A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-Severe Symptom State
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Sjögren's Syndrome (SS)
In brief
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
Key facts
- Study ID
- NCT06245408
- Run by
- Amgen
- People needed
- 434
- Starts
- 2024-04-08
- Expected to finish
- 2026-12-17
- Last updated by the study team
- 2026-01-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Arizona Research Clinic PLLC — Chandler, Arizona, United States
- Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais Ln — Flagstaff, Arizona, United States
- Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St — Gilbert, Arizona, United States
- Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln — Glendale, Arizona, United States
- Arizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove Rd — Tucson, Arizona, United States
- Medvin Clinical Research - Covina — Covina, California, United States
- UCSD Altman Clinical and Translational Research Institute Building — La Jolla, California, United States
- Inland Rheumatology Clinical Trials Incorporated — Upland, California, United States
- Medvin Clinical Research — Whittier, California, United States
- Tekton Research, LLC - 2121 E Harmony Rd - PPDS — Fort Collins, Colorado, United States
- Bradenton Research Center Inc — Bradenton, Florida, United States
- Clinical Research of West Florida Inc - Clearwater — Clearwater, Florida, United States
- West Broward Rheumatology Associates, Inc. — Tamarac, Florida, United States
- BayCare Medical Group Primary Care and Rheumatology - Tampa — Tampa, Florida, United States
- University of Kansas Medical Center — Kansas City, Kansas, United States
- Tufts Medical Center - Rheumatology Research Office - PPDS — Boston, Massachusetts, United States
- Clinical Research Institute of Michigan, LLC-St. Claire Shores — Saint Clair Shores, Michigan, United States
- Kansas City Physician Partners-8350 N Saint Clair Ave — Kansas City, Missouri, United States
- Arthritis, Rheumatic & Bone Disease Associates - P — Voorhees Township, New Jersey, United States
- Albuquerque Center for Rheumatology — Albuquerque, New Mexico, United States
- NYU Langone Health - Joseph S. and Diane H. Steinberg Ambulatory Care Center — Brooklyn, New York, United States
- Arthritis and Osteoporosis Consultants of The Carolinas — Charlotte, North Carolina, United States
- Duke Early Phase Clinical Research Unit - PPDS — Durham, North Carolina, United States
- Onsite Clinical Solutions, LLC - Salisbury — Salisbury, North Carolina, United States
- Arizona Arthritis & Rheumatology Associates - Avondale — Avondale, Arizona, United States
Full record on ClinicalTrials.gov
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