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AstraZeneca
Traitements, essais et publications liés.
Traitements59programmes
Essais40liés
Publications10liées
SourceDBlocale
Traitements
59| Molécule | Indication / population | Phase | Objectif | Pays | Résultat |
|---|---|---|---|---|---|
| Anifrolumab (blinded)The purpose of this multicenter, randomized, placebo-controlled and double-blind study is to evaluate the efficacy and safety of subcutaneous anifrolumab compared with placebo on the overall disease activity in participants with moderate to severe Idiopathic Inflammatory Myopathies (IIM) \[polymyositis (PM) or dermatomyositis (DM)\] while receiving standard of care (SoC) treatment. | Myopathies | Phase 3 | Immunomodulation | United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, … | À vérifier |
| Anifrolumab (unblinded, open label)The purpose of this multicenter, randomized, placebo-controlled and double-blind study is to evaluate the efficacy and safety of subcutaneous anifrolumab compared with placebo on the overall disease activity in participants with moderate to severe Idiopathic Inflammatory Myopathies (IIM) \[polymyositis (PM) or dermatomyositis (DM)\] while receiving standard of care (SoC) treatment. | Myopathies | Phase 3 | Immunomodulation | United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, … | À vérifier |
| Anifrolumab + APFSThe purpose of this study is to characterize the pharmacokinetics (PK), pharmacodynamics (PD), and safety of subcutaneous (SC) anifrolumab in pediatric participants with moderate to severe systemic lupus erythematosus (SLE) while on background standard of care (SoC) therapy. | Lupus | Phase 2 | À vérifier | Australia, Belgium, Chile, Israel, Japan, Netherlands, Peru, Philippines, … | À vérifier |
| ASTER — A Treatment Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical PracticeAnifrolumab Study of Treatment Effectiveness in the Real World (ASTER) study will collect real world data to obtain a good understanding of the (sustained) clinical effect and patient quality of life outcomes among diagnosed SLE patients who initiate anifrolumab treatment. ASTER will generate critical real-world evidence on the benefits of adding anifrolumab to standard of care treatment for SLE in routine clinical practice, to inform physicians, payers and patients. | Lupus | À vérifier | À vérifier | Austria, Belgium, Canada, France, Germany, Israel, Italy, Sweden, … | À vérifier |
| AZD0120 - Regimen 1This trial is a Phase 1b, open-label, multi-center, clinical study of AZD0120, a BCMA/CD19 dual targeting CAR+ T-cell therapy, to evaluate the safety and tolerability in adult participants with Multiple Sclerosis. | SEP | Phase 1 | Thérapie cellulaire | United States, Australia, Canada, Germany, United Kingdom | À vérifier |
| AZD0120 - Regimen 2This trial is a Phase 1b, open-label, multi-center, clinical study of AZD0120, a BCMA/CD19 dual targeting CAR+ T-cell therapy, to evaluate the safety and tolerability in adult participants with Multiple Sclerosis. | SEP | Phase 1 | Thérapie cellulaire | United States, Australia, Canada, Germany, United Kingdom | À vérifier |
| AZD5492The purpose of this study is to measure the safety, tolerability, PK, and PD of AZD5492 administered subcutaneously in adult participants with SLE or IIM or RA Study details include: • The study duration will be a minimum of 180 days in addition to the screening period. Additional follow-up visits may be required up to 12 months from study start. * Depending on the study part they are assigned to, participants will be administered AZD5492 once (Part 1) or twice (Part 2). * Study visits will occur at: Screening, Days 1-4, 8, 15, 22, 30, 60, 90, 120, 150, and 180 in Part 1, Screening, Days 1-4, 8-11, 15, 22, 29, 43, 60, 90, 120, 150, and 180 in Part 2. | Lupus | Phase 1 | À vérifier | United States, Canada, China, France, Germany, Hong Kong, Japan, Netherlands, … | À vérifier |
| Baxdrostat/dapagliflozinInternational, Multicenter, Double-Blind, Placebo-Controlled and Event-driven study to assess efficacy, safety and Tolerability of Baxdrostat in combination with Dapagliflozin on renal outcomes and cardiovascular mortality in participants with chronic kidney disease and high blood pressure | Hypertension, Maladie rénale chronique | Phase 3 | À vérifier | United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, … | À vérifier |
