VX-121 Combination Therapy for Cystic Fibrosis

Recruiting in Palo Alto (17 mi)

+194 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Vertex Pharmaceuticals Incorporated

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with cystic fibrosis.

Research Team

Eligibility Criteria

This trial is for individuals with cystic fibrosis who previously participated in certain VX-121 studies and completed the treatment or visits, even if they had interruptions. It's not open to pregnant or breastfeeding women or those who couldn't tolerate the drug before.

Inclusion Criteria

I completed or was part of the VX20-121-102 or VX20-121-103 study without permanently stopping the study drug.

Exclusion Criteria

I am not pregnant or breastfeeding.

You had a bad reaction to the study drug in a previous study.

Treatment Details

Interventions

VX-121/TEZ/D-IVA (CFTR Modulator)

Trial OverviewThe study is testing the long-term safety and effectiveness of a combination therapy called VX-121/TEZ/D-IVA designed for people with cystic fibrosis to see how well it works over an extended period.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: VX-121/TEZ/D-IVAExperimental Treatment1 Intervention

Part A: Participants will receive VX-121/TEZ/D-IVA once daily for 96 weeks. Part B: Participants will receive VX-121/TEZ/D-IVA once daily for an additional 48 weeks.