CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 163 enrolled
Drug / intervention
Nipocalimab +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04968912
NCT04968912Phase 2Completed
CompareCT.gov

A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)

Janssen Research & Development, LLC·interventional·Posted Jul 20, 2021·Updated Nov 5, 2025

In Brief

A Phase 2 clinical trial evaluating Placebo, Nipocalimab, and 1 other intervention for Sjogren's Syndrome. Completed, enrolled 163 participants across 69 sites in 10 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of nipocalimab in participants with primary Sjogren's syndrome (pSS) versus placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSjogren's Syndrome
CountriesFrance, Germany, Italy, Japan, Netherlands, Poland, Portugal, Spain, Taiwan, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedJul 20, 2021
Enrollment StartSep 21, 2021
Primary CompletionOct 23, 2023
Study CompletionNov 30, 2023
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 5.0 years ago

Interventions

Placeboother

Placebo infusion will be administered intravenously.

Nipocalimabdrug

Nipocalimab dose 1 and dose 2 infusions will be administered intravenously.

Standard of Care Treatmentdrug

Standard of care treatment including ophthalmic drops, artificial tears and saliva, punctum plugs, and secretagogues, and/or one immunomodulator with or without low-dose glucocorticosteroids will be administered topically/orally.