TAK-079 ( DrugBank: - )


3 diseases
告示番号疾患名(ページ内リンク)臨床試験数
11重症筋無力症2
49全身性エリテマトーデス1
63特発性血小板減少性紫斑病6

11. 重症筋無力症


臨床試験数 : 332 薬物数 : 234 - (DrugBank : 81) / 標的遺伝子数 : 45 - 標的パスウェイ数 : 127
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-003383-47-IT
(EUCTR)
12/08/202025/09/2020A Study to Investigate the Safety, Tolerability, and Efficacy of TAK-079 in Participants With Generalized Myasthenia GravisA Phase 2, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of TAK-079 in Patients With Generalized Myasthenia Gravis - - Generalized Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: TAK-079
Product Code: [TAK-079, TSF-021, TSF79]
INN or Proposed INN: TAK-079
Other descriptive name: TAK-079
Product Name: metilprdnisolone
Product Code: [-]
INN or Proposed INN: METILPREDNISOLONE
Other descriptive name: methylprednisolone
Product Name: difenidramina
Product Code: [NA]
INN or Proposed INN: DIFENIDRAMINA CLORIDRATO
Other descriptive name: diphenhydramine hydrochloride
Product Name: paracetamolo
Product Code: [acetominofene]
INN or Proposed INN: PARACETAMOLO
Other descriptive name: acetaminophen
MILLENNIUM PHARMACEUTICALS, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
36Phase 2United States;Serbia;Canada;Spain;Poland;Italy
2NCT04159805
(ClinicalTrials.gov)
January 20, 20208/11/2019A Study of TAK-079 in People With Generalized Myasthenia GravisA Phase 2, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of TAK-079 in Patients With Generalized Myasthenia GravisMyasthenia GravisDrug: TAK-079;Drug: TAK-079 PlaceboTakedaNULLCompleted18 YearsN/AAll36Phase 2United States;Canada;Italy;Poland;Serbia;Spain

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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03724916
(ClinicalTrials.gov)
November 26, 201818/10/2018A Study to Evaluate the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of TAK-079 in Combination With Standard Background Therapy in Participants With Moderate to Severe Systemic Lupus Erythematosus (SLE)A Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TAK-079 in Combination With Standard Background Therapy in Patients With Moderate to Severe Systemic Lupus ErythematosusSystemic Lupus Erythematosus;Lupus Erythematosus, SystemicDrug: TAK-079;Drug: TAK-079 PlaceboMillennium Pharmaceuticals, Inc.NULLCompleted18 Years75 YearsAll58Phase 1United States

63. 特発性血小板減少性紫斑病


臨床試験数 : 391 薬物数 : 235 - (DrugBank : 50) / 標的遺伝子数 : 49 - 標的パスウェイ数 : 139
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-004103-12-DE
(EUCTR)
22/02/202102/04/2020A Study to Evaluate Safety, Tolerability and Efficacy of TAK-079 in Patients with Immune ThrombocytopeniaA Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability and Efficacy of TAK-079 in Patients with Persistent/Chronic Primary Immune Thrombocytopenia Primary immune thrombocytopenia
MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: TAK-079
Product Code: TAK-079
INN or Proposed INN: TAK-079
Other descriptive name: TAK-079
Takeda Development Center Americas, Inc. (Takeda)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
54Phase 2United States;Slovenia;Ukraine;Croatia;Bulgaria;Germany;Italy
2EUCTR2019-004103-12-BG
(EUCTR)
15/12/202022/06/2020A Study to Evaluate Safety, Tolerability and Efficacy of TAK-079 in Patients with Immune ThrombocytopeniaA Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability and Efficacy of TAK-079 in Patients with Persistent/Chronic Primary Immune Thrombocytopenia Primary immune thrombocytopenia
MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: TAK-079
Product Code: TAK-079
INN or Proposed INN: Mezagitamab
Other descriptive name: TAK-079
Takeda Development Center Americas, Inc. (Takeda)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
54Phase 2United States;Slovenia;Greece;Spain;Ukraine;Croatia;Bulgaria;Germany;Italy;Japan;China
3NCT04278924
(ClinicalTrials.gov)
November 9, 202019/2/2020A Study of TAK-079 in Adults With Persistent/Chronic Primary Immune ThrombocytopeniaA Phase 2, Randomized, Double-blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of TAK-079 in Patients With Persistent/Chronic Primary Immune ThrombocytopeniaPrimary Immune ThrombocytopeniaDrug: Placebo;Drug: TAK-079TakedaNULLRecruiting18 YearsN/AAll54Phase 2United States;Bulgaria;Croatia;Germany;Italy;Slovenia;Ukraine
4EUCTR2019-004103-12-HR
(EUCTR)
25/09/202023/11/2020A Study to Evaluate Safety, Tolerability and Efficacy of TAK-079 in Patients with Immune ThrombocytopeniaA Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability and Efficacy of TAK-079 in Patients with Persistent/Chronic Primary Immune Thrombocytopenia Primary immune thrombocytopenia
MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: TAK-079
Product Code: TAK-079
INN or Proposed INN: TAK-079
Other descriptive name: TAK-079
Millennium Pharmaceuticals, Inc. (Takeda)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
54Phase 2United States;Slovenia;Ukraine;Croatia
5EUCTR2019-004103-12-SI
(EUCTR)
16/09/202028/04/2020A Study to Evaluate Safety, Tolerability and Efficacy of TAK-079 in Patients with Immune ThrombocytopeniaA Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability and Efficacy of TAK-079 in Patients with Persistent/Chronic Primary Immune Thrombocytopenia Primary immune thrombocytopenia
MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: TAK-079
Product Code: TAK-079
INN or Proposed INN: TAK-079
Other descriptive name: TAK-079
Millennium Pharmaceuticals, Inc. (Takeda)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
54Phase 2United States;Slovenia;Ukraine;Croatia;Bulgaria;Germany
6EUCTR2019-004103-12-IT
(EUCTR)
24/07/202021/01/2021A Study to Evaluate Safety, Tolerability and Efficacy of TAK-079 in Patients with Immune ThrombocytopeniaA Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability and Efficacy of TAK-079 in Patients with Persistent/Chronic Primary Immune Thrombocytopenia - / Primary immune thrombocytopenia
MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: TAK-079
Product Code: [TAK-079]
INN or Proposed INN: TAK-079
Product Name: difenidramina
Product Code: [NA]
INN or Proposed INN: DIFENIDRAMINA CLORIDRATO
Other descriptive name: dyphenhydramine hydrochloride
Product Name: paracetamolo
Product Code: [acetominofene]
INN or Proposed INN: PARACETAMOLO
Other descriptive name: acetominophen
Product Name: metilprednisolone
Product Code: [/]
INN or Proposed INN: METILPREDNISOLONE
Other descriptive name: methylprednisolone
MILLENNIUM PHARMACEUTICALS, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
54Phase 2United States;Slovenia;Ukraine;Croatia;Bulgaria;Germany;Italy