14 terminated, 13 completed, 12 recruiting, 5 active not recruiting. 23 Phase 2, 15 Phase 1, 11 Phase 3, 3 Phase 4, 1 Early Phase 1.
Follow ublituximab: new trials by email Literature Review of ublituximab trials Research Report on ublituximab
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study to Evaluate the Efficacy and Safety of Maintenance Ublituximab Following Induction With Efgartigimod Administration in Participants With Myasthenia Gravis (MG) Ublituximab, Placebo - Myasthenia Gravis | Phase 2 | Recruiting | TG Therapeutics, Inc. | 120 | 2026-10-01 | 2026-09-22 |
| An Open-Label Phase II Feasibility Study for the Use of Ublituximab in Adults With Down Syndrome Regression Disorder Ublituximab - Down Syndrome Regression Disorder (DSRD), Down Syndrome (Trisomy 21) | Phase 2 | Not yet recruiting | Jonathan Santoro | 20 | 2026-10-01 | 2026-09-23 |
| Study to Evaluate the Safety and Efficacy of Ublituximab in Participants With Schizophrenia Ublituximab - Schizophrenia | Phase 2 | Recruiting | TG Therapeutics, Inc. | 60 | 2026-07-27 | 2026-09-23 |
| Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis Ublituximab, Placebo, Fingolimod - Relapsing Multiple Sclerosis | Phase 2 / Phase 3 | Recruiting | TG Therapeutics, Inc. | 240 | 2026-07-01 | 2026-09-21 |
| Exploration of Novel Imaging Biomarkers on OCT for Ublituximab Treatment Response in Multiple Sclerosis Ublituximab, Other disease modifying therapies - Multiple Sclerosis (MS) - Relapsing-remitting | Not applicable | Recruiting | University of Maryland, Baltimore | 30 | 2026-05-01 | 2026-07-29 |
| Ublituximab in Autoantibody Positive Immune Mediated Necrotizing Myopathy Ublituximab, Placebo for Ublituximab - Autoimmune Disorders | Phase 2 | Recruiting | National Institute of Allergy and Infectious Diseases (NIAID) | 30 | 2026-04-21 | 2026-09-17 |
| 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) Ublituximab, Prefilled pen - Multiple Sclerosis | Phase 2 | Recruiting | TG Therapeutics, Inc. | 350 | 2026-04-01 | 2026-09-21 |
| Study of Ublituximab for Ocrelizumab Wearing-Off in Multiple Sclerosis Ublituximab, Ocrelizumab - Multiple Sclerosis | Phase 4 | Recruiting | Johns Hopkins University | 50 | 2026-02-10 | 2026-05-06 |
| Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis Ublituximab - Multiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting | Phase 4 | Recruiting | Northwestern University | 40 | 2025-11-28 | 2026-03-17 |
| Effects of Ublituximab on Motor Functions in Multiple Sclerosis Ublituximab - Multiple Sclerosis (MS) - Relapsing-remitting | Early Phase 1 | Recruiting | Georgia State University | 25 | 2025-11-13 | 2026-02-09 |
| A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab in Participants With Relapsing Multiple Sclerosis (RMS) Ublituximab - Relapsing Multiple Sclerosis | Phase 3 | Active not recruiting | TG Therapeutics, Inc. | 360 | 2025-07-09 | 2026-10-23 |
| A Single-Center Study to Characterize the Safety and Efficacy of Ublituximab in Older Adults With Relapsing Forms of Multiple Sclerosis (RMS) Ublituximab - Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis | Recruiting | Neurology Center of New England P.C. | 20 | 2024-08-13 | 2024-11-18 | |
| Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab Ublituximab, Placebo - Relapsing Multiple Sclerosis | Phase 3 | Recruiting | TG Therapeutics, Inc. | 800 | 2023-06-13 | 2026-10-23 |
| Tazemetostat in Combination With Umbralisib and Ublituximab for the Treatment Relapsed or Refractory Follicular Lymphoma Tazemetostat, Ublituximab, Umbralisib - Recurrent Follicular Lymphoma, Refractory Follicular Lymphoma | Phase 1 / Phase 2 | Withdrawn | City of Hope Medical Center | 2023-05-01 | 2023-05-31 | |
