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

Boehringer Ingelheim

Status and phase

Enrolling

Phase 3

Conditions

Schizophrenia

Treatments

Drug: BI 425809

Study type

Interventional

Funder types

Industry

Identifiers

NCT05211947

1346-0014

2020-003745-11 (EudraCT Number)

Details and patient eligibility

About

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 Iclepertin in the long term.

Participants take Iclepertin 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.

Enrollment

1,401 estimated patients

Sex

All

Ages

18 to 51 years old

Volunteers

No Healthy Volunteers

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.