Study to Evaluate the Safety and Efficacy of Ublituximab in Participants With Schizophrenia
ConditionSchizophrenia
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Ublituximab
DrugAdministered as an IV infusion.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: UblituximabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of Participants with at Least 20% Reduction From Baseline in PANSS Total Score
Time frame
At Week 12Secondary outcomes
1
Change From Baseline in PANSS Total Score
Time frame
Baseline, Week 12, 24, and 482
Change From Baseline in Clinical Global Impressions - Improvement (CGI-I)
Time frame
Baseline, Week 12, 24, 483
Change From Baseline in 4-Item Negative Symptom Assessment (NSA-4)
Time frame
Baseline, Week 12, 24, and 484
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame
Up to Week 48Sponsors and contacts
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Source ClinicalTrials.gov