ARISE
Research type
Research Study
Full title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Adjunctive KarXT in Subjects with Inadequately Controlled Symptoms of Schizophrenia.
IRAS ID
1009361
Contact name
Nicolas James
Contact email
Sponsor organisation
Karuna Therapeutics, Inc.
Eudract number
2022-001665-12
Clinicaltrials.gov Identifier
Research summary
This KAR-012 study is looking at whether the investigational drug, KarXT, works to reduce the symptoms of schizophrenia in addition to a patient’s current antipsychotic treatment. Many patients with schizophrenia have an inadequate response to currently available antipsychotic therapies and continue to be symptomatic.
This study will also try to answer several questions about the investigational drug, such as how well the body tolerates it when taken with other schizophrenia medications and how it is processed by the body.
Participants in this study will be adults aged ≥18 to <60 years old who have schizophrenia with an inadequate response to their current antipsychotic treatment. All participants will be on a stable dose of their current antipsychotic medication for at least 8 weeks prior to receiving either the investigational drug or a placebo (tablets that look the same as the investigational drug but contain no active medication) in this study.
The study will include about 400 participants at about 135 sites globally.
The study includes a 28- to 40-day screening period, a 6-week treatment period and a follow-up safety period (end of week 7).
During the treatment period, half the participants will receive the investigational drug KarXT and the other half will receive a placebo twice daily for 6 weeks (with the exception of Day 1 and last date of the study treatment period when they will only take 1 dose of KarXT/placebo). This is a “double-blind” study which means that the participant and their study doctor will not know which study drug the subject is receiving. The amount of KarXT given during the treatment period can increase or decrease depending on how well the participant tolerates it.The maximum total duration of the study is approximately 90 days. Participants that complete the study will be offered the possibility to continue into an extension study, during which they will receive KarXT for up to 1 year
REC name
London - Central Research Ethics Committee
REC reference
24/LO/0320
Date of REC Opinion
5 Jun 2024
REC opinion
Further Information Favourable Opinion