NI-0501

DRUG3 trials

Sponsors

Swedish Orphan Biovitrum

Conditions

Healthy VolunteersPrimary Haemophagocytic LymphohistiocytosisRare Diseases

Phase 1

First in Human Study of an Anti-IFN Gamma Monoclonal Antibody in Healthy Volunteers

CompletedNCT01459562

Swedish Orphan BiovitrumHealthy Volunteers

Start: 2011-09-30End: 2013-01-31Updated: 2023-08-09

A Study to Evaluate Emapalumab in Japanese Healthy Volunteers.

CompletedNCT04765553

Swedish Orphan BiovitrumRare Diseases

Start: 2021-01-14End: 2021-07-25Updated: 2023-11-30

Phase 2

Study to Investigate Safety, Efficacy of an Anti-IFNγ mAb in Children With Primary Haemophagocytic Lymphohistiocytosis

CompletedNCT01818492

Swedish Orphan BiovitrumPrimary Haemophagocytic Lymphohistiocytosis

Start: 2013-07-31End: 2019-01-31Updated: 2023-02-21

Related Papers

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

2024-04-251 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

Real-World Demographics, Clinical Characteristics, and Treatment Patterns of Patients Treated with Emapalumab for Primary Hemophagocytic Lymphohistiocytosis in the United States: The Real-HLH Study

Blood2022-11-15

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

Blood2021-11-052 citations

Safety of Emapalumab in Children with Primary Hemophagocytic Lymphohistiocytosis: Results of the Primary Analysis of the Pivotal Phase 2/3 Study

Blood2020-11-052 citations

Population Pharmacokinetic Analysis of Emapalumab, a Fully Human, Anti-Interferon Gamma Monoclonal Antibody, in Children with Primary Hemophagocytic Lymphohistiocytosis

Blood2020-11-051 citations

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

Blood2020-11-05

Sensitivity Analysis of Overall Response Rate (ORR) with Emapalumab in Children with Primary Hemophagocytic Lymphohistiocytosis (HLH)

Blood2020-11-05

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