IVA: Clinical Trials

42 completed, 3 terminated, 2 active not recruiting, 2 approved for marketing. 36 Phase 3, 9 Phase 2, 6 Phase 1.

By phase and status

Phase	Trials	Status
Phase 3	36	Completed 32, Active not recruiting 2, Terminated 2
Phase 2	9	Completed 8, Terminated 1
Phase 1	6	Completed 5, Recruiting 1

Follow IVA: new trials by email Literature Review of IVA trials Research Report on IVA

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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

Trial	Phase	Status	Sponsor	Enrollment	Start	Updated
Evaluation of VX-581 in Healthy Participants and in Participants With Cystic Fibrosis VX-581, Placebo, D-IVA - Cystic Fibrosis	Phase 1	Recruiting	Vertex Pharmaceuticals Incorporated	152	2025-12-09	2026-10-19
Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Participants 12 Months of Age and Older ELX/TEZ/IVA, IVA - Cystic Fibrosis	Phase 3	Active not recruiting	Vertex Pharmaceuticals Incorporated	50	2024-11-21	2026-06-05
Evaluation of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis (CF) Participants 12 to Less Than 24 Months of Age ELX/TEZ/IVA, IVA - Cystic Fibrosis	Phase 3	Completed	Vertex Pharmaceuticals Incorporated	67	2023-06-27	2026-10-15
A Phase 1/2 Study of VX-522 in Participants With Cystic Fibrosis (CF) VX-522 mRNA therapy, IVA - Cystic Fibrosis	Phase 1 / Phase 2	Completed	Vertex Pharmaceuticals Incorporated	26	2023-02-27	2026-10-09
Study to Evaluate Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) Long-term Safety and Efficacy in Subjects Without F508del ELX/TEZ/IVA, IVA - Cystic Fibrosis	Phase 3	Active not recruiting	Vertex Pharmaceuticals Incorporated	297	2022-11-23	2026-10-27
Evaluation of Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis Subjects Without an F508del Mutation ELX/TEZ/IVA, IVA, Placebo (matched to ELX/TEZ/IVA) - Cystic Fibrosis	Phase 3	Completed	Vertex Pharmaceuticals Incorporated	307	2022-05-09	2024-08-01
Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis (CF) Participants 2 Years and Older ELX/TEZ/IVA, IVA - Cystic Fibrosis	Phase 3	Completed	Vertex Pharmaceuticals Incorporated	71	2022-01-17	2026-03-03
A Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Participants With Cystic Fibrosis (CF) ELX/TEZ/IVA, IVA - Cystic Fibrosis	Phase 3	Completed	Vertex Pharmaceuticals Incorporated	86	2022-01-14	2023-07-11
A Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive (TCR) CFTR Mutation and No F508del Mutation VX-121/TEZ/D-IVA, ELX/TEZ/IVA, IVA - Cystic Fibrosis	Phase 3	Completed	Vertex Pharmaceuticals Incorporated	597	2021-10-27	2024-06-13
A Study to Evaluate ELX/TEZ/IVA on Cough and Physical Activity in Participants With Cystic Fibrosis (CF) ELX/TEZ/IVA, IVA - Cystic Fibrosis	Phase 3	Completed	Vertex Pharmaceuticals Incorporated	82	2021-10-12	2025-09-24
A Phase 3 Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Heterozygous for F508del and a Minimal Function Mutation (F/MF) VX-121/TEZ/D-IVA, ELX/TEZ/IVA, IVA - Cystic Fibrosis	Phase 3	Completed	Vertex Pharmaceuticals Incorporated	435	2021-09-14	2024-10-03
A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Participants With Cystic Fibrosis (CF) ELX/TEZ/IVA, IVA - Cystic Fibrosis	Phase 3	Completed	Vertex Pharmaceuticals Incorporated	69	2021-01-15	2023-08-03
A Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis (CF) Particpants 6 Years and Older and F/MF Genotypes ELX/TEZ/IVA, IVA - Cystic Fibrosis	Phase 3	Completed	Vertex Pharmaceuticals Incorporated	120	2021-01-11	2024-05-08
Evaluation of ELX/TEZ/IVA in Cystic Fibrosis (CF) Subjects 2 Through 5 Years ELX/TEZ/IVA, IVA - Cystic Fibrosis	Phase 3	Completed	Vertex Pharmaceuticals Incorporated	83	2020-11-19	2023-06-28
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 ELX/TEZ/IVA, IVA, Placebo (matched to ELX/TEZ/IVA) - Cystic Fibrosis	Phase 3	Completed	Vertex Pharmaceuticals Incorporated	121	2020-06-19	2022-07-26
A Study Evaluating the Long-Term Safety of Elexacaftor Combination Therapy ELX/TEZ/IVA, IVA - Cystic Fibrosis	Phase 3	Completed	Vertex Pharmaceuticals Incorporated	172	2020-05-04	2023-07-28
Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA TC Combination Therapy in Participants With Cystic Fibrosis Who Are 6 Years of Age and Older ELX/TEZ/IVA, IVA - Cystic Fibrosis	Phase 3	Completed	Vertex Pharmaceuticals Incorporated	64	2020-02-17	2025-05-18
Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy ELX/TEZ/IVA, IVA - Cystic Fibrosis	Phase 3	Completed	Vertex Pharmaceuticals Incorporated	251	2019-12-05	2024-01-16
A Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del ELX/TEZ/IVA, TEZ/IVA, IVA - Cystic Fibrosis	Phase 3	Completed	Vertex Pharmaceuticals Incorporated	176	2019-10-03	2021-08-18
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) ELX/TEZ/IVA, IVA, TEZ/IVA - Cystic Fibrosis	Phase 3	Completed	Vertex Pharmaceuticals Incorporated	271	2019-08-28	2021-07-02

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Conditions studied

Cystic Fibrosis (50)

Sponsors

Vertex Pharmaceuticals Incorporated (50)

Countries

United Kingdom (34)  ·  Australia (33)  ·  United States (32)  ·  Canada (29)  ·  Germany (28)  ·  Belgium (20)  ·  Netherlands (18)  ·  Ireland (17)  ·  Spain (17)  ·  Denmark (14)  ·  France (14)  ·  Switzerland (13)  ·  Israel (12)  ·  Italy (10)  ·  Austria (8)

Results publications

PMID 37983082, PMID 33331662, PMID 30334693, PMID 36842446, PMID 39756424, PMID 29886024, PMID 30334692, PMID 31253540, PMID 31679946, PMID 31697873, PMID 32546431, PMID 33023304, PMID 33095038, PMID 33581080, PMID 33734030, PMID 34437784, PMID 34942085, PMID 35190292, PMID 35771568, PMID 36921081, PMID 37154609, PMID 40209082, PMID 40454869, PMID 40788823

NIH funding

2017 (9), 2018 (9), 2016 (5), 2019 (5), 2023 (3), 2014 (2), 2015 (1)