ABBV-2222 ( DrugBank: - )


1 disease
IDDisease name (Link within this page)Number of trials
299Cystic fibrosis10

299. Cystic fibrosis


Clinical trials : 1,696 Drugs : 1,644 - (DrugBank : 272) / Drug target genes : 96 - Drug target pathways : 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
4EUCTR2019-000750-63-PL
(EUCTR)
15/09/202021/07/2020Cystic Fibrosis: A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in subjects who have two copies of the F508del mutationA Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous 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: ABBV-2222
Product Code: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
Product Name: ABBV-2222
Product Code: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
Product Name: ABBV-2222
Product Code: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
Product Name: ABBV-3067
Product Code: ABBV-3067
Other descriptive name: ABBV-3067
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
189Phase 2United States;Serbia;Slovakia;Spain;United Kingdom;France;Czech Republic;Hungary;Canada;Puerto Rico;Poland;Belgium;Netherlands
5NCT03969888
(ClinicalTrials.gov)
December 11, 201930/5/2019A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del MutationCystic FibrosisDrug: ABBV-3067;Drug: Placebo ABBV-3067;Drug: ABBV-2222;Drug: Placebo ABBV-2222AbbVieNULLRecruiting18 YearsN/AAll189Phase 2United States;Belgium;Canada;Czechia;France;Hungary;Netherlands;New Zealand;Poland;Romania;Serbia;Slovakia;Spain;United Kingdom
6EUCTR2019-000750-63-FR
(EUCTR)
15/11/201922/08/2019Cystic Fibrosis: A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in subjects who have two copies of the F508del mutationA Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous 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: ABBV-2222
Product Code: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
Product Name: ABBV-3067
Product Code: ABBV-3067
Other descriptive name: ABBV-3067
AbbVie DeutschlandNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
189 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;France;Hungary;Czech Republic;Slovakia;Puerto Rico;Canada;Belgium;Spain;Netherlands;United Kingdom
7EUCTR2019-000750-63-NL
(EUCTR)
31/10/201905/08/2019Cystic Fibrosis: A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in subjects who have two copies of the F508del mutationA Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous 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: ABBV-2222
Product Code: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
Product Name: ABBV-3067
Product Code: ABBV-3067
INN or Proposed INN: TBD
Other descriptive name: ABBV-3067
AbbVie DeutschlandNULLNot RecruitingFemale: yes
Male: yes
189Phase 2Serbia;United States;Slovakia;Spain;United Kingdom;France;Czech Republic;Hungary;Canada;Puerto Rico;Belgium;Poland;Netherlands
8EUCTR2019-000750-63-GB
(EUCTR)
31/10/201926/06/2019Cystic Fibrosis: A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in subjects who have two copies of the F508del mutationA Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous 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: ABBV-2222
Product Code: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
Product Name: ABBV-3067
Product Code: ABBV-3067
Other descriptive name: ABBV-3067
AbbVie DeutschlandNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
189Phase 2Serbia;France;United States;Hungary;Czech Republic;Slovakia;Puerto Rico;Canada;Belgium;Spain;Netherlands;United Kingdom
9EUCTR2019-000750-63-BE
(EUCTR)
27/09/201907/08/2019Cystic Fibrosis: A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in subjects who have two copies of the F508del mutationA Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous 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: ABBV-2222
Product Code: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
Product Name: ABBV-3067
Product Code: ABBV-3067
Other descriptive name: ABBV-3067
AbbVie DeutschlandNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
189 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;France;United States;Hungary;Czech Republic;Slovakia;Puerto Rico;Canada;Spain;Belgium;Netherlands;United Kingdom
10EUCTR2019-000750-63-HU
(EUCTR)
03/09/201901/07/2019Cystic Fibrosis: A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in subjects who have two copies of the F508del mutationA Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous 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: ABBV-2222
Product Code: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
Product Name: ABBV-3067
Product Code: ABBV-3067
Other descriptive name: ABBV-3067
AbbVie DeutschlandNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
189Phase 2Serbia;France;United States;Czech Republic;Hungary;Slovakia;Puerto Rico;Canada;Belgium;Spain;Netherlands;United Kingdom