Nipocalimab in Moderate to Severe Sjogren's Disease
Condition(s) studied
Investigational drug(s) / intervention(s)
Nipocalimab: Nipocalimab SC.
Placebo: Placebo SC.
Standard of care treatment: Protocol-defined topical and systemic standard of care background treatments.
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).
Eligibility
Primary outcome measure(s)
- Change from Baseline in Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ClinESSDAI) Score at Week 48 — Baseline to Week 48
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.
Trial sites (254)
| Facility | City | Region | Status |
|---|---|---|---|
| Advanced Clinical Research Center | Chula Vista | California | |
| Providence Medical Foundation | Fullerton | California | |
| Arthritis & Osteoporosis Medical Center - La Palma | La Palma | California | |
| NovaMed Research | Monterey Park | California | |
| Medvin Clinical Research San Leandro | San Leandro | California | |
| Providence Saint John s Health Center | Santa Monica | California | |
| Solace Clinical Research California | Tustin | California | |
| Inland Rheumatology Clinical Trials Inc. | Upland | California | |
| Denver Arthritis Clinic | Denver | Colorado | |
| Clinical Research of West Florida Inc | Clearwater | Florida | |
| UF Health Rheumatology | Jacksonville | Florida | |
| Suncoast Clinical Research | New Port Richey | Florida | |
| Sarasota Arthritis Center | Sarasota | Florida | |
| BioResearch Partner | South Miami | Florida | |
| Immunology and Rheumatology Research Associates LLC | Suwanee | Georgia | |
| Clinical Investigation Specialists - Clinic of Robert Hozman | Skokie | Illinois | |
| Willow Rheumatology and Wellness PLLC | Willowbrook | Illinois | |
| University of Iowa Hospital and Clinics | Iowa City | Iowa | |
| University of Kansas Medical Center | Kansas City | Kansas | |
| Clinical Research Institute of Michigan, LLC | Saint Clair Shores | Michigan | |
| St. Paul Rheumatology P A | Eagan | Minnesota | |
| AARA Clinical Research- Kansas City Physicians Partners | Kansas City | Missouri | |
| Arthritis Rheumatic And Back Disease Associates | Voorhees Township | New Jersey | |
| NYU Langone Health - Clinical and Translational Science Institute | New York | New York | |
| Pioneer Clinical Research NY | New York | New York | |
| Joint and Muscle Research Institute | Charlotte | North Carolina | |
| Atrium Health SouthPark Rheumatology | Charlotte | North Carolina | |
| Onsite Clinical Solutions | Salisbury | North Carolina | |
| Wright State Physicians Health Center | Fairborn | Ohio | |
| OMRF Rheumatology Center of Excellence | Oklahoma City | Oklahoma | |
| Rheumatology Associates of Oklahoma | Oklahoma City | Oklahoma | |
| Altoona Center For Clinical Research | Duncansville | Pennsylvania | |
| Clinical Research Philadelphia | Philadelphia | Pennsylvania | |
| Low Country Rheumatology PA | Summerville | South Carolina | |
| West Tennessee Research Institute | Jackson | Tennessee | |
| AARA Clinical Research - Murfreesboro Medical Clinic | Murfreesboro | Tennessee | |
| Amarillo Premier Research | Amarillo | Texas | |
| Texas Rheumatology Research Institute LLC | Plano | Texas | |
| Fort Bend Rheumatology Associates PLLC | Sugar Land | Texas | |
| Advanced Rheumatology of Houston | The Woodlands | Texas |
+ 214 more sites — see the full list on the official registry below.
More Janssen Research & Development, LLC trials in Italy
Other trials for the same condition
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 NCT06741969 on ClinicalTrials.gov ↗ ← All trials in Italy