Emapalumab ( DrugBank: 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 |
| 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
| 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 | 01/08/2022 | 07/07/2022 | Evaluate Efficacy, Safety and Tolerability, PK and PD of Emapalumab in Children and Adults With MAS in Still's or SLE | A Two-cohort, Open-label, Single-arm, Multicenter Study to Evaluate Efficacy, Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of Emapalumab in Children and Adults with Macrophage Activation Syndrome (MAS) in Still's Disease (Including Systemic Juvenile Idiopathic Arthritis and Adult Onset Still's Disease) or with MAS in Systemic Lupus Erythematosus - EMERALD | 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;United States;Japan |
| 2 | NCT05001737 (ClinicalTrials.gov) | December 15, 2021 | 16/6/2021 | Evaluate Efficacy, Safety and Tolerability, PK and PD of Emapalumab in Children and Adults With MAS in Still's or SLE | A Two-cohort, Open-label, Single Arm, Multicenter Study to Evaluate Efficacy, Safety and Tolerability, PK and PD, of Emapalumab in Children and Adults With MAS in Still's Disease or With MAS in Systemic Lupus Erythematous | Macrophage Activation Syndrome;Secondary Hemophagocytic Lymphohistiocytosis;Still Disease;Systemic Lupus Erythematosus;SJIA;AOSD;MAS | 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;Sweden;United Kingdom |
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
| 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 Alemtuzumab, Busulfan and TBI-based Conditioning Regimen Combined With Cytokine (IL-6, +/- IFN-gamma) Antagonists | Phase I/II Study Using Allogeneic Hematopoietic Stem Cell Transplantation for Chronic Granulomatous Disease With an Alemtuzumab, Busulfan and TBI-based Conditioning Regimen Combined With Cytokine (IL-6, +/- IFN-gamma) Antagonists | Chronic Granulomatous Disease | Drug: Sirolimus;Drug: Cyclophosphamide;Drug: Alemtuzumab;Drug: Busulfan;Biological: Pheripheral blood stem cells;Drug: Emapalumab-Izsg;Drug: Tociluzumab;Drug: Total Body Irradiation | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Recruiting | 4 Years | 65 Years | All | 50 | Phase 1/Phase 2 | United States |
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
| 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 | 01/08/2022 | 07/07/2022 | Evaluate Efficacy, Safety and Tolerability, PK and PD of Emapalumab in Children and Adults With MAS in Still's or SLE | A Two-cohort, Open-label, Single-arm, Multicenter Study to Evaluate Efficacy, Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of Emapalumab in Children and Adults with Macrophage Activation Syndrome (MAS) in Still's Disease (Including Systemic Juvenile Idiopathic Arthritis and Adult Onset Still's Disease) or with MAS in Systemic Lupus Erythematosus - EMERALD | 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;United States;Japan |
| 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 tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) in Still’s disease (including systemic juvenile idiopathic arthritis and Adult onset Still’s disease) or with MAS in Systemic lupus erythematous - NI-0501-14 | A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) in Still’s disease (including systemic juvenile idiopathic arthritis and Adult onset Still’s disease) or with MAS in Systemic lupus erythematous - NI-0501-14 | Macrophage activation syndrome (MAS) in the context of Systemic juvenile inflammatory arthritis (sJIA) and Adult onset Still’s disease (AOSD).MAS in the context of pediatric and adult Systemic lupus erythematous (SLE). MedDRA version: 21.1;Level: PT;Classification code 10071583;Term: Haemophagocytic lymphohistiocytosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: Emapalumab Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: 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;Germany;Netherlands;China;Japan;Sweden | ||
| 3 | EUCTR2021-001577-24-PL (EUCTR) | 31/10/2021 | 28/09/2021 | A study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) | A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) in Still’s disease (including systemic juvenile idiopathic arthritis and Adult onset Still’s disease) or with MAS in Systemic lupus erythematous - NI-0501-14 | Macrophage activation syndrome (MAS) in the context of Systemic juvenile inflammatory arthritis (sJIA) and Adult onset Still’s disease (AOSD).MAS in the context of pediatric and adult Systemic lupus erythematous (SLE). MedDRA version: 21.1;Level: PT;Classification code 10071583;Term: Haemophagocytic lymphohistiocytosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: Emapalumab Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: 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;Poland;Belgium;Netherlands;Germany;China;Japan;Sweden | ||
| 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 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: 21.1;Level: LLT;Classification code 10053867;Term: Macrophage activation syndrome;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | 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 Systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD) Developing Macrophage Activation Syndrome/Secondary HLH (MAS/sHLH) | A Pilot, Open-label, Single Arm, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous Administrations of Emapalumab, an Anti-interferon Gamma (Anti-IFN?) Monoclonal Antibody, in Patients With Systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD) Developing Macrophage Activation Syndrome/Secondary HLH (MAS/sHLH) | Macrophage Activation Syndrome;Lymphohistiocytosis, Hemophagocytic;Arthritis, Juvenile;Adult Onset Still Disease | 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 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 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 Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD) 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 emapalumab, an anti-interferon gamma (anti-IFN?) monoclonal antibody, in patients with systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD) developing Macrophage Activation Syndrome/secondary HLH (MAS/sHLH) | Macrophage activation syndrome / Secondary