🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the UK / NCT06741969
Active, not recruiting Phase 3

Nipocalimab in Moderate to Severe Sjogren's Disease

NCT06741969 · tracked via the Priya Life Science UK tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2024-12-04
Last updated
2026-08-28

Condition(s) studied

Sjogrens Syndrome

Investigational drug(s) / intervention(s)

NipocalimabPlaceboStandard of care treatment

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria:- * Medically stable on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG) performed at screening * Meets criteria for diagnosis of SjD by the 2016 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria * Seropositive for antibodies to Ro/SSA (Ro60 and/or Ro52) at screening * Total ClinESSDAI score greater than or equal to (\>=) 5 at screening * Participants of childbearing potential must have a negative highly sensitive serum (beta-hCG) pregnancy test at screening and a negative urine pregnancy test at Week 0 prior to randomization Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (254)

FacilityCityRegionStatus
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.

Official registry record

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 the UK