Iclepertin for Schizophrenia

No longer recruiting at 183 trial locations

Overseen By Boehringer Ingelheim

Age: 18 - 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Boehringer Ingelheim

Must be taking: Antipsychotics

Must not be taking: Clozapine, Stimulants

Disqualifiers: Bipolar, Major depressive, Substance use, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 16

Duration: 26 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a medication called Iclepertin can improve learning and memory in people with schizophrenia. Participants will be randomly assigned to take either Iclepertin or a placebo, while continuing their usual schizophrenia medication. The trial seeks individuals with schizophrenia who are stable in their condition and experience challenges in daily activities, such as remembering instructions or staying focused. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment for schizophrenia.

Will I have to stop taking my current medications?

No, you will not have to stop taking your current medications. Participants are required to continue their normal medication for schizophrenia during the trial.

Is there any evidence suggesting that Iclepertin is likely to be safe for humans?

Research has shown that iclepertin has been generally well tolerated in past studies. Reports from several trials suggest that most people taking iclepertin did not experience major problems. These studies found that iclepertin, which blocks a specific protein called GlyT1, had side effects similar to a placebo. This means the side effects were not much different from those experienced by participants who took a non-medicine pill. Ongoing studies continue to monitor safety to ensure participants' well-being. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for schizophrenia?

Researchers are excited about Iclepertin for schizophrenia because it offers a fresh approach by targeting cognitive impairment, which is often not addressed by existing treatments. While most current treatments focus on alleviating symptoms like hallucinations and delusions, Iclepertin aims to enhance cognitive function, potentially improving memory and thinking skills. This novel mechanism could provide a much-needed boost in quality of life for patients, making it a promising addition to the treatment landscape.

What evidence suggests that Iclepertin might be an effective treatment for schizophrenia?

Research has shown that iclepertin, which participants in this trial may receive, may help improve thinking skills, such as learning and memory, in people with schizophrenia. In an earlier study, patients who took iclepertin experienced better cognitive improvements than those who took a placebo. However, more recent research did not find a clear benefit on thinking skills or daily functioning. While some early results are promising, the overall findings remain mixed. The treatment is generally well tolerated, which is important for long-term use. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

Adults aged 18-50 with schizophrenia, stable on current antipsychotic treatment (except clozapine), not hospitalized for worsening symptoms in the last 12 weeks. Must have a study partner and be capable of consent. Women must use effective birth control.

Inclusion Criteria

I am taking two antipsychotics, and both are within the recommended dose limits.

I am on a stable dose of my antipsychotic medication, even if the form has changed.

I am not taking more than the allowed dose of any psychoactive medication.

Exclusion Criteria

I haven't used specific medications like Clozapine or undergone treatments like ECT in the last 6 months.

I am between 18 and 50 years old.

Have you been hospitalized for worsening schizophrenia symptoms in the past year?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants take Iclepertin or placebo tablets once daily for 26 weeks, with regular assessments of learning and memory

26 weeks

15 visits (in-person), 3 phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Iclepertin

Trial Overview

The trial tests if Iclepertin improves cognition compared to placebo over 26 weeks. Participants also continue their usual schizophrenia medication, attend regular visits for health checks and cognitive assessments using questionnaires and computer tests.

How Is the Trial Designed?

Group I: Iclepertin 10 mg Experimental Treatment 1 Intervention

This arm comprised participants who received 10 mg tablet of iclepertin orally once daily, with doses administered at least 24 hours (hrs) apart, taken with water. Participants were treated for 26 weeks, followed by 4 weeks follow-up after trial drug termination.

Group II: Placebo Placebo Group 1 Intervention

This arm comprised participants who received 10 mg tablet of iclepertin-matched Placebo orally once daily, with doses administered at least 24 hrs apart, taken with water. Participants were treated for 26 weeks, followed by 4 weeks follow-up after trial drug termination.

