EMAPALUMAB

( DrugBank: Emapalumab / KEGG DRUG: Emapalumab )

3 diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
49	全身性エリテマトーデス	2
65	原発性免疫不全症候群	1

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	14

49. 全身性エリテマトーデス

臨床試験数 : 993 / 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200

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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
1	JPRN-jRCT2031220187 (jRCT2031220187)	01/08/2022	07/07/2022	Evaluate Efficacy, Safety and Tolerability, PK and PD of Emapalumabin Children and Adults With MAS i ...	A Two-cohort, Open-label, Single-arm, Multicenter Study to Evaluate Efficacy, Safety and Tolerabilit ...	Macrophage Activation Syndrome, Secondary Hemophagocytic Lymphohistiocytosis, Still Disease, SLE	Emapalumab iv infusion initial dose: 6 mg/kg Subsequent doses: 3 mg/kg	Nakaoku Takahiro	NULL	Recruiting	>= 6month old	<= 80age old	Both	2	Phase 2-3	Belgium;Canada;China;Czechia;France;Germany;Italy;Netherlands;Poland;Spain;Sweden;United Kingdom;Uni ...
2	NCT05001737 (ClinicalTrials.gov)	December 15, 2021	16/6/2021	Evaluate Efficacy, Safety and Tolerability, PK and PD of Emapalumabin Children and Adults With MAS i ...	A Two-cohort, Open-label, Single Arm, Multicenter Study to Evaluate Efficacy, Safety and Tolerabilit ...	Macrophage Activation Syndrome;Secondary Hemophagocytic Lymphohistiocytosis;Still Disease;Systemic L ...	Drug: Emapalumab	Swedish Orphan Biovitrum	NULL	Recruiting	6 Months	80 Years	All	41	Phase 3	United States;Belgium;Canada;China;Czechia;France;Germany;Italy;Japan;Netherlands;Poland;Spain;Swede ...

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65. 原発性免疫不全症候群

臨床試験数 : 500 / 薬物数 : 614 - (DrugBank : 119) / 標的遺伝子数 : 92 - 標的パスウェイ数 : 217

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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
1	NCT05463133 (ClinicalTrials.gov)	July 8, 2022	15/7/2022	Allogeneic Hematopoietic Stem Cell Transplantation for Chronic Granulomatous Disease (CGD) With an A ...	Phase I/II Study Using Allogeneic Hematopoietic Stem Cell Transplantation for Chronic Granulomatous ...	Chronic Granulomatous Disease	Drug: Sirolimus;Drug: Cyclophosphamide;Drug: Alemtuzumab;Drug: Busulfan;Biological: Pheripheral bloo ...	National Institute of Allergy and Infectious Diseases (NIAID)	NULL	Recruiting	4 Years	65 Years	All	50	Phase 1/Phase 2	United States