| Budesonide Turbuhaler 200 µgThe purpose of this study is to determine whether Symbicort dosed according to the Symbicort Maintenance and Reliever Therapy (SMART) concept is superior to standard asthma treatment according to the local German treatment guidelines. | SEP | Phase 3 | À vérifier | Germany | À vérifier |
| CLEAR-HTN — Observational Study That Will Evaluate Treatment Patterns in the Management of Hypertension in the Public Primary Care SystemThis is a retrospective observational cohort study based on secondary use of routinely collected electronic health data. The design was selected to enable population-level characterisation of treatment patterns and clinical inertia (both diagnostic and therapeutic) in the management of hypertension across diverse settings in Brazil's public primary care system (SUS). | Hypertension | À vérifier | À vérifier | Brazil | À vérifier |
| D1843R00359 — Prospective Observational Multicenter Study of Patients With AH and CKD Markers in Kazakhstan (PROGRESS-CKD)Multicenter, non-interventional PRospective Observational study with retrospective analysis to describe the rate of CKD diaGnosis in patients with aRtErial hypErtenSion and CKD markerS in Kazakhstan | Hypertension | À vérifier | À vérifier | Kazakhstan | À vérifier |
| DapagliflozinRecent trials have demonstrated positive renal outcomes of sodium-glucose co-transporter-2 inhibitors (SGLT2i) additive to angiotensin-converting-enzyme inhibitors (ACEis) in adult patients with diabetic and non-diabetic chronic kidney disease (CKD). These trials included no children. The hypothesis of DOUBLE PRO-TECT Alport is to demonstrate superiority of the SGLT2i dapagliflozin in preventing progression of the chronic kidney disease Alport syndrome in children and young adults at early stages of disease. Preventing the rise of albuminuria by dapagliflozin would result in a very significant delay of end-stage kidney failure (ESKF) and improved quality of life. If successful, DOUBLE PRO-TECT Alport will change the treatment recommendations for children with CKD, who have a very high unmet medical need. | Maladie coronarienne, Maladie rénale chronique | Phase 4 | Ralentissement de la progression | China | À vérifier |
| Epidemiological Study of Treatment Approaches in AChR-Antibody Positive Generalized Myasthenia Gravis in RussiaThis is a multicenter, non-interventional, retrospective-prospective, single-arm observational study designed to describe real-world treatment approaches and clinical outcomes among adults with acetylcholine receptor (AChR) antibody-positive generalized myasthenia gravis (gMG) in routine clinical practice in Russia. | Myasthénie | À vérifier | À vérifier | Russia | À vérifier |
| Fluticasone Discus 250 µgThe purpose of this study is to determine whether Symbicort dosed according to the Symbicort Maintenance and Reliever Therapy (SMART) concept is superior to standard asthma treatment according to the local German treatment guidelines. | SEP | Phase 3 | À vérifier | Germany | À vérifier |
| Formoterol Turbuhaler 4.5 µgThe purpose of this study is to determine whether Symbicort dosed according to the Symbicort Maintenance and Reliever Therapy (SMART) concept is superior to standard asthma treatment according to the local German treatment guidelines. | SEP | Phase 3 | À vérifier | Germany | À vérifier |
| iCaReMe Global Registry: Multinational Real-world Evidence in Cardiorenal and Metabolic DiseasesTo provide real world data on patient characteristics, disease management, healthcare utilization, and outcomes in patients with type 2 diabetes, Hypertension, Heart failure and/or Chronic kidney diseases | Hypertension | À vérifier | À vérifier | Brazil, Chile, Costa Rica, Côte d’Ivoire, Egypt, Georgia, Ghana, Hong Kong, … | À vérifier |
| INTERSTELLAR - International Study Evaluating Lupus Outcomes After Anifrolumab Real World UseINTERSTELLAR study will generate critical prospective real-world evidence on the benefits of adding Anifrolumab to standard of care treatment for SLE in routine clinical practice, to inform physicians, payers and patients. The study will use clinical assessments that are relevant for SLE-treating physicians in routine clinical practice, as well as introduce a specific measure for skin manifestations to affirm the potency of anifrolumab in treating SLE-related skin manifestations. The study will use standardized objectives, inclusion/exclusion criteria and outcome measures across all countries participating in this study including GCC (Qatar, KSA), Mexico, CAMCAR (Costa Rica, Panama, Dominican Republic), Colombia, Argentina, Taiwan, and Egypt, and any other countries that may be included in the study, in order to facilitate a comparison and analysis across all countries included in this study. | Lupus | À vérifier | À vérifier | Argentina, China, Costa Rica, Egypt, Guatemala, Kazakhstan, Kuwait, Mexico, … | À vérifier |
