Ublituximab
- Generic Name
- Ublituximab
- Brand Names
- Briumvi
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 1174014-05-1
- Unique Ingredient Identifier
- U59UGK3IPC
- Background
CD20, an antigen expressed by various B and T cells, is an attractive therapeutic target in various cancers and autoimmune conditions. Monoclonal antibodies for B cell depletion rely on their binding affinity and ability to clear bound cells through mechanisms such as antibody-dependent cellular cytotoxicity (ADCC), mediated by interactions between an antibo...
- Indication
Ublituximab is indicated in adult patients for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease by the FDA. It is also indicated by the EMA to treat relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or im...
- Associated Conditions
- Clinically Isolated Syndrome (CIS), Relapsing Remitting Multiple Sclerosis (RRMS), Active Secondary Progressive Multiple Sclerosis (SPMS), Relapsed Multiple sclerosis
- Associated Therapies
- -
A Single-Center Study to Characterize the Safety and Efficacy of Ublituximab in Older Adults With Relapsing Forms of Multiple Sclerosis (RMS)
- Conditions
- First Posted Date
- 2024-11-08
- Last Posted Date
- 2024-11-18
- Lead Sponsor
- Neurology Center of New England P.C.
- Target Recruit Count
- 20
- Registration Number
- NCT06681623
- Locations
- 🇺🇸
Neurology Center of New England P.C., Foxboro, Massachusetts, United States
Effects of Ublituximab on Motor Functions in Multiple Sclerosis
- Conditions
- Interventions
- First Posted Date
- 2024-10-07
- Last Posted Date
- 2024-10-07
- Lead Sponsor
- Georgia State University
- Target Recruit Count
- 25
- Registration Number
- NCT06629428
- Locations
- 🇺🇸
Georgia State University, Atlanta, Georgia, United States
🇺🇸Atlanta Neuroscience Institute, Atlanta, Georgia, United States
Study to Evaluate Efficacy When Transitioning From a Current Disease Modifying Therapy (DMT) to Ublituximab
- First Posted Date
- 2023-05-26
- Last Posted Date
- 2024-12-02
- Lead Sponsor
- TG Therapeutics, Inc.
- Target Recruit Count
- 300
- Registration Number
- NCT05877963
- Locations
- 🇺🇸
TG Therapeutics Investigational Trial SiteCharlotte, Charlotte, North Carolina, United States
🇺🇸TG Therapeutics Investigational Trial Site, Spokane, Washington, United States
🇺🇸TG Investigational Site, Farmington, Michigan, United States
Acalabrutinib, Umbralisib, and Ublituximab for the Treatment of Previously Untreated Mantle Cell Lymphoma
- Conditions
- Interventions
- First Posted Date
- 2021-03-05
- Last Posted Date
- 2024-12-02
- Lead Sponsor
- City of Hope Medical Center
- Target Recruit Count
- 12
- Registration Number
- NCT04783415
- Locations
- 🇺🇸
City of Hope Medical Center, Duarte, California, United States
Clinical Trial of Ublituximab and Umbralisib With CHOP (U2-CHOP) Followed by U2 Maintenance (U2-CHOP-U2) in Previously Untreated Mantle Cell Lymphoma (MCL)
- First Posted Date
- 2020-12-31
- Last Posted Date
- 2023-09-28
- Lead Sponsor
- University of Alabama at Birmingham
- Target Recruit Count
- 1
- Registration Number
- NCT04692155
- Locations
- 🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States
Acalabrutinib, Umbralisib, and Ublituximab (AU2) In Relapsed and Untreated CLL
- Conditions
- Interventions
- First Posted Date
- 2020-11-12
- Last Posted Date
- 2024-11-04
- Lead Sponsor
- Jennifer R. Brown, MD, PhD
- Target Recruit Count
- 60
- Registration Number
- NCT04624633
- Locations
- 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Ublituximab Followed by Response-driven Addition of Umbralisib for Treatment-naive Follicular or Marginal Zone Lymphoma
- Conditions
- Interventions
- First Posted Date
- 2020-08-11
- Last Posted Date
- 2024-03-21
- Lead Sponsor
- University of Colorado, Denver
- Target Recruit Count
- 4
- Registration Number
- NCT04508647
- Locations
- 🇺🇸
University of Colorado Hospital, Aurora, Colorado, United States
Umbralisib Plus Ublituximab (U2) in Progressive CLL After Novel Therapy
- Conditions
- Interventions
- First Posted Date
- 2019-11-04
- Last Posted Date
- 2023-06-15
- Lead Sponsor
- Weill Medical College of Cornell University
- Target Recruit Count
- 1
- Registration Number
- NCT04149821
- Locations
- 🇺🇸
Weill Cornell Medicine, New York, New York, United States
An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis
- Conditions
- Interventions
- First Posted Date
- 2019-10-18
- Last Posted Date
- 2024-12-02
- Lead Sponsor
- TG Therapeutics, Inc.
- Target Recruit Count
- 1100
- Registration Number
- NCT04130997
- Locations
- 🇺🇦
TG Therapeutics Investigational Trial Site, Úzhgorod, Ukraine
🇭🇷TG Investigational Trial Site, Zagreb, Croatia
Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Participants With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib, Acalabrutinib or Venetoclax
- Conditions
- Interventions
- First Posted Date
- 2019-07-11
- Last Posted Date
- 2023-07-24
- Lead Sponsor
- TG Therapeutics, Inc.
- Target Recruit Count
- 41
- Registration Number
- NCT04016805
- Locations
- 🇺🇸
TG Therapeutics Investigational Trial Site, New York, New York, United States
Drug Development Updates
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