Tests nipocalimab against placebo in adults with lupus
Tests nipocalimab against placebo in adults with moderate to severe lupus.
Key facts
- Who runs it
- Janssen Research & Development, LLC
- Where
- Helsinki, Lahti, Oulu, and Turku, FinlandSee the 4 sitesAlso in 32 other countries, 269 sites
- Trial code
- Registry title
- A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 600 people, planned
- Started
- 5 Mar 2026
- Expected to end
- 7 Nov 2031
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Nipocalimab
- Placebo
- Standard of care treatment
- Record updated
- 3 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with moderate to severe systemic lupus erythematosus (SLE) to compare nipocalimab with a placebo.
- Age
- 18 Years to 75 Years
- Sex
- All sexes can join.
- Disease stage
- Moderate to severe SLE, diagnosed at least 24 weeks before screening. Disease activity scores must be high enough (SLEDAI-2K >= 6 at screening, clinical SLEDAI-2K >= 4), with at least 1 BILAG-2004 A score or 2 BILAG-2004 B scores.
Main reasons for not taking part
- Severe, progressive or uncontrolled liver, stomach and gut, kidney, lung, heart, mental health, nerve or muscle disorder, high blood pressure or another autoimmune disorder
- Unstable or worsening SLE that would likely need stronger treatment than the permitted background medicines
- Known or suspected immunodeficiency not caused by SLE treatment, or a family history of inherited immunodeficiency unless ruled out in the person
- Past severe immediate allergic reaction, such as anaphylaxis, to therapeutic proteins
- Known or suspected allergy or intolerance to nipocalimab or the placebo ingredients
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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
Who cannot take part
- Any unstable or progressive manifestation of SLE that is likely to warrant escalation in therapy beyond permitted background medications
- Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis, to therapeutic proteins
- 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
- Suspected or known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients, or excipients used in the placebo formulation
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in Finland
Also in 32 other countries, 269 sites
- HUS-YhtymaeHelsinki, FinlandTaking people
- Paeijaet-Haemeen hyvinvointialueLahti, FinlandTaking people
- Northern Clinical Trial Coordinators OyOulu, FinlandTaking people
- Turku University HospitalTurku, FinlandTaking people
About the trial
What the trial wants to find out
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).
The 2 groups in the trial
- NipocalimabTreatment being tested
Participants will receive nipocalimab up to Week 52 in the double blind treatment period along with standard of care treatments. At Week 52, eligible participants from both studies will have the option to enter an open-label long-term extension (OLE) period, where they will continue to receive nipocalimab until Week 156 or until the study intervention is discontinued.
Treatment: Nipocalimab and Standard of care treatment
- PlaceboPlacebo, for comparison
Participants will receive placebo up to Week 52 in the double blind treatment period along with standard of care treatment. At Week 52, eligible participants from both studies will have the option to enter an OLE period, where they will continue to receive nipocalimab until Week 156 or until the study intervention is discontinued.
Treatment: Nipocalimab, Placebo, and Standard of care treatment
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
- Plain-language title
- Tests nipocalimab against placebo in adults with lupusGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Fit questions
- Built from NCT07438496, who can take part
- Record updated
- 3 November 2026