NCT06741969

Nipocalimab in Moderate to Severe Sjogren's Disease

A Randomized, Placebo-controlled, Double-blind, Multicenter Phase 3 Protocol to Assess the Efficacy and Safety of Nipocalimab in Adults With Moderate to Severe Sjogren's Disease (SjD)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 655 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This clinical development program for nipocalimab in SjD includes 2 identical double blind, placebo-controlled studies to evaluate the efficacy, safety, and tolerability of nipocalimab in participants greater than or equal to (\>=) 18 years of age with moderate to severe SjD.

Conditions

• Sjogrens Syndrome

Interventions

Type	Name	Description
DRUG	Nipocalimab	Nipocalimab SC.
DRUG	Placebo	Placebo SC.
DRUG	Standard of care treatment	Protocol-defined topical and systemic standard of care background treatments.

Timeline

• Start date: 2024-12-04
• Primary completion: 2028-01-01
• Completion: 2029-08-02
• First posted: 2024-12-19
• Last updated: 2026-04-13

Locations

254 sites across 28 countries: United States, Argentina, Austria, Brazil, Bulgaria, Canada, China, Czechia, Denmark, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Romania, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study