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

Published Research Related to This Trial

Lumateperone (CAPLYTA™) is a novel antipsychotic approved for treating schizophrenia, showing efficacy in managing a broad range of symptoms, including positive symptoms and comorbid depression, based on data from 20 clinical trials involving over 1900 participants.

This medication works by simultaneously modulating serotonin, dopamine, and glutamate neurotransmission, which contributes to its effectiveness while maintaining a favorable safety profile with fewer intolerable side effects compared to traditional antipsychotics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of the pharmacology and clinical profile of lumateperone for the treatment of schizophrenia. Snyder, GL., Vanover, KE., Davis, RE., et al.[2021]

Lumateperone (Caplyta®) is a first-in-class medication that modulates serotonin, dopamine, and glutamate, making it a unique treatment option for schizophrenia and potentially other neuropsychiatric disorders.

Approved in December 2019 for schizophrenia in adults, lumateperone is also being studied for various conditions, including bipolar depression and Alzheimer's-related behavioral disorders, highlighting its broad therapeutic potential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lumateperone: First Approval. Blair, HA.[2021]

Iloperidone has been shown to be effective in treating schizophrenia, with multiple dosing groups demonstrating significant improvements over placebo in three randomized, double-blind studies involving 1943 patients.

Iloperidone was associated with a lower risk of motor-related side effects compared to other antipsychotics like risperidone and haloperidol, making it a safer option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of iloperidone in the treatment of schizophrenia: initial phase 3 studies. Potkin, SG., Litman, RE., Torres, R., et al.[2022]

In a phase 3 clinical trial involving 450 patients, lumateperone (42 mg) significantly improved schizophrenia symptoms compared to placebo, as measured by the Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression-Severity (CGI-S) scores.

Lumateperone was well tolerated, showing no significant motor side effects or adverse changes in cardiometabolic or endocrine factors, suggesting it may be a safer alternative to current antipsychotic medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Lumateperone for Treatment of Schizophrenia: A Randomized Clinical Trial. Correll, CU., Davis, RE., Weingart, M., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11699300/

Efficacy and safety of iclepertin (BI 425809) with adjunctive ...

A Phase II proof-of-concept trial demonstrated improved cognition in adults with schizophrenia after 2—25 mg iclepertin treatment versus placebo ...

2.

boehringer-ingelheim.com

boehringer-ingelheim.com/human-health/mental-health/schizophrenia/update-phase-iii-connex-clinical-program-schizophrenia

Update Phase III CONNEX clinical program schizophrenia

Overall, no statistically significant effects on cognition or functioning were observed in patients treated with iclepertin versus placebo at ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10661489/

Efficacy and safety of iclepertin (BI 425809) in patients with ...

A 12-wk, Phase II trial (NCT02832037) in 509 patients (pts) with schizophrenia demonstrated that iclepertin was well tolerated and significantly improved ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04846868

Study Details | NCT04846868 | Clinical Trial of Iclepertin ...

The purpose of this study is to find out whether a medicine called Iclepertin improves learning and memory in people with schizophrenia.

5.

psychiatrictimes.com

psychiatrictimes.com/view/new-baseline-data-on-iclepertin-for-schizophrenia

New Baseline Data on Iclepertin for Schizophrenia

“This extension study will allow the examination of long-term safety and descriptive analyses of cognitive and functional end points of ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S2215001324000416

Efficacy and safety of iclepertin (BI 425809) with adjunctive ...

Despite significant patient burden, there are no approved pharmacotherapies to treat symptoms of cognitive impairment associated with schizophrenia (CIAS).

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39759424/

Efficacy and safety of iclepertin (BI 425809) with adjunctive ...

This double-blind, placebo-controlled, parallel-group Phase II trial assessed the efficacy and safety of pharmacological augmentation of at-home ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11862520/

Preliminary data from the CONNEX-X extension trial ...

Preliminary data from the CONNEX-X extension trial examining the long-term safety of iclepertin in patients with schizophrenia who completed Phase III CONNEX ...