Study to Evaluate the Safety and Efficacy of Ublituximab... | NCT07680946

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

NCT07680946

Sponsor

TG Therapeutics, Inc.

Status

Not yet recruiting

Last Update Posted

Jul 2, 2026Actual

Enrollment

60Estimated

Phase

Phase 2

Conditions

Schizophrenia

Interventions

Ublituximab

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 6, 2026Estimated

Primary Completion Date

Dec 1, 2028Estimated

Completion Date

Mar 1, 2029Estimated

First Submitted Date

Jun 26, 2026

First Submission Date that Met QC Criteria

Jun 26, 2026

First Posted Date

Jul 2, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 26, 2026

Last Update Posted Date

Jul 2, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ublituximab	Experimental	Participants will receive ublituximab intravenous (IV) infusion.	Drug: Ublituximab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ublituximab	Drug	Administered as an IV infusion.	Ublituximab	BRIUMVI

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in PANSS Total Score		Baseline, Week 12, 24, and 48
Change From Baseline in Clinical Global Impressions - Improvement (CGI-I)		Baseline, Week 12, 24, 48

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
TG Therapeutics Clinical Support Team	Contact	1-877-575-8489		clinicalsupport@tgtxinc.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000619007	ublituximab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided