Fully human anti-interferon gamma monoclonal antibody ( DrugBank: Interferon Gamma )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
107若年性特発性関節炎1

107. 若年性特発性関節炎


臨床試験数 : 441 薬物数 : 282 - (DrugBank : 56) / 標的遺伝子数 : 52 - 標的パスウェイ数 : 142
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agemin
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PhaseCountries
1EUCTR2016-004223-23-FR
(EUCTR)
13/02/2017A study to investigate a new medication, NI-0501, in children with the disease systemic Juvenile Idiopathic Arthritis (sJIA) developing Macrophage Activation Syndrome/secondary Hemophagocytic Lymphohistiocytosis (MAS/sHLH)A pilot, open-label, single arm, multicenter study to evaluate safety, tolerability, pharmacokinetics and efficacy of intravenous administrations of NI-0501, an anti-interferon gamma (anti-IFN?) monoclonal antibody, in patients with systemic Juvenile Idiopathic Arthritis (sJIA) developing Macrophage Activation Syndrome/secondary HLH (MAS/sHLH) Macrophage activation syndrome / Secondary hemophagocytic lymphohistiocytosis (MAS/sHLH) in patients with Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 20.0;Level: LLT;Classification code 10053867;Term: Macrophage activation syndrome;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Emapalumab
Product Code: NI-0501
INN or Proposed INN: EMAPALUMAB
Other descriptive name: Fully human anti-interferon gamma monoclonal antibody
Novimmune SANULLNot RecruitingFemale: yes
Male: yes
10Phase 2United States;France;Canada;Spain;Netherlands;Italy;United Kingdom