Investigational Prescription Digital Therapeutic CT-155 for Negative Symptoms of Schizophrenia Meets Primary Study Endpoint

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Boehringer Ingelheim and Click Therapeutics today announced that the pivotal phase 3 CONVOKE study of CT-155 (BI 3972080), an investigational prescription digital therapeutic (PDT), met its primary endpoint. Investigators compared the effectiveness and safety of CT-155 vs a digital control app as an adjunct to standard of care antipsychotic therapy in individuals with symptoms of schizophrenia and found that CT-155 showed a reduction in experiential negative symptoms.¹

CT-155 aims to provide interactive psychosocial intervention techniques as an adjunct to standard antipsychotic therapy to individuals living with schizophrenia who are experiencing negative symptoms.

“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, the medical director US, SVP Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. “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 (NCT05838625) was a phase 3, multicenter, randomized, double-blind, 16-week study evaluating the efficacy and safety of CT-155 compared with a digital control app as an adjunct to standard of care antipsychotic therapy in individuals with negative symptoms of schizophrenia. Investigators enrolled adults and late adolescents with schizophrenia who were stable on antipsychotic medication. The primary endpoint evaluated improvement in experiential negative symptoms as an adjunct to standard of care as measured by changes from baseline to week 16 in the Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure Scale (CAINS-MAP). Other endpoints included change from baseline in CAINS-MAP at week 8; change from baseline in CAINS expressivity scale at weeks 8 and 16; change from baseline in positive symptoms measured by the Positive and Negative Syndrome Scale at weeks 8 and 16; change from baseline in social functioning measured by the Personal and Social Performance Scale at weeks 8 and 16; and patient global impression of improvement measured by Patient Global Impression of Improvement Scale at weeks 8 and 16.

In terms of safety, CT-155 was well tolerated and demonstrated a favorable safety profile consistent with past studies.

“Findings from CONVOKE provide the first phase 3 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, the 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.”

In January 2024, CT-155 was granted Breakthrough Device designation by the US Food and Drug Administration.²

Boehringer Ingelheim and Click Therapeutics will present further detailed results at the Novel Therapeutics Symposium on Monday, October 13 at the 38th Annual European College of Neuropsychopharmacology Congress in Amsterdam, The Netherlands.

References

1. Boehringer and Click Therapeutics’ investigational prescription digital therapeutic CT-155 meets primary endpoint in CONVOKE study for negative symptoms in schizophrenia. News release. August 7, 2025. Accessed August 7, 2025. https://www.boehringer-ingelheim.com/human-health/mental-health/schizophrenia/phase-iii-convoke-study-meets-primary-endpoint

2. Boehringer Ingelheim and Click Therapeutics receive FDA breakthrough device designation for schizophrenia prescription digital therapeutic. News release. January 4, 2024. Accessed August 7, 2025. https://www.boehringer-ingelheim.com/human-health/mental-health/schizophrenia/fda-grants-breakthrough-status-schizophrenia-treatment