A Clinical Study to Evaluate the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia

An Open-label Extension Study to Assess the Safety and Tolerability of SEP-363856 in Subjects With Schizophrenia

This is a clinical trial to determine the long-term safety and tolerability of an investigational drug in people with schizophrenia. Participants in the study will receive the drug being studied. This study is accepting male and female participants between 13 and 65 years old who have been diagnosed with schizophrenia and have completed Study SEP361-301 (NCT04072354) or Study SEP361-302 (NCT04092686). This study will be conducted in approximately 80 study centers worldwide. The treatment duration for this study is one (1) year.

Study Overview

• Status: Terminated
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: SEP-363856

Detailed Description

An open-label extension study to assess the safety and tolerability of SEP-363856 in participants with schizophrenia This is an open-label extension study to evaluate long-term safety and tolerability of SEP-363856. This is a 52-week, outpatient, multicenter, flexible-dose, open-label extension study designed to evaluate the long-term safety and tolerability of SEP-363856 (25 to 100 mg/day) for the treatment of participants with schizophrenia who have completed the Treatment Period of one of the two following double-blind studies: Study SEP361-301 (NCT04072354) or Study SEP361-302 (NCT04092686).

Sumitomo Pharma America Inc. was the former Sponsor and conducted this study. Sumitomo was responsible for analysis and clinical study report (CSR) completion. Otsuka took over study after IND was transferred and is concluding activities with registry postings.

• Study Type: Interventional
• Enrollment (Actual): 463
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Burgas, Bulgaria, 8000
    • Research Site
  • Kardzhali, Bulgaria, 6600
    • Research Site
  • Novi Iskar, Bulgaria, 1282
    • Research Site
  • Pazardzhik, Bulgaria, 4400
    • Research Site
  • Pleven, Bulgaria, 5800
    • Research Site
  • Sofia, Bulgaria, 1431
    • Research Site
  • Veliko Tarnovo, Bulgaria, 5000
    • Research Site
  • Vratsa, Bulgaria, 3000
    • Research Site
• Colombia
  • Barranquilla, Colombia, 080020
    • Research Site
  • Bogotá, Colombia, 111166
    • Research Site
• Croatia
  • Zagreb, Croatia, 10090
    • Research Site
• Latvia
  • Daugavpils, Latvia, LV-5417
    • Research Site
  • Riga, Latvia, LV-1005
    • Research Site
  • Strenci, Latvia, LV-4730
    • Research Site
• Russian Federation
  • Chelyabinsk, Russian Federation, 454087
    • Research Site
  • Leningrad, Russian Federation, 188820
    • Research Site
  • Matrosy, Russian Federation, 186131
    • Research Site
  • Moscow, Russian Federation, 107076
    • Research Site
  • Moscow, Russian Federation, 117152
    • Research Site
  • Moscow, Russian Federation, 141371
    • Research Site
  • Nizhniy Novgorod, Russian Federation, 603155
    • Research Site
  • Saint Petersburg, Russian Federation, 197341
    • Research Site
  • Saint Petersburg, Russian Federation, 191167
    • Research Site
  • Saint Petersburg, Russian Federation, 188357
    • Research Site
  • Saint Petersburg, Russian Federation, 190005
    • Research Site
  • Saint Petersburg, Russian Federation, 192019
    • Research Site
  • Samara, Russian Federation, 443016
    • Research Site
  • Saratov, Russian Federation, 410028
    • Research Site
  • Saratov, Russian Federation, 410060
    • Research Site
  • Saratov, Russian Federation, 413124
    • Research Site
  • St. Petersburg, Russian Federation, 192019
    • Research Site
  • Stavropol, Russian Federation, 357034
    • Research Site
  • Talagi, Russian Federation, 163530
    • Research Site
• Serbia
  • Belgrade, Serbia, 11000
    • Research Site
  • Gornja Toponica, Serbia, 18202
    • Research Site
  • Kovin, Serbia, 26220
    • Research Site
  • Kragujevac, Serbia, 34000
    • Research Site
  • Nis, Serbia, 18000
    • Research Site
  • Novi Knezevac, Serbia, 23330
    • Research Site
  • Novi Sad, Serbia, 21000
    • Research Site
  • Vrsac, Serbia, 26300
    • Research Site
• Ukraine
  • Ivano-Frankivsk, Ukraine, 76011
    • Research Site
  • Kharkiv, Ukraine, 61068
    • Research Site
  • Kherson, Ukraine, 73488
    • Research Site
  • Kyiv, Ukraine, 01030
    • Research Site
  • Kyiv, Ukraine, 01133
    • Research Site
  • Kyiv, Ukraine, 02192
    • Research Site
  • Kyiv, Ukraine, 04080
    • Research Site
  • Kyiv, Ukraine, 08631
    • Research Site
  • Lviv, Ukraine, 79021
    • Research Site
  • Nove, Ukraine, 25491
    • Research Site
  • Odesa, Ukraine, 65006
    • Research Site
  • Odesa, Ukraine, 67513
    • Research Site
  • Vinnytsia, Ukraine, 21005
    • Research Site
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Research Site
    • Rogers, Arkansas, United States, 72758
      • Research Site
  • California
    • Anaheim, California, United States, 92805
      • Research Site
    • Culver City, California, United States, 90230
      • Research Site
    • Lemon Grove, California, United States, 91945
      • Research Site
    • Long Beach, California, United States, 90806
      • Research Site
    • Long Beach, California, United States, 90807
      • Research Site
    • Montclair, California, United States, 91763
      • Research Site
    • San Diego, California, United States, 92102
      • Research Site
    • Sherman Oaks, California, United States, 91403
      • Research Site
  • Florida
    • Miami Springs, Florida, United States, 33166
      • Research Site
    • Oakland Park, Florida, United States, 33334
      • Research Site
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Research Site
    • Atlanta, Georgia, United States, 30331
      • Research Site
    • Atlanta, Georgia, United States, 30030
      • Research Site
    • Decatur, Georgia, United States, 30030
      • Research Site
  • Louisiana
    • Lake Charles, Louisiana, United States, 70629
      • Research Site
  • Maryland
    • Gaithersburg, Maryland, United States, 20877
      • Research Site
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Research Site
  • Missouri
    • Saint Louis, Missouri, United States, 63125
      • Research Site
  • New Jersey
    • Marlton, New Jersey, United States, 08053
      • Research Site
  • New York
    • New York, New York, United States, 10032
      • Research Site
  • Ohio
    • Dayton, Ohio, United States, 45417
      • Research Site
  • Texas
    • Austin, Texas, United States, 78754
      • Research Site
    • Richardson, Texas, United States, 75080
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Participant (or participants parent/legal guardian for adolescents) must give written informed consent and privacy authorization prior to participation in the study; adolescents must also provide informed assent.
2. Participant has completed the Treatment Period of Study SEP361-301 or Study SEP361-302.
3. Participant has not taken any medication other than the study drug and protocol-allowed medications for the purpose of controlling schizophrenia symptoms during Study SEP361-301 or SEP361-302.
4. Female participant must have a negative urine pregnancy test at the End of Treatment (EOT) Visit of Study SEP361-301 or Study SEP361-302.
5. Female participants of childbearing potential must agree to use highly effective and reliable contraception throughout the study and for at least 30 days after the last dose of study drug has been taken.
6. Male participants must agree to avoid fathering a child and use highly effective methods of birth control from screening in Study SEP361-301 or Study SEP361-302, until at least 30 days after the last study drug administration in the present study (SEP361-303).

