8 completed, 8 recruiting, 3 not yet recruiting, 3 terminated. 15 Phase 2, 6 Phase 3, 3 Phase 1, 1 Early Phase 1, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 15 | Recruiting 6, Completed 3, Not yet recruiting 3, Terminated 3 |
| Phase 3 | 6 | Completed 4, Terminated 2 |
| Phase 1 | 3 | Completed 2, Recruiting 1 |
| Early Phase 1 | 1 | Recruiting 1 |
| Phase 4 | 1 | Completed 1 |
Follow Emapalumab: new trials by email Literature Review of Emapalumab trials Research Report on Emapalumab
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 |
|---|---|---|---|---|---|---|
| Targeting Interferon Gamma With Emapalumab to Lung Transplant Recipients With Interferon Gamma-high Acute Lung Allograft Dysfunction Emapalumab, Placebo - Lung Transplant | Phase 2 | Not yet recruiting | University of California, San Francisco | 40 | 2026-11-02 | 2026-04-20 |
| Severe Hepatitis Intervention With Emapalumab for Liver Disease Emapalumab - Hepatitis | Phase 2 | Not yet recruiting | Children's Healthcare of Atlanta | 28 | 2026-09-01 | 2026-08-04 |
| Emapalumab MDA5 Rapidly Progressive Interstitial Lung Disease (RP-ILD) Study Emapalumab - Dermatomyositis, Dermatomyositis Sine Myositis | Phase 2 | Recruiting | University of Miami | 5 | 2026-07-23 | 2026-08-25 |
| Emapalumab With Post-Transplant Cyclophosphamide, Tacrolimus and Mycophenolate Mofetil for the Prevention of Graft-versus-Host Disease After Donor Reduced-Intensity Hematopoietic Cell Transplant Biospecimen Collection, Busulfan, Computed Tomography - Acute Myeloid Leukemia, Graft Versus Host Disease | Phase 1 | Recruiting | City of Hope Medical Center | 15 | 2026-06-12 | 2026-07-01 |
| Emapalumab Prophylaxis of Bispecific T-Cell Engagers (BiTEs) Associated CRS and ICANS Emapalumab - Multiple Myeloma, Large B-cell Lymphoma (LBCL) | Phase 2 | Not yet recruiting | NYU Langone Health | 60 | 2026-05-11 | 2026-05-06 |
| Prevention of Graft Rejection in Hematopoietic Stem Cell Transplant (HSCT) Recipients Emapalumab 3 mg/kg, Emapalumab 10 mg/kg - Hematopoietic Stem Cell Transplantation, Graft Failure | Early Phase 1 | Recruiting | Children's Hospital Medical Center, Cincinnati | 20 | 2026-01-07 | 2026-01-22 |
| Randomized Stepped Wedge Study of Emapalumab in APECED Enteritis Emapalumab - Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy Enteritis | Phase 2 | Recruiting | National Institute of Allergy and Infectious Diseases (NIAID) | 30 | 2025-11-12 | 2026-09-09 |
| Emapalumab Prevention of CAR-T Cell Associated Toxicities Emapalumab, Cyclophosphamide, Fludarabine Phosphate - Large B-cell Lymphoma, Relapsed Non-Hodgkin Lymphoma | Phase 2 | Recruiting | Marcela V. Maus, M.D.,Ph.D. | 28 | 2024-09-18 | 2026-10-06 |
| A Pilot Study of Emapalumab for the Treatment of CAR T-Cell Therapy-Associated Prolonged Cytopenia Emapalumab - Cytopenia | Phase 2 | Recruiting | M.D. Anderson Cancer Center | 32 | 2024-07-05 | 2026-08-07 |
| A Study of Emapalumab for Pediatric Aplastic Anemia Emapalumab - Aplastic Anemia, Cytopenia | Phase 2 | Recruiting | Memorial Sloan Kettering Cancer Center | 35 | 2024-05-21 | 2025-12-17 |
| A Study of Treatment of Inflammation Before Stem Cell Transplant in People With a Primary Immune Regulatory Disorder (PIRD) and/or an Autoinflammatory Condition Emapalumab, Fludarabine and Dexamethasone, Allogeneic hematopoietic stem cell transplant (allo-HCT) - Primary Immune Regulatory Disorder, Autoimmune Lymphoproliferative | Phase 2 | Recruiting | Joseph Oved | 39 | 2023-03-15 | 2026-06-02 |
| A Post-authorization Study to Describe the Safety and Efficacy of Emapalumab for the Treatment of pHLH in Treatment Experienced Chinese Patients Emapalumab-Lzsg 5 MG/ML [Gamifant] - Primary Hemophagocytic Lymphohistiocytosis | Phase 4 | Completed | Swedish Orphan Biovitrum | 13 | 2023-02-03 | 2026-08-26 |
