CLINICAL TRIALS PROFILE FOR GAMIFANT

All Clinical Trials for GAMIFANT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03311854 ↗	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/sHL	Completed	NovImmune SA	Phase 2	2018-03-02	Macrophage Activation Syndrome (MAS) is a rare, life-threatening condition characterized by uncontrolled hyperinflammation which may develop on the background of systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD). Emapalumab is a monoclonal antibody neutralizing interferon-gamma (IFN-gamma), a key cytokine which contributes to the inflammation and tissue damage seen in MAS. The purpose of this study is to assess the safety, tolerability and efficacy of emapalumab in sJIA or AOSD patients developing MAS, presenting an inadequate response to high dose glucocorticoid treatment.
NCT03311854 ↗	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/sHL	Completed	Swedish Orphan Biovitrum	Phase 2	2018-03-02	Macrophage Activation Syndrome (MAS) is a rare, life-threatening condition characterized by uncontrolled hyperinflammation which may develop on the background of systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD). Emapalumab is a monoclonal antibody neutralizing interferon-gamma (IFN-gamma), a key cytokine which contributes to the inflammation and tissue damage seen in MAS. The purpose of this study is to assess the safety, tolerability and efficacy of emapalumab in sJIA or AOSD patients developing MAS, presenting an inadequate response to high dose glucocorticoid treatment.
NCT04765553 ↗	A Study to Evaluate Emapalumab in Japanese Healthy Volunteers.	Completed	Swedish Orphan Biovitrum	Phase 1	2021-01-14	This is a randomized, placebo controlled and double-blinded study to evaluate the pharmacokinetics (PK), pharmacodynamics (PD) and safety of a single dose (1 mg/kg) of emapalumab in adult healthy Japanese subjects.
NCT05744063 ↗	A Post-authorization Study to Describe the Safety and Efficacy of Emapalumab for the Treatment of pHLH in Treatment Experienced Chinese Patients	Recruiting	Swedish Orphan Biovitrum	Phase 4	2023-02-03	The goal of this post-authorization study is to describe safety and efficacy of emapalumab in treatment experienced Chinese patients with pHLH.

Clinical Trial Conditions for GAMIFANT

Condition Name

Condition Name for GAMIFANT
Intervention	Trials
Adult Onset Still Disease	1
Arthritis, Juvenile	1
Lymphohistiocytosis, Hemophagocytic	1
Macrophage Activation Syndrome	1

Condition MeSH

Condition MeSH for GAMIFANT
Intervention	Trials
Lymphohistiocytosis, Hemophagocytic	2
Syndrome	1
Still's Disease, Adult-Onset	1
Macrophage Activation Syndrome	1

Clinical Trial Locations for GAMIFANT

Trials by Country

Trials by Country for GAMIFANT
Location	Trials
China	2
Spain	1
Japan	1
Italy	1
United States	1

Trials by US State

Trials by US State for GAMIFANT
Location	Trials
Ohio	1

Clinical Trial Progress for GAMIFANT

Clinical Trial Phase

Clinical Trial Phase for GAMIFANT
Clinical Trial Phase	Trials
Phase 4	1
Phase 2	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for GAMIFANT
Clinical Trial Phase	Trials
Completed	2
Recruiting	1

Clinical Trial Sponsors for GAMIFANT

Sponsor Name

Sponsor Name for GAMIFANT
Sponsor	Trials
Swedish Orphan Biovitrum	3
NovImmune SA	1

Sponsor Type

Sponsor Type for GAMIFANT
Sponsor	Trials
Industry	4