Bristol-Myers Squibb — Biomedical Watch V2

Traitements23programmes

Essais13liés

Publications22liées

SourceDBlocale

Traitements

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
AfimetoranThe purpose of this study is to evaluate the effectiveness, safety and tolerability of Afimetoran in participants with active Systemic Lupus Erythematosus (SLE). The extension period will provide additional long-term safety and efficacy data and enable those participants initially randomized to placebo to receive treatment with Afimetoran.	Lupus	Phase 2	À vérifier	United States, Argentina, Australia, Brazil, Chile, China, Colombia, France, …	À vérifier
BENCHMARK-SLE — A Study in Participants With Active Systemic Lupus Erythematosus With Inadequate Response to Glucocorticoids and ≥2 ImmunosuppressantsThe purpose of this study is to characterize the efficacy and safety of current standard of care treatment options in participants with active systemic lupus erythematosus (SLE; including lupus nephritis) with inadequate response to glucocorticoids and at least two immunosuppressants	Lupus	À vérifier	À vérifier	United States, Argentina, Brazil, Canada, France, Germany, Israel, Italy, …	À vérifier
BMS-986165The purpose of this study is to allow the continued administration of Deucravacitinib in participants with Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) who have completed study IM011074 or Study IM011132	Lupus	Phase 4	À vérifier	United States	À vérifier
danicamtivThe purpose of this Phase 2a study is to establish safety and preliminary efficacy of treatment with danicamtiv in patients with primary dilated cardiomyopathy (DCM) due to MYH7 or TTN variants or other causalities.	Myopathies	Phase 2	À vérifier	United States, Germany, Spain, United Kingdom	À vérifier
DeucravacitinibThis study is designed to provide treatment with deucravacitinib for participants with SLE/SjD (Systemic Lupus Erythematosus/Sjögren's Disease) and pediatric participants with PsO/PsA (Psoriasis/Psoriatic Arthritis) who have completed their qualified parent studies and/or long-term extension if applicable.	Lupus	Phase 3	À vérifier		À vérifier
FingolimodThe purpose of the Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis (MS) is to continuously monitor, evaluate, and assess for major and minor teratogenic effects in the offspring of women exposed to fingolimod before (up to 8 weeks before last menstrual period (LMP)) and during pregnancy in routine clinical practice. The overall aim is to collect and evaluate data on maternal, fetal, and infant outcomes and compare it with reference populations.	SEP	Phase 3	À vérifier	United States, Australia, Italy, Mexico, Poland, Portugal, Puerto Rico, Romania, …	À vérifier
KarX-ECThe purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease	Alzheimer	Phase 3	À vérifier	United States, Argentina, Australia, Brazil, Finland, France, Germany, Greece, …	À vérifier
ORION — A Post-Authorization, Long-term Study of Ozanimod Real-world SafetyThe purpose of this study is to determine the rates of adverse events of interest (AEIs) in a real-world population of participants with relapsing remitting multiple sclerosis (RRMS) receiving Ozanimod, sphingosine-1 phosphate (S1P) receptor modulator, compared to the rates of these events in two population of participants: * Participants not exposed to ozanimod with RRMS who have received treatment with other S1P-receptor modulators disease modifying treatments (DMTs) * Participants not exposed to ozanimod with RRMS who have received treatment with other non-S1P-receptor modulators disease modifying treatments (DMTs)	SEP	À vérifier	À vérifier	United States	À vérifier
OzanimodThis study will evaluate the risk of progressive multifocal leukoencephalopathy (PML), a rare brain infection caused by John Cunningham virus (JCV), among people with multiple sclerosis who have been treated with ozanimod. The study will collect and review reported cases of PML to describe patient characteristics and estimate how often PML occurs among people treated with ozanimod. Researchers will assess factors that may be associated with the occurrence of PML, such as age, duration of ozanimod exposure, prior immunosuppressant use, lymphopenia, and JCV antibody status .	SEP	Phase 3	À vérifier	United States, Australia, Italy, Mexico, Poland, Portugal, Puerto Rico, Romania, …	À vérifier
Xanomeline Enteric CapsuleThe purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease.	Alzheimer	Phase 3	À vérifier	United States, Argentina, Chile, Czechia, France, Germany, Hungary, Israel, …	À vérifier
Xanomeline/Trospium Chloride CapsuleThe purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease.	Alzheimer	Phase 3	À vérifier	United States, Argentina, Chile, Czechia, France, Germany, Hungary, Israel, …	À vérifier
FingolimodThe purpose of the Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis (MS) is to continuously monitor, evaluate, and assess for major and minor teratogenic effects in the offspring of women exposed to fingolimod before (up to 8 weeks before last menstrual period (LMP)) and during pregnancy in routine clinical practice. The overall aim is to collect and evaluate data on maternal, fetal, and infant outcomes and compare it with reference populations.	SEP	À vérifier	À vérifier	United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Lebanon, …	À vérifier
