A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have or Have Not Been Treated With Biologic Medicines

Part of paid clinical trials in Mesa, Arizona.

Sponsor
Takeda
Study ID
NCT06671496
Phase
PHASE3
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Zasocitinib — DRUG
    Zasocitinib tablets.
  • Placebo — DRUG
    Zasocitinib matching placebo.

Study Details

Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects the joints and skin in people who have psoriasis (PsO). The main aim of the study is to know how well zasocitinib (TAK-279) works in participants with active PsA based on their previous experience with specific treatments. The participants will be treated with either zasocitinib, or placebo. Participants will be in the study for up to 60 weeks.

Key Dates

Start date
Mar 10, 2025
Status verified
Apr 2026
Primary completion
May 18, 2027
Completion
Jan 26, 2028

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Zasocitinib Dose A
    Participants will receive zasocitinib Dose A, tablets, orally, once daily (QD) for up to Week 52.
  • Experimental: Zasocitinib Dose B
    Participants will receive zasocitinib Dose B, tablets, orally, QD for up to Week 52.
  • Experimental: Placebo + Zasoctinib
    Participants will receive placebo, orally, QD for up to Week 16, followed by zasoctinib Dose A or Dose B, orally, QD, from Week 16 up to Week 52.

Primary Outcome Measure

Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo [ Time Frame: At Week 16 ]

Central Contacts

Locations (21)

FacilityCityStateZIPSite coordinators
Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZMesaArizona85210
Site Contact
480-626-6650
Swati Bharadwaj (PRINCIPAL_INVESTIGATOR)
Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZPhoenixArizona85032
Site Contact
480-626-6650
Joonhee Lim (PRINCIPAL_INVESTIGATOR)
Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZTucsonArizona85748
Site Contact
480-626-6650
Jeffrey Loomer (PRINCIPAL_INVESTIGATOR)
Biovin Enterprises LLC dba Medvin Clinical Research | Covina, CACovinaCalifornia91722
Site Contact
Samy Metyas (PRINCIPAL_INVESTIGATOR)
RASF- Clinical Research CenterBoca RatonFlorida33486-1390
Site Contact
5651-361-6547
Shawn Baca (PRINCIPAL_INVESTIGATOR)
Direct Helpers Medical CenterHialeahFlorida33012
Site Contact
Frank Don (PRINCIPAL_INVESTIGATOR)
IRIS Research and Development | Plantation, FLPlantationFlorida33324
Site Contact
954-476-2338
Guillermo Valenzuela (PRINCIPAL_INVESTIGATOR)
BayCare Medical GroupSt. PetersburgFlorida33705
Site Contact
727-519-1904
Sonialy Lugo Ruiz (PRINCIPAL_INVESTIGATOR)
North Georgia Rheumatology Group PCLawrencevilleGeorgia30046
Site Contact
Theresa Lawrence Ford (PRINCIPAL_INVESTIGATOR)
Clinic of Robert HozmanSkokieIllinois60076
Site Contact
847-673-8473
Robert Hozman (PRINCIPAL_INVESTIGATOR)
Graves Gilbert ClinicBowling GreenKentucky42101
Site Contact
270-781-5111
Asad Fraser (PRINCIPAL_INVESTIGATOR)
Johns Hopkins HospitalBaltimoreMaryland21205
Site Contact
410-550-8089
Ana-Maria Orbai (PRINCIPAL_INVESTIGATOR)
Advanced Rheumatology PC | Lansing, MILansingMichigan48910-5894
Site Contact
517-908-3600
Monika Mohan (PRINCIPAL_INVESTIGATOR)
AARR- Kansas City Physician PartnersKansas CityMissouri85032
Site Contact
480-626-6650
Tina Shah (PRINCIPAL_INVESTIGATOR)
DJL Clinical Research | Charlotte, NCCharlotteNorth Carolina28210
Site Contact
704-247-9179
Emily Jane Herron Box (PRINCIPAL_INVESTIGATOR)
University Hospitals | UH Cleveland Medical Center - Department of Medicine - Rheumatology DivisionClevelandOhio44106
Site Contact
Marina Magrey (PRINCIPAL_INVESTIGATOR)
Altoona Center for Clinical Research | Ducansville, PADuncansvillePennsylvania16635
Site Contact
Alan Kivitz (PRINCIPAL_INVESTIGATOR)
AARR- Lone Star Arthritis & Rheumatology AssociatesFort WorthTexas76109
Site Contact
480-626-6650
Himabindu Reddy (PRINCIPAL_INVESTIGATOR)
Biopharma Informatic | HassanHoustonTexas77089
Site Contact
Laila Hassan (PRINCIPAL_INVESTIGATOR)
Advanced Rheumatology of Houston - The WoodlandsThe WoodlandsTexas77382
Site Contact
281-766-7886
Tamar Brionez (PRINCIPAL_INVESTIGATOR)
Swedish Rheumatology ResearchSeattleWashington98122
Site Contact
206-979-1943
Philip Mease (PRINCIPAL_INVESTIGATOR)

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