A Study of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)

Conditions

• Sjogren's Syndrome

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Placebo — OTHER
  Placebo infusion will be administered intravenously.
• Nipocalimab — DRUG
  Nipocalimab dose 1 and dose 2 infusions will be administered intravenously.
• Standard of Care Treatment — DRUG
  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.

Study Details

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

Key Dates

Start date

Sep 21, 2021

Status verified

Nov 2025

Primary completion

Oct 23, 2023

Completion

Nov 30, 2023

Study Design

Enrollment

163 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

• Placebo Comparator: Group 1: Placebo
  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).
• Experimental: Group 2: Nipocalimab Dose 1
  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).
• Experimental: Group 3: Nipocalimab Dose 2
  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).

Primary Outcome Measure

Change from Baseline in Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (clinESSDAI) Score at Week 24 [ Time Frame: Baseline to Week 24 ]

Locations (25)

Find similar trials in Anniston, AL

Related Studies

• Maternal Autoimmune Disease Research Alliance (MADRA) Registry
  Recruiting · Duke University · Durham, North Carolina
• Penn SICCA Follow-up Study
  Not Yet Recruiting · University of Pennsylvania · Philadelphia, Pennsylvania
• Rheumatology Diet Study
  Recruiting · University of Central Florida · Orlando, Florida
• A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Sjogren's Disease
  PHASE1 · Recruiting · Cullinan Therapeutics Inc. · Orlando, Florida