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

June 26, 2026 updated by: TG Therapeutics, Inc.

Evaluating 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ublituximab
Participants will receive ublituximab intravenous (IV) infusion.
Drug: Ublituximab
Administered as an IV infusion.
Other Names:
  • TG-1101
  • BRIUMVI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with at Least 20% Reduction From Baseline in PANSS Total Score
Time Frame: At Week 12
At Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in PANSS Total Score
Time Frame: Baseline, Week 12, 24, and 48
Baseline, Week 12, 24, and 48
Change From Baseline in Clinical Global Impressions - Improvement (CGI-I)
Time Frame: Baseline, Week 12, 24, 48
Baseline, Week 12, 24, 48
Change From Baseline in 4-Item Negative Symptom Assessment (NSA-4)
Time Frame: Baseline, Week 12, 24, and 48
Baseline, Week 12, 24, and 48
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Up to Week 48
Up to Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TG Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 6, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

June 26, 2026

First Submitted That Met QC Criteria

June 26, 2026

First Posted (Actual)

July 2, 2026

Study Record Updates

Last Update Posted (Actual)

July 2, 2026

Last Update Submitted That Met QC Criteria

June 26, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TG1101-SSD-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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