NCT05211947

A Study to Test Long-term Safety of Iclepertin 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 Iclepertin Once Daily in Patients With Schizophrenia Who Have Completed Previous Iclepertin Phase III Trials (CONNEX-X)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,356 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 51 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Iclepertin	One 10 milligram (mg) tablet once daily.

Timeline

• Start date: 2022-03-21
• Primary completion: 2025-02-26
• Completion: 2025-03-18
• First posted: 2022-01-27
• Last updated: 2026-04-08
• Results posted: 2026-04-08

Locations

303 sites across 40 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Japan, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Romania, Serbia, Slovakia, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study