Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany — Biomedical Watch V2

Traitements11programmes

Essais4liés

Publications5liées

SourceDBlocale

Traitements

11

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
Cladribine High DoseThe purpose of this clinical study is to determine the efficacy and safety of a new oral cladribine formulation in participants with Generalized Myasthenia Gravis (gMG) in comparison to placebo. It will also investigate the sustained efficacy, the need for retreatment, and the long-term safety of oral cladribine in gMG. An additional component is included to characterize the Pharmacokinetics (PK) of the new cladribine formulation in gMG participants. This study is divided into 3 periods: the double-blind placebo control (DBPC) pivotal period, and 2 extensions, the blinded extension (BE) and the retreatment (RT) period. Furthermore, in trial interviews will be conducted as a sub-study to MyClad with a sub-set of participants to gain an in depth understanding of the participant cladribine treatment and study experience.	Myasthénie	Phase 3	À vérifier	United States, Argentina, Australia, Belgium, Bulgaria, Canada, China, France, …	À vérifier
Cladribine Low DoseThe purpose of this clinical study is to determine the efficacy and safety of a new oral cladribine formulation in participants with Generalized Myasthenia Gravis (gMG) in comparison to placebo. It will also investigate the sustained efficacy, the need for retreatment, and the long-term safety of oral cladribine in gMG. An additional component is included to characterize the Pharmacokinetics (PK) of the new cladribine formulation in gMG participants. This study is divided into 3 periods: the double-blind placebo control (DBPC) pivotal period, and 2 extensions, the blinded extension (BE) and the retreatment (RT) period. Furthermore, in trial interviews will be conducted as a sub-study to MyClad with a sub-set of participants to gain an in depth understanding of the participant cladribine treatment and study experience.	Myasthénie	Phase 3	À vérifier	United States, Argentina, Australia, Belgium, Bulgaria, Canada, China, France, …	À vérifier
M5049 high doseThe purpose of this study is to evaluate the efficacy and safety of orally administered M5049 in idiopathic inflammatory myopathies, specifically dermatomyositis (DM) and polymyositis (PM) participants for 24 weeks.	Lupus, Myopathies	Phase 2	Immunomodulation	United States, Argentina, Australia, Brazil, Bulgaria, Chile, China, Colombia, …	À vérifier
M5049 low doseThe purpose of the study is to evaluate the long term safety and efficacy of orally administered M5049 in participants with subacute cutaneous lupus erythematosus (SCLE), discoid lupus erythematosus (DLE) and/or systemic lupus erythematosus (SLE) who have completed the 24 week treatment period of Willow study (MS200569\_0003 \[NCT05162586\]).	Lupus	Phase 2	À vérifier	United States, Argentina, Australia, Brazil, Bulgaria, Chile, China, Colombia, …	À vérifier
M5049 medium doseThe purpose of the study is to evaluate the long term safety and efficacy of orally administered M5049 in participants with subacute cutaneous lupus erythematosus (SCLE), discoid lupus erythematosus (DLE) and/or systemic lupus erythematosus (SLE) who have completed the 24 week treatment period of Willow study (MS200569\_0003 \[NCT05162586\]).	Lupus	Phase 2	À vérifier	United States, Argentina, Australia, Brazil, Bulgaria, Chile, China, Colombia, …	À vérifier
MavencladThis study aims to describe participants characteristics that can predict the safety and effectiveness of cladribine tablets, as assessed by time-to-discontinuation of treatment with cladribine tablets, and to assess other patient-reported, clinical, and imaging outcomes in participants with relapsing multiple sclerosis (RMS) in the long term, in a real-world setting.	SEP	À vérifier	À vérifier	Belgium, Czechia, Greece, Netherlands, Poland, Portugal	À vérifier
PimicotinibThe primary purpose of this study is to assess the tolerability, pharmacokinetics, and efficacy of pimicotinib in Japanese participants with TGCT	Myopathies	Phase 2	À vérifier	Japan	À vérifier
MavencladThis study aims to describe participants characteristics that can predict the safety and effectiveness of cladribine tablets, as assessed by time-to-discontinuation of treatment with cladribine tablets, and to assess other patient-reported, clinical, and imaging outcomes in participants with relapsing multiple sclerosis (RMS) in the long term, in a real-world setting.	SEP	À vérifier	À vérifier	Belgium, Czechia, Greece, Netherlands, Poland, Portugal	À vérifier
PimicotinibThe primary purpose of this study is to assess the tolerability, pharmacokinetics, and efficacy of pimicotinib in Japanese participants with TGCT	Myopathies	Phase 2	Immunomodulation	Japan	À vérifier
Cladribine Low DoseThe purpose of this clinical study is to determine the efficacy and safety of a new oral cladribine formulation in participants with Generalized Myasthenia Gravis (gMG) in comparison to placebo. It will also investigate the sustained efficacy, the need for retreatment, and the long-term safety of oral cladribine in gMG. An additional component is included to characterize the Pharmacokinetics (PK) of the new cladribine formulation in gMG participants. This study is divided into 3 periods: the double-blind placebo control (DBPC) pivotal period, and 2 extensions, the blinded extension (BE) and the retreatment (RT) period. Furthermore, in trial interviews will be conducted as a sub-study to MyClad with a sub-set of participants to gain an in depth understanding of the participant cladribine treatment and study experience.	Myasthénie	Phase 3	À vérifier	United States, Argentina, Australia, Belgium, Bulgaria, Canada, China, France, Georgia, Germany, Greece, Hungary, India, Italy, Japan, Poland, Romania, Serbia, South Korea, Spain, …	À vérifier
M5049 low doseThe purpose of the study is to evaluate the long term safety and efficacy of orally administered M5049 in participants with subacute cutaneous lupus erythematosus (SCLE), discoid lupus erythematosus (DLE) and/or systemic lupus erythematosus (SLE) who have completed the 24 week treatment period of Willow study (MS200569\_0003 \[NCT05162586\]).	Lupus	Phase 2	À vérifier	United States, Argentina, Australia, Brazil, Bulgaria, Chile, China, Colombia, Greece, Israel, Japan, Mauritius, Mexico, Moldova, Philippines, Poland, Romania, Serbia, South Africa, South Korea, …	À vérifier

