Topline Findings
- CT-155 achieves Phase III success: Boehringer Ingelheim and Click Therapeutics’ digital therapeutic met the primary endpoint in the CONVOKE trial treating the negative symptoms of schizophrenia.
- Favorable safety and tolerability: CT-155 demonstrated a safety profile that was consistent with previous studies and was well tolerated as an adjunct to standard antipsychotic treatment.
- Addressing a major unmet need: This is the first Phase III evidence supporting a prescription digital therapeutic to improve negative symptoms in schizophrenia, impacting millions of patients worldwide.
Results from the Phase III CONVOKE trial (NCT05838625) showed that Boehringer Ingelheim and Click Therapeutics’ novel prescription digital therapeutic CT-155 (BI 3972080) met its primary endpoint treating negative symptoms in schizophrenia. According to Boehringer Ingelheim, full detailed results will be presented at the upcoming European College of Neuropsychopharmacology Congress.1
Can CT-155 Become the First Approved Treatment for Negative Symptoms in Schizophrenia?
“Today’s positive results from the CT-155 pivotal trial are an important moment for people living with the negative symptoms of schizophrenia,” said Emmanuelle Clerisme-Beaty, medical director, US, SVP, medicine, Boehringer Ingelheim Pharmaceuticals, Inc, in a press release. “Although treatments are being used to help manage negative symptoms, there are no US regulatory authority-approved treatments indicated for the negative symptoms of schizophrenia to date. This is one of the largest unmet needs for these patients and those who care for them. We are proud to work in partnership with multiple stakeholders and innovative partners like Click Therapeutics on this journey.”
CONVOKE Trial Design and Primary Endpoint
- The multicenter, randomized, double-blind, 16-week CONVOKE trial evaluated the efficacy and safety of CT-155 compared to a digital control app as an adjunct to standard of care antipsychotic therapy in 464 patients with schizophrenia experiencing experiential negative symptoms.
- The primary endpoint was improvement in experiential negative symptoms, measured by change from baseline to week 16 on the Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure Scale (CAINS-MAP).
Key Secondary Endpoints and Safety
- Key secondary endpoints include change from baseline in CAINS-MAP at week eight; change from baseline in CAINS expressivity scale at weeks eight and 16; change from baseline in positive symptoms measured by the Positive and Negative Syndrome Scale at weeks eight and 16; change from baseline in social functioning measured by the Personal and Social Performance Scale at weeks eight and 16; and patient global impression of improvement measured by the Patient Global Impression of Improvement Scale at weeks eight and 16.1,2
- CT-155 demonstrated a favorable safety profile consistent with previous studies and was reported to be well tolerated.1
Schizophrenia Epidemiology and Unmet Need
- According to the National Institutes of Mental Health, the estimated prevalence of schizophrenia in the United States is between 0.25% and 0.64%.
- Global estimates of schizophrenia for those who are not institutionalized range from 0.33% to 0.75%.
- Schizophrenia is considered one of the top 15 leading causes of disability globally.
- Approximately 4.9% of people living with schizophrenia die by suicide, much more than the general population.
- Nearly 50% of people with schizophrenia also have additional behavioral disorders.3
The World Health Organization reports that people with schizophrenia are two to three times more likely to die prematurely compared to the general population, largely due to physical conditions such as cardiovascular, metabolic, and infectious diseases. Notably, only 31.3% of people with psychosis receive specialist mental health care, despite schizophrenia accounting for 50% of all mental health facility diagnoses.4
Expert Commentary
“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, Click Therapeutics, in the press release. “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.”
References
- Boehringer and Click Therapeutics’ investigational prescription digital therapeutic CT-155 meets primary endpoint in CONVOKE study for negative symptoms in schizophrenia. Boehringer Ingelheim, August 8, 2025. Accessed August 8, 2025. https://www.boehringer-ingelheim.com/human-health/mental-health/schizophrenia/phase-iii-convoke-study-meets-primary-endpoint
- Study of Two Digital Therapeutics for the Treatment of Experiential Negative Symptoms of Schizophrenia (CONVOKE). Clinicaltrials.gov. Accessed August 8, 2025. https://clinicaltrials.gov/study/NCT05838625?term=NCT05838625&rank=1
- Schizophrenia. NIH. Accessed August 8, 2025. https://www.nimh.nih.gov/health/statistics/schizophrenia#:~:text=often%20by%20years.-,Prevalence%20of%20Schizophrenia,10
- Schizophrenia. WHO. Accessed August 8, 2025. https://www.who.int/news-room/fact-sheets/detail/schizophrenia#:~:text=Some%20people%20with%20schizophrenia%20experience,worsening%20of%20symptoms%20over%20time.&text=Schizophrenia%20affects%20approximately%2024%20million,%25)%20among%20adults%20(2).
