Nipocalimab in Moderate to Severe Sjogren's Disease

Purpose

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).

Condition

  • Sjogrens Syndrome

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Participants will be randomly assigned to one of the 2 identical studies (conducted under this single protocol) to make a total of 300 participants in each study. Participants in each study will be randomly assigned to one of the arms nipocalimab or placebo respectively.
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: Nipocalimab
    Nipocalimab SC.
    Other names:
    • JNJ-80202135, JNJ-86507083, M281
  • Drug: Standard of care treatment
    Protocol-defined topical and systemic standard of care background treatments.
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.
  • Drug: Placebo
    Placebo SC.
  • Drug: Standard of care treatment
    Protocol-defined topical and systemic standard of care background treatments.

Recruiting Locations

Providence Medical Foundation
Fullerton, California 92835

Inland Rheumatology Clinical Trials Inc.
Upland, California 91786

Denver Arthritis Clinic
Denver, Colorado 80230

Clinical Research of West Florida Inc
Clearwater, Florida 33765

Suncoast Clinical Research
New Port Richey, Florida 34652

Sarasota Arthritis Center
Sarasota, Florida 34239

BioResearch Partner
South Miami, Florida 33143

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

St. Paul Rheumatology P A
Eagan, Minnesota 55121

Atrium Health SouthPark Rheumatology
Charlotte, North Carolina 28211

Onsite Clinical Solutions
Salisbury, North Carolina 28144

Wright State Physicians Health Center
Fairborn, Ohio 45324

Altoona Center For Clinical Research
Duncansville, Pennsylvania 16635

West Tennessee Research Institute
Jackson, Tennessee 38305

Overlake Arthritis and Osteoporosis Center
Bellevue, Washington 98004

More Details

NCT ID
NCT06741969
Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

Study Contact
844-434-4210
Participate-In-This-Study1@its.jnj.com

Detailed Description

This clinical development program for nipocalimab in SjD includes 2 identical double blind, placebo-controlled studies to evaluate the efficacy, safety, and tolerability of nipocalimab in participants greater than or equal to (>=) 18 years of age with moderate to severe SjD.

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center