Phase 2 N=93 Study of VX-809 in Cystic Fibrosis Subjects With the ∆F508-CFTR Gene Mutation
Cystic Fibrosis
Primary: Safety and Tolerability Based on Adverse Events (AEs) — 17; 16; 15; 16 participants
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Phase 3 N=107 A Study of VX-445 Combination Therapy in CF Subjects Homozygous for F508del (F/F)
Cystic Fibrosis
Primary: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) — 0.4; 10.4 percentage points — p=<0.0001
Phase 3 N=111 A Study of VX-659 Combination Therapy in CF Subjects Homozygous for F508del (F/F)
Cystic Fibrosis
Primary: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) — 0.3; 10.2 percentage points — p=< 0.0001
Phase 3 N=559 A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation
Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
Primary: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 24 — -0.44; 3.59; 2.16 percent predicted of FEV1 — p=<0.0001
Phase 3 N=563 A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation
Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
Primary: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 24 — -0.15; 2.46; 2.85 percent predicted of FEV1 — p=0.0004
Phase 2 N=311 Study of VX-809 Alone and in Combination With VX-770 in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR Mutation
Cystic Fibrosis
Primary: Cohort 1: Safety and Tolerability Based on Adverse Events (AEs) — 12; 29; 15; 14 participants
Phase 3 N=573 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
Cystic Fibrosis
Primary: Absolute Change in Percent Predicted Forced Expiratory Volume in 1second (ppFEV1) — 0.0; 0.2 percentage points — p=< 0.0001
Phase 2 N=40 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 Expansion
Cystic Fibrosis
Primary: PC Phase: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) — 6; 5; 15; 13 Participants
Phase 2 N=190 Study of VX-661 Alone and in Combination With Ivacaftor in Subjects Homozygous or Heterozygous to the F508del-Cystic Fibrosis Transmembrane Conductance Regulator(CFTR) Mutation
Cystic Fibrosis
Primary: Safety as Determined by Adverse Events (AEs) — 30; 8; 7; 15 participants
Phase 3 N=57 A Rollover Safety Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
Cystic Fibrosis
Primary: Safety as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) — 56; 15 participants
Phase 1 N=66 Safety and Pharmacokinetic Study of N6022 in Subjects With Cystic Fibrosis Homozygous for the F508del-CFTR Mutation
Cystic Fibrosis
Primary: Safety and Tolerability — 11; 4; 6; 4 participants
Phase 3 N=204 A Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects With CF, Homozygous for the F508del-CFTR Mutation
Cystic Fibrosis
Primary: Absolute Change From Baseline in Lung Clearance Index 2.5 (LCI2.5) Through Week 24 — 0.08; -1.01 Ratio — p=< 0.0001
Phase 3 N=175 A Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del
Cystic Fibrosis
Primary: Absolute Change in CF Questionnaire-Revised (CFQ-R) Respiratory Domain Score — 1.2; 17.1 units on a scale — p=< 0.0001
Phase 2 N=142 A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation
Cystic Fibrosis
Primary: Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs — 65; 66; 32; 28 Participants
Phase 2 N=34 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 Mutation
Cystic Fibrosis
Primary: Absolute Change From Baseline in Mucociliary Clearance (MCC) at Day 28 — -0.5; -0.9 percentage of whole-lung clearance — p=0.7151
Phase 3 N=382 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)
Cystic Fibrosis
Primary: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) — -1.0; 13.0 percentage points — p=<0.0001
Phase 2 N=36 Dose Escalation Study of QR-010 in Homozygous ΔF508 Cystic Fibrosis Patients
Cystic Fibrosis
Primary: Incidence of Subjects Experiencing Treatment Emergent Adverse Events From Baseline Through End of Study — 3; 2; 7; 4 Participants
Phase 4 N=70 A Study of the Effects of Lumacaftor/Ivacaftor (LUM/IVA) on Exercise Tolerance in Subjects With Cystic Fibrosis (CF), Homozygous for the F508del-CFTR Mutation
Cystic Fibrosis
Primary: Relative (Percent) Change From Baseline in Maximal Oxygen Consumption (VO2max) During Cardiopulmonary Exercise Testing (CPET) at Week 24 — -3.5; -6.6 percent change…
Phase 3 N=510 A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor
Cystic Fibrosis
Primary: Absolute Change From Baseline (Day 1) in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Through Week 24 — -0.6; 3.4 Percentage of predicted FEV1…
Phase 3 N=403 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)
Cystic Fibrosis
Primary: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) — -0.2; 13.6 percentage points — p=<0.0001
Phase 2 N=78 A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222
Cystic Fibrosis
Primary: Absolute Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) — 0.3; -2.2; 2.0; 4.5 percent predicted FEV1 (%)
Phase 2 N=117 A Study Evaluating the Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis
Cystic Fibrosis
Primary: Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — 9; 10; 15; 17 participants
Phase 3 N=258 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)
Cystic Fibrosis
Primary: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) for ELX/TEZ/IVA Group — 3.7 percentage points
Phase 2 N=73 A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic Fibrosis
Cystic Fibrosis
Primary: Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) — 9; 9; 9; 15 participants
Phase 3 N=398 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)
Cystic Fibrosis
Primary: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) — 0.3; 0.5 percentage points — p=< 0.0001
Phase 3 N=168 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 Mutation
Cystic Fibrosis
Primary: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 12 — -0.1; 1 Percentage of predicted FEV1 — p== 0.1176
Phase 2 N=51 A Study to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del
Cystic Fibrosis
Primary: Part 1: Absolute Change From Baseline in MRI Global Chest Score at Week 48 — -0.3; -1.7 score on a scale
Phase 1 N=18 Exploratory Study to Evaluate QR-010 in Subjects With Cystic Fibrosis ΔF508 CFTR Mutation
Cystic Fibrosis
Primary: Intra-subject Change From Baseline of CFTR-mediated Total Chloride Transport as Measured by Nasal Potential Difference (NPD). — 1.86; -0.75; -1.11; 1.66 mV
Phase 2 N=225 A Study of VX-445 in Healthy Subjects and Subjects With Cystic Fibrosis
Cystic Fibrosis
Primary: Parts A, B and C: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — 0; 3; 1; 2 Participants
Phase 3 N=248 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) Mutation
Cystic Fibrosis
Primary: Absolute Change From Study Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Average of Week 4 and Week 8 — -0.3; 4.4; 6.5 percentage of…