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Schizophrenia is a common and severe psychiatric illness characterized by extreme disturbances of cognition and thought, affecting language, perception and sense of self. This study will assess adverse events, change in disease activity, and how oral emraclidine moves through the body in adult participants with schizophrenia
Emraclidine is an investigational drug being developed for the treatment of schizophrenia. Participants are placed in one of two parts, Part A or Part B, where each group will receive a different treatment. Participants will receive either oral emraclidine or placebo. Approximately 268 participants will be enrolled across roughly 32 sites in the United States.
Participants in Part A will be assigned to one of multiple ascending doses of emraclidine or placebo administered orally for 14 days or up to 21 days. Participants in Part B will receive Emraclidine or placebo administered orally for up to 42 days. Participants will be followed for 30 days after the last dose of the study drug.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emraclidine Part A | Experimental | 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. |
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| Placebo-Part A | Experimental | 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. |
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| Emraclidine-Part B | Experimental | Participants will receive oral emraclidine for 42 days followed by a 30-day safety follow-up period. |
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| Placebo-Part B | Experimental | Participants will receive placebo for 42 days followed by a 30-day safety follow-up period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emraclidine | Drug | Oral Tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. | Up to approximately 74 days |
| Part A Only-Maximum Observed Plasma Concentration (Cmax) of Emraclidine | Cmax of Emraclidine | Up to approximately 24 days |
| Part A Only-Time to Cmax (Tmax) of Emraclidine | Tmax of Emraclidine | Up to approximately 24 days |
| Part A Only-Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) of Emraclidine | AUCt of Emraclidine | Up to approximately 24 days |
| Part A Only-Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Emraclidine | AUCtau of Emraclidine | Up to approximately 24 days |
| Part A Only-Maximum metabolite concentration (MRCmax) of Emraclidine | MRCmax of Emraclidine | Up to approximately 21 days |
| Part A Only- Area under the metabolite concentration-time curve over the dosing interval (MRAUCtau) of Emraclidine | MRAUCtau of Emraclidine |
| Measure | Description | Time Frame |
|---|---|---|
| Part B Only-Change from Baseline in in Clinical Global Impression of Severity (CGIS) score | CGIS is a single, clinician-reported item that measures the clinician's impression of a participant's current anxiety severity considering their total clinical experience with the patient population. The measure uses a 7-point Likert rating scale with responses ranging from "normal, to at all ill" (1) to "among the most extremely ill patients" (5), with higher scores indicating greater anxiety severity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | Contact | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woodland International Research Group /ID# 275747 | Recruiting | Little Rock | Arkansas | 72211 | United States |
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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| Placebo |
| Drug |
Oral Tablets |
|
| Up to approximately 21 days |
| Part A Only- Minimum plasma concentration (Cmin) of Emraclidine | Cmin of Emraclidine | Up to approximately 21 days |
| Part A Only-Average plasma concentration (Cavg) of Emraclidine | Cavg of Emraclidine | Up to approximately 21 days |
| Part A Only- Terminal Phase Elimination Half-Life (t1/2) of Emraclidine | Terminal phase elimination half-life of Emraclidine | Up to approximately 21 days |
| Part A Only-Terminal elimination rate constant (λz) of Emraclidine | λz of Emraclidine | Up to approximately 21 days |
| Part A Only-Apparent Clearance of Drug from Plasma (CL/F) of Emraclidine | CL/F of Emraclidine | Up to approximately 21 days |
| Part A Only-Apparent Volume of Distribution DuringTerminal Phase (Vz/F) of Emraclidine | Vz/F of Emraclidine | Up to approximately 21 days |
| Part A Only-Peak-to-trough ratio (PTR) of Emraclidine | PTR of Emraclidine | Up to approximately 21 days |
| Part A Only- Accumulation ratio for Cmax (RacCmax) of Emraclidine | RacCmax of Emraclidine | Up to approximately 21 days |
| Part A Only-Accumulation ratio for AUCta (RacAUCtau) of Emraclidine | RacAUCta of Emraclidine | Up to approximately 21 days |
| Part A Only-Maximum Observed Plasma Concentration (Cmax) of Metabolite (CV-0000364) | Cmax of Metabolite (CV-0000364) | Up to approximately 24 days |
| Part A Only-Time to Cmax (Tmax) of Metabolite (CV-0000364) | Tmax of Metabolite (CV-000036) | Up to approximately 24 days |
| Part A Only-Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Metabolite (CV-000036) | AUCtau of Metabolite (CV-000036) | Up to approximately 24 days |
| Part A Only-Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) Metabolite (CV-000036) | AUCt of Metabolite (CV-000036) | Up to approximately 24 days |
| Part A Only-Maximum metabolite concentration (MRCmax) of Metabolite (CV-000036) | MRCmax of Metabolite (CV-000036) | Up to approximately 21 days |
| Part A Only- Area under the metabolite concentration-time curve over the dosing interval (MRAUCtau) of Metabolite (CV-000036) | MRAUCtau of Metabolite (CV-000036) | Up to approximately 21 days |
| Part B Only-Change from Baseline in Positive and Negative Syndrome Scale (PANSS) total score | PANSS is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS consists of 3 subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. | Up to approximately week 6 |
| Up to approximately Week 6 |
| Part B Only-Change from Baseline in Positive and Negative Syndrome Scale (PANSS) total score | PANSS is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS consists of 3 subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. | Up to approximately 74 days |
| Part B Only-Change from Baseline in in Clinical Global Impression of Severity (CGIS) score | CGIS is a single, clinician-reported item that measures the clinician's impression of a participant's current anxiety severity considering their total clinical experience with the patient population. The measure uses a 7-point Likert rating scale with responses ranging from "normal, to at all ill" (1) to "among the most extremely ill patients" (5), with higher scores indicating greater anxiety severity. | Up to approximately 53 days |
| Part B Only-Number of Participants achieving ≥ 30% improvement in PANSS total score | PANSS is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS consists of 3 subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. | Up to approximately week 6 |
| Part B Only-Number of Participants achieving remission (PANSS total score ≤ 60) | PANSS is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS consists of 3 subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. | Up to approximately week 6 |
| Collaborative Neuroscience Research - Garden Grove /ID# 273005 | Recruiting | Garden Grove | California | 92845 | United States |
| California Clinical Trials Medical Group - Parexel /ID# 275751 | Recruiting | Glendale | California | 91206 | United States |
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| Cbh Health - Gaithersburg /ID# 272932 | Recruiting | Gaithersburg | Maryland | 20877 | United States |
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| Cenexel Hassman Research Institute (Hri) /ID# 276128 | Recruiting | Marlton | New Jersey | 08053 | United States |
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| Community Clinical Research - Austin - Cross Park Drive /ID# 272977 | Recruiting | Austin | Texas | 78754 | United States |
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| Pillar Clinical Research - Richardson /ID# 275715 | Recruiting | Richardson | Texas | 75080 | United States |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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