NCT07680946 · TG Therapeutics, Inc.
Study to Evaluate the Safety and Efficacy of Ublituximab in Participants With Schizophrenia
What this study is about
The main objective of this Phase 2 study is to assess the effectiveness of ublituximab as measured by positive and negative syndrome scale (PANSS) total score in participants with schizophrenia.
View original scientific description
The main objective of this Phase 2 study is to assess the efficacy of ublituximab as measured by positive and negative syndrome scale (PANSS) total score in participants with schizophrenia.
Interventions
DRUG
Ublituximab
Administered as an IV infusion.
Primary outcome measures
Percentage of Participants with at Least 20% Reduction From Baseline in PANSS Total Score
Time frame: At Week 12
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Primary diagnosis of schizophrenia.
- Treatment-resistant.
- Requires antipsychotic treatment and is currently receiving "standard of care".
- PANSS total score between 80 and 120, inclusive at screening and baseline.
Exclusion criteria
- Any primary Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) disorder other than schizophrenia.
- Ongoing clozapine treatment.
- Risk for suicidal behavior.
- 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
- Little Rock, Arkansas
- Richardson, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 26, 2026 · Source of record for eligibility and locations