A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-Severe Symptom State
Public ClinicalTrials.gov record NCT06245408. 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 Symptom State (HZNP-DAZ-303)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary Objective: To evaluate the effect of dazodalibep on patient-reported symptoms of SS in participants with moderate-to-severe symptom state Secondary Objectives: 1. To evaluate the effect of dazodalibep on patient-reported outcomes (PROs) in participants with SS. 2. To evaluate the effect of dazodalibep on measures of systemic activity, PROs, and salivary flow in participants with SS 3. To evaluate the safety and tolerability of multiple doses of dazodalibep in participants with SS
Study identification
- NCT ID
- NCT06245408
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 434 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
- Apr 8, 2024 (Actual)
- Primary completion
- Oct 22, 2026 (Estimated)
- Completion
- Dec 17, 2026 (Estimated)
- Last update posted
- Jan 8, 2026
2024 – 2026
United States locations
- U.S. sites
- 41
- U.S. states
- 18
- U.S. cities
- 40
| 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 | — |
| Medvin Clinical Research - Covina | Covina | California | 91723 | — |
| UCSD Altman Clinical and Translational Research Institute Building | La Jolla | California | 92037-1337 | — |
| Inland Rheumatology Clinical Trials Incorporated | Upland | California | 91786-4951 | — |
| Medvin Clinical Research | Whittier | California | 90602 | — |
| Tekton Research, LLC - 2121 E Harmony Rd - PPDS | Fort Collins | Colorado | 80528-3400 | — |
| Bradenton Research Center Inc | Bradenton | Florida | 34205-1704 | — |
| Clinical Research of West Florida Inc - Clearwater | Clearwater | Florida | 33765-2616 | — |
| West Broward Rheumatology Associates, Inc. | Tamarac | Florida | 33321-2956 | — |
| BayCare Medical Group Primary Care and Rheumatology - Tampa | Tampa | Florida | 33614-7101 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160-8500 | — |
| Tufts Medical Center - Rheumatology Research Office - PPDS | Boston | Massachusetts | 02111-1552 | — |
| 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 | — |
| Albuquerque Center for Rheumatology | Albuquerque | New Mexico | 87102-1710 | — |
| 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 | North Carolina | 28207-1100 | — |
| 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 | 45342-3585 | — |
| 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 | — |
| Murfreesboro Medical Clinic Westlawn | Murfreesboro | Tennessee | 37128 | — |
| Amarillo Center For Clinical Research | Amarillo | Texas | 79124-1601 | — |
| Accurate Clinical Management-Baytown | Baytown | Texas | 77521 | — |
| Precision Comprehensive Clinical Research Solutions | Grapevine | Texas | 76051-3143 | — |
| R & H Clinical Research-777 S Fry Rd | Katy | Texas | 77450-2297 | — |
| Texas Arthritis & Rheumatology Associates | Katy | Texas | 77450 | — |
| Valley Arthritis Center | McAllen | Texas | 78501 | — |
| University of Texas - San Antonio - Health Science Center - PPDS | San Antonio | Texas | 78229-3901 | — |
| Advanced Rheumatology of Houston - The Woodlands | The Woodlands | Texas | 77382 | — |
| DM Clinical Research - Migraine and COPD - PPDS | Tomball | Texas | 77375 | — |
| Western Washington Medical Group | Bothell | Washington | 98021-4418 | — |
| 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 153 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06245408, 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 8, 2026 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06245408 live on ClinicalTrials.gov.