Schizophrenia
Conditions
Keywords
Schizophrenia
Brief summary
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.
Detailed description
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.
Interventions
DRUGSEP-363856
SEP-363856 tablet
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
(list is not all inclusive) * Subject has given written informed consent and privacy authorization prior to participation in the study. * Subject has completed the Treatment Period of Study SEP361-308. * Subject has not taken any psychotropic medication other than the study drug, pre-switch antipsychotic and protocol-allowed medications during Study SEP361-308. * Female subject must have a negative rapid urine pregnancy test at the End of Treatment (EOT) Visit of Study SEP361-308.
Exclusion criteria
(list is not all inclusive) * Subject is suicidal based on the Columbia - Suicide Severity Rating Scale (C-SSRS) assessment at the End of Treatment (EOT) Visit of Study SEP361-308. * Subject has a clinically significant abnormality including physical examination, vital signs, or ECG finding at the End of Treatment (EOT) Visit of Study SEP361-308. * Subject has a positive rapid urine drug screen at the EOT Visit of Study SEP361-308. * Female subject is pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | From first dose of study drug up to end of 1 week follow up period (up to Week 25) | 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. |
| Number of Participants With Serious Adverse Events | From first dose of study drug up to end of 1 week follow up period (up to Week 25) | 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. |
| Number of Participants With AEs Leading to Discontinuation of Study | From first dose of study drug up to end of 1 week follow up period (up to Week 25) | 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. |
Countries
United States
Participant flow
Recruitment details
Participants took part in the study at 16 clinical sites in the United States (US) from 31 March 2023 to 23 September 2024.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 75 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Non-Compliance With Study Drug | 2 |
| Overall Study | Reason Not Specified | 1 |
| Overall Study | Withdrawal by Subject | 11 |
Baseline characteristics
| Characteristic | SEP-363856 |
|---|---|
| Age, Continuous | 49.7 years STANDARD_DEVIATION 11.41 |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 13 Participants |
| Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino | 62 Participants |
| Race/Ethnicity, Customized Race Asian | 2 Participants |
| Race/Ethnicity, Customized Race Black or African American | 49 Participants |
| Race/Ethnicity, Customized Race Multiracial | 1 Participants |
| Race/Ethnicity, Customized Race White | 23 Participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 75 |
| other Total, other adverse events | 9 / 75 |
| serious Total, serious adverse events | 4 / 75 |
Outcome results
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.
Time frame: From first dose of study drug up to end of 1 week follow up period (up to Week 25)
Population: Safety population included all participants who received at least one dose of study drug during the 24-week OLE treatment period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SEP-363856 | Number of Participants With Adverse Events (AEs) | 28 Participants |
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.
Time frame: From first dose of study drug up to end of 1 week follow up period (up to Week 25)
Population: Safety population included all participants who received at least one dose of study drug during the 24-week OLE treatment period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SEP-363856 | Number of Participants With AEs Leading to Discontinuation of Study | 1 Participants |
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.
Time frame: From first dose of study drug up to end of 1 week follow up period (up to Week 25)
Population: Safety population included all participants who received at least one dose of study drug during the 24-week OLE treatment period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SEP-363856 | Number of Participants With Serious Adverse Events | 4 Participants |