Nipocalimab in Moderate to Severe Sjogren's Disease
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Sjogrens Syndrome
In brief
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).
Key facts
- Study ID
- NCT06741969
- Run by
- Janssen Research & Development, LLC
- People needed
- 655
- Starts
- 2024-12-04
- Expected to finish
- 2029-05-18
- Last updated by the study team
- 2026-07-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Has a history of severe, progressive and/or uncontrolled hepatic, gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension, and/or any other medical or uncontrolled autoimmune disorder or clinically significant abnormalities in screening laboratory
- Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients or excipients used in the placebo formulation
- Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her SjD or has a family history of congenital or hereditary immunodeficiency
- Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis, to therapeutic proteins (for example [e.g.], monoclonal antibodies, intravenous immunoglobulin)
- Has any unstable or progressive manifestation of SjD that is likely to warrant escalation in therapy beyond permitted background medications
Where it is running
- Providence Medical Foundation — Fullerton, California, United States
- Arthritis & Osteoporosis Medical Center - La Palma — La Palma, California, United States
- NovaMed Research — Monterey Park, California, United States
- Medvin Clinical Research San Leandro — San Leandro, California, United States
- Providence Saint John s Health Center — Santa Monica, California, United States
- Solace Clinical Research California — Tustin, California, United States
- Inland Rheumatology Clinical Trials Inc. — Upland, California, United States
- Denver Arthritis Clinic — Denver, Colorado, United States
- Clinical Research of West Florida Inc — Clearwater, Florida, United States
- UF Health Rheumatology — Jacksonville, Florida, United States
- Suncoast Clinical Research — New Port Richey, Florida, United States
- Sarasota Arthritis Center — Sarasota, Florida, United States
- BioResearch Partner — South Miami, Florida, United States
- Immunology and Rheumatology Research Associates LLC — Suwanee, Georgia, United States
- Clinical Investigation Specialists - Clinic of Robert Hozman — Skokie, Illinois, United States
- Willow Rheumatology and Wellness PLLC — Willowbrook, Illinois, United States
- University of Iowa Hospital and Clinics — Iowa City, Iowa, United States
- University of Kansas Medical Center — Kansas City, Kansas, United States
- Clinical Research Institute of Michigan, LLC — Saint Clair Shores, Michigan, United States
- St. Paul Rheumatology P A — Eagan, Minnesota, United States
- AARA Clinical Research- Kansas City Physicians Partners — Kansas City, Missouri, United States
- Arthritis Rheumatic And Back Disease Associates — Voorhees Township, New Jersey, United States
- NYU Langone Health - Clinical and Translational Science Institute — New York, New York, United States
- Pioneer Clinical Research NY — New York, New York, United States
- Advanced Clinical Research Center — Chula Vista, California, United States
Full record on ClinicalTrials.gov
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