Vertex Pharmaceuticals Incorporated: Cystic Fibrosis trials

The registry lists 125 Cystic Fibrosis studies with Vertex Pharmaceuticals Incorporated as lead sponsor. 4 are open to participants now and 80 have results posted.

Phase 1 31Phase 2 24Phase 3 62Phase 4 2No phase 9(a study in two phases counts in both)

Studies

Page 1 of 2. Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• A Phase 1 Relative Bioavailability Study of a VX-581 Tablet FormulationRecruitingNCT07813039Phase 1
• Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-272 in Healthy ParticipantsRecruitingNCT07437105Phase 1
• Evaluation of VX-581 in Healthy Participants and in Participants With Cystic FibrosisRecruitingNCT07283770Phase 1
• Evaluation of Long-Term Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor in Cystic Fibrosis Participants 1 Year of Age and OlderEnrolling by invitationNCT05844449Phase 3
• Evaluation of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis (CF) Participants 12 to Less Than 24 Months of AgeCompletedNCT05882357Phase 3Results posted
• Evaluation of Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis Subjects Without an F508del MutationCompletedNCT05274269Phase 3Results posted
• A Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Participants With Cystic Fibrosis (CF)CompletedNCT05111145Phase 3Results posted
• 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 MutationCompletedNCT05076149Phase 3Results posted
• 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)CompletedNCT05033080Phase 3Results posted
• A Study to Evaluate ELX/TEZ/IVA on Cough and Physical Activity in Participants With Cystic Fibrosis (CF)CompletedNCT04969224Phase 3Results posted
• A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Participants With Cystic Fibrosis (CF)CompletedNCT04599465Phase 3Results posted
• 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 GenotypesCompletedNCT04545515Phase 3Results posted
• Evaluation of ELX/TEZ/IVA in Cystic Fibrosis (CF) Subjects 2 Through 5 YearsCompletedNCT04537793Phase 3Results posted
• A Study Evaluating the Long-Term Safety of Elexacaftor Combination TherapyCompletedNCT04362761Phase 3Results posted
• A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis and F/MF GenotypesCompletedNCT04353817Phase 3Results posted
• Long-term Safety of Lumacaftor/Ivacaftor in Participants With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment InitiationCompletedNCT04235140Phase 3Results posted
• 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 OlderCompletedNCT04183790Phase 3Results posted
• A Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508delCompletedNCT04105972Phase 3Results posted
• Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination TherapyCompletedNCT04058366Phase 3Results posted
• 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)CompletedNCT04058353Phase 3Results posted
• A Study Evaluating the Long-term Safety of VX-445 Combination TherapyCompletedNCT04043806Phase 3Results posted
• A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic FibrosisCompletedNCT03912233Phase 2Results posted
• A Phase 2 Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic FibrosisCompletedNCT03911713Phase 2Results posted
• Study of VX-121 in Healthy Subjects and in Subjects With Cystic FibrosisCompletedNCT03768089Phase 1/2Results posted
• Evaluation of VX 445/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of AgeCompletedNCT03691779Phase 3Results posted
• Evaluation of VX-659/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of AgeTerminatedNCT03633526Phase 3Results posted
• A Study to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508delCompletedNCT03625466Phase 2Results posted
• Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Participants 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508delCompletedNCT03601637Phase 3Results posted
• A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 Through 11 Years With Cystic FibrosisCompletedNCT03559062Phase 3Results posted
• A Study to Evaluate the Safety and Efficacy of Long-term Treatment With TEZ/IVA in CF Participants With an F508del CFTR MutationCompletedNCT03537651Phase 3Results posted
• A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination TherapyCompletedNCT03525574Phase 3Results posted
• A Study of VX-445 Combination Therapy in CF Subjects Homozygous for F508del (F/F)CompletedNCT03525548Phase 3Results posted
• A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)CompletedNCT03525444Phase 3Results posted
• A Study of VX-659 Combination Therapy in CF Subjects Homozygous for F508del (F/F)CompletedNCT03460990Phase 3Results posted
• A Study Evaluating the Long Term Safety and Efficacy of VX-659 Combination TherapyTerminatedNCT03447262Phase 3Results posted
• A Phase 3 Study of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)CompletedNCT03447249Phase 3Results posted