Essais cliniques

4

Molécule	Indication / population	Phase	NCT	Titre	Statut
M5049 low dose	Lupus	Phase 2	NCT05540327	The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)	ACTIVE_NOT_RECRUITING
Cladribine Low Dose	Myasthénie	Phase 3	NCT06463587	Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad)	RECRUITING
Pimicotinib	Myopathies	Phase 2	NCT07499362	Study of Pimicotinib in Japanese Participants With Tenosynovial Giant Cell Tumor (TGCT) (J-MANEUVER)	RECRUITING
Mavenclad	SEP	À vérifier	NCT05797740	Cladribine Tablets Level of Response Predictors in Clinical Practice (CLODINA)	ACTIVE_NOT_RECRUITING

Publications

5

Molécule	Indication / population	Titre	Journal	Date
Mavenclad		Immune reconstitution for the treatment of myasthenia gravis: the focus on cladribine.	Folia neuropathologica
Pimicotinib		Pimicotinib: a new agent for an orphan disease.	Lancet (London, England)
Pimicotinib		Integrative bioinformatics and molecular simulations identify HMGB3 as a key immune modulator in triple negative breast cancer.	Discover oncology
Mavenclad		Balancing innovation and affordability in relapsing-remitting multiple sclerosis: a budget impact analysis from Saudi Arabia.	Frontiers in public health
Mavenclad		Safety and efficacy of oral cladribine in relapsing multiple sclerosis: a systematic review and meta-analysis.	BMC neurology