Boehringer Ingelheim and Click Therapeutics have reported positive top-line results from the pivotal Phase III CONVOKE study (NCT05838625) evaluating CT-155 (BI 3972080)—an investigational prescription digital therapeutic (PDT) designed to complement standard antipsychotic therapy for experiential negative symptoms of schizophrenia. The findings were presented during an oral session at the 38th Annual European College of Neuropsychopharmacology (ECNP) Congress in Amsterdam, with full results to be published later.
The CONVOKE study met its primary endpoint, showing a significant improvement in negative symptoms from baseline to 16 weeks, as measured by the Clinical Assessment Interview for Negative Symptoms – Motivation and Pleasure Scale (CAINS-MAP). Treatment with CT-155 demonstrated a Cohen’s D effect size of –0.36 (p = 0.0003), corresponding to a 6.8-point improvement compared with a 4.2-point improvement in the digital control arm—a 62% relative improvement.
“The positive primary endpoint results observed from the CT-155 Phase III trial represent an important step forward in exploring how negative symptoms may be better understood, which is an area of long-standing unmet need in mental health care," said Gregory W. Mattingly, MD, Associate Clinical Professor at Washington University in St. Louis. "This research underscores the importance of including innovative approaches in the treatment of schizophrenia. The emergence of prescription digital therapeutics, like CT-155, if approved, may hold the potential for patients to access psychosocial intervention from anywhere."
Engagement during the 16-week trial remained high. Most participants used their assigned app through week 15 (70.4% for CT-155 vs 76.5% for digital control). CT-155 users completed activities on a median of 76 of 112 study days, while those in the control arm completed 92 days. This comparable engagement confirms that CT-155’s clinical benefits stemmed from its therapeutic content, not from differences in design or usage.
“CT-155, which integrates psychosocial interventions delivered using an adaptive goal-setting technique, is the first investigational PDT to show reduction in experiential negative symptoms of schizophrenia in a pivotal trial,” said Emmanuelle Clerisme-Beaty, Medical Director US, SVP Medicine, Boehringer Ingelheim Pharmaceuticals. “In collaboration with Click Therapeutics, we developed CT-155 aiming to address the dual challenges of accessibility and consistency of psychosocial therapy use for people living with negative symptoms of schizophrenia.”
CT-155 was well-tolerated, with adverse event rates of 8.3% compared with 13.4% in the digital control arm. No discontinuations were attributed to CT-155 and no serious treatment-related adverse events occurred.
Schizophrenia affects roughly 3.7 million adults in the U.S., and nearly 60% experience negative symptoms such as low motivation, social withdrawal, and loss of pleasure.
“The design and development of CT-155 was informed by an iterative patient-centered approach with more than 150 people living with schizophrenia,” said Austin Speier, Chief Strategy Officer, Click Therapeutics. “For decades, negative symptoms have represented one of the greatest unmet needs for people living with schizophrenia, and we are proud to be exploring CT-155 as a potential new treatment modality in mental health.”
Boehringer Ingelheim is also conducting the multicenter Enspirus study (NCT06791122) to assess CT-155’s real-world clinical effectiveness, engagement, and safety. In 2024, the U.S. FDA granted Breakthrough Device Designation to CT-155, recognizing its potential to address a major unmet need in schizophrenia care.
