RightFit
RecruitingPhase 2

Study to Evaluate the Safety and Efficacy of Ublituximab in Participants With Schizophrenia

Evaluating Safety and Efficacy of Ublituximab in Participants With Schizophrenia

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 60 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe ublituximab is and how well it works for people with schizophrenia whose illness has not responded well to treatment. It uses a symptom rating scale to measure how well the drug works.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Schizophrenia is your main diagnosis.
  • Your illness has not responded well to treatment.
  • You need antipsychotic medicine and are getting standard care for schizophrenia.
  • Your score on the Positive and Negative Syndrome Scale (PANSS), which rates symptoms, is 80 to 120 at both screening and the study's start.

Who can't join

  • Your main mental health diagnosis is something other than schizophrenia.
  • You are currently taking clozapine.
  • You are at risk for suicidal behavior.
  • You have a severe or poorly controlled medical condition that could affect your ability to take part.
  • Other study rules may also affect whether you can take part.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (2)

AR

TX