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

Status: Recruiting
Location: See all (105) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arkansas
Johnson Dermatology
RECRUITING
Fort Smith
Burke Pharmaceutical Research
RECRUITING
Hot Springs
California
Zenith Research, Inc.
RECRUITING
Beverly Hills
First OC Dermatology Research Inc.
RECRUITING
Fountain Valley
UNISON Clinical Trials (Shahram Jacobs md inc.)
RECRUITING
Sherman Oaks
Connecticut
Central Connecticut Dermatology, PLLC
RECRUITING
Cromwell
Yale University School of Medicine
NOT_YET_RECRUITING
New Haven
Florida
Direct Helpers Research Center
RECRUITING
Hialeah
San Marcus Research Clinic Inc
RECRUITING
Miami Lakes
Advanced Clinical Research Institute
RECRUITING
Tampa
Illinois
Arlington Dermatology
RECRUITING
Rolling Meadows
Endeavor Health Clinical Trials
RECRUITING
Skokie
Indiana
Dawes Fretzin Clinical Research Group, LLC
RECRUITING
Indianapolis
Maryland
Lawrence J Green, MD LLC
RECRUITING
Rockville
Michigan
Henry Ford Health System
NOT_YET_RECRUITING
Detroit
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
New Hampshire
Dartmouth Hitchcock Medical Center
RECRUITING
Lebanon
Nevada
JDR Dermatology Research, LLC
RECRUITING
Las Vegas
New York
Markowitz Medical PLLC dba OptiSkin Medical
RECRUITING
New York
Ohio
Bexley Dermatology Research - Probity - PPDS
RECRUITING
Bexley
Apex Clinical Research Center, LLC - Canton
RECRUITING
Canton
Apex Clinical Research Center, LLC - Mayfield Heights
RECRUITING
Mayfield Heights
Pennsylvania
UPMC Department of Dermatology
NOT_YET_RECRUITING
Pittsburgh
Tennessee
Goodlettsville Dermatology Research
RECRUITING
Goodlettsville
Texas
Arlington Research Center
RECRUITING
Arlington
Bellaire Dermatology Associates
RECRUITING
Bellaire
The University of Texas Health Science Center at Houston (UTHSC-H)
RECRUITING
Bellaire
Reveal Research Institute
RECRUITING
Dallas
San Antonio
RECRUITING
San Antonio
Texas Dermatology and Laser Specialists-San Antonio
RECRUITING
San Antonio
Houston Center for Clinical Research, LLC
RECRUITING
Sugar Land
Other Locations
Bulgaria
Medical Center Asklepii OOD
NOT_YET_RECRUITING
Dupnitsa
Multiprofile Hospital For Active Treatment Dr Tota Venkova
NOT_YET_RECRUITING
Gabrovo
Diagnostic Consultative Center Sveti Georgi EOOD
NOT_YET_RECRUITING
Haskovo
Medical Center Medconsult Pleven - Lovech Branch
NOT_YET_RECRUITING
Lovech
Medical Center Unimed EOOD-Sevlievo
NOT_YET_RECRUITING
Sevlievo
Diagnostic and Consulting Center Aleksandrovska EOOD
NOT_YET_RECRUITING
Sofia
Diagnostic Consultative Center XXVIII - Sofia - EOOD
NOT_YET_RECRUITING
Sofia
Medical Center Hera EOOD-Sofia
NOT_YET_RECRUITING
Sofia
Medical Centre Femiclinic EOOD
NOT_YET_RECRUITING
Sofia
Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
NOT_YET_RECRUITING
Sofia
Canada
Beacon Dermatology - Probity
NOT_YET_RECRUITING
Calgary
VIDA Dermatology - Probity
NOT_YET_RECRUITING
Edmonton
Brunswick Dermatology Centre - Probity
NOT_YET_RECRUITING
Fredericton
Dermatrials Research
RECRUITING
Hamilton
Lima's Excellence In Allergy And Dermatology Research (Leader) Inc. - Probity
RECRUITING
Hamilton
Lynderm Research Inc - Probity
RECRUITING
Markham
Siena Medical Research Corporation
RECRUITING
Montreal
North Bay Dermatology Center - Probity
RECRUITING
North Bay
The Centre for Clinical Trials Inc.
RECRUITING
Oakville
Skin Centre for Dermatology
RECRUITING
Peterborough
Centre de Recherche Dermatologique du Quebec Metropolitain
RECRUITING
Québec
The Centre For Dermatology
RECRUITING
Richmond Hill
Skinsense Medical Research
RECRUITING
Saskatoon
Dr Chih-Ho Hong Medical Inc
RECRUITING
Surrey
Enverus Medical Research - Probity
RECRUITING
Surrey
Alliance Clinical Trials
RECRUITING
Waterloo
XLR8 Medical Research
RECRUITING
Windsor
Wiseman Dermatology Research Inc.
