Nipocalimab for Sjogren's Syndrome

Phase 2

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 36

Summary

This trial is testing nipocalimab, a medicine that targets harmful immune proteins, in people with primary Sjogren's syndrome. The goal is to see if it can reduce inflammation and improve symptoms in these patients.

Eligible Conditions

Sjogren's Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 36

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 36

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 36 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline in Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (clinESSDAI) Score at Week 24

Secondary study objectives

Change from Baseline in European League Against Rheumatism (EULAR) Sjogren Syndrome Patient Reported Index (ESSPRI) Score at Week 24

Disease Response as Assessed by Sjögren's Tool for Assessing Response (STAR) Composite Score at Week 24

Response Elements

+14 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Group 3: Nipocalimab Dose 2Experimental Treatment2 Interventions

Participants will receive nipocalimab dose 2 IV q2w through Week 22 along with standard of care treatments (\[including ophthalmic drops, artificial tears and saliva, punctum plugs, and secretagogues\], and/or one immunomodulator with or without low-dose glucocorticosteroids).

Group II: Group 2: Nipocalimab Dose 1Experimental Treatment2 Interventions

Participants will receive nipocalimab dose 1 IV q2w through Week 22 along with standard of care treatments (\[including ophthalmic drops, artificial tears and saliva, punctum plugs, and secretagogues\], and/or one immunomodulator with or without low-dose glucocorticosteroids).

Group III: Group 1: PlaceboPlacebo Group2 Interventions

Participants will receive placebo intravenously (IV) every 2 weeks (q2w) through Week 22 along with standard of care treatments (\[including ophthalmic drops, artificial tears and saliva, punctum plugs, and secretagogues\], and/or one immunomodulator with or without low-dose glucocorticosteroids).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nipocalimab

2022

Completed Phase 2

~520

Standard of Care Treatment

2016

Completed Phase 3

~410