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

JRCT ID: jRCT2061220034

Registered date:10/06/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: schizophrenia
• Date of first enrollment: 10/06/2022
• Target sample size: 1401
• Countries of recruitment: Korea,Japan,Germany,Japan,USA,Japan,China,Japan,Taiwan,Japan,Mexico,Japan,Italy,Japan
• Study type: Interventional
• Intervention(s): Investigational Medical Product: BI 425809

Outcome(s)

• Primary Outcome: The primary endpoint is the occurrence of treatment emergent adverse events (TEAEs) throughout the extension study.

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Suzuki Yu
• Secondary ID(s): NCT05211947