A Phase 3 interventional study of Iclepertin in Schizophrenia, sponsored by Boehringer Ingelheim. Terminated at 303 sites in 40 countries. Open to participants aged 18 Years to 51 Years. Per ClinicalTrials.gov, last updated 2026-04-08.
Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment
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.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 1,356 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Further exclusion criteria apply.
Participants who received either placebo or iclepertin in the parent trials 1346-0011, 1346-0012, or 1346-0013 took a 10-milligram (mg) tablet of iclepertin once daily.
Drug: Iclepertin
One 10 milligram (mg) tablet once daily.
Also known as: BI 425809
Occurence of Treatment Emergent Adverse Events (TEAEs)
Number of participants with treatment emergent adverse events.
Time frame: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Change From Baseline in Clinical Global Impressions - Severity (CGI-S) to End of Treatment (EOT)
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.
Time frame: At baseline and at EOT. Up to a maximum of 60.1 weeks.
Change From Baseline in Haemaglobin (Hb) to End of Treatment (EOT)
Change in haemoglobin (Hb) from baseline to end of treatment (EOT), calculated as \[last Hb on treatment\] - \[Hb baseline\], is reported.
Time frame: At baseline and at EOT. Up to a maximum of 60.1 weeks.
Multi-center, multi-national, open label, single arm extension trial in patients with cognitive impairment due to schizophrenia who had completed 26 weeks of treatment with 10 milligrams (mg) iclepertin or matching placebo, taken once daily in one of the three Phase III (CONNEX) parent trials (trial 1346-0011, 1346-0012 or 1346-0013).
| Milestone | Iclepertin 10 mg |
|---|---|
| Started | 1356 |
| Completed | 632 |
| Not completed | 724 |
| Withdrew: Study terminated by sponsor | 557 |
| Withdrew: Adverse event | 42 |
| Withdrew: Perceived lack of efficacy | 15 |
| Withdrew: Burden of study procedures | 12 |
| Withdrew: Change of residence | 10 |
| Withdrew: Protocol deviation | 3 |
| Withdrew: No reason available | 9 |
| Withdrew: Other reason than listed | 74 |
| Withdrew: Missing reason | 2 |
Number of participants with treatment emergent adverse events.
| Participants | Iclepertin 10 mg |
|---|---|
| Occurence of Treatment Emergent Adverse Events (TEAEs) | 838 |
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.
| Units on a scale | Iclepertin 10 mg |
|---|---|
| Change From Baseline in Clinical Global Impressions - Severity (CGI-S) to End of Treatment (EOT) | -0.13 ± 0.57 |
Change in haemoglobin (Hb) from baseline to end of treatment (EOT), calculated as \[last Hb on treatment\] - \[Hb baseline\], is reported.
| grams/liter | Iclepertin 10 mg |
|---|---|
| Change From Baseline in Haemaglobin (Hb) to End of Treatment (EOT) | 0.2 ± 8.9 |
Collected over All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Iclepertin 10 mg | 2/1,356 (0.1%) | 82/1,356 (6%) | 261/1,356 (19.2%) |
| Event | Iclepertin 10 mg |
|---|---|
| SchizophreniaPsychiatric disorders | 19/1356 |
| Suicidal ideationPsychiatric disorders | 15/1356 |
| Suicidal behaviourPsychiatric disorders | 6/1356 |
| Suicide attemptPsychiatric disorders | 3/1356 |
| AppendicitisInfections and infestations | 2/1356 |
| SeizureNervous system disorders | 2/1356 |
| AnxietyPsychiatric disorders | 2/1356 |
| Acute myocardial infarctionCardiac disorders | 1/1356 |
| Cardiac failure congestiveCardiac disorders | 1/1356 |
| Pericardial effusionCardiac disorders | 1/1356 |
| Event | Iclepertin 10 mg |
|---|---|
| NasopharyngitisInfections and infestations | 129/1356 |
| HeadacheNervous system disorders | 89/1356 |
| SchizophreniaPsychiatric disorders | 75/1356 |
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
| Age, Continuous(Years) | Iclepertin 10 mg |
|---|---|
| Mean | 35.5 ± 8.8 |
| Sex: Female, Male(Participants) | Iclepertin 10 mg |
|---|---|
| Female | 477 |
| Male | 879 |
| Ethnicity (NIH/OMB)(Participants) | Iclepertin 10 mg |
|---|---|
| Hispanic or Latino | 425 |
| Not Hispanic or Latino | 912 |
| Unknown or Not Reported | 19 |
| Race (NIH/OMB)(Participants) | Iclepertin 10 mg |
|---|---|
| American Indian or Alaska Native | 103 |
| Asian | 418 |
| Native Hawaiian or Other Pacific Islander | 4 |
| Black or African American | 112 |
| White | 682 |
| More than one race | 18 |
| Unknown or Not Reported | 19 |
Showing the first 100 of 303 sites across 40 countries.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Supporting information: Study protocol, Sap, Csr
This study is terminated, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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