Nipocalimab for Sjogren's Syndrome

Recruiting in Palo Alto (17 mi)

+95 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Janssen Research & Development, LLC

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Inclusion Criteria

Meets classification criteria for primary Sjogren's syndrome (pSS) by the 2016 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) at the time of screening, and was diagnosed with pSS no less than 26 weeks prior to screening

Total Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (clinESSDAI) score greater than or equal to (>=) 6

At least one abnormal laboratory marker of pSS-related inflammatory disease activity, and at least low activity in one or more specified European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ESSDAI) domains

See 3 more

Exclusion Criteria

You have another autoimmune condition like rheumatoid arthritis, lupus, scleroderma, or inflammatory bowel disease that could make it difficult to accurately evaluate your symptoms of Sjogren's syndrome.

Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her pSS or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant

Comorbidities (for example, asthma, chronic obstructive pulmonary disease) which have required 3 or more courses of systemic glucocorticoids within the previous 12 months

See 2 more

Treatment Details

Interventions

Nipocalimab (Monoclonal Antibodies)
Placebo (Other)
Standard of Care Treatment (Other)

Participant Groups

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).