A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-Severe Symptom State
Condition(s) studied
Investigational drug(s) / intervention(s)
Dazodalibep: IV infusion
Placebo: IV infusion
Study summary
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
Eligibility
Primary outcome measure(s)
- Change from baseline in ESSPRI score — At Week 48
- Change from baseline in Diary for Assessing Sjogren's Patient Reported Index (DASPRI ) score — At week 48
Trial sites (194)
| Facility | City | Region | Status |
|---|---|---|---|
| Arizona Arthritis & Rheumatology Associates - Avondale | Avondale | Arizona | |
| Arizona Research Clinic PLLC | Chandler | Arizona | |
| Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais Ln | Flagstaff | Arizona | |
| Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St | Gilbert | Arizona | |
| Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln | Glendale | Arizona | |
| Arizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove Rd | Tucson | Arizona | |
| Medvin Clinical Research - Covina | Covina | California | |
| UCSD Altman Clinical and Translational Research Institute Building | La Jolla | California | |
| Inland Rheumatology Clinical Trials Incorporated | Upland | California | |
| Medvin Clinical Research | Whittier | California | |
| Tekton Research, LLC - 2121 E Harmony Rd - PPDS | Fort Collins | Colorado | |
| Bradenton Research Center Inc | Bradenton | Florida | |
| Clinical Research of West Florida Inc - Clearwater | Clearwater | Florida | |
| West Broward Rheumatology Associates, Inc. | Tamarac | Florida | |
| BayCare Medical Group Primary Care and Rheumatology - Tampa | Tampa | Florida | |
| University of Kansas Medical Center | Kansas City | Kansas | |
| Tufts Medical Center - Rheumatology Research Office - PPDS | Boston | Massachusetts | |
| Clinical Research Institute of Michigan, LLC-St. Claire Shores | Saint Clair Shores | Michigan | |
| Kansas City Physician Partners-8350 N Saint Clair Ave | Kansas City | Missouri | |
| Arthritis, Rheumatic & Bone Disease Associates - P | Voorhees Township | New Jersey | |
| Albuquerque Center for Rheumatology | Albuquerque | New Mexico | |
| NYU Langone Health - Joseph S. and Diane H. Steinberg Ambulatory Care Center | Brooklyn | New York | |
| Arthritis and Osteoporosis Consultants of The Carolinas | Charlotte | North Carolina | |
| Duke Early Phase Clinical Research Unit - PPDS | Durham | North Carolina | |
| Onsite Clinical Solutions, LLC - Salisbury | Salisbury | North Carolina | |
| Arthritis & Osteoporosis Center of Southwest Ohio - Miamisburg | Miamisburg | Ohio | |
| University of Toledo Medical Center | Toledo | Ohio | |
| STAT Research-600 Aviator Ct | Vandalia | Ohio | |
| Low Country Rheumatology PA-Summerville | Summerville | South Carolina | |
| Murfreesboro Medical Clinic Westlawn | Murfreesboro | Tennessee | |
| Amarillo Center For Clinical Research | Amarillo | Texas | |
| Accurate Clinical Management-Baytown | Baytown | Texas | |
| Precision Comprehensive Clinical Research Solutions | Grapevine | Texas | |
| R & H Clinical Research-777 S Fry Rd | Katy | Texas | |
| Texas Arthritis & Rheumatology Associates | Katy | Texas | |
| Valley Arthritis Center | McAllen | Texas | |
| University of Texas - San Antonio - Health Science Center - PPDS | San Antonio | Texas | |
| Advanced Rheumatology of Houston - The Woodlands | The Woodlands | Texas | |
| DM Clinical Research - Migraine and COPD - PPDS | Tomball | Texas | |
| Western Washington Medical Group | Bothell | Washington |
+ 154 more sites — see the full list on the official registry below.
More Amgen trials in South Korea
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06245408 on ClinicalTrials.gov ↗ ← All trials in South Korea