| IV RilvegostomigThe purpose of this study is to determine the subcutaneous (SC) dose that gives rilvegostomig exposure comparable to the intravenous (IV) exposure, and to evaluate the pharmacokinetics (PK) and safety of SC rilvegostomig in adult participants with advanced solid tumors previously treated with standard of care therapy for whom immunooncology (IO) monotherapy would be deemed appropriate by the investigator. | Parkinson | Phase 1 | À vérifier | United States, South Korea, Spain, United Kingdom | À vérifier |
| Medi-546The purpose of this study is evaluating the efficacy and safety of SC antifrolumab in adult patients with moderate -to-severe SLE despite receiving standard therapy | Lupus | Phase 3 | À vérifier | United States, Argentina, Bulgaria, Chile, Colombia, Germany, Hungary, Japan, … | À vérifier |
| MG Cohort — A Study in Patients With Myasthenia Gravis in ChinaThis study is a multi-center, prospective cohort study designed to characterize current clinical practice, clinical and patient-reported outcomes (PROs), disease prognosis, treatment patterns and healthcare resource utilization for Chinese patients with myasthenia gravis (MG). This study will enroll patients with MG as diagnosed by physician. Approximately 1,200 MG patients are intended to be recruited from approximately 40 sites across majority of regions in China. The clinical and PROs included MGFA class, MGFA PIS, MG-ADL (Activities of Daily Living), QMG (Quantitative MG score), MG QOL-15R, EQ-5D etc. All MG patients enrolled will be followed up every 6 months until end of 2027. | Myasthénie | À vérifier | À vérifier | China | À vérifier |
| Prophyl C — National Survey on Hypertension in Cardiologic Private PracticeTo evaluate (with sufficient accuracy) the profile(demographic and clinical characteristics, health care management) of hypertensive patients seen in private cardiology consultation by holding account of type of exercise of the cardiologist (private exclusive or mixed hospital and private). | Hypertension | À vérifier | À vérifier | France | À vérifier |
| Recombinant Human Hyaluronidase (rHu)The purpose of this study is to determine the subcutaneous (SC) dose that gives rilvegostomig exposure comparable to the intravenous (IV) exposure, and to evaluate the pharmacokinetics (PK) and safety of SC rilvegostomig in adult participants with advanced solid tumors previously treated with standard of care therapy for whom immunooncology (IO) monotherapy would be deemed appropriate by the investigator. | Parkinson | Phase 1 | À vérifier | United States, South Korea, Spain, United Kingdom | À vérifier |
| RilvegostomigDESTINY-Endometrial01 will investigate the efficacy of first-line T-DXd + rilvegostomig (Arm A) and/or T-DXd+ pembrolizumab (Arm B) when compared to chemotherapy (carboplatin + paclitaxel) + pembrolizumab (Arm C), by assessment of progression free survival (PFS), as assessed by BICR, in participants with HER2-expressing (IHC 3+/2+), pMMR, primary advanced (Stage III/IV) or recurrent EC. | Cancer, Parkinson | Phase 3 | Ralentissement de la progression | United States, Australia, Austria, Belgium, Brazil, Canada, China, Denmark, … | À vérifier |
| Salbutamol pressurized metered dose inhaler (pMDI) 100 µgThe purpose of this study is to determine whether Symbicort dosed according to the Symbicort Maintenance and Reliever Therapy (SMART) concept is superior to standard asthma treatment according to the local German treatment guidelines. | SEP | Phase 3 | À vérifier | Germany | À vérifier |
| SC RilvegostomigThe purpose of this study is to determine the subcutaneous (SC) dose that gives rilvegostomig exposure comparable to the intravenous (IV) exposure, and to evaluate the pharmacokinetics (PK) and safety of SC rilvegostomig in adult participants with advanced solid tumors previously treated with standard of care therapy for whom immunooncology (IO) monotherapy would be deemed appropriate by the investigator. | Parkinson | Phase 1 | À vérifier | United States, South Korea, Spain, United Kingdom | À vérifier |
| SC rilvegostomig + rHuThe purpose of this study is to determine the subcutaneous (SC) dose that gives rilvegostomig exposure comparable to the intravenous (IV) exposure, and to evaluate the pharmacokinetics (PK) and safety of SC rilvegostomig in adult participants with advanced solid tumors previously treated with standard of care therapy for whom immunooncology (IO) monotherapy would be deemed appropriate by the investigator. | Parkinson | Phase 1 | À vérifier | United States, South Korea, Spain, United Kingdom | À vérifier |
