ABBV-119 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
299嚢胞性線維症4

299. 嚢胞性線維症


臨床試験数 : 1,696 薬物数 : 1,644 - (DrugBank : 272) / 標的遺伝子数 : 96 - 標的パスウェイ数 : 170
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-005805-25-BE
(EUCTR)
10/11/202102/07/2021A Study of Galicaftor/Navocaftor/ABBV-119 Combination Therapy in Subjects with Cystic Fibrosis.A Phase 2 Study of Galicaftor/Navocaftor/ABBV-119 Combination Therapy in Subjects with Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation. Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Galicaftor
Product Code: ABBV-2222
INN or Proposed INN: GALICAFTOR
Other descriptive name: ABBV-2222
Product Name: Navocaftor
Product Code: ABBV-3067
INN or Proposed INN: Navocaftor
Product Name: ABBV-119
Product Code: ABBV-119
Other descriptive name: ABBV-119
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 2Hungary;Belgium;Netherlands
2EUCTR2020-005805-25-NL
(EUCTR)
28/10/202123/09/2021A Study of Galicaftor/Navocaftor/ABBV-119 Combination Therapy in Subjects with Cystic Fibrosis.A Phase 2 Study of Galicaftor/Navocaftor/ABBV-119 Combination Therapy in Subjects with Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation. Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Galicaftor
Product Code: ABBV-2222
INN or Proposed INN: GALICAFTOR
Other descriptive name: ABBV-2222
Product Name: Navocaftor
Product Code: ABBV-3067
INN or Proposed INN: Navocaftor
Product Name: ABBV-119
Product Code: ABBV-119
Other descriptive name: ABBV-119
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 2Hungary;Slovakia;Belgium;Australia;Germany;Netherlands;United Kingdom;New Zealand
3EUCTR2020-005805-25-HU
(EUCTR)
13/09/202115/07/2021A Study of Galicaftor/Navocaftor/ABBV-119 Combination Therapy in Subjects with Cystic Fibrosis.A Phase 2 Study of Galicaftor/Navocaftor/ABBV-119 Combination Therapy in Subjects with Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation. Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Galicaftor
Product Code: ABBV-2222
INN or Proposed INN: GALICAFTOR
Other descriptive name: ABBV-2222
Product Name: Navocaftor
Product Code: ABBV-3067
INN or Proposed INN: Navocaftor
Product Name: ABBV-119
Product Code: ABBV-119
Other descriptive name: ABBV-119
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 2Hungary
4NCT04853368
(ClinicalTrials.gov)
September 13, 202119/4/2021Study to Evaluate Adverse Events and Change in Disease Activity With Oral Capsules of Galicaftor/Navocaftor/ABBV-119 Combination Therapy in Adult Participants With Cystic FibrosisA Phase 2 Study of Galicaftor/Navocaftor/ABBV-119 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del MutationCystic Fibrosis (CF)Drug: Galicaftor;Drug: Placebo;Drug: Navocaftor;Drug: ABBV-119AbbVieNULLRecruiting18 YearsN/AAll90Phase 2Australia;Belgium;Germany;Hungary;Netherlands;New Zealand;Slovakia;Czechia