RECRUITING
Winnipeg
France
Centre Hospitalier Le Mans
NOT_YET_RECRUITING
Le Mans
Office of Mireille Ruer-Mulard, MD
NOT_YET_RECRUITING
Martigues
Hopital Charles Nicolle-1 Rue de Germont
NOT_YET_RECRUITING
Rouen
Centre Hospitalier Universitaire de Saint Etienne
NOT_YET_RECRUITING
Saint-etienne
Japan
St. Luke's International Hospital
RECRUITING
Chuo-ku
Fukuoka University Hospital
RECRUITING
Fukuoka
Hino Dermatology Clinic
RECRUITING
Fukutsu-shi
Ohyama Dermatology Clinic
RECRUITING
Kumamoto
Seikoukai Omi Medical Center
RECRUITING
Kusatsu-shi
Nagoya City University Hospital
RECRUITING
Nagoya
Nippon Life Hospital
RECRUITING
Osaka
Investigational Product department Dermatology and Ophthalmology Kume Clinic
RECRUITING
Sakai-shi
Investigational Product department
RECRUITING
Sapporo
JR Sapporo Hospital
RECRUITING
Sapporo
Jichi Medical University Hospital
RECRUITING
Shimotsuke-shi
JCHO Tokyo Yamate Medical Center
RECRUITING
Shinjuku-ku
Tokyo Medical University Hospital
RECRUITING
Shinjuku-ku
Medical Corporation Jitai-kai Tachikawa Dermatology Clinic
RECRUITING
Tachikawa-shi
Shirasaki Dermatology Clinic
RECRUITING
Takaoka-shi
Latvia
Semigallia
NOT_YET_RECRUITING
Kuldīga
Aesthetic dermatology clinic of prof. J. Kisis
NOT_YET_RECRUITING
Riga
Health Center 4, Center of Diagnostics
NOT_YET_RECRUITING
Riga
Health Center 4, Clinic of Dermatology
NOT_YET_RECRUITING
Riga
Outpatient Clinic Adoria
NOT_YET_RECRUITING
Riga
Riga 1st Hospital
NOT_YET_RECRUITING
Riga
Veseliba un estetika Ltd.
NOT_YET_RECRUITING
Riga
Poland
ClinicMed Daniluk, Nowak Spolka Komandytowa
NOT_YET_RECRUITING
Bialystok
Ambulatorium Sp. z o.o. | Elblag, Poland
RECRUITING
Elblag
Centrum Badan Klinicznych Pi-house Sp. Z O. O.
NOT_YET_RECRUITING
Gdansk
NZOZ Holsamed-Oddział Libero
NOT_YET_RECRUITING
Katowice
Krakowskie Centrum Medyczne Sp. z o.o.
NOT_YET_RECRUITING
Krakow
Centrum Terapii Współczesnej J.M. Jasnorzewska S.K.A.
NOT_YET_RECRUITING
Lodz
Dermoklinika-Centrum Medyczne s.c
NOT_YET_RECRUITING
Lodz
Luxderm Specjalistyczny Gabinet Dermatologiczny Dorota Krasowska
NOT_YET_RECRUITING
Lublin
ETYKA Osrodek Badan Klinicznych
NOT_YET_RECRUITING
Olsztyn
DermoDent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski, s.c.
NOT_YET_RECRUITING
Osielsko
Dermedic Jacek Zdybski
NOT_YET_RECRUITING
Ostrowiec Swietokrzyski
Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie
NOT_YET_RECRUITING
Rzeszów
Twoja Przychodnia - Szczecinskie Centrum Medyczne
NOT_YET_RECRUITING
Szczecin
ETG Warszawa - PPDS
RECRUITING
Warsaw
Klinika Ambroziak Dermatologia
NOT_YET_RECRUITING
Warsaw
Klinika Reuma Park Sp. z o.o. sp. k. | Centrum Medyczne Reuma Park
NOT_YET_RECRUITING
Warsaw
MICS Centrum Medyczne Warszawa
NOT_YET_RECRUITING
Warsaw
Royalderm Agnieszka Nawrocka
NOT_YET_RECRUITING
Warsaw
Centrum Columbus
NOT_YET_RECRUITING
Wroclaw
Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p
RECRUITING
Wroclaw
Contact Information
Primary
Takeda Contact
medinfoUS@takeda.com
+1-877-825-3327
Time Frame
Start Date: 2025-07-09
Estimated Completion Date: 2026-07-03
Participants
Target number of participants: 600
Treatments
Experimental: Zasocitinib or Placebo
Participants will receive zasocitinib or matching placebo tablet, orally, once daily (QD) up to Week 16.
Active_comparator: Deucravacitinib or Placebo
Participants will receive deucravacitinib 6 mg or matching placebo capsule, orally, QD up to Week 16.
Related Therapeutic Areas
Sponsors
Leads: Takeda

This content was sourced from clinicaltrials.gov