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Nipocalimab for treating moderate to severe Sjogren's disease

A Randomized, Placebo-controlled, Double-blind, Multicenter Phase 3 Protocol to Assess the Efficacy and Safety of Nipocalimab in Adults With Moderate to Severe Sjogren's Disease (SjD)

Phase 3 Interventional Janssen Research & Development, LLC · NCT06741969

This study is testing if nipocalimab can help adults with moderate to severe Sjogren's disease feel better compared to a placebo and standard care.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment600 (estimated)
Ages18 Years and up
SexAll
SponsorJanssen Research & Development, LLC Industry-sponsored
Drugs / interventionsnipocalimab
Locations59 sites (Fullerton, California and 58 other locations)
Trial IDNCT06741969 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of nipocalimab in adults with moderate to severe Sjogren's disease through two identical double-blind, placebo-controlled studies. Participants aged 18 and older will be assessed for their response to nipocalimab compared to a placebo and standard care treatment. The study aims to determine how well nipocalimab improves symptoms and overall health in these patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have been diagnosed with moderate to severe Sjogren's disease and are seropositive for specific antibodies.

Not a fit: Patients with severe, uncontrolled medical conditions or other significant autoimmune disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from moderate to severe Sjogren's disease.

How similar studies have performed: Other studies have shown promise with similar approaches in treating autoimmune diseases, but this specific application of nipocalimab is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Medically stable on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG) performed at screening
* Meets criteria for diagnosis of SjD by the 2016 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria
* Seropositive for antibodies to Ro/SSA (Ro60 and/or Ro52) at screening
* Total ClinESSDAI score greater than or equal to (\>=) 5 at screening
* Participants of childbearing potential must have a negative highly sensitive serum (beta-hCG) pregnancy test at screening and a negative urine pregnancy test at Week 0 prior to randomization

Exclusion Criteria:

* Has a history of severe, progressive and/or uncontrolled hepatic, gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension, and/or any other medical or uncontrolled autoimmune disorder or clinically significant abnormalities in screening laboratory
* Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients or excipients used in the placebo formulation
* Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her SjD or has a family history of congenital or hereditary immunodeficiency
* Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis, to therapeutic proteins (for example \[e.g.\], monoclonal antibodies, intravenous immunoglobulin)
* Has any unstable or progressive manifestation of SjD that is likely to warrant escalation in therapy beyond permitted background medications

Where this trial is running

Fullerton, California and 58 other locations

+9 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Sjogrens SyndromeSjogrens Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.