A Study to Test Long-term Safety of BI 425809 in People With Schizophrenia Who Took Part in a Previous CONNEX Study

• Status: Not yet recruiting
• Trial end date: 2025-05-24
• Target enrollment: 0
• Participant gender: All

Summary

This study is open to adults with schizophrenia who took part in a previous CONNEX study (study 1346-0011, 1346-0012, or 1346-0013). The purpose of this study is to find out how well people with schizophrenia can tolerate a medicine called BI 425809 in the long term.

Participants take BI 425809 as tablets once a day for 1 year. In addition, all participants take their normal medication for schizophrenia.

Participants are in the study for a little more than 1 year. During this time, they visit the study site about 13 times and get about 9 phone calls from the study team.

The doctors collect information on any health problems of the participants. Doctors also regularly check the participants' symptoms of schizophrenia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: BI 425809

Criteria

Inclusion criteria:

• Signed and dated written informed consent.

• 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 participation in the parent trial.

• Women of childbearing potential must use highly effective methods of birth control.

• Have a study partner who interacts with the patient on a regular basis. Further inclusion criteria apply.

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 since enrolment into the parent phase III trial.

• Any suicidal behavior and/or suicidal ideation of type 5 based on the Columbia Suicidality Severity Rating Scale (C-SSRS) in parent trial and up to and including Visit 1 of this study.

• Positive urine drug screen ≥ 3 times during the treatment period of parent trial.

• Patients who are currently or wish to participate in another investigational drug trial.

• Any clinically significant finding or condition in the judgment of the investigator that would jeopardize the patient´s safety while participating in the trial or their capability to participate in the trial.

Further exclusion criteria apply.