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Active Not Recruiting NCT06741969

Nipocalimab in Moderate to Severe Sjogren's Disease

Conditions: Sjogrens Syndrome

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 655
Sponsor: Janssen Research & Development, LLC

Location: Advanced Clinical Research Center Chula Vista California

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 Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06741969). StuddyBuddy aggregates publicly available trial information.