NCT04846881

Clinical Trial of Iclepertin Effect on Cognition and Functional Capacity in Schizophrenia (CONNEX-2)

A Phase III Randomized, Double-blind, Placebo-controlled, Parallel Group Trial to Examine the Efficacy and Safety of Iclepertin Once Daily Over 26 Week Treatment Period in Patients With Schizophrenia (CONNEX-2)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 611 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This study is open to adults with schizophrenia. Schizophrenia can affect the way a person thinks, their memory and their mental functioning. Examples include struggling to remember things, or to read a book or pay attention to a movie. Some people have difficulty calculating the right change or planning a trip so that they arrive on time. The purpose of this study is to find out whether a medicine called Iclepertin improves learning and memory in people with schizophrenia. Participants are put into two groups randomly, which means by chance. One group takes Iclepertin tablets and the other group takes placebo tablets. Placebo tablets look like Iclepertin tablets but do not contain any medicine. Participants take a tablet once a day for 26 weeks. In addition, all participants take their normal medication for schizophrenia. During this time, doctors regularly test learning and memory of the participants by use of questionnaires, interviews, and computer tests. The results of the mental ability tests are compared between the groups. Participants are in the study for about 8 months. During this time, they visit the study site about 15 times and get about 3 phone calls from the study team. The doctors also regularly check participants' health and take note of any unwanted effects.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Iclepertin	One tablet of 10 mg iclepertin taken once daily for 26 weeks
DRUG	Placebo	One tablet of matching placebo taken once daily for 26 weeks

Timeline

• Start date: 2021-08-24
• Primary completion: 2024-10-18
• Completion: 2024-11-17
• First posted: 2021-04-15
• Last updated: 2025-12-12
• Results posted: 2025-12-12

Locations

127 sites across 18 countries: United States, Argentina, Brazil, Chile, Croatia, France, Hungary, Japan, Malaysia, Netherlands, Poland, Romania, Serbia, Singapore, Slovakia, South Korea, Spain, Ukraine

Regulatory

• FDA-regulated drug study