Study to Evaluate the Safety and Efficacy of Ublituximab in Participants With Schizophrenia
Evaluating Safety and Efficacy of Ublituximab in Participants With Schizophrenia
1 other identifier
interventional
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 schizophrenia
Started Jul 2026
Typical duration for phase_2 schizophrenia
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2026
CompletedFirst Posted
Study publicly available on registry
July 2, 2026
CompletedStudy Start
First participant enrolled
July 3, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2029
July 21, 2026
July 1, 2026
2.4 years
June 26, 2026
July 17, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants with at Least 20% Reduction From Baseline in PANSS Total Score
At Week 12
Secondary Outcomes (4)
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
Change From Baseline in 4-Item Negative Symptom Assessment (NSA-4)
Baseline, Week 12, 24, and 48
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Up to Week 48
Study Arms (1)
Ublituximab
EXPERIMENTALParticipants will receive ublituximab intravenous (IV) infusion.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
TG Therapeutics Investigational Trial Site
Little Rock, Arkansas, 72204, United States
TG Therapeutics Investigational Trial Site
Richardson, Texas, 75080, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2026
First Posted
July 2, 2026
Study Start
July 3, 2026
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
March 1, 2029
Last Updated
July 21, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share