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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513965-38-01

Acronym

80202135SJS3001

Enrollment

309

Registered

2025-06-05

Start date

2025-06-16

Completion date

Unknown

Last updated

2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sjögren's Disease

Brief summary

Change from Baseline in Clinical European League Against Rheumatism Sjogren’s Syndrome Disease Activity Index (ClinESSDAI) Score at Week 48.

Interventions

DRUGJNJ-80202135

DRUGPlacebo subcutaneous without Nipocalimab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from Baseline in Clinical European League Against Rheumatism Sjogren’s Syndrome Disease Activity Index (ClinESSDAI) Score at Week 48.	—

Countries

Austria, Bulgaria, Czechia, Denmark, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026