| Lenalidomide, Umbralisib, and Ublituximab for the Treatment of Relapsed or Refractory Indolent Non-Hodgkin Lymphoma or Mantle Cell Lymphoma Lenalidomide, Ublituximab, Umbralisib - Recurrent B-Cell Non-Hodgkin Lymphoma, Recurrent Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | Phase 1 | Withdrawn | Yazeed Sawalha | 2022-09-30 | 2022-09-30 | |
| Clinical Trial of Ublituximab and Umbralisib With CHOP (U2-CHOP) Followed by U2 Maintenance (U2-CHOP-U2) in Previously Untreated Mantle Cell Lymphoma (MCL) Ublituximab, Umbralisib - Mantle Cell Lymphoma | Phase 1 / Phase 2 | Terminated | University of Alabama at Birmingham | 1 | 2021-08-31 | 2023-09-28 |
| Study of TG-1801 Alone or in Combination With Ublituximab in Subjects With B-Cell Lymphoma or Chronic Lymphocytic Leukemia TG-1801, Ublituximab - CLL, SLL | Phase 1 | Terminated | TG Therapeutics, Inc. | 21 | 2021-04-28 | 2024-07-31 |
| Acalabrutinib, Umbralisib, and Ublituximab for the Treatment of Previously Untreated Mantle Cell Lymphoma Acalabrutinib, Ublituximab, Umbralisib - Mantle Cell Lymphoma | Phase 2 | Active not recruiting | City of Hope Medical Center | 12 | 2021-03-26 | 2026-10-06 |
| Umbralisib Plus Ublituximab (U2) in Progressive CLL After Novel Therapy Umbralisib, Ublituximab - Chronic Lymphocytic Leukemia, CLL Progression | Phase 2 | Terminated | Weill Medical College of Cornell University | 1 | 2021-02-10 | 2023-06-15 |
| Acalabrutinib, Umbralisib, and Ublituximab (AU2) In Relapsed and Untreated CLL Acalabrutinib, Umbralisib, Ublituximab - Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma | Phase 2 | Active not recruiting | Jennifer R. Brown, MD, PhD | 29 | 2020-12-15 | 2026-02-25 |
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Leukemia, Lymphocytic, Chronic, B-Cell (18) · Lymphoma, Non-Hodgkin (7) · Lymphoma, B-Cell, Marginal Zone (6) · Lymphoma, Follicular (6) · Lymphoma, Mantle-Cell (6) · Multiple Sclerosis, Relapsing-Remitting (6) · Lymphoma, B-Cell (5) · Multiple Sclerosis (5) · Recurrence (3) · Waldenstrom Macroglobulinemia (3) · Disease Progression (2) · Lymphoma (2) · Autoimmune Diseases (1) · Down Syndrome (1) · Lymphoma, Large B-Cell, Diffuse (1)
TG Therapeutics, Inc. (29) · City of Hope Medical Center (2) · Johns Hopkins University (2) · National Institute of Allergy and Infectious Diseases (NIAID) (2) · Georgia State University (1) · Jennifer R. Brown, MD, PhD (1) · Jonathan Santoro (1) · Laboratoire français de Fractionnement et de Biotechnologies (1) · Neurology Center of New England P.C. (1) · Northwestern University (1) · The Cleveland Clinic (1) · University of Alabama at Birmingham (1) · University of Colorado, Denver (1) · University of Maryland, Baltimore (1) · Weill Medical College of Cornell University (1)
United States (39) · Poland (8) · United Kingdom (4) · Australia (3) · Georgia (3) · Israel (3) · Italy (3) · Serbia (3) · Ukraine (3) · Bosnia and Herzegovina (2) · Croatia (2) · North Macedonia (2) · Russia (2) · Spain (2) · Belarus (1)
Jeff Sharman, MD (2) · Alexey V Danilov (1) · Amitkumar Mehta (1) · Anthony R. Mato, MD (1) · Constantine S. Tam, MD (1) · Daniel Harrison, MD (1) · Daniel Ontaneda, MD, MSc (1) · Edward Fox, MD, PhD (1) · Farrah J Mateen, MD, PhD (1) · George E. Georges, MD (1) · Jeffrey A. Cohen, MD (1) · Jennifer R Brown, MD, PhD (1) · John Allan, MD (1) · Jonathan Santoro, MD (1)
PMID 36001711, PMID 39512280, PMID 41787239, PMID 42292352, PMID 30709431, PMID 31558467, PMID 33631112, PMID 33683917, PMID 35538512, PMID 37871300, PMID 40085050, PMID 41697690, PMID 42218617
2025 (4), 2017 (2), P30CA033572 (2), 2015 (1), 2016 (1), 2019 (1), UM1AI109565 (1)