FingolimodThe purpose of the Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis (MS) is to continuously monitor, evaluate, and assess for major and minor teratogenic effects in the offspring of women exposed to fingolimod before (up to 8 weeks before last menstrual period (LMP)) and during pregnancy in routine clinical practice. The overall aim is to collect and evaluate data on maternal, fetal, and infant outcomes and compare it with reference populations.	SEP	À vérifier	À vérifier	Egypt	À vérifier
ORION — A Post-Authorization, Long-term Study of Ozanimod Real-world SafetyThe purpose of this study is to determine the rates of adverse events of interest (AEIs) in a real-world population of participants with relapsing remitting multiple sclerosis (RRMS) receiving Ozanimod, sphingosine-1 phosphate (S1P) receptor modulator, compared to the rates of these events in two population of participants: * Participants not exposed to ozanimod with RRMS who have received treatment with other S1P-receptor modulators disease modifying treatments (DMTs) * Participants not exposed to ozanimod with RRMS who have received treatment with other non-S1P-receptor modulators disease modifying treatments (DMTs)	SEP	À vérifier	À vérifier	United States	À vérifier
danicamtivThe purpose of this Phase 2a study is to establish safety and preliminary efficacy of treatment with danicamtiv in patients with primary dilated cardiomyopathy (DCM) due to MYH7 or TTN variants or other causalities.	Myopathies	Phase 2	À vérifier	United States, Germany, Spain, United Kingdom	À vérifier
Xanomeline/Trospium Chloride CapsuleThe purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease.	Alzheimer	Phase 3	À vérifier	United States, Argentina, Brazil, Bulgaria, Canada, China, Croatia, Greece, India, Japan, Mexico, Portugal, Romania, Spain, Taiwan	À vérifier
AfimetoranThe purpose of this study is to evaluate the effectiveness, safety and tolerability of Afimetoran in participants with active Systemic Lupus Erythematosus (SLE). The extension period will provide additional long-term safety and efficacy data and enable those participants initially randomized to placebo to receive treatment with Afimetoran.	Lupus	Phase 2	À vérifier	United States, Argentina, Australia, Brazil, Chile, China, Colombia, France, Germany, India, Ireland, Japan, Mexico, Poland, Puerto Rico, Romania, Spain, Taiwan, United Kingdom	À vérifier
OzanimodThis study will evaluate the risk of progressive multifocal leukoencephalopathy (PML), a rare brain infection caused by John Cunningham virus (JCV), among people with multiple sclerosis who have been treated with ozanimod. The study will collect and review reported cases of PML to describe patient characteristics and estimate how often PML occurs among people treated with ozanimod. Researchers will assess factors that may be associated with the occurrence of PML, such as age, duration of ozanimod exposure, prior immunosuppressant use, lymphopenia, and JCV antibody status .	SEP	À vérifier	À vérifier	United States	À vérifier
BENCHMARK-SLE — A Study in Participants With Active Systemic Lupus Erythematosus With Inadequate Response to Glucocorticoids and ≥2 ImmunosuppressantsThe purpose of this study is to characterize the efficacy and safety of current standard of care treatment options in participants with active systemic lupus erythematosus (SLE; including lupus nephritis) with inadequate response to glucocorticoids and at least two immunosuppressants	Lupus	À vérifier	À vérifier	United States, Argentina, Brazil, Canada, France, Germany, Israel, Italy, Japan, Puerto Rico, Spain, Sweden, United Kingdom	À vérifier
Xanomeline/Trospium Chloride CapsuleThe purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease.	Alzheimer	Phase 3	À vérifier	United States, Argentina, Chile, Czechia, France, Germany, Hungary, Israel, Italy, Poland, Puerto Rico, South Korea, Ukraine, United Kingdom	À vérifier
DeucravacitinibThis study is designed to provide treatment with deucravacitinib for participants with SLE/SjD (Systemic Lupus Erythematosus/Sjögren's Disease) and pediatric participants with PsO/PsA (Psoriasis/Psoriatic Arthritis) who have completed their qualified parent studies and/or long-term extension if applicable.	Lupus	Phase 3	À vérifier		À vérifier
OzanimodThis study will evaluate the risk of progressive multifocal leukoencephalopathy (PML), a rare brain infection caused by John Cunningham virus (JCV), among people with multiple sclerosis who have been treated with ozanimod. The study will collect and review reported cases of PML to describe patient characteristics and estimate how often PML occurs among people treated with ozanimod. Researchers will assess factors that may be associated with the occurrence of PML, such as age, duration of ozanimod exposure, prior immunosuppressant use, lymphopenia, and JCV antibody status .	SEP	Phase 3	À vérifier	United States, Australia, Italy, Mexico, Poland, Portugal, Puerto Rico, Romania, Spain, Taiwan, Turkey (Türkiye)	À vérifier
BMS-986165The purpose of this study is to allow the continued administration of Deucravacitinib in participants with Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) who have completed study IM011074 or Study IM011132	Lupus	Phase 4	À vérifier	United States	À vérifier

Essais cliniques

Molécule	Indication / population	Phase	NCT	Titre	Statut
BMS-986165	Lupus	Phase 4	NCT06875960	A Study to Continue the Administration of Deucravacitinib in Participants With Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) Who Have Completed Study IM011074 or Study IM011132	RECRUITING
Ozanimod	SEP	Phase 3	NCT06408259	Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis	RECRUITING
Deucravacitinib	Lupus	Phase 3	NCT07791199	Continued Access to Deucravacitinib for Adult SLE/SjD and Pediatric PsO/PsA Study Completers	NOT_YET_RECRUITING
Xanomeline/Trospium Chloride Capsule	Alzheimer	Phase 3	NCT07011745	A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease	RECRUITING
BENCHMARK-SLE — A Study in Participants With Active Systemic Lupus Erythematosus With Inadequate Response to Glucocorticoids and ≥2 Immunosuppressants	Lupus	À vérifier	NCT07175285	BENCHMARK-SLE — A Study in Participants With Active Systemic Lupus Erythematosus With Inadequate Response to Glucocorticoids and ≥2 Immunosuppressants	RECRUITING
Ozanimod	SEP	À vérifier	NCT07732907	Risk of Progressive Multifocal Leukoencephalopathy Among Patients With Multiple Sclerosis Exposed to Zeposia	RECRUITING
Afimetoran	Lupus	Phase 2	NCT04895696	A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)	ACTIVE_NOT_RECRUITING
Xanomeline/Trospium Chloride Capsule	Alzheimer	Phase 3	NCT07011732	A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)	RECRUITING
KarXT	Alzheimer	Phase 3	NCT06976203	A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2)	RECRUITING
danicamtiv	Myopathies	Phase 2	NCT04572893	Exploratory Study of Danicamtiv in Patients With Primary Dilated Cardiomyopathy (DCM) Due to Genetic Variants or Other Causalities	TERMINATED
ORION — A Post-Authorization, Long-term Study of Ozanimod Real-world Safety	SEP	À vérifier	NCT05605782	ORION — A Post-Authorization, Long-term Study of Ozanimod Real-world Safety	ACTIVE_NOT_RECRUITING
Fingolimod	SEP	À vérifier	NCT05423769	Safety and Effectiveness of Generic Fingolimod (Sphingomod®, Hikma) in Patients With Relapsing-Remitting Multiple Sclerosis in Egypt	COMPLETED
Fingolimod	SEP	À vérifier	NCT01285479	The Gilenya Pregnancy Registry	COMPLETED

