R-hIL-18BP ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
65原発性免疫不全症候群3

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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-003297-27-DE
(EUCTR)
15/10/201928/03/2019Therapeutic use of Tadekinig alfa in NLRC4 mutation and XIAP deficiencyMulticenter, double-blind, placebo-controlled, randomized withdrawal trial with Tadekinig alfa (r-hIL-18BP) in patients with IL-18 driven monogenic autoinflammatory conditions: NLRC4 mutation and XIAP deficiency NLRC4 mutationXIAP deficiency;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Tadekinig alfa
Product Code: r-hIL-18BP
INN or Proposed INN: Tadekinig alfa
Other descriptive name: TADEKINIG ALFA
AB2 Bio Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
15Phase 3United States;Canada;Germany
2NCT03113760
(ClinicalTrials.gov)
July 21, 201728/2/2017Therapeutic Use of Tadekinig Alfa in NLRC4 Mutation and XIAP DeficiencyMulticenter, Double-blind, Placebo-controlled, Randomized Withdrawal Trial With Tadekinig Alfa (r-hIL-18BP) in Patients With IL-18 Driven Monogenic Autoinflammatory Conditions: NLRC4 Mutation and XIAP DeficiencyNLRC4-MAS;XIAP DeficiencyDrug: Tadekinig alfa;Other: 0.9% sodium chlorideAB2 Bio Ltd.NULLActive, not recruitingN/AN/AAll15Phase 3United States;Canada;Germany
3EUCTR2018-003199-10-DE
(EUCTR)
04/10/2018OPEN-LABEL STUDY: THERAPEUTIC USE OF TADEKINIG ALFA IN NLRC4 MUTATION AND XIAP DEFICIENCYOpen-label extension study with Tadekinig alfa (r-hIL-18BP) to monitor safety and tolerability in patients with IL-18 driven monogenic autoinflammatory conditions: NLRC4 mutation and XIAP deficiency NLRC4 mutation XIAP deficiency;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Tadekinig alfa
Product Code: r-hIL-18BP
INN or Proposed INN: Tadekinig alfa
Other descriptive name: TADEKINIG ALFA
AB2 Bio Ltd.NULLNA Female: yes
Male: yes
10 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Canada;Germany