Tests nipocalimab against placebo in adults with lupus
Tests nipocalimab against placebo in adults with moderate to severe lupus.
Plain-language title generated from the registry record
Registry title: A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
Key facts
- Where
- Goiânia, Juiz de Fora, Porto Alegre, Ribeirão Preto, Salvador, São José do Rio Preto, São Paulo, and Vitória, BrazilSee the 14 sites
- Phase
- Phase 3
Could this be for you?
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?
Source: NCT07438496, who can take part
Where in Brazil
- Hospital das Clinicas - UFGGoiânia, BrazilTaking people
- CMIP - Centro Mineiro de Pesquisa LtdaJuiz de Fora, BrazilTaking people
- Hospital de Clinicas de Porto AlegrePorto Alegre, BrazilTaking people
- Hospital Moinhos de VentoPorto Alegre, BrazilTaking people
- LMK Servicos Medicos S SPorto Alegre, BrazilTaking people
- Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRSPorto Alegre, BrazilTaking people
- Hospital das Clinicas da Faculdade de Medicina de Ribeirao PretoRibeirão Preto, BrazilTaking people
- IDOR - Regional BahiaSalvador, BrazilTaking people
- SER - Servicos Especializados em Reumatologia da BahiaSalvador, BrazilTaking people
- Funfarme SjrpSão José do Rio Preto, BrazilTaking people
- Cepes - FmabcSão Paulo, BrazilTaking people
- Hospital das Clinicas da Faculdade de Medicina da USPSão Paulo, BrazilTaking people
- Hospital Samaritano de Sao PauloSão Paulo, BrazilTaking people
- CEDOES Centro de Pesquisa Clinica e Diagnostico do Espirito Santo LtdaVitória, BrazilTaking people
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?
Trial details
- Who runs it
- Janssen Research & Development, LLC
- Trial code
- NCT07438496EU 2025-523552-31-00
- Record updated
- 3 November 2026
- Original description
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).Read full original descriptionShow less
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
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).
Inclusion: 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: 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.