A Study to Assess Adverse Events, Change in Disease Activity, and How Oral Emraclidine Moves Through the Body in Adult Participants With Schizophrenia
- Registration Number
- NCT07145918
- Lead Sponsor
- AbbVie
- Brief Summary
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 258 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 258
- BMI within 18 to 40 kg/m2 (inclusive of both values), and body weight > 50 kg (110 lbs).
- (Part A only): Positive and Negative Syndrome Scale (PANSS) total score < 80 at Screening and at Baseline
- (Part B only): Participant experiencing an acute exacerbation of psychotic symptoms with onset less than 2 months prior to Screening
- (Part B only): Participant must have a PANSS total score from 80 to 120, inclusive, at Screening and at Baseline
- (Part B only): Participant MUST have a score of ≥ 4 (moderate or greater) for ≥ 2 of the following PANSS Positive Scale items at Screening and at Baseline
- (Part B only): Participant must have a Clinical Global Impression of Severity (CGIS) score ≥ 4 (at least moderately ill) at Screening and Baseline
- Any primary DSM-5 disorder other than schizophrenia (current nicotine use disorder and caffeine use disorder are allowed) within 12 months before Screening.
- History of clozapine exposure.
- History of treatment resistance to schizophrenia medications, defined as failure to respond to 2 or more adequate courses of pharmacotherapy (a minimum of 4 weeks at an adequate dose per the label) within the last 12 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Emraclidine Part A Emraclidine 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. Placebo-Part A Placebo 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. Emraclidine-Part B Emraclidine Participants will receive oral emraclidine for 42 days followed by a 30-day safety follow-up period. Placebo-Part B Placebo Participants will receive placebo for 42 days followed by a 30-day safety follow-up period.
- Primary Outcome Measures
Name Time Method Number of Participants with Adverse Events (AEs) Up to approximately 74 days 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.
Part A Only-Maximum Observed Plasma Concentration (Cmax) of Emraclidine Up to approximately 24 days Cmax of Emraclidine
Part A Only-Time to Cmax (Tmax) of Emraclidine Up to approximately 24 days Tmax of Emraclidine
Part A Only-Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) of Emraclidine Up to approximately 24 days AUCt of Emraclidine
Part A Only-Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Emraclidine Up to approximately 24 days AUCtau of Emraclidine
Part A Only-Maximum metabolite concentration (MRCmax) of Emraclidine Up to approximately 21 days MRCmax of Emraclidine
Part A Only- Area under the metabolite concentration-time curve over the dosing interval (MRAUCtau) of Emraclidine Up to approximately 21 days MRAUCtau of Emraclidine
Part A Only- Minimum plasma concentration (Cmin) of Emraclidine Up to approximately 21 days Cmin of Emraclidine
Part A Only-Average plasma concentration (Cavg) of Emraclidine Up to approximately 21 days Cavg of Emraclidine
Part A Only- Terminal Phase Elimination Half-Life (t1/2) of Emraclidine Up to approximately 21 days Terminal phase elimination half-life of Emraclidine
Part A Only-Terminal elimination rate constant (λz) of Emraclidine Up to approximately 21 days λz of Emraclidine
Part A Only-Apparent Clearance of Drug from Plasma (CL/F) of Emraclidine Up to approximately 21 days CL/F of Emraclidine
Part A Only-Apparent Volume of Distribution DuringTerminal Phase (Vz/F) of Emraclidine Up to approximately 21 days Vz/F of Emraclidine
Part A Only-Peak-to-trough ratio (PTR) of Emraclidine Up to approximately 21 days PTR of Emraclidine
Part A Only- Accumulation ratio for Cmax (RacCmax) of Emraclidine Up to approximately 21 days RacCmax of Emraclidine
Part A Only-Accumulation ratio for AUCta (RacAUCtau) of Emraclidine Up to approximately 21 days RacAUCta of Emraclidine
Part A Only-Maximum Observed Plasma Concentration (Cmax) of Metabolite (CV-0000364) Up to approximately 24 days Cmax of Metabolite (CV-0000364)
Part A Only-Time to Cmax (Tmax) of Metabolite (CV-0000364) Up to approximately 24 days Tmax of Metabolite (CV-000036)
Part A Only-Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Metabolite (CV-000036) Up to approximately 24 days AUCtau of Metabolite (CV-000036)
Part A Only-Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) Metabolite (CV-000036) Up to approximately 24 days AUCt of Metabolite (CV-000036)
Part A Only-Maximum metabolite concentration (MRCmax) of Metabolite (CV-000036) Up to approximately 21 days MRCmax of Metabolite (CV-000036)
Part A Only- Area under the metabolite concentration-time curve over the dosing interval (MRAUCtau) of Metabolite (CV-000036) Up to approximately 21 days MRAUCtau of Metabolite (CV-000036)
Part B Only-Change from Baseline in Positive and Negative Syndrome Scale (PANSS) total score Up to approximately week 6 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.
- Secondary Outcome Measures
Name Time Method Part B Only-Change from Baseline in in Clinical Global Impression of Severity (CGIS) score Up to approximately 53 days 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.
Part B Only-Change from Baseline in Positive and Negative Syndrome Scale (PANSS) total score Up to approximately 74 days 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.
Part B Only-Number of Participants achieving ≥ 30% improvement in PANSS total score Up to approximately week 6 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.
Part B Only-Number of Participants achieving remission (PANSS total score ≤ 60) Up to approximately week 6 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.
Trial Locations
- Locations (4)
Woodland International Research Group /ID# 275747
🇺🇸Little Rock, Arkansas, United States
Collaborative Neuroscience Research - Garden Grove /ID# 273005
🇺🇸Garden Grove, California, United States
Community Clinical Research - Austin - Cross Park Drive /ID# 272977
🇺🇸Austin, Texas, United States
Pillar Clinical Research - Richardson /ID# 275715
🇺🇸Richardson, Texas, United States
Woodland International Research Group /ID# 275747🇺🇸Little Rock, Arkansas, United StatesSite CoordinatorContact501-221-8681