Mezagitamab ( DrugBank: Mezagitamab )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
63特発性血小板減少性紫斑病1
66IgA腎症2

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-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

66. IgA腎症


臨床試験数 : 275 薬物数 : 258 - (DrugBank : 82) / 標的遺伝子数 : 36 - 標的パスウェイ数 : 140
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05174221
(ClinicalTrials.gov)
November 9, 202214/12/2021A Study of Mezagitamab in Adults With Primary Immunoglobulin A Nephropathy Receiving Stable Background TherapyA Phase 1b, Multicenter, Open-Label Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Mezagitamab (TAK-079) in Patients With Primary IgA Nephropathy in Combination With Stable Background TherapyKidney DiseaseDrug: MezagitamabTakedaNULLRecruiting18 YearsN/AAll16Phase 1United States;Australia;Belgium;China;Hungary;Italy;Japan;Korea, Republic of;Serbia;Singapore;Spain;Taiwan;United Kingdom
2JPRN-jRCT2011220009
17/07/202215/06/2022A Study of Mezagitamab in Adults With Primary Immunoglobulin A Nephropathy Receiving Stable Background TherapyA Phase 1b, Multicenter, Open-Label Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Mezagitamab (TAK-079) in Patients With Primary IgA Nephropathy in Combination With Stable Background Therapy Kidney DiseaseTAK-079 (Mezagitamab)
Mezagitamab, subcutaneous injection, once weekly for 8 weeks then once every 2 weeks for 16 weeks in the Main Study. Same dosing regimen will be repeated in LTE Retreatment Period.
Nishizawa AtsushiNULLRecruiting>= 18age oldNot applicableBoth16Phase 1Australia;China;Spain;Italy;South Korea;Serbia;Singapore;Taiwan;USA;Belgium;Hungary;UK;Japan