| SurovatamigThis open-label, Phase I study will assess the safety and tolerability of surovatamig and characterise its PK and PD following subcutaneous administration to participants with RA or SLE. | Lupus | Phase 1 | À vérifier | United States, Australia, Belgium, Brazil, China, Germany, Spain, Taiwan, … | À vérifier |
| Symbicort, used twice daily (b.i.d) and as needed (prn)The purpose of this study is to determine whether Symbicort dosed according to the Symbicort Maintenance and Reliever Therapy (SMART) concept is superior to standard asthma treatment according to the local German treatment guidelines. | SEP | Phase 3 | À vérifier | Germany | À vérifier |
| Terbutaline Turbuhaler 0.5 mgThe purpose of this study is to determine whether Symbicort dosed according to the Symbicort Maintenance and Reliever Therapy (SMART) concept is superior to standard asthma treatment according to the local German treatment guidelines. | SEP | Phase 3 | À vérifier | Germany | À vérifier |
| Trastuzumab deruxtecanDESTINY-Endometrial01 will investigate the efficacy of first-line T-DXd + rilvegostomig (Arm A) and/or T-DXd+ pembrolizumab (Arm B) when compared to chemotherapy (carboplatin + paclitaxel) + pembrolizumab (Arm C), by assessment of progression free survival (PFS), as assessed by BICR, in participants with HER2-expressing (IHC 3+/2+), pMMR, primary advanced (Stage III/IV) or recurrent EC. | Cancer, Parkinson | Phase 4 | Ralentissement de la progression | India | À vérifier |
| VIOLET — NIS to Examine Disease Activity in SLE Patients Treated With Subcutaneous Anifrolumab in Routine CareVIOLET is a prospective, single-arm, multi-centre, non-interventional study (NIS) evaluating real-world clinical and patient-reported outcome (PRO) data in adult patients who are initiated on subcutaneous anifrolumab treatment of systemic lupus erythematosus (SLE) in line with the applicable european summary of product characteristics (SmPC) and neither having used anifrolumab subcutaneous (SC) or intravenous (IV) before. | Lupus | À vérifier | À vérifier | Germany | À vérifier |
| Zibotentan/DapagliflozinThis is a Phase III, randomised, multicentre, double-blinded study to evaluate efficacy, safety and tolerability of treatment with zibotentan/dapagliflozin and dapagliflozin alone in participants with chronic kidney disease (CKD) and high proteinuria | Maladie rénale chronique | Phase 3 | À vérifier | United States, Argentina, Australia, Austria, Brazil, Bulgaria, Canada, China, … | À vérifier |
| Prophyl C — National Survey on Hypertension in Cardiologic Private PracticeTo evaluate (with sufficient accuracy) the profile(demographic and clinical characteristics, health care management) of hypertensive patients seen in private cardiology consultation by holding account of type of exercise of the cardiologist (private exclusive or mixed hospital and private). | Hypertension | À vérifier | À vérifier | France | À vérifier |
| Trastuzumab deruxtecanDESTINY-Endometrial01 will investigate the efficacy of first-line T-DXd + rilvegostomig (Arm A) and/or T-DXd+ pembrolizumab (Arm B) when compared to chemotherapy (carboplatin + paclitaxel) + pembrolizumab (Arm C), by assessment of progression free survival (PFS), as assessed by BICR, in participants with HER2-expressing (IHC 3+/2+), pMMR, primary advanced (Stage III/IV) or recurrent EC. | Parkinson | Phase 3 | Ralentissement de la progression | United States, Australia, Austria, Belgium, Brazil, Canada, China, Denmark, Finland, France, Germany, Hungary, Italy, Japan, Netherlands, Norway, Poland, South Korea, Spain, Sweden, … | À vérifier |
| IV RilvegostomigThe purpose of this study is to determine the subcutaneous (SC) dose that gives rilvegostomig exposure comparable to the intravenous (IV) exposure, and to evaluate the pharmacokinetics (PK) and safety of SC rilvegostomig in adult participants with advanced solid tumors previously treated with standard of care therapy for whom immunooncology (IO) monotherapy would be deemed appropriate by the investigator. | Parkinson | Phase 1 | À vérifier | United States, South Korea, Spain, United Kingdom | À vérifier |
