Nipocalimab in Moderate to Severe Sjogren's Disease

Description

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).

Conditions

Sjogrens Syndrome

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Study Overview

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Study Details

Study overview

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).

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)

Nipocalimab in Moderate to Severe Sjogren's Disease

Condition
Sjogrens Syndrome
Intervention / Treatment

-

Contacts and Locations

Upland

Inland Rheumatology Clinical Trials Inc., Upland, California, United States, 91786

Skokie

Clinical Investigation Specialists - Clinic of Robert Hozman, Skokie, Illinois, United States, 60076

Duncansville

Altoona Center For Clinical Research, Duncansville, Pennsylvania, United States, 16635

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Medically stable on the basis of physical examination, medical history, vital signs, 12-lead electrocardiogram (ECG) and clinical laboratory tests 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 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Janssen Research & Development, LLC,

Janssen Research & Development, LLC Clinical Trial, STUDY_DIRECTOR, Janssen Research & Development, LLC

Study Record Dates

2030-05-29