Study to Evaluate the Safety and Efficacy of Ublituximab in Participants With Schizophrenia
Purpose
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.
Condition
- Schizophrenia
Eligibility
- Eligible Ages
- Between 18 Years and 60 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Ublituximab |
Participants will receive ublituximab intravenous (IV) infusion. |
|
Recruiting Locations
TG Therapeutics Investigational Trial Site
Little Rock, Arkansas 72204
Little Rock, Arkansas 72204
TG Therapeutics Investigational Trial Site
Richardson, Texas 75080
Richardson, Texas 75080
More Details
- Status
- Recruiting
- Sponsor
- TG Therapeutics, Inc.