| RilvegostomigDESTINY-Endometrial01 will investigate the efficacy of first-line T-DXd + rilvegostomig (Arm A) and/or T-DXd+ pembrolizumab (Arm B) when compared to chemotherapy (carboplatin + paclitaxel) + pembrolizumab (Arm C), by assessment of progression free survival (PFS), as assessed by BICR, in participants with HER2-expressing (IHC 3+/2+), pMMR, primary advanced (Stage III/IV) or recurrent EC. | Cancer | Phase 3 | Ralentissement de la progression | United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, Hungary, India, Italy, Japan, Malaysia, Netherlands, Peru, Poland, Puerto Rico, South Korea, … | À vérifier |
| Epidemiological Study of Treatment Approaches in AChR-Antibody Positive Generalized Myasthenia Gravis in RussiaThis is a multicenter, non-interventional, retrospective-prospective, single-arm observational study designed to describe real-world treatment approaches and clinical outcomes among adults with acetylcholine receptor (AChR) antibody-positive generalized myasthenia gravis (gMG) in routine clinical practice in Russia. | Myasthénie | À vérifier | À vérifier | Russia | À vérifier |
| SurovatamigThis open-label, Phase I study will assess the safety and tolerability of surovatamig and characterise its PK and PD following subcutaneous administration to participants with RA or SLE. | Lupus | Phase 1 | À vérifier | United States, Australia, Belgium, Brazil, China, Germany, Spain, Taiwan, Ukraine, United Kingdom | À vérifier |
| Medi-546The purpose of this study is evaluating the efficacy and safety of SC antifrolumab in adult patients with moderate -to-severe SLE despite receiving standard therapy | Lupus | Phase 3 | À vérifier | United States, Argentina, Bulgaria, Chile, Colombia, Germany, Hungary, Japan, Mexico, Philippines, Poland, Spain, Thailand, Ukraine, United Kingdom | À vérifier |
| MG Cohort — A Study in Patients With Myasthenia Gravis in ChinaThis study is a multi-center, prospective cohort study designed to characterize current clinical practice, clinical and patient-reported outcomes (PROs), disease prognosis, treatment patterns and healthcare resource utilization for Chinese patients with myasthenia gravis (MG). This study will enroll patients with MG as diagnosed by physician. Approximately 1,200 MG patients are intended to be recruited from approximately 40 sites across majority of regions in China. The clinical and PROs included MGFA class, MGFA PIS, MG-ADL (Activities of Daily Living), QMG (Quantitative MG score), MG QOL-15R, EQ-5D etc. All MG patients enrolled will be followed up every 6 months until end of 2027. | Myasthénie | À vérifier | À vérifier | China | À vérifier |
| RilvegostomigDESTINY-Endometrial01 will investigate the efficacy of first-line T-DXd + rilvegostomig (Arm A) and/or T-DXd+ pembrolizumab (Arm B) when compared to chemotherapy (carboplatin + paclitaxel) + pembrolizumab (Arm C), by assessment of progression free survival (PFS), as assessed by BICR, in participants with HER2-expressing (IHC 3+/2+), pMMR, primary advanced (Stage III/IV) or recurrent EC. | Cancer | Phase 3 | Ralentissement de la progression | United States, Argentina, Australia, Belgium, Brazil, Canada, China, France, Germany, Hungary, India, Italy, Japan, Malaysia, Netherlands, Peru, Poland, Puerto Rico, South Korea, Spain, … | À vérifier |
| AZD5492The purpose of this study is to measure the safety, tolerability, PK, and PD of AZD5492 administered subcutaneously in adult participants with SLE or IIM or RA Study details include: • The study duration will be a minimum of 180 days in addition to the screening period. Additional follow-up visits may be required up to 12 months from study start. * Depending on the study part they are assigned to, participants will be administered AZD5492 once (Part 1) or twice (Part 2). * Study visits will occur at: Screening, Days 1-4, 8, 15, 22, 30, 60, 90, 120, 150, and 180 in Part 1, Screening, Days 1-4, 8-11, 15, 22, 29, 43, 60, 90, 120, 150, and 180 in Part 2. | Lupus | Phase 1 | Immunomodulation | United States, Canada, China, France, Germany, Hong Kong, Japan, Netherlands, Spain, United Kingdom | À vérifier |
| AZD0120 - Regimen 1This trial is a Phase 1b, open-label, multi-center, clinical study of AZD0120, a BCMA/CD19 dual targeting CAR+ T-cell therapy, to evaluate the safety and tolerability in adult participants with Multiple Sclerosis. | SEP | Phase 1 | Thérapie cellulaire | United States, Australia, Canada, Germany, United Kingdom | À vérifier |
| Baxdrostat/dapagliflozinInternational, Multicenter, Double-Blind, Placebo-Controlled and Event-driven study to assess efficacy, safety and Tolerability of Baxdrostat in combination with Dapagliflozin on renal outcomes and cardiovascular mortality in participants with chronic kidney disease and high blood pressure | Hypertension | Phase 3 | À vérifier | United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, Denmark, Egypt, France, Germany, Greece, Hungary, India, Israel, Italy, … | À vérifier |
