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NCT04882878
A Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus
Completed
Phase 2
Last updated 8 December 2025
What this trial tests
Phase 2 trial testing Placebo in Systemic Lupus Erythematosus in 228 participants. Completed in 26 December 2024.
Timeline
20 August 2021
Primary endpoint
30 April 2024
30 April 2024
26 December 2024
Quick facts
| Lead sponsor | Janssen Research & Development, LLC |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 228 |
| Start date | 20 August 2021 |
| Primary completion | 30 April 2024 |
| Estimated completion | 26 December 2024 |
| Sites | 86 locations across Colombia, Japan, South Africa, Ukraine, Taiwan, Germany, Hungary, Poland |
Drugs / interventions tested
- Placebo
- Nipocalimab (NIPOCALIMAB) — full drug profile →
- Standard-of-care treatment
Conditions studied
- Systemic Lupus Erythematosus — all drugs for Systemic Lupus Erythematosus →
Sponsor
Janssen Research & Development, LLC — full company profile →
Who can join
Adults 18 to 65, any sex, with Systemic Lupus Erythematosus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate the efficacy of nipocalimab versus placebo in participants with active systemic lupus erythematosus (SLE).
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
The therapeutic age of the neonatal Fc receptor.
Pyzik M, Kozicky LK, Gandhi AK, Blumberg RS. · · 2023 · cited 166× · PMID 36726033 · DOI 10.1038/s41577-022-00821-1 -
Targeting TNF/TNFR superfamilies in immune-mediated inflammatory diseases.
Veerasubramanian PK, Wynn TA, Quan J, Karlsson FJ. · · 2024 · cited 26× · PMID 39297883 · DOI 10.1084/jem.20240806 -
Nipocalimab, an immunoselective FcRn blocker that lowers IgG and has unique molecular properties.
Seth NP, Xu R, DuPrie M, Choudhury A, et al · · 2025 · cited 17× · PMID 39936406 · DOI 10.1080/19420862.2025.2461191 -
Targeting the Neonatal Fc Receptor in Autoimmune Diseases: Pipeline and Progress.
Gjølberg TT, Mester S, Calamera G, Telstad JS, et al · · 2025 · cited 10× · PMID 40156757 · DOI 10.1007/s40259-025-00708-2 -
Immunotargets and Therapy for Systemic Lupus Erythematosus.
Mok CC. · · 2025 · cited 3× · PMID 40585390 · DOI 10.2147/itt.s485650 -
Neuro-Immune Crosstalk: Molecular Mechanisms, Biological Functions, Diseases, and Therapeutic Targets.
Guo X, Liu H, Song YJ, Wang JH, et al · · 2026 · cited 2× · PMID 41583906 · DOI 10.1002/mco2.70497
Verify or expand the search:
- PubMed search for NCT04882878
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Nipocalimab
Trials testing the same drug.
- NCT07438496 — A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus · Phase 3 · recruiting
- NCT04883619 — A Study of Nipocalimab in Adult Participants With Active Lupus Nephritis · Phase 2 · withdrawn
- NCT07217587 — Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis · Phase 3 · recruiting
- NCT06533098 — A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thro · Phase 3 · recruiting
- NCT06741969 — Nipocalimab in Moderate to Severe Sjogren's Disease · Phase 3 · active not recruiting
Other recruiting trials for Systemic Lupus Erythematosus
Currently open trials in the same condition.
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- NCT07371468 — A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD) · Phase 1 · recruiting
Other Janssen Research & Development, LLC trials
Trials by the same sponsor.
- NCT07518186 — A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma · Phase 3 · not yet recruiting
- NCT07309445 — A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC · recruiting
- NCT07499232 — A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease · Phase 3 · not yet recruiting
- NCT07438496 — A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus · Phase 3 · recruiting
- NCT07227025 — A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer · Phase 1, PHASE2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04882878 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Janssen Research & Development, LLC
- Last refreshed: 8 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04882878.
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