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A Seamless Phase I/II Trial With an Initial Open-label Dose Escalation Part and a Subsequent Randomised, Double-blind, Placebo-controlled Expansion Part to Evaluate the Safety, Tolerability, and Efficacy of a Single Dose of BI 3720931, an Inhaled Lentiviral Vector Gene Therapy, in Adult People With Cystic Fibrosis Who Are Ineligible for CFTR Modulators (Lenticlair 1)

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A Seamless Phase I/II Trial With an Initial Open-label Dose Escalation Part and a Subsequent Randomised, Double-blind, Placebo-controlled Expansion Part to Evaluate the Safety, Tolerability, and Efficacy of a Single Dose of BI 3720931, an Inhaled Lentiviral Vector Gene Therapy, in Adult People With Cystic Fibrosis Who Are Ineligible for CFTR Modulators (Lenticlair 1)

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 26 Feb 2025

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At a glance

  • Drugs BI 3720931 (Primary)
  • Indications Cystic fibrosis
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Acronyms Lenticlair 1
  • Sponsors Boehringer Ingelheim

    • Most Recent Events

    • 26 Feb 2025 New trial record
    • 20 Feb 2025 According to Boehringer Ingelheim media release, Company announced the start of LENTICLAIRTM 1, a Phase I/II trial of BI 3720931. The trial is expected to be completed in early 2027.
    • 20 Feb 2025 According to an OXB media release, company's lentiviral vector manufacturing technology will be used in Boehringer Ingelheim's newly initiated LENTICLAIR™ 1 trial. This trial builds on the successful collaboration initiated in August 2018 with Boehringer Ingelheim.

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