CLINICAL TRIALS PROFILE FOR ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR

All Clinical Trials for Elexacaftor, Ivacaftor, Tezacaftor; Ivacaftor

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04043806 ↗	A Study Evaluating the Long-term Safety of VX-445 Combination Therapy	Active, not recruiting	Vertex Pharmaceuticals Incorporated	Phase 3	2019-08-09	This study will evaluate the long-term safety and tolerability of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA).
NCT04058353 ↗	A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)	Completed	Vertex Pharmaceuticals Incorporated	Phase 3	2019-08-28	This study will evaluate the efficacy, safety and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a gating or residual function mutation (F/G and F/RF genotypes).
NCT04058366 ↗	Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy	Active, not recruiting	Vertex Pharmaceuticals Incorporated	Phase 3	2019-12-05	This study will evaluate the long-term safety, efficacy, and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for the F508del mutation and a gating or residual function mutation (F/G and F/RF genotypes).
NCT04105972 ↗	A Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del	Completed	Vertex Pharmaceuticals Incorporated	Phase 3	2019-10-03	This study will evaluate the efficacy, safety, and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for F508del.
NCT04183790 ↗	Evaluation of Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older	Active, not recruiting	Vertex Pharmaceuticals Incorporated	Phase 3	2020-02-17	This study will evaluate the long-term safety, tolerability, efficacy, and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF).
NCT04353817 ↗	A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis and F/MF Genotypes	Completed	Vertex Pharmaceuticals Incorporated	Phase 3	2020-06-19	This study will evaluate the efficacy and safety of elexacaftor (ELX) / tezacaftor (TEZ) / ivacaftor (IVA) triple combination (TC) in subjects 6 through 11 years of age with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function (MF) mutation (F/MF genotypes).
NCT04362761 ↗	A Study Evaluating the Long-Term Safety of Elexacaftor Combination Therapy	Active, not recruiting	Vertex Pharmaceuticals Incorporated	Phase 3	2020-05-04	This study will evaluate the long-term safety and tolerability of elexacaftor (ELX)/tezacaftor (TEZ)/ ivacaftor (IVA) triple combination (TC) in subjects with cystic fibrosis (CF) who are homozygous for F508del.

Clinical Trial Conditions for Elexacaftor, Ivacaftor, Tezacaftor; Ivacaftor

Condition Name

Condition Name for Elexacaftor, Ivacaftor, Tezacaftor; Ivacaftor
Intervention	Trials
Cystic Fibrosis	19
Cystic Fibrosis in Children	1
Cystic Fibrosis Liver Disease	1
Drug Drug Interaction	1

Condition MeSH

Condition MeSH for Elexacaftor, Ivacaftor, Tezacaftor; Ivacaftor
Intervention	Trials
Fibrosis	20
Cystic Fibrosis	19
Bronchiectasis	1
Liver Diseases	1

Clinical Trial Locations for Elexacaftor, Ivacaftor, Tezacaftor; Ivacaftor

Trials by Country

Trials by Country for Elexacaftor, Ivacaftor, Tezacaftor; Ivacaftor
Location	Trials
United States	101
Australia	11
United Kingdom	10
Germany	8
Canada	7

Trials by US State

Trials by US State for Elexacaftor, Ivacaftor, Tezacaftor; Ivacaftor
Location	Trials
California	6
North Carolina	6
Colorado	5
Washington	5
Oregon	5

Clinical Trial Progress for Elexacaftor, Ivacaftor, Tezacaftor; Ivacaftor

Clinical Trial Phase

Clinical Trial Phase for Elexacaftor, Ivacaftor, Tezacaftor; Ivacaftor
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	16
N/A	1

Clinical Trial Status

Clinical Trial Status for Elexacaftor, Ivacaftor, Tezacaftor; Ivacaftor
Clinical Trial Phase	Trials
Not yet recruiting	7
Active, not recruiting	6
Recruiting	5

Clinical Trial Sponsors for Elexacaftor, Ivacaftor, Tezacaftor; Ivacaftor

Sponsor Name

Sponsor Name for Elexacaftor, Ivacaftor, Tezacaftor; Ivacaftor
Sponsor	Trials
Vertex Pharmaceuticals Incorporated	16
University of Limerick	1
Royal College of Surgeons, Ireland	1

Sponsor Type

Sponsor Type for Elexacaftor, Ivacaftor, Tezacaftor; Ivacaftor
Sponsor	Trials
Industry	18
Other	14