SchizophreniaPhase 2NCT07680946
Study to Evaluate the Safety and Efficacy of Ublituximab in Participants With Schizophrenia
A Phase 2 study testing Ublituximab in people with Schizophrenia, run by TG Therapeutics, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Ublituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Jul 2026to 1 Mar 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
TG Therapeutics Investigational Trial Site
Little Rock, Arkansas, 72204
- Recruiting
TG Therapeutics Investigational Trial Site
Richardson, Texas, 75080
About this study
Official title: 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.
- Conditions
- Schizophrenia
- Being tested
- Ublituximab
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UblituximabDrug
Also called BRIUMVI, TG-1101
Administered as an IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Ublituximab | Experimental | Participants will receive ublituximab intravenous (IV) infusion. Receives: Drug: Ublituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with at Least 20% Reduction From Baseline in PANSS Total Score
Measured: At Week 12
Secondary outcomes (4)
Change From Baseline in PANSS Total Score
Measured: Baseline, Week 12, 24, and 48
Change From Baseline in Clinical Global Impressions - Improvement (CGI-I)
Measured: Baseline, Week 12, 24, 48
Change From Baseline in 4-Item Negative Symptom Assessment (NSA-4)
Measured: Baseline, Week 12, 24, and 48
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start27 Jul 2026
- Primary completion12 Dec 2028 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by TG Therapeutics, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TG Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07680946
- Sponsor's protocol ID
- TG1101-SSD-201
- Status last verified
- Oct 2026
- First submitted
- 26 Jun 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Safety and Efficacy of Ublituximab in Participants With Schizophrenia
- ClinicalTrials.gov ID
- NCT07680946
- Acronym / sponsor ID
- TG1101-SSD-201
- Conditions
- Schizophrenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- TG Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Jul 2026 (actual)
- Primary completion
- 12 Dec 2028 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ublituximab | Experimental | Drug: UblituximabParticipants will receive ublituximab intravenous (IV) infusion. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UblituximabAlso: BRIUMVI, TG-1101Administered as an IV infusion. | Drug | Ublituximab |
Primary outcome
Percentage of Participants with at Least 20% Reduction From Baseline in PANSS Total Score
Time frame: At Week 12
4 secondary outcomes
Change From Baseline in PANSS Total Score
Time frame: Baseline, Week 12, 24, and 48
Change From Baseline in Clinical Global Impressions - Improvement (CGI-I)
Time frame: Baseline, Week 12, 24, 48
Change From Baseline in 4-Item Negative Symptom Assessment (NSA-4)
Time frame: Baseline, Week 12, 24, and 48
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Week 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ublituximab in people with Schizophrenia, run by TG Therapeutics, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact TG Therapeutics Clinical Support Team (1-877-575-8489, clinicalsupport@tgtxinc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with at Least 20% Reduction From Baseline in PANSS Total Score (time frame: At Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.