Pharmaceutical sponsor
TG Therapeutics, Inc. Clinical Trials
Studies where TG Therapeutics, Inc. is the lead sponsor: its pipeline by phase, what is enrolling now and where. Studies it supports as a collaborator are in the search.
In numbers
Open to volunteers: recruiting, not yet recruiting or enrolling by invitation. Active adds studies under way that have stopped recruiting.
Open to volunteers
All 9Schizophrenia
Study to Evaluate the 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.
- Trial name
- NCT07680946
- Testing
- Ublituximab
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- TG Therapeutics, Inc.
Relapsing Multiple Sclerosis, Multiple Sclerosis
A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)
The purpose of this study is to evaluate safety, effiectiveness, and to gain insight into the treatment experience of participants prescribed BRIUMVI® (ublituximab-xiiy) in the real-world setting
- Trial name
- ENABLE (NCT06433752)
- Testing
- No Intervention
- Where
- 113 sites in United States, Puerto Rico and 1 more
- Volunteers
- 2,000 people
- Sponsor
- TG Therapeutics, Inc.
Multiple Sclerosis
A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS)
The purpose of this study is to evaluate the PK and safety of ublituximab SC at different sites of administration and relative bioavailability of ublituximab SC administered with a prefilled pen versus syringe.
- Trial name
- NCT07503873
- Testing
- Ublituximab, Prefilled pen
- Where
- 44 sites in Bosnia and Herzegovina, Georgia and 4 more
- Volunteers
- 350 people
- Sponsor
- TG Therapeutics, Inc.
Multiple Sclerosis
A Study Evaluating the Effect of BRIUMVI® (Ublituximab) on Pregnancy and Infant Outcomes in Participants With Multiple Sclerosis (MS)
The primary objective of the study is to compare the prevalence rate of major congenital malformations (MCM) between 2 cohorts of pregnant participants with MS who are exposed to BRIUMVI® and who are unexposed to BRIUMVI®.
- Trial name
- NCT06433765
- Testing
- No intervention
- Where
- United States
- Volunteers
- 728 people
- Sponsor
- TG Therapeutics, Inc.
Relapsing Multiple Sclerosis
Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis
The primary purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of ublituximab in participants ages 10 to less than (<)18 years and body weight greater than or equal to (≥)25 kilograms (kg) to…
- Trial name
- NCT07220252
- Testing
- Ublituximab, Fingolimod
- Where
- 6 sites in United States, Poland and 1 more
- Volunteers
- 240 people
- Sponsor
- TG Therapeutics, Inc.
B-cell Mediated Autoimmune Disorders
Long-term Follow-up (LTFU) of Participants Who Received Azer-Cel
The main objective of this study is to collect data on the long-term safety of azer-cel, primarily through the capture of clinical events of interest (CEI) for up to 15 years following participation in TG-Azercel -101 study.
- Trial name
- NCT07577583
- Testing
- No Intervention
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- TG Therapeutics, Inc.
Myasthenia Gravis
A Study to Evaluate the Efficacy and Safety of Maintenance Ublituximab Following Induction With Efgartigimod Administration in Participants With Myasthenia Gravis (MG)
The primary purpose of this study is to evaluate the efficacy of ublituximab in adult participants with MG responding to treatment with efgartigimod.
- Trial name
- NCT07673744
- Testing
- Ublituximab
- Where
- 7 sites in United States
- Volunteers
- 120 people
- Sponsor
- TG Therapeutics, Inc.
B-cell Mediated Autoimmune Disorders
A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders
The main objective of the study is to determine the recommended phase 2 dose (RP2D) of Azercabtagene zapreleucel (azer-cel).
- Trial name
- NCT06680037
- Testing
- Azercabtagene zapreleucel (azer-cel)
- Where
- 8 sites in United States
- Volunteers
- 100 people
- Sponsor
- TG Therapeutics, Inc.
Relapsing Multiple Sclerosis
Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab
The primary purpose of this phase 3b study is to assess the efficacy of a modified regimen of ublituximab in participants with relapsing multiple sclerosis (RMS) as measured by T1 Gadolinium (Gd)-enhancing lesions in Part A; PK…
- Trial name
- ENHANCE (NCT05877963)
- Testing
- Ublituximab
- Where
- 51 sites in United States, Poland
- Volunteers
- 800 people
- Sponsor
- TG Therapeutics, Inc.
Completed, with results posted
All 5Marginal Zone Lymphoma, Waldenstrom Macroglobulinemia
Study to Assess the Efficacy and Safety of Umbralisib in Participants With Non-Follicular Indolent Non-Hodgkin's Lymphoma
This research study will evaluate the safety and efficacy of a study drug called Umbralisib (also known as TGR-1202) alone as a possible treatment for Waldenstrom's Macroglobulinemia that has come back or that has not responded…
- Conditions
- Marginal Zone Lymphoma, Waldenstrom Macroglobulinemia, Non Follicular Indolent Non-Hodgkin Lymphoma
- Trial name
- NCT03364231
- Testing
- Umbralisib
- Where
- 4 sites in United States
- Volunteers
- 21 people
- Sponsor
- TG Therapeutics, Inc.
Chronic Lymphocytic Leukemia
Ublituximab in Combination With Ibrutinib Versus Ibrutinib Alone in Participants With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)
This study evaluates the effect of the addition of ublituximab, a novel monoclonal antibody, to ibrutinib compared to ibrutinib alone on antitumor activity, as measured by the overall response rate (ORR = CR [complete response] +…
- Trial name
- GENUINE (NCT02301156)
- Testing
- Ublituximab, Ibrutinib
- Where
- 88 sites in United States, Israel
- Volunteers
- 126 people
- Sponsor
- TG Therapeutics, Inc.
Relapsing Multiple Sclerosis (RMS)
Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) ( ULTIMATE 1 )
This study determines the Annualized Relapse Rate (ARR) in participants with RMS after 96 weeks (approximately 2 years) treatment with intravenous (IV) infusion of ublituximab/oral placebo compared to 14 mg oral teriflunomide/IV…
- Trial name
- ULTIMATE 1 (NCT03277261)
- Testing
- Ublituximab, Teriflunomide
- Where
- 14 sites in United States
- Volunteers
- 549 people
- Sponsor
- TG Therapeutics, Inc.
Relapsing Multiple Sclerosis (RMS)
Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS)
This study determines the Annualized Relapse Rate (ARR) in participants with RMS after 96 weeks (approximately 2 years) treatment with intravenous (IV) infusion of ublituximab/oral placebo compared to 14 mg oral teriflunomide/IV…
- Trial name
- ULTIMATE II (NCT03277248)
- Testing
- Ublituximab, Teriflunomide
- Where
- 13 sites in United States
- Volunteers
- 545 people
- Sponsor
- TG Therapeutics, Inc.
Multiple Sclerosis
Phase IIa Study of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis
This study evaluates the use of single agent ublituximab, a novel monoclonal antibody, in participants with relapsing forms of multiple sclerosis.
- Trial name
- NCT02738775
- Testing
- Ublituximab
- Where
- 12 sites in United States
- Volunteers
- 49 people
- Sponsor
- TG Therapeutics, Inc.