Emapalumab

DRUG14 trials

Sponsors

Hellenic Institute For The Study Of Sepsis, Swedish Orphan Biovitrum, Memorial Sloan Kettering Cancer Center, M.D. Anderson Cancer Center, Marcela V. Maus, M.D.,Ph.D.

Conditions

AOSDAcute Myeloid LeukemiaAdult Onset Still DiseaseAplastic AnemiaArthritis, JuvenileAutoimmune LymphoproliferativeAutoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy EnteritisCytopenia

Phase 1

Emapalumab With Post-Transplant Cyclophosphamide, Tacrolimus and Mycophenolate Mofetil for the Prevention of Graft-versus-Host Disease After Donor Reduced-Intensity Hematopoietic Cell Transplant

Not yet recruitingNCT06996119

City of Hope Medical CenterAcute Myeloid Leukemia, Graft Versus Host Disease, Myelodysplastic Syndrome

Start: 2026-05-25End: 2027-05-25Target: 15Updated: 2025-05-30

Phase 2

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

CompletedNCT02069899

Swedish Orphan BiovitrumHemophagocytic Lymphohistiocytosis

Start: 2014-08-04End: 2021-05-18Updated: 2022-06-28

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)

CompletedNCT03311854

Swedish Orphan BiovitrumAdult Onset Still Disease, Arthritis, Juvenile, Lymphohistiocytosis, Hemophagocytic +1

Start: 2018-02-20End: 2020-05-19Updated: 2022-05-17

Efficacy and Safety of Emapalumab and Anakinra in Reducing Hyperinflammation and Respiratory Distress in Patients With COVID-19 Infection.

TerminatedNCT04324021

Swedish Orphan BiovitrumSARS-CoV-2

Start: 2020-04-02End: 2020-11-13Updated: 2022-03-10

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.

TerminatedNCT04731298

Swedish Orphan BiovitrumGraft Failure

Start: 2021-05-25End: 2022-04-21Updated: 2023-12-28

A Study of Treatment of Inflammation Before Stem Cell Transplant in People With a Primary Immune Regulatory Disorder (PIRD) and/or an Autoinflammatory Condition

RecruitingNCT05787574

Memorial Sloan Kettering Cancer CenterAutoimmune Lymphoproliferative, Immune System Diseases, Primary Immune Regulatory Disorder

Start: 2023-03-15End: 2027-03-31Target: 39Updated: 2025-10-29

A Pilot Study of Emapalumab for the Treatment of CAR T-Cell Therapy-Associated Prolonged Cytopenia

RecruitingNCT06285825

M.D. Anderson Cancer CenterCytopenia

Start: 2024-07-05End: 2028-08-22Target: 32Updated: 2026-02-11

A Study of Emapalumab for Pediatric Aplastic Anemia

RecruitingNCT06430788

Memorial Sloan Kettering Cancer CenterAplastic Anemia, Cytopenia, Hypocellular Marrow

Start: 2024-05-21End: 2029-05-21Target: 35Updated: 2025-12-17

Emapalumab Prevention of CAR-T Cell Associated Toxicities

RecruitingNCT06550141

Marcela V. Maus, M.D.,Ph.D.Diffuse Large B Cell Lymphoma, Follicular Lymphoma, High-grade B-cell Lymphoma +4

Start: 2024-09-18End: 2027-08-01Target: 28Updated: 2025-11-14

EMAPALUMAB TREATMENT FOR ANTICIPATED CLINICAL BENEFIT IN SEPSIS DRIVEN BY THE INTERFERON-GAMMA ENDOTYPE (THE EMBRACE TRIAL)

Active, not recruitingCTIS2024-515255-38-00

Hellenic Institute For The Study Of SepsisSEPSIS

Start: 2025-03-12Target: 75Updated: 2025-11-03

Randomized Stepped Wedge Study of Emapalumab in APECED Enteritis

RecruitingNCT07202598

National Institute of Allergy and Infectious Diseases (NIAID)Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy Enteritis

Start: 2025-11-12End: 2031-09-01Target: 10Updated: 2025-12-11

Emapalumab MDA5 Rapidly Progressive Interstitial Lung Disease (RP-ILD) Study

Not yet recruitingNCT07486869

University of MiamiDermatomyositis, Dermatomyositis Sine Myositis, Dermatomyositis With Myopathy +4

Start: 2026-05-01End: 2027-05-01Target: 5Updated: 2026-03-23

Phase 3

Study to Assess the Efficacy and Safety of Emapalumab in Primary Haemophagocytic Lymphohistiocytosis

CompletedNCT03312751

Swedish Orphan BiovitrumPrimary Hemophagocytic Lymphohistiocytosis

Start: 2019-02-06End: 2022-09-14Updated: 2024-03-12

Evaluate Efficacy, Safety and Tolerability, PK and PD of Emapalumab in Children and Adults With MAS in Still's or SLE

CompletedNCT05001737

Swedish Orphan BiovitrumAOSD, Macrophage Activation Syndrome, MAS +4

Start: 2021-12-15End: 2025-06-04Updated: 2026-02-19

Related Papers

Population Pharmacokinetics of the Anti-Interferon-Gamma Monoclonal Antibody Emapalumab: An Updated Analysis.

2024-04-251 citations

Real-World Treatment Patterns and Outcomes Among Patients with Secondary Hemophagocytic Lymphohistiocytosis Treated with Emapalumab in the United States: The Real-HLH Study

Blood2023-11-022 citations

Emapalumab, a Fully Human Anti-Interferon Gamma Monoclonal Antibody, in Pediatric Patients with Primary Hemophagocytic Lymphohistiocytosis: Long-Term Follow-up of a Phase 2/3 Study

Blood2023-11-02

P090 Protocol for the two-cohort, open-label, single-arm EMERALD study of emapalumab, an anti-interferon gamma monoclonal antibody, in patients with macrophage activation syndrome in rheumatic diseases

Lara D. Veeken2023-04-01

Efficacy and safety of emapalumab in macrophage activation syndrome

Annals of the Rheumatic Diseases2023-03-31118 citations

Macrophage Activation Syndrome (MAS) in Systemic Juvenile Idiopathic Arthritis (sJIA): Treatment with Emapalumab, an Anti-Interferon Gamma (IFNγ) Monoclonal Antibody

Blood2021-11-057 citations

Trials in Progress: A Two-Cohort, Open-Label, Single-Arm Study of Emapalumab, an Anti-Interferon Gamma (IFNγ) Monoclonal Antibody, in Patients with Macrophage Activation Syndrome (MAS) in Rheumatic Diseases

Blood2021-11-055 citations

Safety of Emapalumab in Pediatric Patients with Primary Hemophagocytic Lymphohistiocytosis (HLH): Relationship to Treatment Exposure

Blood2021-11-052 citations

TCRαβ/CD19 depleted HSCT from an HLA-haploidentical relative to treat children with different nonmalignant disorders

Blood Advances2021-10-0152 citations

Analysis of Hospitalization Events in Patients with Primary Hemophagocytic Lymphohistiocytosis (HLH) Treated with Emapalumab

Blood2020-11-05

Interleukin-1 blockade with high-dose anakinra in patients with COVID-19, acute respiratory distress syndrome, and hyperinflammation: a retrospective cohort study.

2020-05-07711 citations

Emapalumab in Children with Primary Hemophagocytic Lymphohistiocytosis

New England Journal of Medicine2020-05-06478 citations

Safety and Efficacy of Emapalumab in Pediatric Patients with Primary Hemophagocytic Lymphohistiocytosis

Blood2018-11-2925 citations