SchizophreniaPhase 3NCT04109950
A Clinical Study to Evaluate the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia
A Phase 3 study testing SEP-363856 in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 78 sites in 8 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- SEP-363856
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 463 participants
- Where
- 78 sitesin 8 countries
- Study dates
- 20 Nov 2019to 9 Nov 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
- Participant has completed the Treatment Period of Study SEP361-301 or Study SEP361-302.
- 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.
- Female participant must have a negative urine pregnancy test at the End of Treatment (EOT) Visit of Study SEP361-301 or Study SEP361-302.
- 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.
- 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).
Who cannot join
- 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.
- 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.
- 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
- Female participant is pregnant or lactating.
Trial locations and contacts
78 sites in 8 countries.
78 sites in 8 countries
United States25 sites
Research Site
Anaheim, California, 92805
Research Site
Atlanta, Georgia, 30030
Research Site
Atlanta, Georgia, 30318
Research Site
Atlanta, Georgia, 30331
Research Site
Austin, Texas, 78754
Research Site
Culver City, California, 90230
Research Site
Dayton, Ohio, 45417
Research Site
Decatur, Georgia, 30030
Research Site
Flowood, Mississippi, 39232
Research Site
Gaithersburg, Maryland, 20877
Research Site
Lake Charles, Louisiana, 70629
Research Site
Lemon Grove, California, 91945
Research Site
Little Rock, Arkansas, 72211
Research Site
Long Beach, California, 90806
Research Site
Long Beach, California, 90807
Research Site
Marlton, New Jersey, 08053
Research Site
Miami Springs, Florida, 33166
Research Site
Montclair, California, 91763
Research Site
New York, New York, 10032
Research Site
Oakland Park, Florida, 33334
Research Site
Richardson, Texas, 75080
Research Site
Rogers, Arkansas, 72758
Research Site
San Diego, California, 92102
Research Site
Sherman Oaks, California, 91403
Research Site
St Louis, Missouri, 63125
Russia18 sites
Research Site
Chelyabinsk, 454087
Research Site
Matrosy, 186131
Research Site
Moscow, 107076
Research Site
Moscow, 117152
Research Site
Moscow, 141371
Research Site
Nizhny Novgorod, 603155
Research Site
Saint Petersburg, 188357
Research Site
Saint Petersburg, 188820
Research Site
Saint Petersburg, 190005
Research Site
Saint Petersburg, 191167
Research Site
Saint Petersburg, 192019
Research Site
Saint Petersburg, 197341
Research Site
Samara, 443016
Research Site
Saratov, 410028
Research Site
Saratov, 410060
Research Site
Saratov, 413124
Research Site
Stavropol, 357034
Research Site
Talagi, 163530
Ukraine13 sites
Research Site
Ivano-Frankivsk, 76011
Research Site
Kharkiv, 61068
Research Site
Kherson, 73488
Research Site
Kyiv, 01030
Research Site
Kyiv, 01133
Research Site
Kyiv, 02192
Research Site
Kyiv, 04080
Research Site
Kyiv, 08631
Research Site
Lviv, 79021
Research Site
Nove, 25491
Research Site
Odesa, 65006
Research Site
Odesa, 67513
Research Site
Vinnytsia, 21005
Bulgaria8 sites
Research Site
Burgas, 8000
Research Site
Kardzhali, 6600
Research Site
Novi Iskar, 1282
Research Site
Pazardzhik, 4400
Research Site
Pleven, 5800
Research Site
Sofia, 1431
Research Site
Veliko Tarnovo, 5000
Research Site
Vratsa, 3000
Serbia8 sites
Research Site
Belgrade, 11000
Research Site
Gornja Toponica, 18202
Research Site
Kovin, 26220
Research Site
Kragujevac, 34000
Research Site
Niš, 18000
Research Site
Novi Kneževac, 23330
Research Site
Novi Sad, 21000
Research Site
Vršac, 26300
Latvia3 sites
Research Site
Daugavpils, LV-5417
Research Site
Riga, LV-1005
Research Site
Strenči, LV-4730
Colombia2 sites
Research Site
Barranquilla, 080020
Research Site
Bogotá, 111166
About this study
Official title: 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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- SEP-363856
- Keywords
- schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEP-363856Drug
SEP-363856 25mg, 50mg, 75mg, 100mg tablet flexibly dosed once daily
| Study group | Role | What they receive |
|---|---|---|
| SEP-363856 | Experimental | SEP-363856 25mg, 50mg, 75mg, 100mg flexibly dosed once daily Receives: Drug: SEP-363856 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of overall Adverse Events (AEs), Serious Adverse Events (AEs), and Adverse Events (AEs) leading to discontinuation
Measured: 53 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start20 Nov 2019
