8 recruiting, 1 active not recruiting. 9 Phase 3, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 9 | Recruiting 8, Active not recruiting 1 |
| Phase 2 | 2 | Recruiting 2 |
Follow Nipocalimab: new trials by email Literature Review of Nipocalimab trials Research Report on Nipocalimab
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus Nipocalimab, Placebo, Standard of care treatment - Lupus Erythematosus, Systemic | Phase 3 | Recruiting | Janssen Research & Development, LLC | 600 | 2026-03-05 | 2026-09-25 |
| Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis Nipocalimab, Efgartigimod - Myasthenia Gravis | Phase 3 | Recruiting | Janssen Research & Development, LLC | 115 | 2026-01-05 | 2026-09-25 |
| A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) Nipocalimab, Intravenous immunoglobulins (IVIG), Prednisone - Thrombocytopenia, Neonatal Alloimmune | Phase 3 | Recruiting | Janssen Research & Development, LLC | 50 | 2025-02-10 | 2026-10-30 |
| Nipocalimab in Moderate to Severe Sjogren's Disease Nipocalimab, Placebo, Standard of care treatment - Sjogrens Syndrome | Phase 3 | Active not recruiting | Janssen Research & Development, LLC | 655 | 2024-12-04 | 2026-09-25 |
| A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) Nipocalimab, Placebo - Thrombocytopenia, Neonatal Alloimmune | Phase 3 | Recruiting | Janssen Research & Development, LLC | 39 | 2024-11-11 | 2026-09-25 |
| A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN) Nipocalimab, Placebo - Hemolytic Disease of the Fetus and Newborn | Phase 3 | Recruiting | Janssen Research & Development, LLC | 120 | 2023-12-20 | 2026-09-25 |
| Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Nipocalimab, Placebo - Polyradiculoneuropathy, Chronic Inflammatory Demyelinating | Phase 2 / Phase 3 | Recruiting | Janssen Research & Development, LLC | 201 | 2022-09-23 | 2026-09-25 |
| A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis Nipocalimab - Myasthenia Gravis | Phase 2 / Phase 3 | Recruiting | Janssen Research & Development, LLC | 12 | 2022-07-20 | 2026-07-31 |
| A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis Nipocalimab, Placebo, Nipocalimab SC-LIV - Myasthenia Gravis | Phase 3 | Recruiting | Janssen Research & Development, LLC | 199 | 2021-07-15 | 2026-07-27 |
Myasthenia Gravis (3) · Thrombocytopenia, Neonatal Alloimmune (2) · Lupus Erythematosus, Systemic (1) · Polyradiculoneuropathy, Chronic Inflammatory Demyelinating (1) · Sjogren's Syndrome (1)
Janssen Research & Development, LLC (9)
United States (8) · France (6) · Germany (6) · Israel (6) · Italy (6) · Japan (6) · Poland (6) · Spain (6) · United Kingdom (5) · Argentina (4) · Australia (4) · Belgium (4) · Brazil (4) · Canada (4) · China (4)
PMID 39053010, PMID 39862879, PMID 40515798, PMID 40720970, PMID 41021216, PMID 41290206, PMID 41461173, PMID 42084498, PMID 42675831
2023 (4), 2025 (2)