Study to Evaluate the Safety and Efficacy of Ublituximab in Participants With Schizophrenia
Recruiting · NCT07680946 · Interventional (participants receive a specific treatment) · Lead sponsor: TG Therapeutics, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years to 60 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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 it is running
2 locations listed across 2 US states.
- TG Therapeutics Investigational Trial Site - Little Rock, Arkansas, United States
- TG Therapeutics Investigational Trial Site - Richardson, Texas, United States