A Study to Assess Adverse Events, Change in Disease Activity, and How Oral Emraclidine Moves Through the Body in Adult Participants With Schizophrenia
NCT ID: NCT07145918
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
258 participants
INTERVENTIONAL
2025-08-04
2028-02-29
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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Emraclidine Part A
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.
Emraclidine
Oral Tablets
Placebo-Part A
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.
Placebo
Oral Tablets
Emraclidine-Part B
Participants will receive oral emraclidine for 42 days followed by a 30-day safety follow-up period.
Emraclidine
Oral Tablets
Placebo-Part B
Participants will receive placebo for 42 days followed by a 30-day safety follow-up period.
Placebo
Oral Tablets
Interventions
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Emraclidine
Oral Tablets
Placebo
Oral Tablets
Eligibility Criteria
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Inclusion Criteria
* (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
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Woodland International Research Group /ID# 275747
Little Rock, Arkansas, United States
Collaborative Neuroscience Research - Garden Grove /ID# 273005
Garden Grove, California, United States
Cenexel Hassman Research Institute (Hri) /ID# 276128
Marlton, New Jersey, 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
Countries
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Central Contacts
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Facility Contacts
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Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Related Links
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Other Identifiers
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M25-522
Identifier Type: -
Identifier Source: org_study_id