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NCT07615075 · ClinicalTrials.gov registry record · Phase 4
Clinical Trial of an IL-23 Inhibitor for Immune Activation in Clinical Trial of an IL-23 Inhibitor for Immune Activation in People With Schizophrenia
A Phase 4 study, sponsored by University of Maryland, Baltimore.
- Not yet
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
NCT07615075 is a Phase 4 study that has not yet begun recruiting, run by University of Maryland, Baltimore. The registered enrollment target is 40 participants.
The verdict
NCT07615075, a Phase 4 study, has not yet begun recruiting, sponsored by University of Maryland, Baltimore.
- NOT YET RECRUITING
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
Study Summary
This 16 week clinical trial investigates a precision-medicine approach to schizophrenia by targeting a biologically distinct subgroup,-approximately one-third of patients-characterized by the presence of anti-gliadin antibodies (AGA IgG+) which is associated with elevated inflammation in the IL-23/IL-17 immune axis (Th17 pathway). This specific biotype is associated with pronounced negative symptoms, cognitive deficits, and reduced white matter integrity. Building on evidence that this pathway can be modulated to improve clinical outcomes, we are conducting a randomized, double-blind clinical trial of mirikizumab, an FDA-approved monoclonal antibody targeting IL-23, in addition to current antipsychotics, in schizophrenia patients who are positive for AGA IgG. The primary objective is to determine whether mirikizumab - a repurposed FDA approved monoclonal antibody treatment inhibiting IL-23-- will be superior to placebo in treating experiential (e.g., anhedonia and asociality) negative symptoms and cognitive impairments. Secondary aims will be to assess changes in T-cell subtypes and relative abundance by gene expression, peripheral cytokines, and neuroimaging markers (in a smaller subset). By focusing on this patient subgroup, who are identified by their immune status, the research aims to provide a targeted, revolutionary treatment for symptoms that have traditionally remained resistant to standard antipsychotic therapies. This protocol includes a screening phase, with a separate consent form which is intended to identify those with AGA IgG antibodies. This screening portion will also serve to compare other aspects of immune functioning and the TH17 pathway between patient groups and controls in order to further characterize and show that Th17 (and similar immune cell lines) are different between AGA IgG positive, AGA IgG negative and healthy controls of either status.
Interventions
- DRUG Placebo
- DRUG IL-23
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2026-09-01 |
| Est. Completion | 2030-09-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07615075
The ClinicalTrials.gov registry entry for NCT07615075 describes a study currently listed as not yet recruiting, categorized as Phase 4. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07615075 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07615075 about?
NCT07615075 is a clinical study titled "Clinical Trial of an IL-23 Inhibitor for Immune Activation in Clinical Trial of an IL-23 Inhibitor for Immune Activation in People With Schizophrenia". This 16 week clinical trial investigates a precision-medicine approach to schizophrenia by targeting a biologically distinct subgroup,-approximately one-third of patients-characterized by the presence of anti-gliadin antibodies (AGA IgG+) which is associated with elevated inflammation in the IL-23/I...
What is the current status of trial NCT07615075?
This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2026-09-01. Estimated completion is 2030-09-01.
What interventions are being tested in trial NCT07615075?
The interventions under investigation include: Placebo (DRUG), IL-23 (DRUG).
Who is sponsoring clinical trial NCT07615075?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
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