| Evaluate Efficacy, Safety and Tolerability, PK and PD of Emapalumab in Children and Adults With MAS in Still's or SLE Emapalumab - Macrophage Activation Syndrome, Secondary Hemophagocytic Lymphohistiocytosis | Phase 3 | Completed | Swedish Orphan Biovitrum | 33 | 2021-12-15 | 2026-08-26 |
| Study to Investigate the Pharmacokinetics, Pharmacodynamics and Assess the Efficacy and Safety to Support Dose Selection of Emapalumab in Pre-empting Graft Failure in Patients at High Risk After HSCT. Emapalumab - Graft Failure | Phase 2 | Terminated | Swedish Orphan Biovitrum | 2 | 2021-05-25 | 2023-12-28 |
| A Study to Evaluate Emapalumab in Japanese Healthy Volunteers. NI-0501, Saline - Rare Diseases | Phase 1 | Completed | Swedish Orphan Biovitrum | 8 | 2021-01-14 | 2023-11-30 |
| A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Emapalumab in Adult Patients With HLH Emapalumab-Lzsg - Hemophagocytic Lymphohistiocytoses | Phase 2 / Phase 3 | Terminated | Swedish Orphan Biovitrum | 7 | 2020-06-02 | 2023-10-06 |
| Efficacy and Safety of Emapalumab and Anakinra in Reducing Hyperinflammation and Respiratory Distress in Patients With COVID-19 Infection. Emapalumab, Anakinra - SARS-CoV-2 | Phase 2 / Phase 3 | Terminated | Swedish Orphan Biovitrum | 16 | 2020-04-02 | 2022-03-10 |
| Study to Assess the Efficacy and Safety of Emapalumab in Primary Haemophagocytic Lymphohistiocytosis Emapalumab - Primary Hemophagocytic Lymphohistiocytosis | Phase 3 | Completed | Swedish Orphan Biovitrum | 35 | 2019-02-06 | 2024-03-12 |
| A Study to Investigate the Safety and Efficacy of Emapalumab, an Anti-IFN-gamma mAb in Patients With Systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD) Developing Macrophage Activation Syndrome/Secondary HLH (MAS/sHLH) Emapalumab - Macrophage Activation Syndrome, Lymphohistiocytosis, Hemophagocytic | Phase 2 | Completed | Swedish Orphan Biovitrum | 14 | 2018-02-20 | 2022-05-17 |
| A Study for Long-term Follow-up of Hemophagocytic Lymphohistiocytosis (HLH) Participants Who Received Treatment With Emapalumab (NI-0501), an Anti-interferon Gamma Monoclonal Antibody Emapalumab - Hemophagocytic Lymphohistiocytosis | Phase 2 / Phase 3 | Completed | Swedish Orphan Biovitrum | 58 | 2014-08-04 | 2022-06-28 |
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Lymphohistiocytosis, Hemophagocytic (6) · Arthritis, Juvenile (2) · Cytopenia (2) · Macrophage Activation Syndrome (2) · Amyopathic dermatomyositis (1) · Anemia, Aplastic (1) · Bone Marrow Failure Disorders (1) · Dermatomyositis (1) · Graft vs Host Disease (1) · Hepatitis (1) · Immune System Diseases (1) · Leukemia, Myeloid, Acute (1) · Lung Diseases, Interstitial (1) · Lupus Erythematosus, Systemic (1) · Lymphoma, Follicular (1)
Swedish Orphan Biovitrum (11) · Children's Healthcare of Atlanta (1) · Children's Hospital Medical Center, Cincinnati (1) · City of Hope Medical Center (1) · Joseph Oved (1) · M.D. Anderson Cancer Center (1) · Marcela V. Maus, M.D.,Ph.D. (1) · Memorial Sloan Kettering Cancer Center (1) · NYU Langone Health (1) · National Institute of Allergy and Infectious Diseases (NIAID) (1) · University of California, San Francisco (1) · University of Miami (1)
United States (18) · Italy (6) · United Kingdom (6) · Spain (5) · Canada (3) · France (3) · Germany (3) · China (2) · Japan (2) · Sweden (2) · Australia (1) · Belgium (1) · Czechia (1) · Israel (1) · Netherlands (1)
Amandeep Salhotra (1) · Andromachi Scaradavou, MD (1) · Anthony Sabulski, MD (1) · Ashvind Prabahran, Dr (1) · Emanuele Nicastri, MD (1) · Henrique Bittencourt, Dr (1) · John Belperio, Dr. (1) · John Greenland, Dr. (1) · Joseph Oved, MD (1) · Kelly Corbitt, D.O. (1) · Kenichi Furihata, MD, PhD (1) · Matthew Frigault, MD (1) · Michail S Lionakis, M.D. (1) · Oscar B. Lahoud, MD (1)
PMID 38662147, PMID 32374962, PMID 37001971, PMID 33935163
P30CA033572 (1)