Iclepertin for Schizophrenia

Recruiting at 167 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, Ketamine

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: 15

Duration: 26 weeks

620 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medication called Iclepertin to determine if it improves learning and memory in people with schizophrenia. Schizophrenia can make everyday tasks, such as following conversations or remembering instructions, challenging. Participants will take either Iclepertin or a placebo (a look-alike pill with no active medicine) while continuing their regular schizophrenia treatment. The trial seeks individuals who are stable on their current medication but still struggle with daily tasks like planning or staying focused. Researchers will monitor participants over approximately eight months to assess progress and any side effects. As a Phase 3 trial, this is the final step before FDA approval, offering participants a chance 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 tested for safety in people with schizophrenia. In an earlier study, researchers compared Iclepertin to a placebo (a pill with no active ingredients). The results indicated that Iclepertin did not significantly improve thinking skills, but patients generally tolerated it well, meaning most did not experience serious side effects.

However, like any treatment, some participants may have experienced mild or moderate side effects. The details of these side effects were not provided, but they were not serious enough to halt the study. Since this is a Phase 3 trial, earlier studies found Iclepertin safe enough for testing in larger groups. This is a positive sign that the treatment is considered relatively safe for people at this stage. ^{1 2 3 4 5}

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

Iclepertin is unique because it targets the cognitive symptoms of schizophrenia, which many current treatments do not specifically address. Most existing medications for schizophrenia, like antipsychotics, primarily focus on reducing positive symptoms such as hallucinations and delusions, often leaving cognitive impairments untreated. Iclepertin works differently by enhancing synaptic plasticity, potentially improving memory and cognitive function. Researchers are excited about this treatment because it could provide a much-needed option for patients struggling with cognitive deficits, offering a more comprehensive approach to managing schizophrenia.

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

Research suggests that Iclepertin, which participants in this trial may receive, might improve thinking skills, such as learning and memory, in people with schizophrenia. One study showed that patients who took Iclepertin demonstrated better thinking abilities than those who took a placebo. However, other studies have not consistently shown clear improvements in thinking or daily functioning. Despite these mixed results, Iclepertin has generally been safe, with most patients not experiencing serious side effects. This ongoing research aims to better understand Iclepertin's effectiveness for these cognitive challenges in schizophrenia. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

Adults aged 18-50 with schizophrenia, stable on current antipsychotic treatment (except clozapine), and experiencing functional impairment in daily activities can join. They must not have been hospitalized for worsening schizophrenia recently, use effective birth control if applicable, and have a study partner who meets regularly.

Inclusion Criteria

I've been on the same antipsychotic medication for at least 12 weeks.

I have been on the same psychoactive medication, except anticholinergics, for at least 12 weeks and on the current dose for at least 35 days.

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

Exclusion Criteria

I have cognitive issues due to a condition like epilepsy, stroke, or head injury.

My side effects from antipsychotic medication can't be managed with low-dose treatments.

I have not undergone electroconvulsive therapy.

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

14 visits (in-person)

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 Iclepertin's effect on cognitive functions like learning and memory in people with schizophrenia over 26 weeks. Participants are randomly assigned to receive either Iclepertin or a placebo alongside their standard medication while undergoing regular mental ability assessments.

How Is the Trial Designed?

Group I: Iclepertin 10 mg Experimental Treatment 1 Intervention

Patients with schizophrenia took orally once a day one 10 milligram (mg) tablet of iclepertin.

Group II: Placebo-matching Iclepertin 10 mg Placebo Group 1 Intervention

Patients with schizophrenia took orally once a day one tablet of placebo-matching iclepertin.

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

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. psychiatrictimes.com psychiatrictimes.com/view/disappointing-data-from-phase-iii-connex-for-iclepertin-in-addressing-cognition-impairment-in-schizophrenia

Disappointing Data From Phase III CONNEX for Iclepertin ... Iclepertin showed no significant cognitive or functional improvement in schizophrenia patients compared to placebo in the phase III study.

7. mdpi.com mdpi.com/1424-8247/18/10/1453

Pre-Emptive Drug Safety Evaluation of Iclepertin (BI- ... As we have observed that individuals with schizophrenia in the three populations tested had about a 2-fold increase in their MRS compared to the non- ...