Nipocalimab for adults with moderate to severe systemic lupus erythematosus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3, randomized, placebo-controlled trial adds nipocalimab or matching placebo to participants' standard-of-care treatment to measure effects on disease activity and safety. Eligible adults must have a confirmed SLE diagnosis for at least 24 weeks and meet predefined SLEDAI-2K and BILAG-2004 activity thresholds at screening. Participants are monitored with clinical disease activity scores, routine labs, ECGs, and pregnancy testing for those of childbearing potential. The study is sponsored by Janssen Research & Development and is conducted at outpatient rheumatology sites in the United States.

Why it matters

Who can join: the full rules

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 and meeting 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. For eligibility, points attributed to "lupus headache," "alopecia," and "organic brain syndrome" are excluded
* 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

Where it's running

• David S Hallegua MD A Professional Corporation
  Beverly Hills, California, United States Recruiting
• Southland Arthritis and Osteoporosis Medical Center Inc dba Southland Arthritis
  Hemet, California, United States Recruiting
• Advanced Medical Research
  La Palma, California, United States Recruiting
• Providence Medical Foundation
  Mission Viejo, California, United States Recruiting
• Medvin Clinical Research San Leandro
  San Leandro, California, United States Recruiting
• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
  Torrance, California, United States Recruiting

+222 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.