Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F)
Brief Summary: This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation (F/F)


Options:
A: 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)
B: Arm Label: Lumacaftor/Ivacaftor (LUM/IVA); Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor, Drug: Ivacaftor | Intervention Type: DRUG; Name: Lumacaftor; Assigned to Arm(s): Lumacaftor/Ivacaftor (LUM/IVA) | Intervention Type: DRUG; Name: Ivacaftor; Assigned to Arm(s): Lumacaftor/Ivacaftor (LUM/IVA)
C: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: LUM 600 mg qd/IVA 250 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor Plus Ivacaftor Combination, Drug: Ivacaftor | Arm Label: LUM 400 mg q12h/ IVA 250 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor Plus Ivacaftor Combination | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Lumacaftor Plus Ivacaftor Combination; Assigned to Arm(s): LUM 400 mg q12h/ IVA 250 mg q12h, LUM 600 mg qd/IVA 250 mg q12h | Intervention Type: DRUG; Name: Ivacaftor; Assigned to Arm(s): LUM 600 mg qd/IVA 250 mg q12h
D: Arm Label: TEZ/IVA; Type: ACTIVE_COMPARATOR; Interventions: Drug: TEZ/IVA, Drug: IVA, Drug: Placebo | Arm Label: VX-445/TEZ/IVA TC; Type: EXPERIMENTAL; Interventions: Drug: VX-445/TEZ/IVA, Drug: IVA, Drug: Placebo | Intervention Type: DRUG; Name: VX-445/TEZ/IVA; Assigned to Arm(s): VX-445/TEZ/IVA TC | Intervention Type: DRUG; Name: TEZ/IVA; Assigned to Arm(s): TEZ/IVA | Intervention Type: DRUG; Name: IVA; Assigned to Arm(s): TEZ/IVA, VX-445/TEZ/IVA TC | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): TEZ/IVA | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): VX-445/TEZ/IVA TC

Answer: D