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Looking for participantsPhase3

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

Sponsor: Janssen Research & Development, LLC

NCT ID: NCT07438496

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Nipocalimab (drug), Placebo (drug), Standard of care treatment (drug)
How long the study runs
Study runs about 68 months (dates as stated)
About the drug or intervention
Nipocalimab — drug: Nipocalimab will be administered. · Placebo — drug: Placebo will be administered. · Standard of care treatment — drug: Protocol-defined topical and systemic standard of care background treatments.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 75 Years
Who
All
Number of participants
600
Started
2026-03-05
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for lupus erythematosus, systemic
  • • Phase3 - 600 participants
  • • 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)

Who can take part?

  • • Ages 18 Years to 75 Years
  • • Diagnosed with lupus erythematosus, systemic

Where?

  • • Bath - Royal National Hospital for Rheumatic Diseases
  • • Cambridge - Addenbrookes Hospital
  • • Greater London - Guy's and St Thomas' NHS Foundation Trust
  • • Newcastle upon Tyne - Newcastle Freeman Hospital
  • • +5 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

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).

Lupus Erythematosus, Systemic

How this trial compares with your answers

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What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 75 Years
  • Who can join: All genders

Biomarkers mentioned

have a negativeand a negative

What the study is looking for

  • ✓Medically stable on the basis of physical examination, medical history, vital signs and 12-lead electrocardiogram...
  • ✓Participants of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-hCG) test at...
  • ✓Has at least 1 BILAG-2004 A score or 2 BILAG-2004 B scores observed at screening

Who cannot take part

  • ✗Any unstable or progressive manifestation of SLE that is likely to warrant escalation in therapy beyond permitted...
  • ✗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...
See the full 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

Where Is This Study? (9 UK sites)

Royal National Hospital for Rheumatic Diseases

Bath BA1 3NG, United Kingdom

Recruiting

Addenbrookes Hospital

Cambridge CB2 0QQ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Stephen Kelleher

cuh.research@nhs.net01223 348490

Guy's and St Thomas' NHS Foundation Trust

Greater London SE1 9RT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Main Email: gstt.research.rbhh@nhs.net

gstt.research.rbhh@nhs.netn/a

Newcastle Freeman Hospital

Newcastle upon Tyne NE7 7DN, United Kingdom

Recruiting

Peterborough City Hospital

Peterborough PE3 9GZ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Hannah Wroe

nwangliaft.rddepartment@nhs.net01733 677919

Royal Berkshire Hospital

Reading RG1 5LE, United Kingdom

Recruiting
Hospital R&D contact (matched)

Leslie Frederick-Mokogwu

researchanddevelopment@royalberkshire.nhs.uk0118 322 7449

Southampton University Hospital

Southampton SO16 6HU, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Mikayala King

researchmanagement@uhs.nhs.uk023 81208215

Haywood Hospital

Stoke-on-Trent ST6 7AG, United Kingdom

Recruiting

Great Western Hospital

Swindon SN3 6BB, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Donna Noonan

gwh.researchmanagement@nhs.net01793 605565

How to Get in Touch

Study Contact

Sponsor contact

CONTACT

844-434-4210 Participate-In-This-Study1@its.jnj.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09