> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-test-long-term-safety-of-iclepertin-in-people-bc5ded37-c415-4bd8-8a20-c951b1c3df0d > Record changed: 2026-10-13 # A Study to Test Long-term Safety of Iclepertin in People With Schizophrenia Who Took Part in a Previous CONNEX Study NCT05211947 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05211947) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05211947) Recruitment status Terminated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05211947) Participants 1,356 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05211947) Lead sponsor Boehringer Ingelheim Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05211947) Start date 2022-03-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05211947) Number of sites 303 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05211947) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05211947) **Short title** A Study to Test Long-term Safety of Iclepertin in People With Schizophrenia Who Took Part in a Previous CONNEX Study Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05211947) **Official title** 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05211947) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05211947) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05211947) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05211947) **Recruitment status** Terminated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05211947) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05211947) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05211947) ## Dates **Completion date** 2025-03-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05211947) **First posted** 2022-01-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05211947) **Registry last updated** 2026-04-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05211947) **Primary completion date** 2025-02-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05211947) **Start date** 2022-03-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05211947) ## Size and sites **Actual participants** 1,356 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05211947) **Participants** 1,356 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05211947) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05211947) **Protocol amendments** 9 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05211947) **Number of sites** 303 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05211947) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05211947) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05211947) **Lead sponsor** Boehringer Ingelheim Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05211947) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05211947) ## Identifiers **Registry ID** NCT05211947 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05211947) **ClinicalTrials.gov ID** NCT05211947 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05211947) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05211947) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05211947) ## Outcomes ### Primary outcomes 1. Occurence of Treatment Emergent Adverse Events (TEAEs) Timeframe: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks. Number of participants with treatment emergent adverse events. ### Secondary outcomes 1. Change From Baseline in Clinical Global Impressions - Severity (CGI-S) to End of Treatment (EOT) Timeframe: At baseline and at EOT. Up to a maximum of 60.1 weeks. The change from baseline in the Clinical Global Impressions - Severity score (CGI-S) to end of treatment (EOT), calculated as \\\[CGI-S EOT\\\] - \\\[CGI-S baseline\\\] is reported. The CGI-S is composed of 1 question rated on a 4-point scale describing the severity of a patient's impairment, where 1 = none, 2 = mild, 3 = moderate, and 4 = severe. 2. Change From Baseline in Haemaglobin (Hb) to End of Treatment (EOT) Timeframe: At baseline and at EOT. Up to a maximum of 60.1 weeks. Change in haemoglobin (Hb) from baseline to end of treatment (EOT), calculated as \\\[last Hb on treatment\\\] - \\\[Hb baseline\\\], is reported. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05211947) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 51 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05211947) ## Sites - Advanced Research Center, Inc.Anaheim, United States - Clinical Innovations, IncBellflower, United States - ProScience Research GroupCulver City, United States - Collaborative Neuroscience Network, LLC (CNS)Garden Grove, United States - Omega Clinical Trials,LLCLa Habra, United States - ASCLEPES Research Centers, P.C. dba Alliance ResearchLong Beach, United States - University of California Los AngelesLos Angeles, United States - ATP Clinical Research, Inc.Orange, United States - NRC Research InstituteOrange, United States - CNRI - Los AngelesPico Rivera, United States - Artemis Institute for Clinical Research, LLCSan Diego, United States - Velocity Clinical Research, Santa AnaSanta Ana, United States - Stanford University Medical CenterStanford, United States - Collaborative Neuroscience ResearchTorrance, United States - Institute of LivingHartford, United States - Connecticut Mental Health CenterNew Haven, United States - Advanced Medical Research Group IncHollywood, United States - Accel Research Sites NetworkMaitland, United States - San Marcus Research Clinic, Inc.Miami, United States - CCM Clinical Research Group, LLC-Miami-68482Miami, United States - Optimus U Corporation-Miami-69452Miami, United States - University of MiamiMiami, United States - Nova Psychiatry Inc.Orlando, United States - Synexus Clinical Research-Atlanta-67262Atlanta, United States - American Medical ResearchChicago, United States And 278 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05211947) ## References - Related resource (www.clinicalstudies.boehringer-ingelheim.com) Source: [www.clinicalstudies.boehringer-ingelheim.com](https://www.clinicalstudies.boehringer-ingelheim.com/msw/datatransparency) ### Other registry identifiers - 2020-003745-11 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05211947) ## Related records ### Drugs (1) - [Iclepertin](https://trialight.com/data/asset/iclepertin-4c0281d8-fbd3-472f-97e8-f7007cb50348.md) ### Lead sponsors (1) - [Boehringer Ingelheim](https://trialight.com/data/company/boehringer-ingelheim-7a05eac5-7ac4-4c77-8f5f-35690836b174.md) ### Conditions (1) - [Schizophrenia](https://trialight.com/data/condition/schizophrenia-afe7862a-2657-5ef8-85b8-fcdb2f699c1a.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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