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NCT06741969 · ClinicalTrials.gov registry record · Phase 3
Nipocalimab in Moderate to Severe Sjogren's Disease
A Phase 3 study of Sjogren's Syndrome, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 3
- Development phase
- 655
- Enrollment target
- 20
- Study locations
NCT06741969: Active Phase 3 study of Sjogren's Syndrome, sponsored by Janssen Research & Development.
NCT06741969 is a Phase 3 study of Sjogren's Syndrome that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 655 participants, above the 256-participant average among 20 other Sjogren's Syndrome trials with a reported enrollment target (156% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06741969, a Phase 3 study of Sjogren's Syndrome, is active but no longer recruiting, sponsored by Janssen Research & Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 655 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the clinical efficacy and safety of nipocalimab in participants with moderate to severe Sjogren's disease (SjD).
Primary Outcome
ClinESSDAI is a validated tool used in clinical studies to measure the systemic disease activity in participants with SjD. The ClinESSDAI includes 11 domains divided into 3-4 activity levels, where zero represents no activity and low, medium, and high scores can vary in numerical value depending on the domain being measured. A higher score represents worse disease symptoms.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Nipocalimab
- DRUG Standard of care treatment
Study Locations (20)
California
- Advanced Clinical Research Center - Chula Vista
- Providence Medical Foundation - Fullerton
- Arthritis & Osteoporosis Medical Center - La Palma - La Palma
- NovaMed Research - Monterey Park
- Medvin Clinical Research San Leandro - San Leandro
- Providence Saint John s Health Center - Santa Monica
- Solace Clinical Research California - Tustin
- Inland Rheumatology Clinical Trials Inc. - Upland
Florida
- Clinical Research of West Florida Inc - Clearwater
- UF Health Rheumatology - Jacksonville
- Suncoast Clinical Research - New Port Richey
- Sarasota Arthritis Center - Sarasota
- BioResearch Partner - South Miami
Illinois
- Clinical Investigation Specialists - Clinic of Robert Hozman - Skokie
- Willow Rheumatology and Wellness PLLC - Willowbrook
Colorado
- Denver Arthritis Clinic - Denver
Georgia
- Immunology and Rheumatology Research Associates LLC - Suwanee
Iowa
- University of Iowa Hospital and Clinics - Iowa City
Kansas
- University of Kansas Medical Center - Kansas City
Michigan
- Clinical Research Institute of Michigan, LLC - Saint Clair Shores
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 655 participants |
| Start Date | 2024-12-04 |
| Est. Completion | 2029-08-02 |
| Phase | Phase 3 |
What the registry record for NCT06741969 still lists
NCT06741969 is an interventional study that assigns participants to a tested intervention. The registered 655 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 (156% higher).
The record links to 1 condition, with Sjogren's Syndrome appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06741969 names 20 study sites across 8 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT06741969 about?
NCT06741969 is a clinical study titled "Nipocalimab in Moderate to Severe Sjogren's Disease". The purpose of this study is to evaluate the clinical efficacy and safety of nipocalimab in participants with moderate to severe Sjogren's disease (SjD).
What is the current status of trial NCT06741969?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 655 participants. The study started on 2024-12-04. Estimated completion is 2029-08-02.
What conditions does trial NCT06741969 study?
This clinical trial studies the following conditions: Sjogren's Syndrome.
What interventions are being tested in trial NCT06741969?
The interventions under investigation include: Placebo (DRUG), Nipocalimab (DRUG), Standard of care treatment (DRUG).
Who is sponsoring clinical trial NCT06741969?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06741969 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06741969's enrollment target sits among peer trials
655 3rd of 20 higher than 18 of 20 other Sjogren's Syndrome trials
participants (enrollment target), bucketed by value
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