A Study to Assess the Safety, Tolerability and Pharmacokinetics of XEP527 in Patients With Stable Schizophrenia
Key facts
- Where
- Bentonville, United StatesSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Where in United States
- Pillar Clinical Research LLCBentonville, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT07908680
- Record updated
- 9 November 2026
- Original description
This study is designed to assess the safety and tolerability of the effects of XEP527, with particular emphasis on disease status and its compatibility with the standard of care in patients with stable schizophrenia.Read full original descriptionShow less
A Randomized, Participant and Investigator-blinded, Placebo-controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of XEP527 in Patients With Stable Schizophrenia
This study is designed to assess the safety and tolerability of the effects of XEP527, with particular emphasis on disease status and its compatibility with the standard of care in patients with stable schizophrenia.
Inclusion: Signed informed consent must be obtained prior to participation in the study; Participants 18 to 65 years of age, inclusive at screening; Participant agrees to be hospitalized starting at Day -1 and for at least 28 days after randomization; Participant has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria and confirmed by Mini International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorder Studies (MINI), version 7.0.2. at screening; Participant meets the following requirements per PANSS at screening and baseline: Total PANSS score ≤ 110, Score ≤ 4 (moderate) for item P1-P7, Score ≤ 4 (moderate) for G9; Participant is treated with a single antipsychotic (typical and/or atypical) with a stable dose for at least 12 weeks prior to randomization. Participant must agree to maintain the treatment with standard of care antipsychotic for the duration of the study; Participants who are treated with psychotropic medications other than antipsychotics need to be taking these medications as a stable dose for at least 12 weeks before randomization.
Exclusion: Participant experienced worsening of schizophrenia within 3 months prior to randomization documented by symptom exacerbation and/or hospitalizations (hospitalization for social management and/or day hospital programs within this time are acceptable); Participant was treated with Clozapine, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) in the last 6 months prior to randomization; Participant meets the DSM-5 criteria for another psychotic disorder; Participant has a history of substance or alcohol use disorder, except nicotine or caffeine, within 1 year before screening, or current abuse as determined by urine drug screen or alcohol test; Score "yes" on item 4 or item 5 of the Suicidal Ideation section of the C-SSRS, if this ideation occurred in the past 6 months, or "yes" on any item of the Suicidal Behavior section, except for the "Non-Suicidal Self-Injurious Behavior" (item also included in the Suicidal Behavior section), if this behavior occurred in the past 2 years; Other protocol-defined inclusion/exclusion criteria may apply.