Fully human anti-interferon gamma monoclonal antibody (DrugBank: Interferon Gamma)
8 diseases告示番号 | 疾患名(ページ内リンク) | 臨床試験数 |
---|---|---|
18 | 脊髄小脳変性症(多系統萎縮症を除く。) | 0 |
65 | 原発性免疫不全症候群 | 0 |
85 | 特発性間質性肺炎 | 0 |
107 | 若年性特発性関節炎[全身型若年性特発性関節炎(~2018.3)] | 1 |
228 | 閉塞性細気管支炎 | 0 |
299 | 嚢胞性線維症 | 0 |
301 | 黄斑ジストロフィー | 0 |
326 | 大理石骨病 | 0 |
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
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1 | EUCTR2016-004223-23-FR (EUCTR) | 13/02/2017 | A 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 SA | NULL | Not Recruiting | Female: yes Male: yes | 10 | Phase 2 | United States;France;Canada;Spain;Netherlands;Italy;United Kingdom |