Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover 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-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of VX-661 in combination with ivacaftor (IVA, VX-770) and IVA monotherapy in participants with Cystic Fibrosis (CF) who are heterozygous for F508del-CFTR allele and a second allele with a CFTR mutation predicted to have residual function.


Options:
A: Arm Label: VX-661/Ivacaftor combination; Type: EXPERIMENTAL; Interventions: Drug: VX-661/Ivacaftor, Drug: Ivacaftor, Drug: Placebo matched to Ivacaftor | Arm Label: Ivacaftor monotherapy; Type: EXPERIMENTAL; Interventions: Drug: Ivacaftor, Drug: Placebo matched to VX-661/ ivacaftor | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo matched to VX-661/ ivacaftor, Drug: Placebo matched to Ivacaftor | Intervention Type: DRUG; Name: VX-661/Ivacaftor; Assigned to Arm(s): VX-661/Ivacaftor combination | Intervention Type: DRUG; Name: Ivacaftor; Assigned to Arm(s): Ivacaftor monotherapy, VX-661/Ivacaftor combination | Intervention Type: DRUG; Name: Placebo matched to VX-661/ ivacaftor; Assigned to Arm(s): Ivacaftor monotherapy, Placebo | Intervention Type: DRUG; Name: Placebo matched to Ivacaftor; Assigned to Arm(s): Placebo, VX-661/Ivacaftor combination
B: Arm Label: Treatment Period 1: LUM/IVA to LUM/IVA; Type: EXPERIMENTAL; Interventions: Drug: LUM/IVA | Arm Label: Treatment Period 1: Placebo (PBO) to LUM/IVA; Type: EXPERIMENTAL; Interventions: Drug: LUM/IVA | Arm Label: Treatment Period 1: Observational Cohort; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Treatment Period 2: LUM/IVA; Type: EXPERIMENTAL; Interventions: Drug: LUM/IVA | Intervention Type: DRUG; Name: LUM/IVA; Assigned to Arm(s): Treatment Period 1: LUM/IVA to LUM/IVA, Treatment Period 1: Placebo (PBO) to LUM/IVA | Intervention Type: DRUG; Name: LUM/IVA; Assigned to Arm(s): Treatment Period 2: LUM/IVA
C: Arm Label: Part 1: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Part 1: VX-121/TEZ/VX-561 TC - Low Dose; Type: EXPERIMENTAL; Interventions: Drug: VX-121, Drug: TEZ, Drug: VX-561 | Arm Label: Part 1: VX-121/TEZ/VX-561 TC - Medium Dose; Type: EXPERIMENTAL; Interventions: Drug: VX-121, Drug: TEZ, Drug: VX-561 | Arm Label: Part 1: VX-121/TEZ/VX-561 TC - High Dose; Type: EXPERIMENTAL; Interventions: Drug: VX-121, Drug: TEZ, Drug: VX-561 | Arm Label: Part 2: TEZ/IVA; Type: ACTIVE_COMPARATOR; Interventions: Drug: TEZ/IVA, Drug: IVA | Arm Label: Part 2: VX-121/TEZ/VX-561 TC - High Dose; Type: EXPERIMENTAL; Interventions: Drug: VX-121, Drug: TEZ, Drug: VX-561 | Intervention Type: DRUG; Name: VX-121; Assigned to Arm(s): Part 1: VX-121/TEZ/VX-561 TC - High Dose, Part 1: VX-121/TEZ/VX-561 TC - Low Dose, Part 1: VX-121/TEZ/VX-561 TC - Medium Dose, Part 2: VX-121/TEZ/VX-561 TC - High Dose | Intervention Type: DRUG; Name: TEZ; Assigned to Arm(s): Part 1: VX-121/TEZ/VX-561 TC - High Dose, Part 1: VX-121/TEZ/VX-561 TC - Low Dose, Part 1: VX-121/TEZ/VX-561 TC - Medium Dose, Part 2: VX-121/TEZ/VX-561 TC - High Dose | Intervention Type: DRUG; Name: VX-561; Assigned to Arm(s): Part 1: VX-121/TEZ/VX-561 TC - High Dose, Part 1: VX-121/TEZ/VX-561 TC - Low Dose, Part 1: VX-121/TEZ/VX-561 TC - Medium Dose, Part 2: VX-121/TEZ/VX-561 TC - High Dose | Intervention Type: DRUG; Name: TEZ/IVA; Assigned to Arm(s): Part 2: TEZ/IVA | Intervention Type: DRUG; Name: IVA; Assigned to Arm(s): Part 2: TEZ/IVA | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Part 1: Placebo
D: Arm Label: JBT101 (lenabasum) 1 mg; Type: EXPERIMENTAL; Interventions: Drug: JBT-101 (lenabasum) | Arm Label: JBT-101 (lenabasum) 5 mg; Type: EXPERIMENTAL; Interventions: Drug: JBT-101 (lenabasum) | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Arm Label: JBT-101 (lenabasum) 20 mg QD; Type: EXPERIMENTAL; Interventions: Drug: JBT-101 (lenabasum) | Arm Label: JBT-101 (lenabasum) 20 mg BID; Type: EXPERIMENTAL; Interventions: Drug: JBT-101 (lenabasum) | Arm Label: Placebo BID; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DRUG; Name: JBT-101 (lenabasum); Assigned to Arm(s): JBT-101 (lenabasum) 20 mg BID, JBT-101 (lenabasum) 20 mg QD, JBT-101 (lenabasum) 5 mg, JBT101 (lenabasum) 1 mg | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo, Placebo BID

Answer: A