A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-severe Systemic Disease Activity

Part of paid clinical trials in Avondale, Arizona.

Sponsor
Amgen
Study ID
NCT06104124
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Sjogren's Syndrome

Eligibility Criteria

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

Interventions

  • Dazodalibep — DRUG
    IV infusion
  • Placebo — DRUG
    IV infusion

Study Details

Primary Objective: To evaluate the effect of dazodalibep on systemic manifestations of Sjögren's Syndrome (SS) in participants with moderate-to-severe systemic disease activity. Secondary Objectives: 1. To evaluate the effect of dazodalibep on patient reported outcomes (PROs) in participants with SS. 2. To evaluate the safety and tolerability of dazodalibep in participants with SS

Key Dates

Start date
Jan 24, 2024
Status verified
Jan 2026
Primary completion
Aug 19, 2026
Completion
Aug 19, 2026

Study Design

Enrollment
651 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dazodalibep Dose 1
    Participants will be administered dose 1 of dazodalibep by intravenous (IV) infusion.
  • Experimental: Dazodalibep Dose 2
    Participants will be administered dose 2 of dazodalibep by IV infusion.
  • Placebo Comparator: Placebo
    Participants will be administered placebo by IV infusion.

Primary Outcome Measure

Change from baseline in European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI) Score [ Time Frame: At Week 48 ]

Locations (45)

FacilityCityStateZIPSite coordinators
Arizona Arthritis & Rheumatology Associates - AvondaleAvondaleArizona85392-
Arizona Research Clinic PLLCChandlerArizona85225-2915-
Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais LnFlagstaffArizona86001-6299-
Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome StGilbertArizona85297-7338-
Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly LnGlendaleArizona85306-9800-
Arizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove RdTucsonArizona85704-1140-
UCSD Altman Clinical and Translational Research Institute BuildingLa JollaCalifornia92037-1337-
Inland Rheumatology Clinical Trials IncorporatedUplandCalifornia91786-4951-
Tekton Research, LLC - 2121 E Harmony Rd - PPDSFort CollinsColorado80528-3404-
Bradenton Research Center IncBradentonFlorida34205-1704-
Clinical Research of West Florida Inc - ClearwaterClearwaterFlorida33765-2616-
University of Miami - Leonard M. Miller School of MedicineMiamiFlorida33136-1011-
Suncoast Clinical Research - ATLAS - New Port Richey - PPDSNew Port RicheyFlorida34652-4020-
Millennium ResearchOrmond BeachFlorida32174-1140-
West Broward Rheumatology Associates, Inc.TamaracFlorida33321-2956-
BayCare Medical GroupTampaFlorida33614-7101-
Augusta University Medical Center-Augusta-1120 15th StAugustaGeorgia30912-0004-
OrthoIllinois, LTDRockfordIllinois61114-4937-
University of Kansas Medical CenterKansas CityKansas66160-0001-
Massachusetts General HospitalBostonMassachusetts02114-2621-
Clinical Research Institute of Michigan, LLC-St. Claire ShoresSaint Clair ShoresMichigan48081-
Kansas City Physician Partners-8350 N Saint Clair AveKansas CityMissouri64151-5100-
Arthritis, Rheumatic & Bone Disease Associates - PVoorhees TownshipNew Jersey08043-4509-
NYU Langone Health - Joseph S. and Diane H. Steinberg Ambulatory Care CenterBrooklynNew York11201-5501-
Arthritis and Osteoporosis Consultants of The Carolinas - Charlotte - 1918 Randolph RdCharlotteNorth Carolina28207-
Duke Early Phase Clinical Research Unit - PPDSDurhamNorth Carolina27710-0001-
Onsite Clinical Solutions, LLC - SalisburySalisburyNorth Carolina28144-
Arthritis & Osteoporosis Center of Southwest Ohio - MiamisburgMiamisburgOhio45342-
University of Toledo Medical CenterToledoOhio43614-2595-
STAT Research-600 Aviator CtVandaliaOhio45377-9474-
Low Country Rheumatology PA-SummervilleSummervilleSouth Carolina29486-7887-
Murfreesboro Medical Clinic WestlawnMurfreesboroTennessee37128-
Amarillo Center For Clinical ResearchAmarilloTexas79124-1601-
Tekton Research, LLC - W Gate Blvd - Austin - PPDSAustinTexas78745-1470-
Accurate Clinical Management-BaytownBaytownTexas77521-
Precision Comprehensive Clinical Research SolutionsGrapevineTexas76051-3143-
Prolato Clinical Research CenterHoustonTexas77054-2853-
R & H Clinical Research-777 S Fry RdKatyTexas77450-
Valley Arthritis CenterMcAllenTexas78501-
University of Texas - San Antonio - Health Science Center - PPDSSan AntonioTexas78229-3901-
DM Clinical Research - Migraine and COPD - PPDSTomballTexas77375-
Metrodora InstituteWest Valley CityUtah84119-
Overlake Arthritis & Osteoporosis CenterBellevueWashington98004-3016-
Western Washington Medical Group, Bothell - RheumatologyBothellWashington98021-
Rheumatology and Pulmonary ClinicBeckleyWest Virginia25801-2805-

Find similar trials in Avondale, AZ

By research site
Arizona Arthritis & Rheumatology Associates - Avondale· Avondale, AZArizona Research Clinic PLLC· Chandler, AZArizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais Ln· Flagstaff, AZArizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St· Gilbert, AZArizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln· Glendale, AZArizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove Rd· Tucson, AZ

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