• A Study to Evaluate the Safety of Long-term Ivacaftor Treatment in Participants With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive MutationCompletedNCT03277196Phase 3Results posted
• A Study of VX-445 in Healthy Subjects and Subjects With Cystic FibrosisCompletedNCT03227471Phase 1/2Results posted
• A Study Evaluating the Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic FibrosisCompletedNCT03224351Phase 2Results posted
• A Study to Evaluate Safety, Efficacy, and Tolerability of TEZ/IVA in Orkambi® (Lumacaftor/Ivacaftor) -Experienced Subjects With Cystic Fibrosis (CF)CompletedNCT03150719Phase 3Results posted
• A Rollover Safety Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR MutationCompletedNCT03125395Phase 3Results posted
• A Study to Evaluate Efficacy of Ivacaftor in Subjects With Cystic Fibrosis Who Have a 3849 + 10KB C→T or D1152H CFTR MutationCompletedNCT03068312Phase 3Results posted
• Lumacaftor/Ivacaftor Combination Therapy in Subjects With CF Who Have an A455E CFTR MutationCompletedNCT03061331Phase 2Results posted
• Study to Evaluate the Safety and Efficacy of CTP-656 in Patients With Cystic Fibrosis With CFTR Gating MutationsTerminatedNCT02971839Phase 2Results posted
• A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VX-661/Ivacaftor in Pediatric Subjects With Cystic Fibrosis (CF)CompletedNCT02953314Phase 3Results posted
• A Study Evaluating the Safety of VX-152 Combination Therapy in Adults With Cystic FibrosisCompletedNCT02951195Phase 2Results posted
• A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic FibrosisCompletedNCT02951182Phase 2Results posted
• A Study of the Effects of Lumacaftor/Ivacaftor (LUM/IVA) on Exercise Tolerance in Subjects With Cystic Fibrosis (CF), Homozygous for the F508del-CFTR MutationCompletedNCT02875366Phase 4Results posted
• A Pilot Study to Evaluate the Use of Smart Adherence Technology to Measure Lumacaftor/Ivacaftor Adherence in CF Subjects Homozygous for the F508del CFTR MutationTerminatedNCT02823470Phase 4Results posted
• Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508delCompletedNCT02797132Phase 3Results posted
• A Study to Evaluate Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis Aged 3 Through 5 Years Who Have a Specified CFTR Gating MutationTerminatedNCT02742519Phase 3Results posted
• A Study to Evaluate the Effect of VX-661 in Combination With Ivacaftor on Chest Imaging Endpoints in Subjects With Cystic Fibrosis, Homozygous for the F508del CFTR MutationCompletedNCT02730208Phase 2Results posted
• A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age and Have an Ivacaftor-Responsive CFTR MutationCompletedNCT02725567Phase 3Results posted
• A Study to Evaluate the Safety and Efficacy of Long Term Treatment With VX-661 in Combination With Ivacaftor in Participants With Cystic Fibrosis Who Have an F508del-CFTR MutationCompletedNCT02565914Phase 3Results posted
• Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With IvacaftorCompletedNCT02544451Phase 3Results posted
• A Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR MutationCompletedNCT02516410Phase 3Results posted
• A Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects With CF, Homozygous for the F508del-CFTR MutationCompletedNCT02514473Phase 3Results posted
• A Phase 2 Study to Evaluate Effects of VX-661/Ivacaftor on Lung and Extrapulmonary Systems in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR MutationCompletedNCT02508207Phase 2Results posted
• A Phase 3 Study of Tezacaftor (VX-661) in Combination With Ivacaftor (VX-770) in Subjects Aged 12 Years and Older With Cystic Fibrosis (CF), Who Have One F508del-CFTR Mutation and a Second Mutation That Has Been Demonstrated to be Clinically Responsive to IvacaftorCompletedNCT02412111Phase 3Results posted
• A Phase 3 Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-cystic Fibrosis Transmembrane Conductance Regulator (CFTR) MutationCompletedNCT02392234Phase 3Results posted
• Study to Evaluate Lumacaftor and Ivacaftor Combination Therapy in Subjects 12 Years and Older With Advanced Lung DiseaseCompletedNCT02390219Phase 3Results posted
• A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With IvacaftorCompletedNCT02347657Phase 3Results posted
• Study to Evaluate Safety and Efficacy of VX-661 in Combination With Ivacaftor in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation With an Open-Label ExpansionCompletedNCT02070744Phase 2Results posted
• Roll-Over Study of Ivacaftor in Cystic Fibrosis Pediatric Subjects With a CF Transmembrane Conductance Regulator Gene (CFTR) Gating MutationCompletedNCT01946412Phase 3Results posted
• A Phase 3 Rollover Study of Lumacaftor in Combination With Ivacaftor in Subjects 12 Years and Older With Cystic FibrosisCompletedNCT01931839Phase 3Results posted
