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Long-term Safety of Iclepertin for Schizophrenia

Phase 3
Recruiting
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinically stable outpatients diagnosed with schizophrenia (as per DSM-5)
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is for people with schizophrenia who have taken part in previous studies. The purpose is to see if they can tolerate a medicine called BI 425809 in the long term. They take it once a day for a year, plus their normal medication. They have 13 visits and 9 phone calls with the study team.

Who is the study for?
This trial is for adults with schizophrenia who previously participated in a CONNEX study. They must be clinically stable, use effective birth control if applicable, and have a regular caregiver or partner to interact with them. People can't join if they've had repeated positive drug screens, developed conditions other than schizophrenia that would interfere with the trial, or shown severe suicidal behavior recently.
What is being tested?
The study tests the long-term safety of Iclepertin tablets taken daily for one year by people with schizophrenia while continuing their normal medication. Participants will visit the study site approximately 13 times and receive around 9 calls from researchers over slightly more than a year.
What are the potential side effects?
While specific side effects are not listed here, participants' health problems will be monitored throughout the study to assess how well they tolerate Iclepertin over an extended period.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with schizophrenia and am stable.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change from baseline in Clinical Global Impressions - Severity (CGI-S) to end of treatment (EOT)

Side effects data

From 2022 Phase 2 trial • 200 Patients • NCT03859973
7%
Headache
3%
Vomiting
1%
Colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
BI 425809 10 mg + Computerized Cognitive Training
Placebo + Computerized Cognitive Training

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients with cognitive impairment due to schizophreniaExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 425809
2019
Completed Phase 2
~630

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,550 Previous Clinical Trials
15,767,882 Total Patients Enrolled
15 Trials studying Schizophrenia
4,259 Patients Enrolled for Schizophrenia

Media Library

BI 425809 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05211947 — Phase 3
Schizophrenia Research Study Groups: Patients with cognitive impairment due to schizophrenia
Schizophrenia Clinical Trial 2023: BI 425809 Highlights & Side Effects. Trial Name: NCT05211947 — Phase 3
BI 425809 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05211947 — Phase 3
Schizophrenia Patient Testimony for trial: Trial Name: NCT05211947 — Phase 3
~382 spots leftby Dec 2025
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