A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-severe Systemic Disease Activity
Public ClinicalTrials.gov record NCT06104124. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome With Moderate-to-severe Systemic Disease Activity
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT06104124
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 651 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 23, 2024
- Primary completion
- Aug 18, 2026
- Completion
- Aug 18, 2026
- Last update posted
- Jan 15, 2026
2024 – 2026
United States locations
- U.S. sites
- 45
- U.S. states
- 20
- U.S. cities
- 45
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Arthritis & Rheumatology Associates - Avondale | Avondale | Arizona | 85392 | — |
| Arizona Research Clinic PLLC | Chandler | Arizona | 85225-2915 | — |
| Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais Ln | Flagstaff | Arizona | 86001-6299 | — |
| Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St | Gilbert | Arizona | 85297-7338 | — |
| Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln | Glendale | Arizona | 85306-9800 | — |
| Arizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove Rd | Tucson | Arizona | 85704-1140 | — |
| UCSD Altman Clinical and Translational Research Institute Building | La Jolla | California | 92037-1337 | — |
| Inland Rheumatology Clinical Trials Incorporated | Upland | California | 91786-4951 | — |
| Tekton Research, LLC - 2121 E Harmony Rd - PPDS | Fort Collins | Colorado | 80528-3404 | — |
| Bradenton Research Center Inc | Bradenton | Florida | 34205-1704 | — |
| Clinical Research of West Florida Inc - Clearwater | Clearwater | Florida | 33765-2616 | — |
| University of Miami - Leonard M. Miller School of Medicine | Miami | Florida | 33136-1011 | — |
| Suncoast Clinical Research - ATLAS - New Port Richey - PPDS | New Port Richey | Florida | 34652-4020 | — |
| Millennium Research | Ormond Beach | Florida | 32174-1140 | — |
| West Broward Rheumatology Associates, Inc. | Tamarac | Florida | 33321-2956 | — |
| BayCare Medical Group | Tampa | Florida | 33614-7101 | — |
| Augusta University Medical Center-Augusta-1120 15th St | Augusta | Georgia | 30912-0004 | — |
| OrthoIllinois, LTD | Rockford | Illinois | 61114-4937 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160-0001 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114-2621 | — |
| Clinical Research Institute of Michigan, LLC-St. Claire Shores | Saint Clair Shores | Michigan | 48081 | — |
| Kansas City Physician Partners-8350 N Saint Clair Ave | Kansas City | Missouri | 64151-5100 | — |
| Arthritis, Rheumatic & Bone Disease Associates - P | Voorhees Township | New Jersey | 08043-4509 | — |
| NYU Langone Health - Joseph S. and Diane H. Steinberg Ambulatory Care Center | Brooklyn | New York | 11201-5501 | — |
| Arthritis and Osteoporosis Consultants of The Carolinas - Charlotte - 1918 Randolph Rd | Charlotte | North Carolina | 28207 | — |
| Duke Early Phase Clinical Research Unit - PPDS | Durham | North Carolina | 27710-0001 | — |
| Onsite Clinical Solutions, LLC - Salisbury | Salisbury | North Carolina | 28144 | — |
| Arthritis & Osteoporosis Center of Southwest Ohio - Miamisburg | Miamisburg | Ohio | 45342 | — |
| University of Toledo Medical Center | Toledo | Ohio | 43614-2595 | — |
| STAT Research-600 Aviator Ct | Vandalia | Ohio | 45377-9474 | — |
| Low Country Rheumatology PA-Summerville | Summerville | South Carolina | 29486-7887 | — |
| Murfreesboro Medical Clinic Westlawn | Murfreesboro | Tennessee | 37128 | — |
| Amarillo Center For Clinical Research | Amarillo | Texas | 79124-1601 | — |
| Tekton Research, LLC - W Gate Blvd - Austin - PPDS | Austin | Texas | 78745-1470 | — |
| Accurate Clinical Management-Baytown | Baytown | Texas | 77521 | — |
| Precision Comprehensive Clinical Research Solutions | Grapevine | Texas | 76051-3143 | — |
| Prolato Clinical Research Center | Houston | Texas | 77054-2853 | — |
| R & H Clinical Research-777 S Fry Rd | Katy | Texas | 77450 | — |
| Valley Arthritis Center | McAllen | Texas | 78501 | — |
| University of Texas - San Antonio - Health Science Center - PPDS | San Antonio | Texas | 78229-3901 | — |
| DM Clinical Research - Migraine and COPD - PPDS | Tomball | Texas | 77375 | — |
| Metrodora Institute | West Valley City | Utah | 84119 | — |
| Overlake Arthritis & Osteoporosis Center | Bellevue | Washington | 98004-3016 | — |
| Western Washington Medical Group, Bothell - Rheumatology | Bothell | Washington | 98021 | — |
| Rheumatology and Pulmonary Clinic | Beckley | West Virginia | 25801-2805 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 171 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06104124, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 15, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06104124 live on ClinicalTrials.gov.