- Primary completion9 Nov 2023
- Study completion9 Nov 2023
Why it stopped: Study terminated early, main goals achieved
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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 treatment of participants with schizophrenia who have completed Treatment Period of one of two following double-blind studies: Study SEP361-301 (NCT04072354) or Study SEP361-302 (NCT04092686). The study will consist of two periods: An Open-Label Extension (OLE) Treatment Period (up to 52 weeks); and a Follow-up visit at 7±2 days after last study drug dose for participants who complete the Treatment Period \& those who prematurely discontinue from study. The adolescent cohort includes participants who were 13 to 17 years of age, at time of consent in the SEP361-301 study. For adolescent participants, a reliable informant (e.g., parent, legal guardian, or caregiver) of participant should accompany participant at each visit and support and monitor the participants compliance with taking study medication.
- Masking
- None (open label)
- Enrolment
- 463 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04109950
- Sponsor's protocol ID
- SEP361-303
- Other IDs
- 2019-000696-16, 2019
- Status last verified
- Dec 2024
- First submitted
- 27 Sep 2019
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Extension Study to Assess the Safety and Tolerability of SEP-363856 in Subjects With Schizophrenia
- ClinicalTrials.gov ID
- NCT04109950
- Acronym / sponsor ID
- SEP361-303
- Conditions
- Schizophrenia
- Keywords
- schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated early, main goals achieved
- Enrolment
- 463 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 9 Nov 2023 (actual)
- Study completion
- 9 Nov 2023 (actual)
- First posted
- 1 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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 treatment of participants with schizophrenia who have completed Treatment Period of one of two following double-blind studies: Study SEP361-301 (NCT04072354) or Study SEP361-302 (NCT04092686). The study will consist of two periods: An Open-Label Extension (OLE) Treatment Period (up to 52 weeks); and a Follow-up visit at 7±2 days after last study drug dose for participants who complete the Treatment Period \& those who prematurely discontinue from study. The adolescent cohort includes participants who were 13 to 17 years of age, at time of consent in the SEP361-301 study. For adolescent participants, a reliable informant (e.g., parent, legal guardian, or caregiver) of participant should accompany participant at each visit and support and monitor the participants compliance with taking study medication.
| Arm | Type | Receives |
|---|---|---|
| SEP-363856 | Experimental | Drug: SEP-363856SEP-363856 25mg, 50mg, 75mg, 100mg flexibly dosed once daily |
Who may qualify
- Ages
- 13 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Participant has completed the Treatment Period of Study SEP361-301 or Study SEP361-302.
- 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.
- Female participant must have a negative urine pregnancy test at the End of Treatment (EOT) Visit of Study SEP361-301 or Study SEP361-302.
- 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.
Key exclusion criteria (4 listed)
- 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.
- 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.
- 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
- Female participant is pregnant or lactating.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SEP-363856SEP-363856 25mg, 50mg, 75mg, 100mg tablet flexibly dosed once daily | Drug | SEP-363856 |
Primary outcome
The incidence of overall Adverse Events (AEs), Serious Adverse Events (AEs), and Adverse Events (AEs) leading to discontinuation
Time frame: 53 Weeks
Results and safety
The study was stopped early (reason given: Study terminated early, main goals achieved). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
78 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SEP-363856 in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 78 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 78 sites in United States, Russia, Ukraine, Bulgaria, Serbia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study terminated early, main goals achieved). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of overall Adverse Events (AEs), Serious Adverse Events (AEs), and Adverse Events (AEs) leading to discontinuation (time frame: 53 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.