Schizophrenia
Conditions
Brief 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.
Interventions
DRUGUblituximab
Administered as an IV infusion.
Sponsors
TG Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants with at Least 20% Reduction From Baseline in PANSS Total Score | At Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Up to Week 48 |
| Change From Baseline in 4-Item Negative Symptom Assessment (NSA-4) | Baseline, Week 12, 24, and 48 |
| Change From Baseline in PANSS Total Score | Baseline, Week 12, 24, and 48 |
| Change From Baseline in Clinical Global Impressions - Improvement (CGI-I) | Baseline, Week 12, 24, 48 |
Countries
United States
Contacts
CONTACTTG Therapeutics Clinical Support Team
Outcome results
None listed