Recruiting
Phase 3

SEP-363856

Sponsor:

Otsuka Pharmaceutical Development & Commercialization, Inc.

Code:

NCT06894212

Conditions

Schizophrenia

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

SEP-363856

Placebo

Study Details

Brief summary:

Evaluate the efficacy and safety of Ulotaront (SEP-363856) in acutely psychotic subjects with schizophrenia

Conditions

Schizophrenia

Study ID

NCT06894212

Start date

Feb 28, 2025

Status verified date

Jun, 2026

Completion date

Oct 29, 2026

Anticipated

Primary completion date

Oct 20, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

  • Male or female participants between 18 to 65 years of age (inclusive) at the time of consent.
  • Participant has an identified reliable informant (eg, caregiver, relative, friend, case worker, residential treatment staff).
  • Participant is experiencing an acute exacerbation or relapse of symptoms, with onset ≤ 2 months prior to screening

1. The participant requires hospitalization for this acute exacerbation or relapse of symptoms.
2. If already an inpatient at screening, has been hospitalized for less than 2 weeks for the current exacerbation at the time of screening.
  • Participants who are experiencing an acute exacerbation of psychotic symptoms and marked deterioration of usual function as demonstrated by meeting ALL of the following criteria at the screening and baseline visits:

1. Participant must have a PANSS total score ≥ 80

AND
2. Participant must have a CGI-S score ≥ 4.
  • Participants who have received previous outpatient antipsychotic treatment at an adequate dose (minimal recommended dose for the treatment of schizophrenia according to the manufacturer labeling) for an adequate duration (at least 6 weeks) and who showed a previous good response.

Key Exclusion Criteria:

  • Sexually active participants or persons of childbearing potential who do not agree to practice 2 different clinical trial sponsor approved methods of birth control or remain abstinent during the course of the trial and for 30 days after the last dose of study drug.
  • Participant has a current DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia.
  • Participant has had psychiatric hospitalization(s) for more than 30 days (cumulative) during the 90 days prior to screening.
  • Participant has previously received SEP-363856 or was previously enrolled in a SEP-363856 clinical study

Study Design

Enrollment

522 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Placebo

experimental: SEP-363856 75 mg

SEP-363856 75 mg/day

experimental: SEP-363856 100 mg

SEP-363856 100 mg/day

Interventions

SEP-363856

tablet

Placebo

tablet

Primary outcome measure

  • The change from baseline in Positive And Negative Syndrome Scale (PANSS) total score at Week 6 [ Time Frame: Baseline to Week 6 ]

Central Contacts and Locations

Central contacts

Otsuka Call Center

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

Locations

Pillar Clinical Research (Little Rock AR) Site

Recruiting

Little Rock, Arkansas, United States, 72204

Woodland International Research Group Site

Recruiting

Little Rock, Arkansas, United States, 72211

Woodland Research Northwest Site

Recruiting

Rogers, Arkansas, United States, 72758

Clinical Innovations, Inc. dba CITrials (Bellflower)

Recruiting

Bellflower, California, United States, 90706

Schuster Medical Research Institute

Recruiting

Sherman Oaks, California, United States, 91403

Innovative Clinical Research, Inc. Site

Recruiting

Miami Lakes, Florida, United States, 33016

Synexus Clinical Research US Inc - Atlanta

Recruiting

Atlanta, Georgia, United States, 30328

CenExel ACMR (Atlanta Center for Medical Research, LLC) Site

Recruiting

Atlanta, Georgia, United States, 30331

Accelerated Clinical Trials in Peachtree Corners GA Site

Recruiting

Peachtree Corners, Georgia, United States, 30071

Uptown Research Institute

Recruiting

Chicago, Illinois, United States, 60640

Hassman Research Institute, LLC

Recruiting

Marlton, New Jersey, United States, 20877

Community Clinical Research Inc

Recruiting

Austin, Texas, United States, 78754

Pillar Clinical Research LLC (Richardson, TX) Site

Recruiting

Richardson, Texas, United States, 75080

More Information

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Last update posted

Jun 30, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Otsuka Pharmaceutical Development & Commercialization, Inc. on 2026-06-30.