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

Otsuka

Status and phase: Not yet enrolling; Phase 3

Conditions: Generalized Anxiety Disorder

Treatments: Drug: SEP-363856

Study type: Interventional

Funder types: Industry

Identifiers

NCT07786454

2026-526032-40-00 (EU Trial (CTIS) Number)

382-201-00034

1014199 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 1,120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,120 participants in 1 patient group

SEP-363856

Experimental group

Description:

Participants will receive SEP-363856 50 mg or 75 mg tablet, orally, once daily for up to 26 weeks.

Treatment:

Drug: SEP-363856