XEP527 in stable schizophrenia: safety and how it behaves in the body

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, blinded, placebo-controlled Phase 1 trial will enroll adults with stable schizophrenia across multiple centers. Participants will be assigned to one of three dosing cohorts of XEP527 or placebo, with a 28-day inpatient treatment period and additional screening and follow-up. The study aims to characterize safety, tolerability, and pharmacokinetics, while monitoring disease status and compatibility with standard care. Hospitalization is required for the initial treatment period to ensure close monitoring and dose administration.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* 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

Key Exclusion Criteria:

* 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.

Where it's running

• Pillar Clinical Research LLC
  Bentonville, Arkansas, United States Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.