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Investigating Mirikizumab for Schizophrenia with Inflammation

This 16-week study is looking into a new approach for schizophrenia, focusing on people who have specific antibodies (anti-gliadin antibodies or AGA IgG+) linked to inflammation. We are testing a drug called mirikizumab, which is an FDA-approved monoclonal antibody. It works by targeting a specific part of the immune system (IL-23) that can cause inflammation. The goal is to see if mirikizumab, given alongside current antipsychotics, can help improve negative symptoms in people with schizophrenia or schizoaffective disorder who have these antibodies. We are also including healthy volunteers. The study aims to enroll 40 participants aged 18 to 64 years old.

Study design
This is a randomized, double-blind study, meaning participants will be randomly assigned to receive either mirikizumab or a placebo (an inactive substance), and neither you nor the study team will know which you are receiving. It plans to enroll 40 participants.
What's involved
Participants will receive mirikizumab intravenously (through a vein) at the start, week 4, and week 8, and then subcutaneously (under the skin) at week 12. The study measures changes in negative symptoms over 16 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at 16 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07615075

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

Not Yet Recruiting
PHASE4Ages 18–64InterventionalTreatment
University of Maryland, Baltimore
~40 participants
Updated 2026-05-29 on ClinicalTrials.gov
What's tested:PlaceboIL-23

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in negative symptoms in schizophrenia
Measured over 16 weeks

Conditions

Schizophrenia
Schizo Affective Disorder
Healthy

Explore related trials

Healthy VolunteersSchizoaffective DisorderSchizophreniaAGA Gene

NCT07615075

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Maryland Psychiatric Research Center (MPRC) Outpatient Research Program (ORP); the MPRC Treatment Research Program (TRP)

    Catonsville, Marylandno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Deanna L Kelly, PharmD, BCPP · PRINCIPAL_INVESTIGATOR · University of Maryland, Baltimore

Who to contact

Ann Kearns, MS
[email protected]
410-402-6854
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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.
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

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
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

What this trial measures

  • Change in negative symptoms in schizophrenia16 weeks

    Change in negative symptoms in schizophrenia, specific experiential negative symptoms (i.e., motivation and pleasure) using The Clinical Assessment Interview for Negative Symptoms (CAINS) is a clinician-rated tool developed to assess the negative symptoms of schizophrenia, aligning with the NIMH's consensus on negative symptom domains. It comprises two main subscales: the Motivation and Pleasure (MAP) scale and the Expression (EXP) scale. The CAINS-MAP subscale specifically evaluates deficits in motivation, social engagement, and hedonic experience across social, vocational, and recreational contexts. The 0-4 Scoring System:0: No impairment (within the range of normal variation) 1. Mild impairment 2. Moderate impairment 3. Moderately severe impairment 4. Severe deficit or impairment. Higher total scores indicate a greater severity of negative symptoms