ARISE KAR-013
Research type
Research Study
Full title
An Open-label Extension Study to Assess the Long-term Safety and Tolerability of Adjunctive KarXT in Subjects with Inadequately Controlled Symptoms of Schizophrenia
IRAS ID
1009636
Contact name
Nicolas James
Contact email
Sponsor organisation
Karuna Therapeutics, Inc.
Eudract number
2022-001666-35
Clinicaltrials.gov Identifier
Research summary
This study is a roll-over, open-label extension study of a former study, KAR-012, looking at whether the investigational drug, KarXT, works to reduce the symptoms of schizophrenia in addition to the participant’s current antipsychotic treatment. This extension study will evaluate the long-term safety and tolerability of the investigational drug, KarXT, in participants with schizophrenia who have an inadequate response to currently available antipsychotic therapies and continue to be symptomatic.
Participants in this study will be adults aged ≥18 to <60 years old and will have successfully completed the treatment period of the former study.
This extension study will include about 280 participants at about 135 sites globally.
This extension study consists of two 26-week treatment periods and a 2-week follow-up period.
During the first 26-week period (period 1), all participants will continue with their stable dose of current antipsychotic medication, as taken during the former KAR-012 study, and will also receive the investigational drug, KarXT, two times per day. The dose of KarXT given during period 1 may increase at week 2 and again at week 3 depending on how well the participant tolerates KarXT and how well their body responds to it.
During the second 26-week period (period 2) some participants who are responding well to the study treatment and maintain clinically stability for the last 4 weeks of period 1 may be randomised to withdraw their current antipsychotic medication and receive KarXT only, as monotherapy. The dosing of KarXT will be flexible based on tolerability and how well the participant responds to it. Any participant who does not qualify to receive KarXT on its own will continue in the study receiving their current antipsychotic medication and KarXT during period 2.
There will be a 2-week safety follow-up visit at week 54, after the last dose of KarXT is received.
The maximum total duration of the study is approximately 54 weeks.REC name
London - Central Research Ethics Committee
REC reference
24/LO/0321
Date of REC Opinion
16 Jul 2024
REC opinion
Further Information Favourable Opinion