| D1843R00359 — Prospective Observational Multicenter Study of Patients With AH and CKD Markers in Kazakhstan (PROGRESS-CKD)Multicenter, non-interventional PRospective Observational study with retrospective analysis to describe the rate of CKD diaGnosis in patients with aRtErial hypErtenSion and CKD markerS in Kazakhstan | Hypertension | À vérifier | À vérifier | Kazakhstan | À vérifier |
| VIOLET — NIS to Examine Disease Activity in SLE Patients Treated With Subcutaneous Anifrolumab in Routine CareVIOLET is a prospective, single-arm, multi-centre, non-interventional study (NIS) evaluating real-world clinical and patient-reported outcome (PRO) data in adult patients who are initiated on subcutaneous anifrolumab treatment of systemic lupus erythematosus (SLE) in line with the applicable european summary of product characteristics (SmPC) and neither having used anifrolumab subcutaneous (SC) or intravenous (IV) before. | Lupus | À vérifier | À vérifier | Germany | À vérifier |
| CLEAR-HTN — Observational Study That Will Evaluate Treatment Patterns in the Management of Hypertension in the Public Primary Care SystemThis is a retrospective observational cohort study based on secondary use of routinely collected electronic health data. The design was selected to enable population-level characterisation of treatment patterns and clinical inertia (both diagnostic and therapeutic) in the management of hypertension across diverse settings in Brazil's public primary care system (SUS). | Hypertension | À vérifier | À vérifier | Brazil | À vérifier |
| Trastuzumab deruxtecanDESTINY-Endometrial01 will investigate the efficacy of first-line T-DXd + rilvegostomig (Arm A) and/or T-DXd+ pembrolizumab (Arm B) when compared to chemotherapy (carboplatin + paclitaxel) + pembrolizumab (Arm C), by assessment of progression free survival (PFS), as assessed by BICR, in participants with HER2-expressing (IHC 3+/2+), pMMR, primary advanced (Stage III/IV) or recurrent EC. | Cancer | Phase 2 | Ralentissement de la progression | United States | À vérifier |
| INTERSTELLAR - International Study Evaluating Lupus Outcomes After Anifrolumab Real World UseINTERSTELLAR study will generate critical prospective real-world evidence on the benefits of adding Anifrolumab to standard of care treatment for SLE in routine clinical practice, to inform physicians, payers and patients. The study will use clinical assessments that are relevant for SLE-treating physicians in routine clinical practice, as well as introduce a specific measure for skin manifestations to affirm the potency of anifrolumab in treating SLE-related skin manifestations. The study will use standardized objectives, inclusion/exclusion criteria and outcome measures across all countries participating in this study including GCC (Qatar, KSA), Mexico, CAMCAR (Costa Rica, Panama, Dominican Republic), Colombia, Argentina, Taiwan, and Egypt, and any other countries that may be included in the study, in order to facilitate a comparison and analysis across all countries included in this study. | Lupus | À vérifier | À vérifier | Argentina, China, Costa Rica, Egypt, Guatemala, Kazakhstan, Kuwait, Mexico, Oman, Qatar, Saudi Arabia, Taiwan | À vérifier |
| Trastuzumab deruxtecanDESTINY-Endometrial01 will investigate the efficacy of first-line T-DXd + rilvegostomig (Arm A) and/or T-DXd+ pembrolizumab (Arm B) when compared to chemotherapy (carboplatin + paclitaxel) + pembrolizumab (Arm C), by assessment of progression free survival (PFS), as assessed by BICR, in participants with HER2-expressing (IHC 3+/2+), pMMR, primary advanced (Stage III/IV) or recurrent EC. | Cancer | Phase 4 | Ralentissement de la progression | India | À vérifier |
| iCaReMe Global Registry: Multinational Real-world Evidence in Cardiorenal and Metabolic DiseasesTo provide real world data on patient characteristics, disease management, healthcare utilization, and outcomes in patients with type 2 diabetes, Hypertension, Heart failure and/or Chronic kidney diseases | Hypertension | À vérifier | À vérifier | Brazil, Chile, Costa Rica, Côte d’Ivoire, Egypt, Georgia, Ghana, Hong Kong, India, Iraq, Kazakhstan, Kenya, Malaysia, Mexico, Nigeria, Philippines, South Africa, Taiwan, Ukraine, United Arab Emirates | À vérifier |
