A Trial of the Efficacy and Safety of a Fixed Dose of SEP-363856 in Adults With Generalized Anxiety Disorder

NCT07767903 | Recruiting Phase 3 FDA Drug

• 2 other identifiers: 382-201-000332026-526034-10-00
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 2

Brief Summary

This is a global, phase 3, randomized, double-blind, parallel-group, 2-arm, placebo controlled, multicenter trial designed to compare the efficacy, safety and tolerability of a fixed dose of SEP-363856 (75 millligrams per day \[mg/day\]) to placebo over an 8-week double-blind treatment period in adults with generalized anxiety disorder (GAD).

Conditions

Generalized Anxiety Disorder

Keywords

Generalized Anxiety Disorder; GAD; Anxiety

Outcome Measures

Primary Outcomes (1)

• Change From Baseline at Week 8 in Hamilton Anxiety Rating Scale (HAM-A) Total Score

  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.

  Baseline, Week 8

Secondary Outcomes (2)

• Change From Baseline at Week 8 in Clinical Global Impression-Severity (CGI-S) Score

  Baseline, Week 8

• Proportion of Participants Achieving HAM-A Response Criterion at Week 8 (Greater Than or Equal to [≥] 50 Percent [%] Improvement From Baseline in HAM-A Total Score)

  Baseline, Week 8

Other Outcomes (9)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Discontinuation

  Throughout the trial (up to Week 9)

• Percentage of Participants With any Change in Laboratory Tests Values From Baseline

  Baseline, Weeks 4 and 8

• Percentage of Participants With Any Change From Baseline in Vital Signs

  From Baseline up to Week 8

Study Arms (2)

SEP-363856

EXPERIMENTAL

Participants will receive SEP-363856, 50 mg (Days 1 to 3) and 75 mg/day tablet, from Days 4 to 56, orally, QD.

Drug: SEP-363856

Placebo

PLACEBO COMPARATOR

Participants will receive SEP-363856-matching placebo tablet, orally, QD from Days 1 to 56.

Drug: Placebo

Interventions

SEP-363856 DRUG

Oral tablet

Also known as: Ulotaront

SEP-363856

Placebo DRUG

Oral tablet

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants at least 18 years of age at the time of informed consent
• Primary diagnosis of GAD per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by Mini-International Neuropsychiatric Interview (MINI) and clinical psychiatric evaluation
• Body Mass Index (BMI) 18-40 kilograms per square meter (kg/m\^2)
• Participant is willing and able to comply with study procedures and visit schedule
• Medically stable as determined by medical history, physical exam, vital signs, and laboratory tests and able to comply with study procedures
• Willing and able to discontinue prohibited medications/therapies per protocol
• (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
• Willing and able to discontinue prohibited medications/therapies per protocol

You may not qualify if:

• Current DSM-5 diagnosis of major depressive episode, post traumatic stress disorder (PTSD), or any psychiatric disorder other than GAD that was the primary focus of treatment within 12 months prior to screening
• Substance use disorder (excluding nicotine/caffeine) within 12 months prior to screening
• Lifetime history of certain psychiatric disorders (e.g., schizophrenia spectrum disorders, bipolar disorder, obsessive-compulsive disorder, borderline or antisocial personality disorder)
• Significant suicide risk e.g., recent suicidal behavior/ideation per Columbia-Suicide Severity Rating Scale \[C-SSRS\] or MADRS)
• Use of prohibited medications/therapies within protocol-defined timeframes (e.g., certain antipsychotics, mood stabilizers, benzodiazepines, investigational treatments)
• Prior exposure to restricted treatments
• Pregnant or breastfeeding females
• Participation in another investigational study within 180 days (or more than \[\>\] 1 trial in last year)
• Known history of human immunodeficiency virus seropositivity, hepatitis B or C

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (2)

Lumina Clinical Research Center

Cherry Hill, New Jersey, 08002, United States

RECRUITING

Basil Clinical

Jamaica, New York, 11413, United States

RECRUITING

Related Links

• Otsuka Clinical Trials Website
• Otsuka Clinical Trial Transparency

MeSH Terms

Conditions

Generalized Anxiety Disorder; Anxiety Disorders

Interventions

SEP-363856

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Otsuka Call Center

CONTACT

844-687-8522; ProfessionalServices@otsuka-us.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 17, 2026
• Study Start: August 7, 2026
• Primary Completion (Estimated): October 25, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
• Access Criteria: Otsuka will share data on the Vivli data sharing platform: https://vivli.org/ourmember/Otsuka/

Locations

US (2)