Nipocalimab in Moderate to Severe Sjogren's Disease

Conditions

• Sjogrens Syndrome

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Nipocalimab — DRUG
  Nipocalimab SC.
• Placebo — DRUG
  Placebo SC.
• Standard of care treatment — DRUG
  Protocol-defined topical and systemic standard of care background treatments.

Study Details

The purpose of this study is to evaluate the clinical efficacy and safety of nipocalimab in participants with moderate to severe Sjogren's disease (SjD).

Key Dates

Start date

Dec 4, 2024

Status verified

Jun 2026

Primary completion

Jan 1, 2028

Completion

May 18, 2029

Study Design

Enrollment

655 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Nipocalimab
  Participants will receive nipocalimab subcutaneously (SC) along with standard of care treatments. At the Week 48 visit, eligible participants from both studies will have the option to enter an open-label long-term extension (OLE) phase, where they will continue to receive nipocalimab until Week 143 or until the study intervention is discontinued and participants opt to withdraw from the study.
• Placebo Comparator: Placebo
  Participants will receive placebo subcutaneously along with standard of care treatments. At the Week 48 visit, eligible participants from both studies will have the option to enter an OLE phase, where they will receive nipocalimab until Week 143 or until the study intervention is discontinued and participants opt to withdraw from the study.

Primary Outcome Measure

Change from Baseline in Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ClinESSDAI) Score at Week 48 [ Time Frame: Baseline to Week 48 ]

Locations (43)

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