Recruiting
Phase 1

XEP527

Sponsor:

Novartis Pharmaceuticals

Code:

NCT07908680

Conditions

Schizophrenia

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

XEP527

Placebo

Study Details

Brief summary:

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.

Conditions

Schizophrenia

Study ID

NCT07908680

Start date

Nov 4, 2026

Status verified date

Nov, 2026

Completion date

Mar 6, 2028

Anticipated

Primary completion date

Mar 6, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1: Dose Level 1 XEP527

Cohort 1: Dose Level 1 XEP527

experimental: Cohort 2: Dose Level 2 XEP527

Cohort 2: Dose Level 2 XEP527

experimental: Cohort 3: Dose Level 3 XEP527

Cohort 3: Dose Level 3 XEP527

placebo comparator: Cohort 1: Placebo

Placebo

placebo comparator: Cohort 2: Placebo

Placebo

placebo comparator: Cohort 3: Placebo

Placebo

Interventions

XEP527

Participants will receive XEP527

Placebo

Placebo

Primary outcome measure

  • Incidence of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to approximately 56 days ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682novartis.email@novartis.com

Novartis Pharmaceuticals

+41613241111

Locations

Pillar Clinical Research LLC

Recruiting

Bentonville, Arkansas, United States, 72712

Contacts

Eric Foster

+1 479 367 2688efoster@pillarhc.com

Principal Investigator:

Fayz A Hudefi

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Nov 9, 2026

Last verified

Nov, 2026

Keywords

  • XEP527
  • stable schizophrenia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-10. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-11-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.