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
Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Percentage of Participants with at Least 20% Reduction From Baseline in PANSS Total Score — At Week 12
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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