TG Therapeutics, Inc. — Biomedical Watch V2

Traitements14programmes

Essais10liés

Publications2liées

SourceDBlocale

Traitements

14

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
Azercabtagene zapreleucel (azer-cel)The main objective of the study is to determine the recommended phase 2 dose (RP2D) of Azercabtagene zapreleucel (azer-cel).	Myasthénie	Phase 1	À vérifier	United States	À vérifier
ENABLE — 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	SEP	À vérifier	À vérifier	United States, Puerto Rico	À vérifier
PROVIDE — A Study Evaluating the Presence and Concentration of BRIUMVI™ (Ublituximab) in Breast MilkThe primary objective of the lactation study is to characterize the presence and concentration of BRIUMVI™ in breast milk among breastfeeding participants who receive BRIUMVI™ therapeutically for the treatment of relapsing forms of multiple sclerosis (RMS).	SEP	À vérifier	À vérifier	United States	À vérifier
UblituximabThe proposed study is a pilot study of ublituximab involving people with multiple sclerosis (MS) who are experiencing a "wearing off" phenomenon (return or worsening of MS-related symptoms) while being treated with ocrelizumab, and exploring whether switching to ublituzimab can resolve, improve or delay this phenomenon.	Myasthénie, Myopathies, SEP	Phase 2	Traitement symptomatique	United States	À vérifier
UblituximabThe proposed study is a pilot study of ublituximab involving people with multiple sclerosis (MS) who are experiencing a "wearing off" phenomenon (return or worsening of MS-related symptoms) while being treated with ocrelizumab, and exploring whether switching to ublituzimab can resolve, improve or delay this phenomenon.	SEP	Phase 4	Traitement symptomatique	United States	À vérifier
UblituximabThe proposed study is a pilot study of ublituximab involving people with multiple sclerosis (MS) who are experiencing a "wearing off" phenomenon (return or worsening of MS-related symptoms) while being treated with ocrelizumab, and exploring whether switching to ublituzimab can resolve, improve or delay this phenomenon.	Myopathies	Phase 2	Traitement symptomatique	United States	À vérifier
Azercabtagene zapreleucel (azer-cel)The main objective of the study is to determine the recommended phase 2 dose (RP2D) of Azercabtagene zapreleucel (azer-cel).	Myasthénie	Phase 1		United States	À vérifier
UblituximabThe proposed study is a pilot study of ublituximab involving people with multiple sclerosis (MS) who are experiencing a "wearing off" phenomenon (return or worsening of MS-related symptoms) while being treated with ocrelizumab, and exploring whether switching to ublituzimab can resolve, improve or delay this phenomenon.	Myasthénie	Phase 2	Traitement symptomatique	United States	À vérifier
UblituximabThe proposed study is a pilot study of ublituximab involving people with multiple sclerosis (MS) who are experiencing a "wearing off" phenomenon (return or worsening of MS-related symptoms) while being treated with ocrelizumab, and exploring whether switching to ublituzimab can resolve, improve or delay this phenomenon.	SEP	Non applicable	Traitement symptomatique	United States	À vérifier
UblituximabThe proposed study is a pilot study of ublituximab involving people with multiple sclerosis (MS) who are experiencing a "wearing off" phenomenon (return or worsening of MS-related symptoms) while being treated with ocrelizumab, and exploring whether switching to ublituzimab can resolve, improve or delay this phenomenon.	SEP	Phase 3	Traitement symptomatique	Bosnia and Herzegovina, Bulgaria, Croatia, Czechia, Georgia, Hungary, North Macedonia, Serbia, Ukraine	À vérifier
PROVIDE — A Study Evaluating the Presence and Concentration of BRIUMVI™ (Ublituximab) in Breast MilkThe primary objective of the lactation study is to characterize the presence and concentration of BRIUMVI™ in breast milk among breastfeeding participants who receive BRIUMVI™ therapeutically for the treatment of relapsing forms of multiple sclerosis (RMS).	SEP	À vérifier	À vérifier	United States	À vérifier
UblituximabThe proposed study is a pilot study of ublituximab involving people with multiple sclerosis (MS) who are experiencing a "wearing off" phenomenon (return or worsening of MS-related symptoms) while being treated with ocrelizumab, and exploring whether switching to ublituzimab can resolve, improve or delay this phenomenon.	SEP	Phase 3	Traitement symptomatique	United States, Belarus, Croatia, Georgia, Poland, Russia, Serbia, Ukraine	À vérifier
UblituximabThe proposed study is a pilot study of ublituximab involving people with multiple sclerosis (MS) who are experiencing a "wearing off" phenomenon (return or worsening of MS-related symptoms) while being treated with ocrelizumab, and exploring whether switching to ublituzimab can resolve, improve or delay this phenomenon.	SEP	Phase 3	Traitement symptomatique	United States, Poland	À vérifier
ENABLE — 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	SEP	À vérifier	À vérifier	United States, Puerto Rico	À vérifier

Essais cliniques

10

Molécule	Indication / population	Phase	NCT	Titre	Statut
ENABLE — A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)	SEP	À vérifier	NCT06433752	ENABLE — A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)	RECRUITING
Ublituximab	SEP	Phase 3	NCT05877963	ENHANCE — Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab	RECRUITING
Ublituximab	SEP	Phase 3	NCT04130997	An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis	ACTIVE_NOT_RECRUITING
PROVIDE — A Study Evaluating the Presence and Concentration of BRIUMVI™ (Ublituximab) in Breast Milk	SEP	À vérifier	NCT06143514	PROVIDE — A Study Evaluating the Presence and Concentration of BRIUMVI™ (Ublituximab) in Breast Milk	RECRUITING
Ublituximab	SEP	Phase 3	NCT07211633	A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab in Participants With Relapsing Multiple Sclerosis (RMS)	ACTIVE_NOT_RECRUITING
Ublituximab	SEP	Non applicable	NCT06864936	Exploration of Novel Imaging Biomarkers on OCT for Ublituximab Treatment Response in Multiple Sclerosis	RECRUITING
Ublituximab	Myasthénie	Phase 2	NCT07673744	A Study to Evaluate the Efficacy and Safety of Maintenance Ublituximab Following Induction With Efgartigimod Administration in Participants With Myasthenia Gravis (MG)	RECRUITING
Azercabtagene zapreleucel (azer-cel)	Myasthénie	Phase 1	NCT06680037	A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders	RECRUITING
Ublituximab	Myopathies	Phase 2	NCT07103746	SUMMIT — Ublituximab in Autoantibody Positive Immune Mediated Necrotizing Myopathy	RECRUITING
Ublituximab	SEP	Phase 4	NCT07389590	Study of Ublituximab for Ocrelizumab Wearing-Off in Multiple Sclerosis	RECRUITING

Publications

2

Molécule	Indication / population	Titre	Journal	Date
Ublituximab		Optimizing Infusion Center Efficiency in Multiple Sclerosis: A Nursing Multicenter Survey on Organizational Impact of Ublituximab.	Healthcare (Basel, Switzerland)
Ublituximab		Infusion-related reactions and premedication patterns in ublituximab-treated multiple sclerosis patients: a multicenter real-world study.	Frontiers in neurology