Study to Evaluate the Safety and Efficacy of Ublituximab in Participants With Schizophrenia
ConditionSchizophrenia
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorTG Therapeutics, Inc.
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Ublituximab
Treatment groups
60 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov