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EMD Serono Research & Development Institute, Inc.
Traitements, essais et publications liés.
Traitements11programmes
Essais5liés
Publications8liées
SourceDBlocale
Traitements
11| Molécule | Indication / population | Phase | Objectif | Pays | Résultat |
|---|---|---|---|---|---|
| EnpatoranThe purpose of this global, multicenter, Phase 3 study is to evaluate the efficacy and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic disease. Study details include: Study Duration: Up to 35 weeks. Treatment Duration: 24 weeks. Visit Frequency: every 4 weeks, with the exception of the Week 2 televisit. Study Intervention Name: Enpatoran, Placebo. Intervention Form: Film-coated tablet. | Lupus | Phase 3 | À vérifier | United States, Bulgaria, France, Germany, Israel, Italy, Japan, Poland, … | À vérifier |
| M1774This is an open-label, Phase I, first-in-human (FIH) multicenter, clinical study conducted in multiple parts to establish the safety, tolerability and pharmacokinetic/pharmacodynamic (PK/PD) profile (with and without food) and early signs of efficacy of Tuvuseritib (M1774) as monotherapy and in combination with the poly (ADP-ribose) polymerase (PARP) inhibitor niraparib. | Cancer | Phase 1 | À vérifier | United States, China, Japan, Spain, United Kingdom | À vérifier |
| M5049 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. | Myopathies | Phase 2 | Immunomodulation | United States, Czechia, Greece, Italy, Poland, Spain, United Kingdom | À vérifier |
| NiraparibThis is an open-label, Phase I, first-in-human (FIH) multicenter, clinical study conducted in multiple parts to establish the safety, tolerability and pharmacokinetic/pharmacodynamic (PK/PD) profile (with and without food) and early signs of efficacy of Tuvuseritib (M1774) as monotherapy and in combination with the poly (ADP-ribose) polymerase (PARP) inhibitor niraparib. | Cancer | Phase 1 | À vérifier | United States, China, Japan, Spain, United Kingdom | À vérifier |
| Precemtabart tocentecanThis study aims to address the unmet medical need of participants with metastatic colorectal cancer (mCRC) who have previously been treated with irinotecan, oxaliplatin, a fluoropyrimidine, and bevacizumab, by demonstrating an overall survival prolongation with precemtabart tocentecan (Precem-TcT) as single agent or Precem-TcT in combination with bevacizumab compared to trifluoride/tipiracil (FTD-TPI) plus bevacizumab. | Cancer | Phase 3 | À vérifier | United States, Australia, Canada, China, Japan, South Korea, Taiwan | À vérifier |
| Trifluridine/Tipiracil (FTD-TPI)This study aims to address the unmet medical need of participants with metastatic colorectal cancer (mCRC) who have previously been treated with irinotecan, oxaliplatin, a fluoropyrimidine, and bevacizumab, by demonstrating an overall survival prolongation with precemtabart tocentecan (Precem-TcT) as single agent or Precem-TcT in combination with bevacizumab compared to trifluoride/tipiracil (FTD-TPI) plus bevacizumab. | Cancer | Phase 3 | À vérifier | United States, Australia, Canada, China, Japan, South Korea, Taiwan | À vérifier |
| M5049 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. | Myopathies | Phase 2 | Immunomodulation | United States, Czechia, Greece, Italy, Poland, Spain, United Kingdom | À vérifier |
| M1774This is an open-label, Phase I, first-in-human (FIH) multicenter, clinical study conducted in multiple parts to establish the safety, tolerability and pharmacokinetic/pharmacodynamic (PK/PD) profile (with and without food) and early signs of efficacy of Tuvuseritib (M1774) as monotherapy and in combination with the poly (ADP-ribose) polymerase (PARP) inhibitor niraparib. | Cancer | Phase 1 | À vérifier | United States, China, Japan, Spain, United Kingdom | À vérifier |
