A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

Purpose

The purpose of this study is to evaluate how well nipocalimab works as compared to placebo in participants with moderate to severe Systemic lupus erythematosus (SLE, a long-term disease where the immune system mistakenly attacks its own healthy tissues, causing swelling and redness in various organs).

Condition

  • Lupus Erythematosus, Systemic

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • - Medically stable on the basis of physical examination, medical history, vital signs and 12-lead electrocardiogram (ECG) performed at screening - Clinical diagnosis of systemic lupus erythematosus (SLE) for more than or equal to (>=) 24 weeks prior to screening according to european league against rheumatism/american college of rheumatology (EULAR/ACR) classification criteria - Must have a systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score >= 6 and a clinical SLEDAI-2K >= 4 at screening, AND a clinical SLEDAI-2K score >= 4 points at Week 0, excluding points attributed to "lupus headache," "alopecia," and "organic brain syndrome" - Participants of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-hCG) test at screening and a negative urine (β- hCG) test at Week 0 prior to randomization - Has at least 1 BILAG-2004 A score or 2 BILAG-2004 B scores observed at screening

Exclusion Criteria

  • 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 (s) or clinically significant abnormalities in screening laboratory - Any unstable or progressive manifestation of SLE that is likely to warrant escalation in therapy beyond permitted background medications - Confirmed or suspected clinical immunodeficiency syndrome not related to treatment of SLE or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant - Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis, to therapeutic proteins - Suspected or known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients, or excipients used in the placebo formulation

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
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Nipocalimab 		Participants will receive nipocalimab up to Week 52 in the double blind treatment period along with standard of care treatments. At Week 52, eligible participants from both studies will have the option to enter an open-label long-term extension (OLE) period, where they will continue to receive nipocalimab until Week 156 or until the study intervention is discontinued.
  • Drug: Nipocalimab
    Nipocalimab will be administered.
  • Drug: Standard of care treatment
    Protocol-defined topical and systemic standard of care background treatments.
Placebo Comparator
Placebo 		Participants will receive placebo up to Week 52 in the double blind treatment period along with standard of care treatment. At Week 52, eligible participants from both studies will have the option to enter an OLE period, where they will continue to receive nipocalimab until Week 156 or until the study intervention is discontinued.
  • Drug: Nipocalimab
    Nipocalimab will be administered.
  • Drug: Placebo
    Placebo will be administered.
  • Drug: Standard of care treatment
    Protocol-defined topical and systemic standard of care background treatments.

Recruiting Locations

David S Hallegua MD A Professional Corporation
Beverly Hills, California 90211

Southland Arthritis and Osteoporosis Medical Center Inc dba Southland Arthritis
Hemet, California 92543

Advanced Medical Research
La Palma, California 90623

Solace Clinical Research California
Tustin, California 92780

Inland Rheumatology Clinical Trials Inc.
Upland, California 91786

Arthritis & Rheumatic Disease Specialties
Aventura, Florida 33180

Clinical Research of West Florida 1
Clearwater, Florida 33765

Avanti Clinical Research Corp
Hialeah, Florida 33013

LeJenue Research Associates PLLC
Miami, Florida 33126

Floridian Clinical Research LLC
Miami Lakes, Florida 33016

Clinical Research of West Florida
Tampa, Florida 33606

Willow Rheumatology and Wellness PLLC
Willowbrook, Illinois 60527

Accurate Clinical Research, Inc.
Lake Charles, Louisiana 70605

Joint and Muscle Research Institute
Charlotte, North Carolina 28204

DJL Clinical Research, PLLC
Charlotte, North Carolina 28211

Cross Creek Medical Clinic
Fayetteville, North Carolina 28304 4422

Paramount Medical Research & Consulting
Middleburg Heights, Ohio 44130

Clinical Research Philadelphia
Philadelphia, Pennsylvania 19114

West Tennessee Research Institute
Jackson, Tennessee 38305

Arthritis and Rheumatology Research Institute
Allen, Texas 75013

Amarillo Center for Clinical Research
Amarillo, Texas 79124

R and H Clinical Research
Katy, Texas 77449

Southwest Rheumatology Research LLC
Mesquite, Texas 75150

Texas Rheumatology Research Institute LLC
Plano, Texas 75024

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

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