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RecruitingNCT07680946Updated Oct 30, 2026

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

A Phase 2 interventional study of Ublituximab in Schizophrenia, sponsored by TG Therapeutics, Inc.. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by TG Therapeutics, Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Schizophrenia

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03

In context

Schizophrenia

3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.

This study's planned enrollment of 60 is below the median of 71 across 2,944 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

TG Therapeutics, Inc. is the lead sponsor of 40 studies on the registry; 9 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 9 (56%) have results posted.

Browse TG Therapeutics, Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria

  1. Any primary , 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

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Ublituximab

    Participants will receive ublituximab intravenous (IV) infusion.

    Drug: Ublituximab

Interventions

  • DrugUblituximab

    Administered as an IV infusion.

    Also known as: BRIUMVI, TG-1101

06

What researchers measure

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

07

Study locations

2 of 2 sites recruiting
  • TG Therapeutics Investigational Trial Site
    Little Rock, Arkansas 72204, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Richardson, Texas 75080, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2026 (actual). Primary completion is estimated for Dec 2028, 28 months after the start.

Of 57 industry-sponsored phase 2 interventional studies under Schizophrenia, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 32. This study's planned 28 months is above that.

Counting every sponsor, half of 101 studies reached it within 25 months; a quarter within 15 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 26, 2026
First posted
Jul 2, 2026
StartActual
Jul 27, 2026
Primary completionEst.
Dec 12, 2028
CompletionEst.
Mar 1, 2029
Last update
Oct 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 30, 2026
Show all 1 update
  1. Oct 30, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07680946
Lead sponsor
TG Therapeutics, Inc.
Responsible party
Sponsor
First posted
Jul 2, 2026
Start date
Jul 27, 2026
Primary completion
Dec 12, 2028 (estimated)
Completion
Mar 1, 2029 (estimated)
Last update
Oct 30, 2026

Study contacts

TG Therapeutics Clinical Support Team
Contact
clinicalsupport@tgtxinc.com
1-877-575-8489

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Ublituximab

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