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 Sex
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

Advanced Clinical Research Center
Chula Vista 5336899, California 5332921 91910

Providence Medical Foundation
Fullerton 5351247, California 5332921 92835

Arthritis & Osteoporosis Medical Center - La Palma
La Palma 5364022, California 5332921 90623

NovaMed Research
Monterey Park 5374406, California 5332921 91754

Medvin Clinical Research San Leandro
San Leandro 5392263, California 5332921 94578

Providence Saint John s Health Center
Santa Monica 5393212, California 5332921 90404

Solace Clinical Research California
Tustin 5404119, California 5332921 92780

Inland Rheumatology Clinical Trials Inc.
Upland 5404915, California 5332921 91786

Denver Arthritis Clinic
Denver 5419384, Colorado 5417618 80230

Clinical Research of West Florida Inc
Clearwater 4151316, Florida 4155751 33765

UF Health Rheumatology
Jacksonville 4160021, Florida 4155751 32256

Suncoast Clinical Research
New Port Richey 4165869, Florida 4155751 34652

Sarasota Arthritis Center
Sarasota 4172131, Florida 4155751 34239

BioResearch Partner
South Miami 4173495, Florida 4155751 33143

Immunology and Rheumatology Research Associates LLC
Suwanee 4225309, Georgia 4197000 30024

Clinical Investigation Specialists - Clinic of Robert Hozman
Skokie 4911600, Illinois 4896861 60076

Willow Rheumatology and Wellness PLLC
Willowbrook 4916709, Illinois 4896861 60527

University of Iowa Hospital and Clinics
Iowa City 4862034, Iowa 4862182 52242

University of Kansas Medical Center
Kansas City 4273837, Kansas 4273857 66160

Clinical Research Institute of Michigan, LLC
Saint Clair Shores 5010978, Michigan 5001836 48081

St. Paul Rheumatology P A
Eagan 5024825, Minnesota 5037779 55121

AARA Clinical Research- Kansas City Physicians Partners
Kansas City 4393217, Missouri 4398678 64151

Arthritis Rheumatic And Back Disease Associates
Voorhees Township 5105860, New Jersey 5101760 08043

NYU Langone Health - Clinical and Translational Science Institute
New York 5128581, New York 5128638 10016

Pioneer Clinical Research NY
New York 5128581, New York 5128638 10016

Joint and Muscle Research Institute
Charlotte 4460243, North Carolina 4482348 28204

Atrium Health SouthPark Rheumatology
Charlotte 4460243, North Carolina 4482348 28211

Onsite Clinical Solutions
Salisbury 4489985, North Carolina 4482348 28144

Wright State Physicians Health Center
Fairborn 4511263, Ohio 5165418 45324

OMRF Rheumatology Center of Excellence
Oklahoma City 4544349, Oklahoma 4544379 73104

Rheumatology Associates of Oklahoma
Oklahoma City 4544349, Oklahoma 4544379 73116

Altoona Center For Clinical Research
Duncansville 5187508, Pennsylvania 6254927 16635

Clinical Research Philadelphia
Philadelphia 4560349, Pennsylvania 6254927 19114

Low Country Rheumatology PA
Summerville 4597919, South Carolina 4597040 29486

West Tennessee Research Institute
Jackson 4632595, Tennessee 4662168 38305

Amarillo Premier Research
Amarillo 5516233, Texas 4736286 79124

Texas Rheumatology Research Institute LLC
Plano 4719457, Texas 4736286 75024

Fort Bend Rheumatology Associates PLLC
Sugar Land 4734825, Texas 4736286 77479

Advanced Rheumatology of Houston
The Woodlands 4736476, Texas 4736286 77382

Alpine Research TC LLC
Layton 5777107, Utah 5549030 84041

Tidewater Clinical Research
Chesapeake 4752186, Virginia 6254928 23320

Overlake Arthritis and Osteoporosis Center
Bellevue 5786882, Washington 5815135 98004

More Details

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.