Publications

Molécule	Titre	Journal
Ozanimod	Comprehensive Analysis of Ozanimod-Related Adverse Events Based on the FAERS Database.	World journal of oncology
Ozanimod	Novel Agents on the Therapeutic Horizon For Paediatric Inflammatory Bowel Diseases: An Analysis of Clinical Trials Registries.	Paediatric drugs
Ozanimod	Ozanimod and other sphingosine-1-phosphate receptor 1 modulators normalize neuropathic injury-enhanced inhibition of central lateral amygdala neurons expressing corticotropin-releasing hormone.	Neuropharmacology
danicamtiv	Danicamtiv increases cardiac mechanical efficiency.	The Journal of physiology
Fingolimod	Fingolimod induces cytotoxic stress and apoptosis-like cell death in drug-sensitive and P-glycoprotein-overexpressing acute myeloid leukemia cells.	Biochemical and biophysical research communications
Fingolimod	Investigating FTY720-NF immunomodulation of key lipid, gene, and protein mediators to enhance oral tissue regeneration.	Biomaterials advances
danicamtiv	Cardiac Myosin Activators in Heart Failure: Experimental Advances Amid Clinical Uncertainty.	Drug design, development and therapy
danicamtiv	The role of cardiac myosin activators in dilated cardiomyopathy pharmacotherapy.	Expert opinion on pharmacotherapy
Afimetoran	Structural and immunological impacts of TOLLIP nsSNPs: A computational biology approach to drug discovery and immune system modulation.	PloS one
Afimetoran	Development of Kilogram-Scale Electrochemical Ni-Catalyzed Cross Electrophile Coupling in Flow.	Organic process research & development
Fingolimod	A tumor microenvironment-responsive calcium overload nanoplatform inducing PANoptosis for enhanced cancer immunotherapy.	Materials today. Bio
Fingolimod	Natalizumab and Tyruko (natalizumab biosimilar) for treating highly active relapsing-remitting multiple sclerosis after at least one disease-modifying therapy: a systematic review and economic model.	Health technology assessment (Winchester, England)
Fingolimod	Lymphatic therapies open the valve in Marfan syndrome.	The Journal of clinical investigation
Fingolimod	Serum Glial Fibrillary Acidic Protein Dynamics, Disease Progression, and Therapy Response in Multiple Sclerosis.	JAMA neurology
Fingolimod	FTY720 Increases Doxorubicin Sensitivity in Resistant Acute Myeloid Leukemia Cells.	Journal of visualized experiments : JoVE
Fingolimod	MicroRNA Expression Profiles as Biomarkers of Response to Disease-Modifying Therapies in Multiple Sclerosis: A Systematic Review.	International journal of molecular sciences
Fingolimod	IGF2R: a new player in the IGF2 loop sustaining adrenocortical carcinogenesis.	Cell communication and signaling : CCS
Fingolimod	Response to "Nanoformulated fingolimod for spinal cord injury: promising anti‑neuroinflammatory effects but unsubstantiated bioavailability claims".	Spinal cord
Fingolimod	Nanoformulated fingolimod for spinal cord injury: promising anti‑neuroinflammatory effects but unsubstantiated bioavailability claims.	Spinal cord
Fingolimod	Fingolimod Acutely Facilitates the Activation of TRKB in a BDNF-dependent Manner.	Cellular and molecular neurobiology
Fingolimod	Effects of Drugs for the Treatment of Multiple Sclerosis in Severe Acute Respiratory Syndrome Coronavirus 2 Infection on the Expression of Angiotensin-converting Enzyme 2 in vitro.	Current neuropharmacology
Fingolimod	Impact of multiple sclerosis disease-modifying therapies on chronic lesion tissue expansion.	Multiple sclerosis (Houndmills, Basingstoke, England)