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).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (9 UK sites)
Royal National Hospital for Rheumatic Diseases
Bath BA1 3NG, United Kingdom
Addenbrookes Hospital
Cambridge CB2 0QQ, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
Greater London SE1 9RT, United Kingdom
Newcastle Freeman Hospital
Newcastle upon Tyne NE7 7DN, United Kingdom
Peterborough City Hospital
Peterborough PE3 9GZ, United Kingdom
Royal Berkshire Hospital
Reading RG1 5LE, United Kingdom
Leslie Frederick-Mokogwu
researchanddevelopment@royalberkshire.nhs.uk0118 322 7449Southampton University Hospital
Southampton SO16 6HU, United Kingdom
Haywood Hospital
Stoke-on-Trent ST6 7AG, United Kingdom
Great Western Hospital
Swindon SN3 6BB, United Kingdom
How to Get in Touch
Study Contact
Sponsor contactCONTACT
