Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07680946

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

TG Therapeutics Investigational Trial Site, Little Rock, Arkansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Note: Other protocol-specified Inclusion/Exclusion criteria may apply

Treatment and study plan

Ublituximab

Drug

Administered as an IV infusion.

Other names: BRIUMVI, TG-1101

Primary outcomes

  1. Percentage of Participants with at Least 20% Reduction From Baseline in PANSS Total Score

    Time frame: At Week 12

Secondary outcomes

  1. Change From Baseline in PANSS Total Score

    Time frame: Baseline, Week 12, 24, and 48

  2. Change From Baseline in Clinical Global Impressions - Improvement (CGI-I)

    Time frame: Baseline, Week 12, 24, 48

  3. Change From Baseline in 4-Item Negative Symptom Assessment (NSA-4)

    Time frame: Baseline, Week 12, 24, and 48

  4. Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Up to Week 48

Study contacts

Contact information is provided by the study sponsor or research team.

TG Therapeutics Clinical Support Team

CONTACT

[email protected]

1-877-575-8489

Sponsors and collaborators

Lead sponsor

TG Therapeutics, Inc.

Industry

Registry information

Official study title

Evaluating Safety and Efficacy of Ublituximab in Participants With Schizophrenia

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jul 2, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.