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Recruiting
NCT07680946
Study to Evaluate the Safety and Efficacy of Ublituximab in Participants With Schizophrenia
Conditions: Schizophrenia
Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 60
Sponsor: TG Therapeutics, Inc.
Location: TG Therapeutics Investigational Trial Site Little Rock Arkansas
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.
Eligibility Criteria
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/Exclusion criteria may apply
Source: ClinicalTrials.gov (NCT07680946). StuddyBuddy aggregates publicly available trial information.
