NCT07680946PHASE2Recruiting
Study to Evaluate the Safety and Efficacy of Ublituximab in Participants With Schizophrenia
TG Therapeutics, Inc.
Start Date
7/3/2026
Completion Date
3/1/2029
Summary
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.
Eligibility Criteria
Age Range: 18 years to 60 years
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
Interventions
DRUG
Ublituximab
Conditions
Schizophrenia
Locations
TG Therapeutics Investigational Trial Site
Little Rock, Arkansas 72204
United States
TG Therapeutics Investigational Trial Site
Richardson, Texas 75080
United States