| EnpatoranThe purpose of this global, multicenter, Phase 3 study is to evaluate the efficacy and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic disease. Study details include: Study Duration: Up to 35 weeks. Treatment Duration: 24 weeks. Visit Frequency: every 4 weeks, with the exception of the Week 2 televisit. Study Intervention Name: Enpatoran, Placebo. Intervention Form: Film-coated tablet. | Lupus | Phase 3 | À vérifier | United States, Bulgaria, France, Germany, Israel, Italy, Japan, Poland, Romania, Slovakia, South Korea, Spain, Switzerland, Taiwan | À vérifier |
| Precemtabart tocentecanThis study aims to address the unmet medical need of participants with metastatic colorectal cancer (mCRC) who have previously been treated with irinotecan, oxaliplatin, a fluoropyrimidine, and bevacizumab, by demonstrating an overall survival prolongation with precemtabart tocentecan (Precem-TcT) as single agent or Precem-TcT in combination with bevacizumab compared to trifluoride/tipiracil (FTD-TPI) plus bevacizumab. | Cancer | Phase 3 | À vérifier | United States, Australia, Canada, China, Japan, South Korea, Taiwan | À vérifier |
| EnpatoranThe purpose of this global, multicenter, Phase 3 study is to evaluate the efficacy and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic disease. Study details include: Study Duration: Up to 35 weeks. Treatment Duration: 24 weeks. Visit Frequency: every 4 weeks, with the exception of the Week 2 televisit. Study Intervention Name: Enpatoran, Placebo. Intervention Form: Film-coated tablet. | Lupus | Phase 3 | À vérifier | United States, Bulgaria, Canada, China, Czechia, Germany, Israel, Italy, Poland, Romania, South Korea, Spain, Switzerland, Taiwan | À vérifier |
Essais cliniques
5| Molécule | Indication / population | Phase | NCT | Titre | Statut |
|---|---|---|---|---|---|
| Enpatoran | Lupus | Phase 3 | NCT07355218 | A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2) | RECRUITING |
| Precemtabart tocentecan | Cancer | Phase 3 | NCT07549412 | A Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03) | RECRUITING |
| Enpatoran | Lupus | Phase 3 | NCT07332481 | ELOWEN-1 — A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease | RECRUITING |
| M1774 | Cancer | Phase 1 | NCT04170153 | Tuvusertib (M1774) in Participants With Metastatic or Locally Advanced Unresectable Solid Tumors (DDRiver Solid Tumors 301) | ACTIVE_NOT_RECRUITING |
| M5049 dose | Myopathies | Phase 2 | NCT05650567 | Study of M5049 in DM and PM Participants (NEPTUNIA) | TERMINATED |
Publications
8| Molécule | Indication / population | Titre | Journal | Date |
|---|---|---|---|---|
| Enpatoran | Efficacy and safety of enpatoran, a Toll-like receptor 7/8 inhibitor, in patients with skin manifestations of cutaneous lupus erythematosus or systemic lupus erythematosus: findings from Cohort A of a multicentre, international, double-blind, placebo-controlled, dose-finding phase 2 trial. | The Lancet. Rheumatology | ||
| Enpatoran | Enpatoran: promising mechanism, pharmacodynamic challenge. | The Lancet. Rheumatology | ||
| Enpatoran | TLR7 Inhibition Limits Ischemic Cardiac Injury by Disrupting ITGAM-Dependent Immune-Endothelial Interactions. | JACC. Basic to translational science | ||
| Niraparib | Combined effects of electroporation and 100 mGy X-ray on the anticancer activity of newly synthesized niraparib-based Schiff base, Pd(II) and Fe(II) complexes in SKOV-3 cancer cells. | Bioorganic chemistry | ||
| Niraparib | Design, synthesis and anti-breast cancer activity evaluation of 6,7-dihydro-5-pyrrolo[3,4-]pyrimidine-based PARP1/ATR dual inhibitors. | Journal of enzyme inhibition and medicinal chemistry | ||
| M1774 | Combined MEK1/2 and ATR inhibition promotes myeloma cell death through a STAT3-dependent mechanism in vitro and in vivo. | British journal of haematology | ||
| M1774 | Quantitation of Tuvusertib (M1774) in Human Plasma by LC-MS/MS. | Biomedical chromatography : BMC | ||
| M1774 | The ATR inhibitor tuvusertib (M1774) sensitizes prostate carcinoma to natural killer cell-mediated cytotoxicity, which is further augmented by the IL-15 receptor superagonist N-803. | Cancer immunology, immunotherapy : CII |