| ASTER — A Treatment Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical PracticeAnifrolumab Study of Treatment Effectiveness in the Real World (ASTER) study will collect real world data to obtain a good understanding of the (sustained) clinical effect and patient quality of life outcomes among diagnosed SLE patients who initiate anifrolumab treatment. ASTER will generate critical real-world evidence on the benefits of adding anifrolumab to standard of care treatment for SLE in routine clinical practice, to inform physicians, payers and patients. | Lupus | À vérifier | À vérifier | Austria, Belgium, Canada, France, Germany, Israel, Italy, Sweden, United Arab Emirates | À vérifier |
| Anifrolumab + APFSThe purpose of this study is to characterize the pharmacokinetics (PK), pharmacodynamics (PD), and safety of subcutaneous (SC) anifrolumab in pediatric participants with moderate to severe systemic lupus erythematosus (SLE) while on background standard of care (SoC) therapy. | Lupus | Phase 2 | À vérifier | Australia, Belgium, Chile, Israel, Japan, Netherlands, Peru, Philippines, Portugal, Serbia | À vérifier |
| Anifrolumab (blinded)The purpose of this multicenter, randomized, placebo-controlled and double-blind study is to evaluate the efficacy and safety of subcutaneous anifrolumab compared with placebo on the overall disease activity in participants with moderate to severe Idiopathic Inflammatory Myopathies (IIM) \[polymyositis (PM) or dermatomyositis (DM)\] while receiving standard of care (SoC) treatment. | Myopathies | Phase 3 | Immunomodulation | United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czechia, Denmark, France, Germany, Hungary, India, Israel, Italy, Japan, Mexico, … | À vérifier |
| Symbicort, used twice daily (b.i.d) and as needed (prn)The purpose of this study is to determine whether Symbicort dosed according to the Symbicort Maintenance and Reliever Therapy (SMART) concept is superior to standard asthma treatment according to the local German treatment guidelines. | SEP | Phase 3 | À vérifier | Germany | À vérifier |
| DapagliflozinRecent trials have demonstrated positive renal outcomes of sodium-glucose co-transporter-2 inhibitors (SGLT2i) additive to angiotensin-converting-enzyme inhibitors (ACEis) in adult patients with diabetic and non-diabetic chronic kidney disease (CKD). These trials included no children. The hypothesis of DOUBLE PRO-TECT Alport is to demonstrate superiority of the SGLT2i dapagliflozin in preventing progression of the chronic kidney disease Alport syndrome in children and young adults at early stages of disease. Preventing the rise of albuminuria by dapagliflozin would result in a very significant delay of end-stage kidney failure (ESKF) and improved quality of life. If successful, DOUBLE PRO-TECT Alport will change the treatment recommendations for children with CKD, who have a very high unmet medical need. | Maladie rénale chronique | Phase 3 | Ralentissement de la progression | Germany | À vérifier |
| Zibotentan/DapagliflozinThis is a Phase III, randomised, multicentre, double-blinded study to evaluate efficacy, safety and tolerability of treatment with zibotentan/dapagliflozin and dapagliflozin alone in participants with chronic kidney disease (CKD) and high proteinuria | Maladie rénale chronique | Phase 3 | À vérifier | United States, Argentina, Australia, Austria, Brazil, Bulgaria, Canada, China, Denmark, France, Germany, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Poland, … | À vérifier |
| DapagliflozinRecent trials have demonstrated positive renal outcomes of sodium-glucose co-transporter-2 inhibitors (SGLT2i) additive to angiotensin-converting-enzyme inhibitors (ACEis) in adult patients with diabetic and non-diabetic chronic kidney disease (CKD). These trials included no children. The hypothesis of DOUBLE PRO-TECT Alport is to demonstrate superiority of the SGLT2i dapagliflozin in preventing progression of the chronic kidney disease Alport syndrome in children and young adults at early stages of disease. Preventing the rise of albuminuria by dapagliflozin would result in a very significant delay of end-stage kidney failure (ESKF) and improved quality of life. If successful, DOUBLE PRO-TECT Alport will change the treatment recommendations for children with CKD, who have a very high unmet medical need. | Maladie coronarienne | Phase 4 | Ralentissement de la progression | China | À vérifier |
