Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Participants 12 Months of Age and Older

Last updated: February 12, 2025
Sponsor: Vertex Pharmaceuticals Incorporated
Overall Status: Active - Enrolling

Phase

3

Condition

Cystic Fibrosis

Lung Disease

Scar Tissue

Treatment

IVA

ELX/TEZ/IVA

Clinical Study ID

NCT06460506
VX22-445-123
2023-509563-24-00
  • Ages > 12
  • All Genders

Study Summary

The purpose of the study is to evaluate the long-term safety, tolerability, efficacy, and pharmacodynamics (PD) of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Completed study drug treatment in the parent study VX22-445-122 Part B (NCT05882357)OR had study drug interruption(s) in the parent study but did not permanentlydiscontinue study drug and completed study visits up to the last scheduled visit ofthe Treatment Period of the parent study

Exclusion

Key Exclusion Criteria:

  • History of drug intolerance in the parent study that would pose an additional riskto the participant

  • Current participation in an investigational drug trial other than the parent study

Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: IVA
Phase: 3
Study Start date:
November 21, 2024
Estimated Completion Date:
September 30, 2027

Connect with a study center

  • The Kids Research Institute Australia

    Nedlands,
    Australia

    Site Not Available

  • The Royal Children's Hospital

    Parkville,
    Australia

    Site Not Available

  • Queensland Children's Hospital

    South Brisbane,
    Australia

    Site Not Available

  • The Hospital for Sick Children

    Toronto,
    Canada

    Site Not Available

  • British Columbia Children's Hospital

    Vancouver,
    Canada

    Site Not Available

  • Juliane Marie Center, Rigshospitalet

    Copenhagen,
    Denmark

    Site Not Available

  • Charite Paediatric Pulmonology Department

    Berlin,
    Germany

    Site Not Available

  • Kinderklinik III, Abt. fur Pneumologie

    Essen,
    Germany

    Site Not Available

  • Erasmus Medical Center

    Rotterdam,
    Netherlands

    Site Not Available

  • Inselspital - Universitaetsspital Bern

    Bern,
    Switzerland

    Site Not Available

  • Kinderspital Zurich

    Zurich,
    Switzerland

    Site Not Available

  • Children and Young Adults Research Unit

    Cardiff,
    United Kingdom

    Site Not Available

  • Leeds General Infirmary

    Leeds,
    United Kingdom

    Site Not Available

  • Alder Hey Children's NHS Foundation Trust

    Liverpool,
    United Kingdom

    Site Not Available

  • Great Ormond Street Hospital for Children

    London,
    United Kingdom

    Site Not Available

  • Royal Brompton Hospital

    London,
    United Kingdom

    Site Not Available

  • Southampton General Hospital

    Southampton,
    United Kingdom

    Site Not Available

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