Recruiting NCT07680946
Study to Evaluate the Safety and Efficacy of Ublituximab in Participants With Schizophrenia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ublituximab.
- Who it may be relevant to
- Registry conditions: Schizophrenia. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluating Safety and Efficacy of Ublituximab in Participants With Schizophrenia
Overview
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
- Drug Ublituximab
Administered as an IV infusion.
Primary outcome measures
- Percentage of Participants with at Least 20% Reduction From Baseline in PANSS Total Score [Time frame: At Week 12]
Secondary outcome measures (4)
- Change From Baseline in PANSS Total Score [Time frame: Baseline, Week 12, 24, and 48]
- Change From Baseline in Clinical Global Impressions - Improvement (CGI-I) [Time frame: Baseline, Week 12, 24, 48]
- Change From Baseline in 4-Item Negative Symptom Assessment (NSA-4) [Time frame: Baseline, Week 12, 24, and 48]
- Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) [Time frame: Up to Week 48]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- TG Therapeutics Investigational Trial Site — Little Rock
- TG Therapeutics Investigational Trial Site — Richardson
Identifiers
NCT: NCT07680946 · TG1101-SSD-201