Emraclidine for Schizophrenia

Recruiting at 4 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AbbVie

Must not be taking: Clozapine

Disqualifiers: Other DSM-5 disorders, treatment resistance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: Unknown

258 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called emraclidine for people with schizophrenia, a mental health condition that can seriously affect thinking and perception. The study examines the drug's impact on symptoms, its side effects, and its movement through the body. Participants will take either emraclidine or a placebo (a pill with no active drug) for varying durations. Suitable candidates for this trial should have experienced an increase in psychotic symptoms that began less than two months ago and are affecting their daily lives. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in schizophrenia treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop your current medications. However, it does exclude those with a history of treatment resistance to schizophrenia medications, which might imply some restrictions. It's best to discuss your current medications with the trial coordinators.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that emraclidine is generally well-tolerated by people with schizophrenia. Studies have found that the side effects were expected and manageable. The most common side effects were mild and did not cause many participants to leave the study. It is important to remember that the treatment remains under investigation, and these trials are designed to closely monitor safety and side effects. This ensures that any issues are quickly addressed. ^{1 2 3 4 5}

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

Researchers are excited about emraclidine for schizophrenia because it offers a novel approach to treatment by targeting the M4 muscarinic receptor, unlike current antipsychotics that primarily focus on dopamine receptors. This new mechanism of action could potentially reduce the side effects commonly associated with traditional treatments like clozapine or risperidone, such as weight gain and sedation. Additionally, emraclidine is administered orally, making it a convenient option for patients. By offering a different pathway to manage symptoms, emraclidine could improve quality of life for those with schizophrenia.

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

Research shows that emraclidine is a new drug targeting the M4 receptor in the brain, which may help manage schizophrenia symptoms. Early studies suggest that emraclidine effectively reaches the brain and interacts with this receptor. In this trial, participants will receive either emraclidine or a placebo to evaluate its effectiveness. A recent study found that emraclidine did not significantly reduce schizophrenia symptoms compared to a placebo. Despite this, the unique mechanism of emraclidine still offers hope for future research and potential benefits in treating schizophrenia. ^{5 6 7 8 9}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

Adults with schizophrenia can join this study. They'll take a new drug, Emraclidine, or a placebo for up to 42 days and be monitored for another 30 days. The trial requires regular hospital or clinic visits for medical checks and questionnaires.

Inclusion Criteria

For Part B: Participant must have a CGIS score ≥ 4 at Screening and Baseline

For Part A: PANSS total score < 80 at Screening and at Baseline

For Part B: Participant experiencing an acute exacerbation of psychotic symptoms with onset less than 2 months prior to Screening

Exclusion Criteria

Any primary DSM-5 disorder other than schizophrenia within 12 months before Screening

I have taken clozapine in the past.

My schizophrenia medication has not worked well in the past year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive multiple ascending doses of oral emraclidine or placebo for 14 to 21 days

3 weeks

Regular visits at a hospital or clinic

Treatment Part B

Participants receive oral emraclidine or placebo for up to 42 days

6 weeks

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Emraclidine

Trial Overview The trial is testing how Emraclidine affects people with schizophrenia compared to a placebo. It's divided into two parts: Part A tests multiple doses over 14-21 days; Part B uses one dose for up to 42 days across approximately 32 US sites.

How Is the Trial Designed?

Group I: Placebo-Part B Experimental Treatment 1 Intervention

Participants will receive placebo for 42 days followed by a 30-day safety follow-up period.

Group II: Placebo-Part A Experimental Treatment 1 Intervention

Participants will be assigned to received one of multiple ascending doses of oral placebo for 14 or up to 21 days, followed by a 30-day safety follow-up period.

Group III: Emraclidine-Part B Experimental Treatment 1 Intervention

Participants will receive oral emraclidine for 42 days followed by a 30-day safety follow-up period.

Group IV: Emraclidine Part A Experimental Treatment 1 Intervention

Participants will be assigned to received one of multiple ascending doses of oral emraclidine for 14 or up to 21 days, followed by a 30-day safety follow-up period.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07145918

NCT07145918 | A Study to Assess Adverse Events ... A Study to Assess Adverse Events, Change in Disease Activity, and How Oral Emraclidine Moves Through the Body in Adult Participants With Schizophrenia · Study ...

2. prnewswire.com prnewswire.com/news-releases/abbvie-provides-update-on-phase-2-results-for-emraclidine-in-schizophrenia-302301190.html

AbbVie Provides Update on Phase 2 Results for ... About Schizophrenia​​ Only 20% of patients report favorable treatment outcomes and medication adherence is poor, with a compliance rate of about ...

3. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(22)01990-0/abstract

Emraclidine, a novel positive allosteric modulator of ... Emraclidine is a novel, brain-penetrant, highly selective M4 receptor positive allosteric modulator in development for the treatment of schizophrenia.

4. pharmexec.com pharmexec.com/view/abbvie-emraclidine-fails-reduce-schizophrenia-symptoms-compared-placebo

AbbVie's Emraclidine Fails to Reduce Schizophrenia ... Results from the Phase II EMPOWER trial found that emraclidine failed to meet its primary endpoint of reducing Positive and Negative Syndrome ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0140673622019900

Emraclidine, a novel positive allosteric modulator of ... Emraclidine is a novel, brain-penetrant, highly selective M4 receptor positive allosteric modulator in development for the treatment of schizophrenia.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05443724

A Study to Evaluate Safety and Tolerability of CVL-231 ... The primary purpose of this study is to assess the long-term safety and tolerability of oral emraclidine in adult participants with schizophrenia.

7. news.abbvie.com news.abbvie.com/2024-11-11-AbbVie-Provides-Update-on-Phase-2-Results-for-Emraclidine-in-Schizophrenia

AbbVie Provides Update on Phase 2 Results for ... In the EMPOWER trials, emraclidine was well-tolerated with a safety profile comparable to that observed in the Phase 1b trial. The most commonly ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36528376/

Emraclidine, a novel positive allosteric modulator of ... Part A evaluated the safety and tolerability of emraclidine in five cohorts of participants with stable schizophrenia who received ascending ...

9. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=CVL-231-2003

A Study to Evaluate Safety and Tolerability of CVL-231 ... The primary purpose of this study is to assess the long-term safety and tolerability of oral emraclidine in adult participants with schizophrenia.