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An Extension study to a clinical study that will continue to evaluate the effectiveness and safety of SEP-363856 in people with schizophrenia that switch to SEP-363856 from their current antipsychotic medication. This study will accept both male and female participants that have completed study SEP361-308. This study will be held in approximately 24 study sites in North America. Participation in the study will be approximately up to 25 weeks.
This is a 24-week, outpatient, multicenter, flexible-dose, open-label extension study designed to evaluate the long-term safety and tolerability of SEP-363856 (50 to 100 mg/day) for the treatment of subjects with schizophrenia who have completed Study SEP361-308 treatment period, during which they were switched from a previous antipsychotic treatment to SEP-363856.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SEP-363856 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SEP-363856 | Drug | SEP-363856 tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease occurring after the administration of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. | From first dose of study drug up to end of 1 week follow up period (up to Week 25) |
| Number of Participants With Serious Adverse Events | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease occurring after the administration of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. A serious adverse event is any AE occurring at any dose that results in death, is life-threatening, results in persistent or significant disability/incapacity, requires in-patient hospitalization or prolongation of existing hospitalization, or is a congenital anomaly/birth defect. | From first dose of study drug up to end of 1 week follow up period (up to Week 25) |
| Number of Participants With AEs Leading to Discontinuation of Study | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease occurring after the administration of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. AEs leading to discontinuation from the study are those AEs which caused participant to discontinue from the study. | From first dose of study drug up to end of 1 week follow up period (up to Week 25) |
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Inclusion Criteria: (list is not all inclusive)
Exclusion Criteria: (list is not all inclusive)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Anaheim | California | 92805 | United States | ||
| Research Site |
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.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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.
Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
A total of 75 participants rolled over from Study SEP361-308 (NCT05628103) into Study SEP361-309, and all 75 participants received at least one dose of SEP-363856 in the 24-week treatment period.
Participants took part in the study at 16 clinical sites in the United States (US) from 31 March 2023 to 23 September 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | SEP-363856 | Participants received SEP-363856 at the same dose they were taking upon completion of Study SEP361-308 (NCT05628103), orally, once daily (QD). Thereafter, the dose was adjusted within the range of 50 milligrams/day (mg/day) to 100 mg/day in 25 milligrams (mg) increments (i.e. 50 mg/day, 75 mg/day, or 100 mg/day), based on clinical judgment. Participants continued to receive flexible dose of SEP-363856 (50 mg/day to 100 mg/day) up to Week 24. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 28, 2023 | Oct 31, 2025 |
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| Bellflower |
| California |
| 90706 |
| United States |
| Research Site | Garden Grove | California | 92845 | United States |
| Research Site | Lemon Grove | California | 91945 | United States |
| Research Site | Santee | California | 92071 | United States |
| Research Site | Torrance | California | 90502 | United States |
| Research Site | Hollywood | Florida | 33021 | United States |
| Research Site | Miami | Florida | 33122 | United States |
| Research Site | Atlanta | Georgia | 30318 | United States |
| Research Site | Atlanta | Georgia | 30331 | United States |
| Research Site | Chicago | Illinois | 60640 | United States |
| Research Site | Gaithersburg | Maryland | 20877 | United States |
| Research Site | Berlin | New Jersey | 08009 | United States |
| Research Site | Charlotte | North Carolina | 28211 | United States |
| Research Site | Hickory | North Carolina | 28601 | United States |
| Research Site | Richardson | Texas | 75080 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Safety population included all participants who received at least one dose of study drug during the 24-week open-label extension (OLE) treatment period.
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| ID | Title | Description |
|---|---|---|
| BG000 | SEP-363856 | Participants received SEP-363856 at the same dose they were taking upon completion of Study SEP361-308 (NCT05628103), orally, QD. Thereafter, the dose was adjusted within the range of 50 mg/day to 100 mg/day in 25 mg increments (i.e. 50 mg/day, 75 mg/day, or 100 mg/day), based on clinical judgment. Participants continued to receive flexible dose of SEP-363856 (50 mg/day to 100 mg/day) up to Week 24. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease occurring after the administration of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. | Safety population included all participants who received at least one dose of study drug during the 24-week OLE treatment period. | Posted | Count of Participants | Participants | From first dose of study drug up to end of 1 week follow up period (up to Week 25) |
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| Primary | Number of Participants With Serious Adverse Events | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease occurring after the administration of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. A serious adverse event is any AE occurring at any dose that results in death, is life-threatening, results in persistent or significant disability/incapacity, requires in-patient hospitalization or prolongation of existing hospitalization, or is a congenital anomaly/birth defect. | Safety population included all participants who received at least one dose of study drug during the 24-week OLE treatment period. | Posted | Count of Participants | Participants | From first dose of study drug up to end of 1 week follow up period (up to Week 25) |
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| Primary | Number of Participants With AEs Leading to Discontinuation of Study | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease occurring after the administration of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. AEs leading to discontinuation from the study are those AEs which caused participant to discontinue from the study. | Safety population included all participants who received at least one dose of study drug during the 24-week OLE treatment period. | Posted | Count of Participants | Participants | From first dose of study drug up to end of 1 week follow up period (up to Week 25) |
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From first dose of study drug up to end of 1 week follow up period (up to Week 25)
Safety population included all participants who received at least one dose of study drug during the 24-week OLE treatment period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SEP-363856 | Participants received SEP-363856 at the same dose they were taking upon completion of Study SEP361-308 (NCT05628103), orally, QD. Thereafter, the dose was adjusted within the range of 50 mg/day to 100 mg/day in 25 mg increments (i.e. 50 mg/day, 75 mg/day, or 100 mg/day), based on clinical judgment. Participants continued to receive flexible dose of SEP-363856 (50 mg/day to 100 mg/day) up to Week 24. | 0 | 75 | 4 | 75 | 9 | 75 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Delusion | Psychiatric disorders | MedDRA22.0 | Systematic Assessment |
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| Psychotic disorder | Psychiatric disorders | MedDRA22.0 | Systematic Assessment |
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| Schizophrenia | Psychiatric disorders | MedDRA22.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA22.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Weight decreased | Investigations | MedDRA22.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA22.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Transparency | Otsuka Pharmaceutical Development & Commercialization, Inc. | 1-800-441-6763 | SMB_ClinicalTranspa@otsuka-us.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 22, 2024 | Oct 31, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000705647 | SEP-363856 |
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