Exclusion Criteria

1. Participant answered "yes" to "suicidal ideation" Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) on the Columbia Suicide Severity Rating Scale (C-SSRS) assessment at the End of treatment (EO) Visit of Study SEP361-301 or SEP361-302.
2. Participant has a clinically significant abnormality including physical examination, vital signs, ECG, or laboratory test at the EOT Visit of Study SEP361-301 or SEP361-302 that the investigator in consultation with the medical monitor considers to be inappropriate to allow participation in the study.
3. Participant has a positive urine drug screen (UDS) at the EOT Visit of Study SEP361-301 or SEP361-302. However, a positive UDS test may not result in exclusion of participants if the Investigator determines that the positive test is as a result of prescription medicine(s). participants may enter this study before the urine drug screen results are received from the central laboratory. However, after receipt and review of the results any participant meeting this exclusion criterion must be discontinued from the study. Retesting of the UDS is allowed once with prior approval from the Medical Monitor with the retest used to determine eligibility
4. Female participant is pregnant or lactating.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SEP-363856; SEP-363856 25mg, 50mg, 75mg, 100mg flexibly dosed once daily	Drug: SEP-363856; SEP-363856 25mg, 50mg, 75mg, 100mg tablet flexibly dosed once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The incidence of overall Adverse Events (AEs), Serious Adverse Events (AEs), and Adverse Events (AEs) leading to discontinuation	53 Weeks

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Investigators: Study Chair: CNS Medical Director, Sumitomo Pharma America, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2019
• Primary Completion (Actual): November 9, 2023
• Study Completion (Actual): November 9, 2023

Study Registration Dates

• First Submitted: September 27, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (Actual): October 1, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: schizophrenia
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia
• Other Study ID Numbers: SEP361-303; 2019-000696-16 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
• IPD Sharing 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.
• IPD Sharing Access Criteria: Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No