A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
Recruiting
Phase 3Interventional 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.
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
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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…
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
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.