, 467-8602, Japan

Location

Fukuoka University Hospital

Fukuoka, Fukuoka, 814-0180, Japan

Location

Hino Dermatology Clinic

Fukutsu-shi, Fukuoka, 811-3217, Japan

Location

JR Sapporo Hospital

Sapporo, Hokkaido, 060-0033, Japan

Location

Investigational Product department

Sapporo, Hokkaido, 060-0063, Japan

Location

Nippon Life Hospital

Osaka, Osaka, 550-0006, Japan

Location

Investigational Product department Dermatology and Ophthalmology Kume Clinic

Sakai-shi, Osaka, 593-8324, Japan

Location

Seikoukai Omi Medical Center

Kusatsu-shi, Shiga, 525-8585, Japan

Location

Jichi Medical University Hospital

Shimotsuke-shi, Tochigi, 329-0498, Japan

Location

St. Luke's International Hospital

Chuo-ku, Tokyo, 104-8560, Japan

Location

Tokyo Medical University Hospital

Shinjuku-Ku, Tokyo, 160-0023, Japan

Location

Medical Corporation Jitai-kai Tachikawa Dermatology Clinic

Tachikawa-shi, Tokyo, 190-0023, Japan

Location

JCHO Tokyo Yamate Medical Center

Shinjuku-ku, Tokyo-to, 169-0073, Japan

Location

Shirasaki Dermatology Clinic

Takaoka-shi, Toyama, 933-0871, Japan

Location

Ohyama Dermatology Clinic

Kumamoto, 861-4101, Japan

Location

Semigallia

Kuldīga, LV-3301, Latvia

Location

Health Center 4, Center of Diagnostics

Riga, 1003, Latvia

Location

Health Center 4, Clinic of Dermatology

Riga, 1013, Latvia

Location

Riga 1st Hospital

Riga, LV-1001, Latvia

Location

Aesthetic dermatology clinic of prof. J. Kisis

Riga, LV-1003, Latvia

Location

Veseliba un estetika Ltd.

Riga, LV-1009, Latvia

Location

Outpatient Clinic Adoria

Riga, LV-1011, Latvia

Location

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

Osielsko, Kuyavian-Pomeranian Voivodeship, 86-031, Poland

Location

Krakowskie Centrum Medyczne Sp. z o.o.

Krakow, Lesser Poland Voivodeship, 31-501, Poland

Location

Dermedic Jacek Zdybski

Ostrowiec Swietokrzyski, Lower Silesian Voivodeship, 27-400, Poland

Location

Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p

Wroclaw, Lower Silesian Voivodeship, 50-566, Poland

Location

Centrum Columbus

Wroclaw, Lower Silesian Voivodeship, 51-503, Poland

Location

Luxderm Specjalistyczny Gabinet Dermatologiczny Dorota Krasowska

Lublin, Lublin Voivodeship, 20-573, Poland

Location

MICS Centrum Medyczne Warszawa

Warsaw, Masovian Voivodeship, 00-874, Poland

Location

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

Warsaw, Masovian Voivodeship, 02-665, Poland

Location

ETG Warszawa - PPDS

Warsaw, Masovian Voivodeship, 02-677, Poland

Location

Klinika Ambroziak Dermatologia

Warsaw, Masovian Voivodeship, 02-953, Poland

Location

Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie

Rzeszów, Podkarpackie Voivodeship, 35-055, Poland

Location

ClinicMed Daniluk, Nowak Spolka Komandytowa

Bialystok, Podlaskie Voivodeship, 15-879, Poland

Location

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

Gdansk, Pomeranian Voivodeship, 80-546, Poland

Location

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

Elblag, Warmian-Masurian Voivodeship, 20-573, Poland

Location

NZOZ Holsamed-Oddział Libero

Katowice, 229 40-600, Poland

Location

ETYKA Osrodek Badan Klinicznych

Olsztyn, 10-117, Poland

Location

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, 71-500, Poland

Location

Royalderm Agnieszka Nawrocka

Warsaw, 02 962, Poland

Location

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

Lodz, Łódź Voivodeship, 90-338, Poland

Location

Dermoklinika-Centrum Medyczne s.c

Lodz, Łódź Voivodeship, 90-436, Poland

Location

Related Links

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MeSH Terms

Interventions

deucravacitinib

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 15, 2025
• Study Start: July 9, 2025
• Primary Completion: April 22, 2026
• Study Completion: April 22, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

PL (20); LA (7); US (31); CA (18); FR (4); BU (10); CZ (8); JP (15)