9 recruiting, 8 completed, 2 active not recruiting, 1 temporarily not available. 9 Phase 3, 8 Phase 2, 5 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 9 | Recruiting 8, Active not recruiting 1 |
| Phase 2 | 8 | Completed 4, Recruiting 2, Active not recruiting 1, Withdrawn 1 |
| Phase 1 | 5 | Completed 4, Recruiting 1 |
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 to Assess Nipocalimab Concentrations in Breast Milk of Healthy Lactating Women Nipocalimab, Breast Milk Sampling - Healthy | Phase 1 | Recruiting | Janssen Research & Development, LLC | 8 | 2026-06-23 | 2026-09-29 |
| 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 |
| A Study of Nipocalimab in Adult Participants With Active Lupus Nephritis Placebo, Nipocalimab, Standard-of-care treatment - Lupus Nephritis | Phase 2 | Withdrawn | Janssen Research & Development, LLC | 2026-01-15 | 2026-02-27 | |
| 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 | 2026-09-25 |
| 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 |
| A Study to Evaluate the Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis Placebo, Nipocalimab, Certolizumab - Arthritis, Rheumatoid | Phase 2 | Completed | Janssen Research & Development, LLC | 103 | 2023-08-15 | 2025-10-16 |
| A Study on the Effect of Nipocalimab on Vaccine Responses in Healthy Participants Nipocalimab, Tdap, PPSV23 - Healthy | Phase 1 | Completed | Janssen Research & Development, LLC | 32 | 2023-04-12 | 2025-03-04 |
| 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 in Participants With Active Idiopathic Inflammatory Myopathies Nipocalimab, Placebo, Glucocorticoids - Myositis | Phase 2 | Active not recruiting | Janssen Research & Development, LLC | 36 | 2022-07-05 | 2026-09-21 |
| A Study of JNJ-80202135 in Healthy Chinese Adult Participants Nipocalimab - Healthy | Phase 1 | Completed | Janssen Research & Development, LLC | 30 | 2022-05-30 | 2022-10-26 |
| A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid Arthritis Placebo, Nipocalimab - Arthritis, Rheumatoid | Phase 2 | Completed | Janssen Research & Development, LLC | 53 | 2021-10-14 | 2025-08-22 |
| A Study of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS) Placebo, Nipocalimab, Standard of Care Treatment - Sjogren's Syndrome | Phase 2 | Completed | Janssen Research & Development, LLC | 163 | 2021-09-21 | 2025-11-05 |
| A Study of Nipocalimab With Co-administration of Etanercept or Hydroxychloroquine in Healthy Participants Nipocalimab, Etanercept, Hydroxychloroquine - Healthy | Phase 1 | Completed | Janssen Research & Development, LLC | 48 | 2021-08-31 | 2025-03-04 |
| A Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus Placebo, Nipocalimab, Standard-of-care treatment - Systemic Lupus Erythematosus | Phase 2 | Completed | Janssen Research & Development, LLC | 228 | 2021-08-20 | 2025-12-08 |
| 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 |
| A Study of Nipocalimab in Healthy Male and Female Participants Nipocalimab, Placebo - Healthy | Phase 1 | Completed | Janssen Research & Development, LLC | 89 | 2021-05-25 | 2023-07-03 |
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Myasthenia Gravis (3) · Arthritis, Rheumatoid (2) · Lupus Erythematosus, Systemic (2) · Sjogren's Syndrome (2) · Thrombocytopenia, Neonatal Alloimmune (2) · Lupus Nephritis (1) · Myositis (1) · Polyradiculoneuropathy, Chronic Inflammatory Demyelinating (1)
Janssen Research & Development, LLC (21)
United States (14) · Germany (12) · Poland (11) · Spain (10) · Japan (9) · France (8) · Italy (8) · United Kingdom (8) · Netherlands (7) · Argentina (6) · Hungary (6) · Israel (6) · Taiwan (6) · Canada (5) · China (5)
PMID 42084498, PMID 38942592, PMID 39053010, PMID 39862879, PMID 40232701, PMID 40389701, PMID 40515798, PMID 40720970, PMID 41021216, PMID 41284548, PMID 41290206, PMID 41461173, PMID 41781163, PMID 42675831
2023 (6), 2025 (2)