36 Participants NeededMy employer runs this trial

XEP527 for Schizophrenia

NP
Overseen ByNovartis Pharmaceuticals
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Novartis Pharmaceuticals

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with a confirmed diagnosis of stable schizophrenia, who have been on the same antipsychotic medication (and any other psychiatric meds) at a steady dose for at least 12 weeks. Participants must agree to stay in the hospital for about a month during the study.

Inclusion Criteria

I have signed the consent form to join the study.
I am between 18 and 65 years old.
I have been on one antipsychotic at a stable dose for at least 12 weeks.
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What Are the Treatments Tested in This Trial?

Interventions

  • XEP527

Trial Overview

The study is testing XEP527 compared to a placebo in people with stable schizophrenia, while they continue their usual antipsychotic treatment. The main goal is to see if XEP527 is safe and well-tolerated.

How Is the Trial Designed?

6

Treatment groups

Experimental Treatment

Placebo Group

Group I: Cohort 3: Dose Level 3 XEP527Experimental Treatment1 Intervention
Group II: Cohort 2: Dose Level 2 XEP527Experimental Treatment1 Intervention
Group III: Cohort 1: Dose Level 1 XEP527Experimental Treatment1 Intervention
Group IV: Cohort 1: PlaceboPlacebo Group1 Intervention
Group V: Cohort 2: PlaceboPlacebo Group1 Intervention
Group VI: Cohort 3: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials
2,963
Recruited
4,275,000+
Founded
1996
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Gleevec, Cosentyx, Entresto, Kisqali
Dr. Vas Narasimhan profile image

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye profile image

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD