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

NCT07759128 | Recruiting Phase 3 FDA Drug

• 2 other identifiers: 382-201-000322026-526033-25-00
• Study Type: interventional
• Target: 576
• Locations: 1 country
• Sites: 3

Brief Summary

This is a global, phase 3, randomized, double-blind, parallel-group, 3-arm, placebo-controlled, multicenter study designed to compare the efficacy, safety, and tolerability of fixed doses of SEP-363856 (50 and 75 milligrams per day \[mg/day\]) to placebo in adults at least 18 years of age with generalized anxiety disorder (GAD) over 8 weeks.

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 (3)

SEP-363856 50 mg

EXPERIMENTAL

Participants will receive 50 milligrams (mg) SEP-363856 tablet, orally, once a day (QD) from Days 1 to 56.

Drug: SEP-363856

SEP-363856 75 mg

EXPERIMENTAL

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

Drug: SEP-363856

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

SEP-363856 DRUG

Oral tablet

Also known as: Ulotaront

SEP-363856 50 mg; SEP-363856 75 mg

Placebo OTHER

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 Generalized Anxiety Disorder (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) between 18 and 40 kilograms per square meter (kg/m\^2) (inclusive)
• 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
• 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
• Participant is willing and able to safely discontinue all prohibited medications/therapies/herbal supplements in accordance with the protocol-required washouts prior to baseline/Day 1 and during the trial period.

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 (3)

Clinical Neuroscience Solutions, LLC

Jacksonville, Florida, 32256, United States

RECRUITING

Manhattan Behavioral Medicine PLLC

New York, New York, 10036, United States

RECRUITING

FutureSearch Trials of Dallas

Dallas, Texas, 75251, 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 6, 2026
• First Posted: August 12, 2026
• Study Start: July 28, 2026
• Primary Completion (Estimated): December 6, 2028
• Study Completion (Estimated): December 13, 2028
• Last Updated: August 12, 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 (3)