A Trial of the Safety and Tolerability of SEP‑363856 in Adults With Generalized Anxiety Disorder

Sponsor ID
382-201-00034
Clinicaltrials.gov ID
NCT07786454
EudraCT ID
N/A
EUCTIS ID
2026-526032-40-00
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
844-687-8522 or [email protected]
Will Be Recruiting
Sponsor ID
382-201-00034
Trial Details
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Age
18+ years
Therapeutic Area
  • Anxiety
    • Sex
    Female & Male
    Trial Dates
    Oct 2026 - May 2029
    Healthy Volunteers
    No
    • Key Inclusion Criteria
    • Male or female participants at least 18 years of age at the time of informed consent
    • Completed one of the prior GAD Phase 3 studies involving SEP-363856 through Week 8 without discontinuation of trial intervention
    • Able to continue treatment without interruption, and is considered by investigator to potentially benefit from SEP-363856
    • Participant is willing and able to comply with study procedures and visit schedule
    • i) Females of childbearing potential: negative pregnancy test and agreement to use acceptable contraception ii) Males: agreement to follow protocol-defined contraception and reproductive restrictions
    • Key Exclusion Criteria
    • Diagnosis other than GAD that is the primary focus of treatment
    • Clinically significant psychiatric or medical condition that may interfere with study participation
    • Lifetime history of meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for, or was diagnosed during the prior study with, a psychiatric disorder that would compromise accurate assessment of safety and efficacy outcomes
    • Clinically significant abnormal laboratory values or ECG findings
    • Significant suicide risk
    • Substance use/positive drug screen
    • Use of prohibited medications/therapies
    • Known sensitivity to SEP-363856

    Study Summary

    This is a global, Phase 3, multicenter, open-label extension trial designed to evaluate the long-term safety, tolerability and efficacy of SEP-363856 administered at doses of 50 milligrams (mg) or 75 mg per day in adult participants with generalized anxiety disorder (GAD) over a treatment period of 26 weeks.

    Additional Study Details

    Phase
    Phase 3
    Study Drug
    Drug: SEP-363856
    Type
    Interventional
    Masking
    None (Open Label)
    Estimated Enrollment
    1120
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Key Inclusion Criteria
    • 1. Male or female participants at least 18 years of age at the time of informed consent

    Exclusion Criteria

    Inclusion and Exclusion Criteria
    • Key Inclusion Criteria
    • Male or female participants at least 18 years of age at the time of informed consent
    • Completed one of the prior GAD Phase 3 studies involving SEP-363856 through Week 8 without discontinuation of trial intervention
    • Able to continue treatment without interruption, and is considered by investigator to potentially benefit from SEP-363856
    • Participant is willing and able to comply with study procedures and visit schedule
    • i) Females of childbearing potential: negative pregnancy test and agreement to use acceptable contraception ii) Males: agreement to follow protocol-defined contraception and reproductive restrictions
    • Key Exclusion Criteria
    • Diagnosis other than GAD that is the primary focus of treatment
    • Clinically significant psychiatric or medical condition that may interfere with study participation
    • Lifetime history of meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for, or was diagnosed during the prior study with, a psychiatric disorder that would compromise accurate assessment of safety and efficacy outcomes
    • Clinically significant abnormal laboratory values or ECG findings
    • Significant suicide risk
    • Substance use/positive drug screen
    • Use of prohibited medications/therapies
    • Known sensitivity to SEP-363856

    Locations

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