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 From Their Current Antipsychotic Medication

Launched by SUMITOMO PHARMA AMERICA, INC. · Feb 13, 2023

Keywords

ClinConnect Summary

This is an open-label extension study to keep checking the safety and tolerability of SEP-363856 in people with schizophrenia who have already switched to this drug in a prior study. It runs about 24 weeks (up to 25 weeks) as an outpatient at roughly 24 sites across North America. Participants will take SEP-363856 tablets once daily in a flexible dose of 50 to 100 mg, chosen by the study team based on how each person responds. The main goal is to see how safe the drug is and how well people tolerate it over the longer term, rather than to compare it with another treatment.

Who can join: adults 18 to 65 with schizophrenia who completed the previous treatment period (SEP361-308) and switched to SEP-363856. They must not use other psychotropic medicines during the extension (except for meds allowed by the protocol) and must meet basic safety criteria. For women, a negative pregnancy test is required. Exclusions include active suicidal risk, significant health problems found at screening, or a positive drug test. The study will track the frequency of side effects, serious side effects, and side effects that cause stopping the drug through about week 25. The trial is sponsored by Sumitomo Pharma America, is regulated by the FDA, and results may be shared with researchers through the Vivli data-sharing system after posting.

Gender

ALL

Eligibility criteria

• • 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.