Ublituximab in people with schizophrenia
Official title: Evaluating Safety and Efficacy of Ublituximab in Participants With Schizophrenia
Run by TG Therapeutics, Inc. · NCT07680946 · Data updated 2026-11-12
This study tests whether ublituximab can help reduce symptoms in adults with treatment‑resistant schizophrenia who are already taking standard antipsychotic therapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | TG Therapeutics, Inc. Industry-sponsored |
| Drugs / interventions | ublituximab |
| Locations | 2 sites (Little Rock, Arkansas and 1 other locations) |
| Status | Recruiting |
| Started | July 27, 2026 |
| Main results expected | December 12, 2028 |
| Study ends | March 1, 2029 |
| Registry record updated | October 30, 2026 |
| Trial ID | NCT07680946 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with treatment‑resistant schizophrenia who are on standard antipsychotic therapy and have a PANSS score 80–120 at screening/baseline.
✕Probably not a fit
Individuals with nonresponse to ublituximab, or those with conditions excluding participation, may not experience symptom improvement.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2, interventional trial evaluates the safety and potential symptom benefit of ublituximab in participants with schizophrenia who have not responded adequately to prior treatments. Eligibility requires a primary schizophrenia diagnosis, ongoing antipsychotic treatment, and a PANSS total score between 80 and 120 at screening/baseline. The study focuses on measuring changes in PANSS total score to determine efficacy, while monitoring safety in a treatment‑resistant population. Conducted at TG Therapeutics investigational sites in Little Rock, AR and Richardson, TX, the trial is sponsored by TG Therapeutics, Inc.
Why it matters
Potential benefit: If successful, participants could experience a reduction in schizophrenia symptom severity as measured by PANSS total score.
How similar studies have gone: Previous studies in related populations have shown potential signals but this approach with ublituximab is exploratory in schizophrenia.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Primary diagnosis of schizophrenia. 2. Treatment-resistant. 3. Requires antipsychotic treatment and is currently receiving "standard of care". 4. PANSS total score between 80 and 120, inclusive at screening and baseline. Exclusion Criteria 1. Any primary Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) disorder other than schizophrenia. 2. Ongoing clozapine treatment. 3. Risk for suicidal behavior. 4. Any severe or uncontrolled medical condition that could affect the participant's ability to participate. Note: Other protocol-specified Inclusion/Exclusion criteria may apply
Where it's running
-
TG Therapeutics Investigational Trial Site
Little Rock, Arkansas, United States Recruiting -
TG Therapeutics Investigational Trial Site
Richardson, Texas, United States Recruiting
Study contacts
- Study coordinator: TG Therapeutics Clinical Support Team
- Email: clinicalsupport@tgtxinc.com
- Phone: 1-877-575-8489
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Using Lumateperone to improve motivation in patients with schizophrenia and psychosis
This study is testing if Lumateperone can help people with schizophrenia or schizoaffective disorders feel more motivated and less apathetic.
-
Examining the effects of combined therapy for schizophrenia
This study is testing whether combining two therapies, one for managing thoughts and another for improving cognitive skills, can help people with schizophrenia do better in their daily lives compared to using just one of the therapies.
-
XEP527 in stable schizophrenia: safety and how it behaves in the body
This small, early-stage study tests the safety and how XEP527 behaves in people with stable schizophrenia who are on a single antipsychotic.
-
Theta-Burst Transcranial Magnetic Stimulation for Treatment-Resistant Auditory Hallucinations
This study tests whether theta-burst transcranial magnetic stimulation can lessen persistent auditory verbal hallucinations in adults with schizophrenia-spectrum or psychotic disorders who have not responded to antipsychotic meds.
-
Quality of life and safety in quetiapine use for schizophrenia or bipolar disorder
This study looks at how patients with schizophrenia or bipolar disorder feel and stay safe when treated with quetiapine alone or with other antipsychotics.
-
Neuronavigated rTMS for treatment-resistant auditory hallucinations
We are testing whether personalized neuronavigated inhibitory rTMS can reduce persistent auditory verbal hallucinations in adults who don’t respond to medication.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.