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
Randomized Double-Blind Clinical Trial of an IL-23 Inhibitor for Immune Activation in People With Schizophrenia
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 64 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This 16-week study tests mirikizumab, a drug that blocks an immune protein called IL-23, against a placebo while people keep taking their antipsychotic medicine. It is for adults with schizophrenia or schizoaffective disorder who have high levels of certain antibodies called AGA IgG. Researchers will see if it helps with thinking, loss of pleasure, and lack of interest in being with others.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- For screening and the treatment trial: Be 18–64 years old.
- For the patient screening group and treatment trial: Have a diagnosis of schizophrenia or schizoaffective disorder.
- For the healthy comparison screening group: Do not have schizophrenia, schizoaffective disorder, bipolar disorder, or major depression.
- For the treatment trial: Score 70 or lower on the Personal and Social Performance scale, which measures daily and social functioning.
- For the treatment trial: Have taken the same antipsychotic medicine for at least 30 days, with a steady treatment dose for at least 15 days before joining.
- For the treatment trial: Have at least one past test showing an AGA IgG antibody level above 15.
Who can't join
- For screening: Have a known active infection. For the treatment trial: Have a current infection, including HIV, hepatitis C, or tuberculosis (TB).
- For screening and the treatment trial: Take medicines that weaken the immune system, such as regularly scheduled oral steroids or chemotherapy.
- For screening and the treatment trial: Regularly take anti-inflammatory medicines such as ibuprofen, celecoxib, or naproxen, or take more than 81 mg of aspirin daily. The treatment trial allows anti-inflammatory medicines taken only as needed.
- For screening and the treatment trial: Score below 10 out of 12 on the ESC test.
- For the treatment trial: Have a brain disorder or another medical condition whose effects or treatment could change schizophrenia symptoms or care, or greatly raise the risks of study treatment.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: Screening * Age range of 18-64 * Schizophrenia Group: Meet meet DSM 5 criteria for schizophrenia or schizoaffective disorder * Healthy Control Group: Does NOT meet DSM 5 criteria for schizophrenia or schizoaffective disorder, bipolar disorder, or major depressive disorder. Exclusion Criteria: Screening * Known current active infection, or taking an immunosuppressive medications (e.g. oral scheduled corticosteroids, chemotherapy or transplantation or HIV/AIDs associated drugs), or the scheduled use of anti-inflammatory medications, including NSAIDs (e.g. ibuprofen, celecoxib, or naproxen) or aspirin \> 81 mg on a daily basis will be excluded. * Score of less than 10/12 on the ESC Inclusion Criteria: Clinical Trial * Age range of 18-64 * Meet meet DSM 5 criteria for schizophrenia or schizoaffective disorder * Personal and Social Performance (PSP) Scale score of ≤70. * Treated with the same antipsychotic for at least 30 days and having received a constant therapeutic dose for at least 15 days prior to study entry * One test in the past of elevated AGA IgG antibodies (AGA IgG \> 15) Exclusion Criteria: Clinical Trial * Current infection, including HIV, and Hepatitis C (blood draw) or tuberculosis (TB\*); or an organic brain disorder or medical condition, whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol. * Currently taking immunosuppressive medications (e.g. oral scheduled corticosteroids, chemotherapy or transplantation or HIV/AIDs associated drugs); or the scheduled use of anti-inflammatory medications, including NSAIDs (e.g. ibuprofen, celecoxib, or naproxen) or aspirin \> 81 mg on a daily basis will be excluded. The use of PRN anti-inflammatory agents will be allowed * Score of less than 10/12 on the ESC
Study sites (1)
MD
- Maryland Psychiatric Research Center (MPRC) Outpatient Research Program (ORP); the MPRC Treatment Research Program (TRP) · Catonsville, MD 21228More trials in Catonsville