A Trial of the Efficacy and Safety of SEP‑363856 in Acutely Psychotic Participants With Schizophrenia

Sponsor ID
382-201-00035
Clinicaltrials.gov ID
NCT06894212
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Active, Not Recruiting
Sponsor ID
382-201-00035
Trial Details
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Age
18 - 65 Years
Therapeutic Area
  • Schizophrenia
    • Sex
    Female & Male
    Trial Dates
    Feb 2025 - Oct 2026
    Healthy Volunteers
    No
    • Male or female participants between 18 to 65 years of age (inclusive) at the time of consent.
    • Participant has an identified reliable informant (eg, caregiver, relative, friend, case worker, residential treatment staff).
    • Participant is experiencing an acute exacerbation or relapse of symptoms, with onset ≤ 2 months prior to screening
    • The participant requires hospitalization for this acute exacerbation or relapse of symptoms.
    • If already an inpatient at screening, has been hospitalized for less than 2 weeks for the current exacerbation at the time of screening.
    • Participants who are experiencing an acute exacerbation of psychotic symptoms and marked deterioration of usual function as demonstrated by meeting ALL of the following criteria at the screening and baseline visits:
    • Participant must have a PANSS total score ≥ 80
    • AND
    • Participant must have a CGI-S score ≥ 4.
    • Participants who have received previous outpatient antipsychotic treatment at an adequate dose (minimal recommended dose for the treatment of schizophrenia according to the manufacturer labeling) for an adequate duration (at least 6 weeks) and who showed a previous good response.
    • Sexually active participants or persons of childbearing potential who do not agree to practice 2 different clinical trial sponsor approved methods of birth control or remain abstinent during the course of the trial and for 30 days after the last dose of study drug.
    • Participant has a current DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia.
    • Participant has had psychiatric hospitalization(s) for more than 30 days (cumulative) during the 90 days prior to screening.
    • Participant has previously received SEP-363856 or was previously enrolled in a SEP-363856 clinical study

    Study Summary

    Evaluate the efficacy and safety of Ulotaront (SEP-363856) in acutely psychotic subjects with schizophrenia

    Additional Study Details

    Phase
    Phase 3
    Study Drug
    Drug: SEP-363856
    Type
    Interventional
    Masking
    Single
    Estimated Enrollment
    538
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • * Male or female participants between 18 to 65 years of age (inclusive) at the time of consent.
    • * Participant has an identified reliable informant (eg, caregiver, relative, friend, case worker, residential treatment staff).

    Exclusion Criteria

    • * Sexually active participants or persons of childbearing potential who do not agree to practice 2 different clinical trial sponsor approved methods of birth control or remain abstinent during the course of the trial and for 30 days after the last dose of study drug.
    • * Participant has a current DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia.
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    • Male or female participants between 18 to 65 years of age (inclusive) at the time of consent.
    • Participant has an identified reliable informant (eg, caregiver, relative, friend, case worker, residential treatment staff).
    • Participant is experiencing an acute exacerbation or relapse of symptoms, with onset ≤ 2 months prior to screening
    • The participant requires hospitalization for this acute exacerbation or relapse of symptoms.
    • If already an inpatient at screening, has been hospitalized for less than 2 weeks for the current exacerbation at the time of screening.
    • Participants who are experiencing an acute exacerbation of psychotic symptoms and marked deterioration of usual function as demonstrated by meeting ALL of the following criteria at the screening and baseline visits:
    • Participant must have a PANSS total score ≥ 80
    • AND
    • Participant must have a CGI-S score ≥ 4.
    • Participants who have received previous outpatient antipsychotic treatment at an adequate dose (minimal recommended dose for the treatment of schizophrenia according to the manufacturer labeling) for an adequate duration (at least 6 weeks) and who showed a previous good response.
    Exclusion Criteria:
    • Sexually active participants or persons of childbearing potential who do not agree to practice 2 different clinical trial sponsor approved methods of birth control or remain abstinent during the course of the trial and for 30 days after the last dose of study drug.
    • Participant has a current DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia.
    • Participant has had psychiatric hospitalization(s) for more than 30 days (cumulative) during the 90 days prior to screening.
    • Participant has previously received SEP-363856 or was previously enrolled in a SEP-363856 clinical study

    Locations

    Location
    Status
    Location
    Pillar Clinical Research LLC - Bentonville Site
    Bentonville, Arkansas, United States, 72712
    Status
    N/A
    Location
    Pillar Clinical Research (Little Rock AR) Site
    Little Rock, Arkansas, United States, 72204
    Status
    N/A
    Location
    Woodland International Research Group Site
    Little Rock, Arkansas, United States, 72211
    Status
    N/A
    Location
    Woodland Research Northwest Site
    Rogers, Arkansas, United States, 72758
    Status
    N/A
    Location
    Clinical Innovations, Inc. dba CITrials (Bellflower)
    Bellflower, California, United States, 90706
    Status
    N/A
    Location
    ProScience Research Group Site
    Culver City, California, United States, 90230
    Status
    N/A
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