A study to test long-term safety of BI 425809 in people with schizophrenia who took part in a previous CONNEX study

An open label, single arm, extension trial to examine long-term safety of BI 425809 once daily in patients with schizophrenia who have completed previous BI 425809 Phase III trials.(CONNEX-X)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2061220034

Enrollment

1401

Registered

2022-06-10

Start date

2022-06-10

Completion date

Unknown

Last updated

2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

schizophrenia

Interventions

Investigational Medical Product: BI 425809

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Clinically stable outpatients who have been diagnosed with schizophrenia (as per Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)). Patients, who completed 26 weeks of treatment in the parent trial, must enter the extension trial: - Within 2 weeks the end of treatment visit in 1346-0011, 1346-0013. - At the end of safety follow up in 1346-0012. Have a study partner, defined as any person capable of understanding trial related procedures, with a minimum of 8th grade level of education, who knows the patient well, has been capable of interacting with the patient on a regular basis. Preferably be the same person throughout the study.

Exclusion criteria

Exclusion criteria: Participant who developed DSM-5 diagnosis other than Schizophrenia or any condition that would prevent the patient from participating in the extension trial Any suicidal behavior and/ or suicidal ideation of type 5 based on the C-SSRS in parent trial and up to and including Visit 1 of this study. Patients diagnosed with moderate or severe substance use disorder Haemoglobin- Hb drop below 100g/L (10g/dL) OR Hb decrease of 25% or more from baseline and is below lower limit of normal in parent trial (alert 3 from last measure Hb in parental trial) Patients who have been diagnosed with hemoglobinopathies during the parent trial.

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the occurrence of treatment emergent adverse events (TEAEs) throughout the extension study.	—

Secondary

Measure	Time frame
The secondary endpoints are change from baseline in Clinical Global Impressions-Severity (CGI-S) to end of treatment (EOT) and Change from baseline in Hb to EOT.	—

Countries

China, Germany, Italy, Japan, Korea, Mexico, Taiwan, USA

Contacts

Public ContactTomohiro Yamagami

Boehringer Ingelheim

medchiken.jp@boehringer-ingelheim.com+81-120-189-779

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026