RightFit
RecruitingPhase 3

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

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well nipocalimab works compared with a placebo, a treatment with no active medicine. It is for adults with moderate to severe systemic lupus erythematosus (SLE), or lupus. Lupus is a long-term disease in which the immune system attacks healthy parts of the body, causing swelling and redness.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Your health must be stable based on an exam, health history, vital signs, and an ECG, a test of your heart’s electrical activity.
  • You must have had a lupus diagnosis for at least 24 weeks and meet the study’s rules for classifying lupus.
  • Your lupus activity score (SLEDAI-2K) must be at least 6 at screening. The clinical part of this score must be at least 4 at screening and Week 0. Lupus headache, hair loss, and a brain function condition called organic brain syndrome do not count toward these scores.
  • If you can become pregnant, you must have a negative blood pregnancy test at screening and a negative urine pregnancy test at Week 0 before being assigned a treatment.
  • On another lupus activity scale (BILAG-2004), you must have at least one A score or two B scores at screening.

Who can't join

  • You have a history of severe, worsening, or uncontrolled health problems affecting organs, mental health, nerves, muscles, or bones; high blood pressure; other medical or uncontrolled immune system diseases; or important abnormal screening lab results.
  • Your lupus is unstable or worsening and will likely need more treatment than the study allows.
  • You have a known or suspected condition that weakens your immune system, not caused by lupus treatment. A family history of an inherited immune weakness also excludes you unless tests confirm you do not have it.
  • You have had a severe, immediate allergic reaction to protein-based medicines, such as anaphylaxis, a life-threatening allergic reaction.
  • You have a known or suspected allergy, unusual sensitivity, or inability to tolerate nipocalimab or other ingredients in the study medicine or placebo.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (38)

CA

CO

FL

GA

IL

LA

MI

NC

NJ

OH

PA

TN

TX

VA