Boehringer, Click Therapeutics investigational prescription digital therapeutic meets primary endpoint in study for schizophrenia
Boehringer Ingelheim and Click Therapeutics have announced that the pivotal Phase III CONVOKE study (NCT05838625) of CT-155 (BI 3972080), an investigational prescription digital therapeutic (PDT), met its primary endpoint.
The randomized, double-blind, controlled study investigated the effectiveness and safety of CT-155 versus a digital control app as an adjunct to standard of care antipsychotic therapy in people diagnosed and living with schizophrenia experiencing negative symptoms. The study’s primary endpoint was change in experiential negative symptoms from baseline to week 16 as measured by the Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure Scale (CAINS-MAP).
In the CONVOKE study, CT-155 was well tolerated and demonstrated a favorable safety profile consistent with past studies.
“Findings from CONVOKE provide the first Phase III evidence supporting the potential of a prescription digital therapeutic as an adjunct to standard of care antipsychotic therapy to treat a core element of schizophrenia,” said Shaheen Lakhan, MD, PhD, FAAN, chief medical and scientific officer of Click Therapeutics. “The observed clinical benefit on experiential negative symptoms in this study, without additional known safety concerns, marks a critical advancement in understanding how we might address this long unmet need.”
Detailed results will be presented during the Novel Therapeutics Symposium on Monday, October 13 at the 38th Annual European College of Neuropsychopharmacology (ECNP) Congress being held in Amsterdam, The Netherlands.
