Recruiting
Phase 2

Ublituximab

Sponsor:

TG Therapeutics, Inc.

Code:

NCT07680946

Conditions

Schizophrenia

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Ublituximab

Study Details

Brief summary:

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.

Conditions

Schizophrenia

Study ID

NCT07680946

Start date

Jul 27, 2026

Status verified date

Aug, 2026

Completion date

Mar 1, 2029

Anticipated

Primary completion date

Dec 12, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ublituximab

Participants will receive ublituximab intravenous (IV) infusion.

Interventions

Ublituximab

Administered as an IV infusion.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

TG Therapeutics Clinical Support Team

1-877-575-8489clinicalsupport@tgtxinc.com

Locations

TG Therapeutics Investigational Trial Site

Recruiting

Little Rock, Arkansas, United States, 72204

TG Therapeutics Investigational Trial Site

Recruiting

Richardson, Texas, United States, 75080

More Information

Sponsor

TG Therapeutics, Inc.

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by TG Therapeutics, Inc. on 2026-08-26.