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107. 若年性特発性関節炎

臨床試験数 : 447 / 薬物数 : 297 - (DrugBank : 57) / 標的遺伝子数 : 52 - 標的パスウェイ数 : 146

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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
1	JPRN-jRCT2031220187 (jRCT2031220187)	01/08/2022	07/07/2022	Evaluate Efficacy, Safety and Tolerability, PK and PD of Emapalumabin Children and Adults With MAS i ...	A Two-cohort, Open-label, Single-arm, Multicenter Study to Evaluate Efficacy, Safety and Tolerabilit ...	Macrophage Activation Syndrome, Secondary Hemophagocytic Lymphohistiocytosis, Still Disease, SLE	Emapalumab iv infusion initial dose: 6 mg/kg Subsequent doses: 3 mg/kg	Nakaoku Takahiro	NULL	Recruiting	>= 6month old	<= 80age old	Both	2	Phase 2-3	Belgium;Canada;China;Czechia;France;Germany;Italy;Netherlands;Poland;Spain;Sweden;United Kingdom;Uni ...
2	EUCTR2021-001577-24-ES (EUCTR)	15/12/2021	25/08/2021	A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and tolerabilit ...	A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and tolerabilit ...	Macrophage activation syndrome (MAS) in the context of Systemic juvenile inflammatory arthritis (sJI ...	Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: Emapalumab Product Name: Emapalumab ...	Swedish Orphan Biovitrum AG (Sobi AG)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	41	Phase 2;Phase 3	United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Poland;Ger ...
3	EUCTR2021-001577-24-PL (EUCTR)	31/10/2021	28/09/2021	A study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of ema ...	A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and tolerabilit ...	Macrophage activation syndrome (MAS) in the context of Systemic juvenile inflammatory arthritis (sJI ...	Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: Emapalumab Product Name: Emapalumab ...	Swedish Orphan Biovitrum AG (Sobi AG)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	41	Phase 2;Phase 3	United States;Czechia;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Pol ...
4	EUCTR2016-004223-23-NL (EUCTR)	09/08/2018	13/02/2018	A study to investigate a new medication, NI-0501, in children with the disease systemic Juvenile Idi ...	A pilot, open-label, single arm, multicenter study to evaluate safety, tolerability, pharmacokinetic ...	Macrophage activation syndrome / Secondary hemophagocytic lymphohistiocytosis (MAS/sHLH) in patients ...	Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: EMAPALUMAB	Novimmune SA	NULL	Not Recruiting			Female: yes Male: yes	10	Phase 2	France;United States;Canada;Spain;Germany;Netherlands;United Kingdom;Italy
5	NCT03311854 (ClinicalTrials.gov)	February 20, 2018	21/8/2017	A Study to Investigate the Safety and Efficacy of Emapalumab, an Anti-IFN-gamma mAb in Patients With ...	A Pilot, Open-label, Single Arm, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetic ...	Macrophage Activation Syndrome;Lymphohistiocytosis, Hemophagocytic;Arthritis, Juvenile;Adult Onset S ...	Drug: Emapalumab	Swedish Orphan Biovitrum	NULL	Completed	N/A	N/A	All	14	Phase 2	United States;France;Italy;Spain;United Kingdom;Netherlands
6	EUCTR2016-004223-23-ES (EUCTR)	25/09/2017	09/06/2017	A study to investigate a new medication, NI-0501, in children with the disease systemic Juvenile Idi ...	A pilot, open-label, single arm, multicenter study to evaluate safety, tolerability, pharmacokinetic ...	Macrophage activation syndrome / Secondary hemophagocytic lymphohistiocytosis (MAS/sHLH) in patients ...	Product Code: NI-0501 INN or Proposed INN: Emapalumab Other descriptive name: NI-0501	Novimmune SA	NULL	Not Recruiting			Female: yes Male: yes	5	Phase 2	France;Spain;Netherlands;Germany;United Kingdom;Italy
7	EUCTR2016-004223-23-GB (EUCTR)	12/09/2017	02/03/2017	A study to investigate a new medication, emapalumab, in children with the disease systemic Juvenile ...	A pilot, open-label, single arm, multicenter study to evaluate safety, tolerability, pharmacokinetic ...	Macrophage activation syndrome / Secondary hemophagocytic lymphohistiocytosis (MAS/sHLH) in patients ...	Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: EMAPALUMAB	Swedish Orphan Biovitrum AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	12	Phase 2	France;United States;Canada;Spain;Netherlands;Italy;United Kingdom
8	EUCTR2016-004223-23-FR (EUCTR)		13/02/2017	A study to investigate a new medication, NI-0501, in children with the disease systemic Juvenile Idi ...	A pilot, open-label, single arm, multicenter study to evaluate safety, tolerability, pharmacokinetic ...	Macrophage activation syndrome / Secondary hemophagocytic lymphohistiocytosis (MAS/sHLH) in patients ...	Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: EMAPALUMAB Other descriptive name: ...	Novimmune SA	NULL	Not Recruiting			Female: yes Male: yes	10	Phase 2	United States;France;Canada;Spain;Netherlands;Italy;United Kingdom
9	EUCTR2021-001577-24-BE (EUCTR)		27/10/2021	A study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics of emap ...	A Two-cohort, Open-label, Single arm, Multicenter Study to Evaluate Efficacy, Safety and Tolerabilit ...	Macrophage activation syndrome (MAS) in the context of Systemic Juvenile Idiopathic Arthritis (sJIA) ...	Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: Emapalumab Product Name: Emapalumab ...	Swedish Orphan Biovitrum AG (Sobi AG)	NULL	NA			Female: yes Male: yes	41	Phase 2;Phase 3	United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Bel ...
10	EUCTR2021-001577-24-CZ (EUCTR)		18/10/2021	A study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of ema ...	A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and tolerabilit ...	Macrophage activation syndrome (MAS) in the context of Systemic juvenile inflammatory arthritis (sJI ...	Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: Emapalumab Product Name: Emapalumab ...	Swedish Orphan Biovitrum AG (Sobi AG)	NULL	NA			Female: yes Male: yes	41	Phase 2;Phase 3	United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Bel ...

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