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A phase III randomized, double-blind, placebo-controlled parallel group trial to examine the efficacy and safety of BI 425809 once daily over 26 week treatment period in patients with schizophrenia (CONNEX-1)

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Trial Profile

A phase III randomized, double-blind, placebo-controlled parallel group trial to examine the efficacy and safety of BI 425809 once daily over 26 week treatment period in patients with schizophrenia (CONNEX-1)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Jan 2025

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At a glance

  • Drugs Iclepertin (Primary)
  • Indications Schizophrenia
  • Focus Registrational; Therapeutic Use
  • Acronyms CONNEX-1
  • Sponsors Boehringer Ingelheim; Boehringer Ingelheim GmbH International; Boehringer Ingelheim Pharma KG

Most Recent Events

  • 16 Jan 2025 According to Boehringer Ingelheim media release, the company announced that full efficacy and safety data will be submitted for presentation at an upcoming medical meeting.
  • 16 Jan 2025 Primary endpoint(Change from baseline in overall composite T-score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) after 26 weeks of treatment) has not been met.
  • 09 Oct 2024 Status changed from active, no longer recruiting to completed.

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