Nipocalimab in Moderate to Severe Sjogren's Disease

Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Dec 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called nipocalimab for people with moderate to severe Sjogren's disease, which is an autoimmune condition that can cause dryness in the mouth and eyes, among other symptoms. The main goal of the study is to see how effective and safe nipocalimab is for patients dealing with this condition. The trial is currently recruiting participants who are between the ages of 65 and 74 and meet specific health criteria, such as being diagnosed with Sjogren's disease and having certain antibody levels in their blood.

To be eligible for this trial, participants must be in stable health and not have any serious, uncontrolled medical issues. They should also have a specific score indicating the severity of their Sjogren's disease. If someone joins the study, they can expect to receive either the nipocalimab treatment or a placebo (a dummy treatment) and will be monitored closely for any changes in their condition. It’s important to note that participants who are pregnant or have a history of severe allergic reactions to similar treatments may not be eligible. This trial is a step towards finding better treatments for those suffering from Sjogren's disease.

Gender

ALL

Eligibility 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