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NCT06104124 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-severe Systemic Disease Activity
A Phase 3 study of Sjogren's Syndrome, sponsored by Amgen.
- Active
- Registry status
- Phase 3
- Development phase
- 651
- Enrollment target
- 20
- Study locations
NCT06104124: Active Phase 3 study of Sjogren's Syndrome, sponsored by Amgen.
NCT06104124 is a Phase 3 study of Sjogren's Syndrome that is active but no longer recruiting, run by Amgen. The registered enrollment target is 651 participants, above the 256-participant average among 20 other Sjogren's Syndrome trials with a reported enrollment target (154% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06104124, a Phase 3 study of Sjogren's Syndrome, is active but no longer recruiting, sponsored by Amgen.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 651 participants
- Enrollment target
- 20
- Study locations
Study Summary
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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Dazodalibep
Study Locations (20)
Florida
- Bradenton Research Center Inc - Bradenton
- Clinical Research of West Florida Inc - Clearwater - Clearwater
- University of Miami - Leonard M. Miller School of Medicine - Miami
- Suncoast Clinical Research - ATLAS - New Port Richey - PPDS - New Port Richey
- Millennium Research - Ormond Beach
- West Broward Rheumatology Associates, Inc. - Tamarac
- BayCare Medical Group - Tampa
Arizona
- Arizona Arthritis & Rheumatology Associates - Avondale - Avondale
- Arizona Research Clinic PLLC - Chandler
- Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais Ln - Flagstaff
- Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St - Gilbert
- Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln - Glendale
- Arizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove Rd - Tucson
California
- UCSD Altman Clinical and Translational Research Institute Building - La Jolla
- Inland Rheumatology Clinical Trials Incorporated - Upland
Colorado
- Tekton Research, LLC - 2121 E Harmony Rd - PPDS - Fort Collins
Georgia
- Augusta University Medical Center-Augusta-1120 15th St - Augusta
Illinois
- OrthoIllinois, LTD - Rockford
Kansas
- University of Kansas Medical Center - Kansas City
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 651 participants |
| Start Date | 2024-01-24 |
| Est. Completion | 2026-08-19 |
| Phase | Phase 3 |
What the registry record for NCT06104124 still lists
NCT06104124 is an interventional study that assigns participants to a tested intervention. The registered 651 participants enrollment target is mid-sized for trials with a published cap, above the 256-participant average among 20 other Sjogren's Syndrome trials with a reported enrollment target (154% higher).
The record links to 1 condition, with Sjogren's Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06104124 names 20 study sites across 8 states, led by Florida, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT06104124 about?
NCT06104124 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-severe Systemic Disease Activity". 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...
What is the current status of trial NCT06104124?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 651 participants. The study started on 2024-01-24. Estimated completion is 2026-08-19.
What conditions does trial NCT06104124 study?
This clinical trial studies the following conditions: Sjogren's Syndrome.
What interventions are being tested in trial NCT06104124?
The interventions under investigation include: Placebo (DRUG), Dazodalibep (DRUG).
Who is sponsoring clinical trial NCT06104124?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06104124 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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651 4th of 20 higher than 17 of 20 other Sjogren's Syndrome trials
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