• Study of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous for the F508del-CFTR MutationCompletedNCT01897233Phase 3Results posted
• A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR MutationCompletedNCT01807949Phase 3Results posted
• A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR MutationCompletedNCT01807923Phase 3Results posted
• Safety and Pharmacokinetic Study of N6022 in Subjects With Cystic Fibrosis Homozygous for the F508del-CFTR MutationCompletedNCT01746784Phase 1Results posted
• Rollover Study of Ivacaftor in Subjects With Cystic Fibrosis and a Non G551D CFTR MutationCompletedNCT01707290Phase 3Results posted
• Study of Ivacaftor in Cystic Fibrosis Subjects 2 Through 5 Years of Age With a CFTR Gating MutationCompletedNCT01705145Phase 3Results posted
• Pilot Study Testing the Effect of Ivacaftor on Lung Function in Subjects With Cystic Fibrosis and Residual CFTR FunctionCompletedNCT01685801Phase 2Results posted
• Study of Ivacaftor in Subjects With Cystic Fibrosis (CF) Who Have a Non-G551D CF Transmembrane Conductance Regulator (CFTR) Gating MutationCompletedNCT01614470Phase 3Results posted
• Study of Ivacaftor in Subjects With Cystic Fibrosis (CF) Who Have the R117H-CF Transmembrane Conductance Regulator (CFTR) Mutation (KONDUCT)CompletedNCT01614457Phase 3Results posted
• Study of VX-661 Alone and in Combination With Ivacaftor in Subjects Homozygous or Heterozygous to the F508del-Cystic Fibrosis Transmembrane Conductance Regulator(CFTR) MutationCompletedNCT01531673Phase 2Results posted
• Study of the Effect of Ivacaftor on Lung Clearance Index in Subjects With Cystic Fibrosis and the G551D MutationCompletedNCT01262352Phase 2Results posted
• Study of VX-809 Alone and in Combination With VX-770 in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR MutationCompletedNCT01225211Phase 2Results posted
• Study of the Effect of VX-770 on Hyperpolarized Helium-3 Magnetic Resonance Imaging in Subjects With Cystic Fibrosis and the G551D MutationCompletedNCT01161537Phase 2Results posted
• Rollover Study of VX-770 in Cystic Fibrosis SubjectsCompletedNCT01117012Phase 3Results posted
• Study of Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Homozygous for the F508del-CFTR MutationTerminatedNCT00953706Phase 2Results posted
• Study of Ivacaftor in Cystic Fibrosis Subjects Aged 6 to 11 Years With the G551D MutationCompletedNCT00909727Phase 3Results posted
• Study of Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older With the G551D MutationCompletedNCT00909532Phase 3Results posted
• Study of VX-809 in Cystic Fibrosis Subjects With the ∆F508-CFTR Gene MutationCompletedNCT00865904Phase 2Results posted
• Safety Study of Ivacaftor in Subjects With Cystic FibrosisCompletedNCT00457821Phase 2Results posted
• Effect of Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ/TEZ/D-IVA) on the PK of Rosuvastatin in Healthy ParticipantsCompletedNCT07349394Phase 1
• A Phase 1 Study to Evaluate the Relative Bioavailability of a VX-828 Tablet FormulationCompletedNCT06861413Phase 1
• Natural History Study of Exocrine Pancreatic Function in Infants With Cystic Fibrosis (CF)CompletedNCT06506773
• Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Participants 12 Months of Age and OlderActive, not recruitingNCT06460506Phase 3
• A Study to Evaluate the Relative Bioavailability and Food Effect of a VX-118 Tablet FormulationCompletedNCT06312787Phase 1
• A Study To Evaluate the Relative Bioavailability, Food Effect, and Dose Proportionality of a Granule Formulation of Vanzacaftor/Tezacaftor/Deutivacaftor(VNZ/TEZ/D-IVA)CompletedNCT06299709Phase 1
• A Study of Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ/TEZ/D-IVA) in Healthy Adult PanelistsCompletedNCT06299696Phase 1
• Evaluation of VX-828 in Healthy Participants and in Participants With Cystic FibrosisCompletedNCT06154447Phase 1
• An Electrocardiogram Study to Evaluate the Effect of Vanzacaftor on the QT/QTc Interval in Healthy ParticipantsCompletedNCT05867147Phase 1
• A Phase 1/2 Study of VX-522 in Participants With Cystic Fibrosis (CF)CompletedNCT05668741Phase 1/2
• A Study to Evaluate the Relative Bioavailability of a Fixed-dose Combination Tablet of VX-121/Tezacaftor/DeutivacaftorCompletedNCT05535959Phase 1
• A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination TherapyActive, not recruitingNCT05444257Phase 3
• Pharmacokinetics and Safety Assessment of VX-121/Tezacaftor/Deutivacaftor in Participants With Moderate Hepatic ImpairmentCompletedNCT05437120Phase 1
• Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Years of AgeActive, not recruitingNCT05422222Phase 3
• Study to Evaluate Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) Long-term Safety and Efficacy in Subjects Without F508delActive, not recruitingNCT05331183Phase 3
• Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis (CF) Participants 2 Years and OlderCompletedNCT05153317Phase 3