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Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT06104124

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.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 2:25 AM EDT

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
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Amgen
Industry
Enrollment
651 participants

Conditions and interventions

Interventions

Drug

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 24, 2024 (Actual)
Primary completion
Jul 23, 2026 (Actual)
Completion
Aug 17, 2026 (Actual)
Last update posted
Sep 14, 2026

2024 – 2026

United States locations

U.S. sites
37
U.S. states
18
U.S. cities
37
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 —
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 —
University of Kansas Medical Center Kansas City Kansas 66160-0001 —
Massachusetts General Hospital (MGH) - Rheumatology Associates 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 - Voorhees 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 - 801 E Morehead St Charlotte North Carolina 28202 —
Duke Early Phase Clinical Research Unit - PPDS Durham North Carolina 27710-0001 —
Onsite Clinical Solutions, LLC - Salisbury Salisbury North Carolina 28144 —
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 —
Cedar Health Research - Arlington - PPDS Euless Texas 76040 —
R & H Clinical Research - Katy - 1531 Westborough Dr Katy Texas 77449 —
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 —
Overlake Arthritis & Osteoporosis Center Bellevue Washington 98004-3016 —
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 169 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 Sep 14, 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 NCT06104124 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →