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

NCT07786454
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Phase
Phase 3
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Recruitment status
Not yet recruiting
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Participants
1,120
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Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
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Start date
2026-10-06
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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.
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Short title
A Trial of the Safety and Tolerability of SEP-363856 in Adults With Generalized Anxiety Disorder
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Official title
A Phase 3, Multicenter, Open-Label Extension Trial to Evaluate the Safety and Tolerability of SEP-363856 in the Treatment of Adults With Generalized Anxiety Disorder
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Not yet recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2029-06-02
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First posted
2026-08-26
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Registry last updated
2026-08-26
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Primary completion date
2029-05-26
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Start date
2026-10-06
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Participants
1,120
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Participant count basis
Estimated
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Planned participants
1,120
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Protocol amendments
0
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07786454
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ClinicalTrials.gov ID
NCT07786454
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Registry record
Open registry record
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Allocation
Not applicable
Model
Single group
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation

    Timeframe: Throughout the trial (up to Week 27)

  1. Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score

    Timeframe: Baseline, Weeks 8, 14, and 26

    The HAM-A is a clinician-administered rating scale developed to quantify the severity of anxiety symptomatology. It consists of 14 items, each defined by a series of symptoms. Each item is scored on a 5-point Likert-type scale ranging from 0 (absent) to 4 (very severe). The total score ranges from 0 to 56, with higher scores indicating greater severity.

  2. Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score

    Timeframe: Baseline, Weeks 8, 14, and 26

    The CGI-S is a clinician-rated assessment of the participant's current illness state on a 7-point Likert-type scale (1=normal, not at all ill; 7=among the most extremely ill participants), where a higher score is associated with greater illness severity. A decrease in value indicates improvement.

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

Key Inclusion Criteria

  1. Male or female participants at least 18 years of age at the time of informed consent
  2. Completed one of the prior GAD Phase 3 studies involving SEP-363856 through Week 8 without discontinuation of trial intervention
  3. Able to continue treatment without interruption, and is considered by investigator to potentially benefit from SEP-363856
  4. Participant is willing and able to comply with study procedures and visit schedule
  5. 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

  1. Diagnosis other than GAD that is the primary focus of treatment
  2. Clinically significant psychiatric or medical condition that may interfere with study participation
  3. 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
  4. Clinically significant abnormal laboratory values or ECG findings
  5. Significant suicide risk
  6. Substance use/positive drug screen
  7. Use of prohibited medications/therapies
  8. Known sensitivity to SEP-363856
Sources for eligibility
clinicaltrials.gov

  • 2026-526032-40-00
  • 1014199
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)

Targets (2)