hemophagocytic lymphohistiocytosis (MAS/sHLH) in patients with Systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD) MedDRA version: 21.1;Level: LLT;Classification code 10053867;Term: Macrophage activation syndrome;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | 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 | EUCTR2021-001577-24-NL (EUCTR) | 21/04/2022 | A study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) | A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) in Still’s disease (including systemic juvenile idiopathic arthritis and Adult onset Still’s disease) or with MAS in Systemic lupus erythematous - NI-0501-14 | Macrophage activation syndrome (MAS) in the context of Systemic juvenile idiopathic arthritis (sJIA) and Adult onset Still’s disease (AOSD).MAS in the context of pediatric and adult Systemic lupus erythematous (SLE). MedDRA version: 21.1;Level: PT;Classification code 10071583;Term: Haemophagocytic lymphohistiocytosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: Emapalumab Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: 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;Belgium;Poland;Netherlands;Germany;China;Japan;Sweden | |||
| 9 | EUCTR2021-001577-24-FR (EUCTR) | 27/08/2021 | A study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) | A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) in Still’s disease (including systemic juvenile idiopathic arthritis and Adult onset Still’s disease) or with MAS in Systemic lupus erythematous - NI-0501-14 | Macrophage activation syndrome (MAS) in the context of Systemic juvenile inflammatory arthritis (sJIA) and Adult onset Still’s disease (AOSD).MAS in the context of pediatric and adult Systemic lupus erythematous (SLE). MedDRA version: 21.1;Level: PT;Classification code 10071583;Term: Haemophagocytic lymphohistiocytosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: Emapalumab Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: 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;Canada;Belgium;Poland;Germany;Netherlands;China;Japan;Sweden | |||
| 10 | EUCTR2021-001577-24-CZ (EUCTR) | 18/10/2021 | A study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) | A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) in Still’s disease (including systemic juvenile idiopathic arthritis and Adult onset Still’s disease) or with MAS in Systemic lupus erythematous - NI-0501-14 | Macrophage activation syndrome (MAS) in the context of Systemic juvenile inflammatory arthritis (sJIA) and Adult onset Still’s disease (AOSD).MAS in the context of pediatric and adult Systemic lupus erythematous (SLE). MedDRA version: 21.1;Level: PT;Classification code 10071583;Term: Haemophagocytic lymphohistiocytosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: Emapalumab Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: 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;Belgium;Poland;Germany;Netherlands;China;Japan;Sweden | |||
| 11 | EUCTR2021-001577-24-BE (EUCTR) | 27/10/2021 | A study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics of emapalumab in children and adults with macrophage activation syndrome (MAS) | A Two-cohort, Open-label, Single arm, Multicenter Study to Evaluate Efficacy, Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of Emapalumab in Children and Adults with Macrophage Activation Syndrome (MAS) in Still’s disease (Including Systemic Juvenile Idiopathic Arthritis and Adult onset Still’s disease) or with MAS in Systemic Lupus Erythematous - NI-0501-14 | Macrophage activation syndrome (MAS) in the context of Systemic Juvenile Idiopathic Arthritis (sJIA) and Adult onset Still’s disease (AOSD).MAS in the context of pediatric and adult Systemic Lupus Erythematous (SLE). MedDRA version: 21.1;Level: PT;Classification code 10071583;Term: Haemophagocytic lymphohistiocytosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: Emapalumab Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: 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;Belgium;Poland;Netherlands;Germany;China;Japan;Sweden | |||
| 12 | 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 | |||
| 13 | EUCTR2021-001577-24-IT (EUCTR) | 16/09/2021 | A study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) | A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) in Still’s disease (including systemic juvenile idiopathic arthritis and Adult onset Still’s disease) or with MAS in Systemic lupus erythematous - NI-0501-14 | Macrophage activation syndrome (MAS) in the context of Systemic juvenile inflammatory arthritis (sJIA) and Adult onset Still’s disease (AOSD).MAS in the context of pediatric and adult Systemic lupus erythematous (SLE). MedDRA version: 21.1;Level: PT;Classification code 10071583;Term: Haemophagocytic lymphohistiocytosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Emapalumab Product Code: [NI-0501] INN or Proposed INN: Emapalumab Product Name: Emapalumab Product Code: [NI-0501] INN or Proposed INN: Emapalumab Product Name: Profilassi per Herpes Zoster Product Code: [Profilassi per Herpes Zoster] INN or Proposed INN: Antivirale ad uso diretto | Swedish Orphan Biovitrum 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;Belgium;Poland;Germany;Netherlands;China;Japan;Sweden | |||
| 14 | EUCTR2021-001577-24-SE (EUCTR) | 22/11/2021 | A study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) | A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and adults with macrophage activation syndrome (MAS) in Still’s disease (including systemic juvenile idiopathic arthritis and Adult onset Still’s disease) or with MAS in Systemic lupus erythematous - NI-0501-14 | Macrophage activation syndrome (MAS) in the context of Systemic juvenile inflammatory arthritis (sJIA) and Adult onset Still’s disease (AOSD).MAS in the context of pediatric and adult Systemic lupus erythematous (SLE). MedDRA version: 21.1;Level: PT;Classification code 10071583;Term: Haemophagocytic lymphohistiocytosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: Emapalumab Product Name: Emapalumab Product Code: NI-0501 INN or Proposed INN: 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;Canada;Belgium;Poland;Germany;Netherlands;China;Japan;Sweden |