Nipocalimab for Moderate to Severe Lupus

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

Recruiting Phase 3 Interventional Study
Lupus Erythematosus, Systemic
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
600 (estimated)
Sponsor
Janssen Research & Development, LLC · Industry
Who this trial is looking for

This trial is looking for adults with moderate to severe lupus. Participants will receive either the drug nipocalimab or a placebo to see how well it works.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with lupus for at least 24 weeks.
  • I have a lupus disease activity score of 6 or higher.
  • I have at least one significant symptom of lupus.
  • I am medically stable based on my health check.
  • I am a woman of childbearing potential and have had a negative pregnancy test.

You may not be able to join if

  • I have a history of severe health problems or uncontrolled autoimmune disorders.
  • I have unstable or worsening lupus symptoms needing stronger treatment.
  • I have a confirmed or suspected immune deficiency unrelated to lupus.
  • I have had a severe allergic reaction to therapeutic proteins before.
  • I am allergic to nipocalimab or its components.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

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About This Trial

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).

Trial Locations
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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 eu…
Contacts

Study Contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

CONTACT