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

Phase 3

Terminated

• Conditions: Schizophrenia
• Interventions: Drug: BI 425809

• Registration Number: NCT05211947
• Lead Sponsor: Boehringer Ingelheim

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-14
• Study First Submitted QC: 2022-01-14
• Study First Posted: 2022-01-27
• Study Start: 2022-03-21
• Primary Completion: 2025-02-26
• Study Completion: 2025-03-18
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-26
• Last Update Posted: 2025-05-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1362

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with cognitive impairment due to schizophrenia	BI 425809	-

Primary Outcome Measures

Name	Time	Method
Occurrence of treatment emergent adverse events (TEAEs)	up to 1 year and 12 days

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Haemoglobin (Hb) to EOT	up to 1 year
Change from baseline in Clinical Global Impressions - Severity (CGI-S) to end of treatment (EOT)	up to 1 year	The CGI-S is a one-item evaluation completed by the clinician on the patient's severity of psychopathology. The CGI-S is rated ordinal from 1 to 7, with 1=normal (not at all ill) to 7=patient among the most extremely ill patients.

Trial Locations

Locations (303)

Advanced Research Center, Inc.; 🇺🇸 Anaheim, California, United States

Clinical Innovations, Inc; 🇺🇸 Bellflower, California, United States

ProScience Research Group; 🇺🇸 Culver City, California, United States

Collaborative Neuroscience Network, LLC (CNS); 🇺🇸 Garden Grove, California, United States

Omega Clinical Trials,LLC; 🇺🇸 La Habra, California, United States

ASCLEPES Research Centers, P.C. dba Alliance Research; 🇺🇸 Long Beach, California, United States

University of California Los Angeles; 🇺🇸 Los Angeles, California, United States

ATP Clinical Research, Inc.; 🇺🇸 Orange, California, United States

NRC Research Institute; 🇺🇸 Orange, California, United States

CNRI - Los Angeles; 🇺🇸 Pico Rivera, California, United States

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