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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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Trial Profile

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: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 10 Dec 2025

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At a glance

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

Most Recent Events

  • 24 Nov 2025 Planned End Date changed from 21 Mar 2028 to 4 Jul 2028.
  • 24 Nov 2025 Planned primary completion date changed from 30 Nov 2027 to 14 Mar 2028.
  • 30 Oct 2025 Planned End Date changed from 10 Feb 2028 to 21 Mar 2028.

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