Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy of Lumacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis Who Have an A455E-CFTR Mutation
Brief Summary: This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, crossover study that will evaluate the efficacy of LUM/IVA in subjects with CF 12 years of age and older who have at least one A455E mutation.


Options:
A: Arm Label: Treatment Sequence 1; Type: EXPERIMENTAL; Interventions: Drug: LUM/IVA, Drug: Placebo | Arm Label: Treatment Sequence 2; Type: EXPERIMENTAL; Interventions: Drug: LUM/IVA, Drug: Placebo | Intervention Type: DRUG; Name: LUM/IVA; Assigned to Arm(s): Treatment Sequence 1, Treatment Sequence 2 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Treatment Sequence 1, Treatment Sequence 2
B: Arm Label: LUM/IVA; Type: EXPERIMENTAL; Interventions: Drug: VX-809, Drug: VX-770 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: VX-809; Assigned to Arm(s): LUM/IVA | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: VX-770; Assigned to Arm(s): LUM/IVA
C: Arm Label: Ataluren (PTC124®); Type: EXPERIMENTAL; Interventions: Drug: Ataluren (PTC124®) | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Ataluren (PTC124®); Assigned to Arm(s): Ataluren (PTC124®) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
D: Arm Label: Part A: Pooled Placebo (Except Cohort A7); Type: PLACEBO_COMPARATOR; Interventions: Drug: Matched Placebo | Arm Label: Part A: VX-445 (Except Cohort A7); Type: EXPERIMENTAL; Interventions: Drug: VX-445 | Arm Label: Part A: VX-445 (Cohort A7); Type: EXPERIMENTAL; Interventions: Drug: VX-445 | Arm Label: Part B: Pooled Placebo (Cohort B1 to B4); Type: PLACEBO_COMPARATOR; Interventions: Drug: Matched Placebo | Arm Label: Part B: VX-445 (Cohort B1 to B4); Type: EXPERIMENTAL; Interventions: Drug: VX-445 | Arm Label: Part C: Pooled Placebo (Cohort C1 to C3); Type: PLACEBO_COMPARATOR; Interventions: Drug: Matched Placebo | Arm Label: Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3); Type: EXPERIMENTAL; Interventions: Drug: IVA, Drug: TEZ/IVA, Drug: VX-445 | Arm Label: Part D: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Matched Placebo | Arm Label: Part D: VX-445/TEZ/IVA TC - Low Dose; Type: EXPERIMENTAL; Interventions: Drug: IVA, Drug: TEZ/IVA, Drug: VX-445 | Arm Label: Part D: VX-445/TEZ/IVA TC - Medium Dose; Type: EXPERIMENTAL; Interventions: Drug: IVA, Drug: TEZ/IVA, Drug: VX-445 | Arm Label: Part D: VX-445/TEZ/IVA TC - High Dose; Type: EXPERIMENTAL; Interventions: Drug: IVA, Drug: TEZ/IVA, Drug: VX-445 | Arm Label: Part E: TEZ/IVA; Type: ACTIVE_COMPARATOR; Interventions: Drug: TEZ/IVA | Arm Label: Part E: VX-445/TEZ/IVA TC; Type: EXPERIMENTAL; Interventions: Drug: IVA, Drug: TEZ/IVA, Drug: VX-445 | Arm Label: Part F: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Matched Placebo | Arm Label: Part F: VX-445/TEZ/VX-561 TC; Type: EXPERIMENTAL; Interventions: Drug: VX-445, Drug: TEZ, Drug: VX-561 | Intervention Type: DRUG; Name: IVA; Assigned to Arm(s): Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3), Part D: VX-445/TEZ/IVA TC - High Dose, Part D: VX-445/TEZ/IVA TC - Low Dose, Part D: VX-445/TEZ/IVA TC - Medium Dose, Part E: VX-445/TEZ/IVA TC | Intervention Type: DRUG; Name: TEZ/IVA; Assigned to Arm(s): Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3), Part D: VX-445/TEZ/IVA TC - High Dose, Part D: VX-445/TEZ/IVA TC - Low Dose, Part D: VX-445/TEZ/IVA TC - Medium Dose, Part E: TEZ/IVA, Part E: VX-445/TEZ/IVA TC | Intervention Type: DRUG; Name: VX-445; Assigned to Arm(s): Part A: VX-445 (Cohort A7), Part A: VX-445 (Except Cohort A7), Part B: VX-445 (Cohort B1 to B4), Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3), Part D: VX-445/TEZ/IVA TC - High Dose, Part D: VX-445/TEZ/IVA TC - Low Dose, Part D: VX-445/TEZ/IVA TC - Medium Dose, Part E: VX-445/TEZ/IVA TC, Part F: VX-445/TEZ/VX-561 TC | Intervention Type: DRUG; Name: Matched Placebo; Assigned to Arm(s): Part A: Pooled Placebo (Except Cohort A7), Part B: Pooled Placebo (Cohort B1 to B4), Part C: Pooled Placebo (Cohort C1 to C3), Part D: Placebo, Part F: Placebo | Intervention Type: DRUG; Name: TEZ; Assigned to Arm(s): Part F: VX-445/TEZ/VX-561 TC | Intervention Type: DRUG; Name: VX-561; Assigned to Arm(s): Part F: VX-445/TEZ/VX-561 TC | Intervention Type: DRUG; Name: VX-445; Assigned to Arm(s): Part A: VX-445 (Cohort A7)

Answer: A