| DapagliflozinRecent trials have demonstrated positive renal outcomes of sodium-glucose co-transporter-2 inhibitors (SGLT2i) additive to angiotensin-converting-enzyme inhibitors (ACEis) in adult patients with diabetic and non-diabetic chronic kidney disease (CKD). These trials included no children. The hypothesis of DOUBLE PRO-TECT Alport is to demonstrate superiority of the SGLT2i dapagliflozin in preventing progression of the chronic kidney disease Alport syndrome in children and young adults at early stages of disease. Preventing the rise of albuminuria by dapagliflozin would result in a very significant delay of end-stage kidney failure (ESKF) and improved quality of life. If successful, DOUBLE PRO-TECT Alport will change the treatment recommendations for children with CKD, who have a very high unmet medical need. | Maladie rénale chronique | Phase 4 | Ralentissement de la progression | China | À vérifier |
Essais cliniques
40| Molécule | Indication / population | Phase | NCT | Titre | Statut |
|---|---|---|---|---|---|
| Dapagliflozin | Maladie rénale chronique | Phase 4 | NCT06610526 | A Study of Dapagliflozin in Chinese Adult Patients With Chronic Kidney Disease | ACTIVE_NOT_RECRUITING |
| Dapagliflozin | Maladie coronarienne | Phase 4 | NCT07351643 | DAPA-PCAT — CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome | RECRUITING |
| Zibotentan/Dapagliflozin | Maladie rénale chronique | Phase 3 | NCT06087835 | Study to Investigate Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to Dapagliflozin in Participants With Chronic Kidney Disease and High Proteinuria (ZENITH High Proteinuria) | ACTIVE_NOT_RECRUITING |
| Dapagliflozin | Maladie rénale chronique | Phase 3 | NCT05944016 | DOUBLE_PROTECT — Phase 3 Clinical Trial With Dapagliflozin in Chronic Kidney Disease in Adolescents and Young Adult Patients | RECRUITING |
| Symbicort, used twice daily (b.i.d) and as needed (prn) | SEP | Phase 3 | NCT00252863 | DESOLO - SiT Peri-Launch: A Comparison of Symbicort Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma in Adults | COMPLETED |
| Anifrolumab | Myopathies | Phase 3 | NCT07691970 | ROSY-S — Rollover Study for Participants Who Have Completed a Previous Clinical Study With Anifrolumab (Saphnelo) and Clinically Benefited From Continued Treatment | RECRUITING |
| Anifrolumab (blinded) | Myopathies | Phase 3 | NCT06455449 | JASMINE — A Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis) | RECRUITING |
| Anifrolumab + APFS | Lupus | Phase 2 | NCT07630714 | A Study to Investigate Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Anifrolumab in Pediatric Participants 5 to < 18 Years of Age With Systemic Lupus Erythematosus | RECRUITING |
| Anifrolumab | Lupus | À vérifier | NCT06673043 | SLE-ARTEMIS — Anifrolumab Real-world Treatment Outcomes in Systemic Lupus Erythematosus | ACTIVE_NOT_RECRUITING |
| ASTER — A Treatment Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice | Lupus | À vérifier | NCT05637112 | ASTER — A Treatment Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice | ACTIVE_NOT_RECRUITING |
| iCaReMe Global Registry: Multinational Real-world Evidence in Cardiorenal and Metabolic Diseases | Hypertension | À vérifier | NCT03549754 | iCaReMe Global Registry: Multinational Real-world Evidence in Cardiorenal and Metabolic Diseases | RECRUITING |
| Trastuzumab deruxtecan | Cancer | Phase 4 | NCT06429761 | STRIDE — Phase 4 Study to Assess the Safety of Trastuzumab Deruxtecan, in Indian Patients | ACTIVE_NOT_RECRUITING |
| INTERSTELLAR - International Study Evaluating Lupus Outcomes After Anifrolumab Real World Use | Lupus | À vérifier | NCT06314282 | INTERSTELLAR - International Study Evaluating Lupus Outcomes After Anifrolumab Real World Use | RECRUITING |
| Anifrolumab | Lupus | À vérifier | NCT06659029 | PRIMULA_Preg — Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users | RECRUITING |
| Trastuzumab deruxtecan | Cancer | Phase 2 | NCT06750484 | Trial of Trastuzumab Deruxtecan in Previously Treated HER2 | RECRUITING |
| CLEAR-HTN — Observational Study That Will Evaluate Treatment Patterns in the Management of Hypertension in the Public Primary Care System | Hypertension | À vérifier | NCT07361276 | CLEAR-HTN — Observational Study That Will Evaluate Treatment Patterns in the Management of Hypertension in the Public Primary Care System | RECRUITING |
| VIOLET — NIS to Examine Disease Activity in SLE Patients Treated With Subcutaneous Anifrolumab in Routine Care | Lupus | À vérifier | NCT07424261 | VIOLET — NIS to Examine Disease Activity in SLE Patients Treated With Subcutaneous Anifrolumab in Routine Care | RECRUITING |
| D1843R00359 — Prospective Observational Multicenter Study of Patients With AH and CKD Markers in Kazakhstan (PROGRESS-CKD) | Hypertension | À vérifier | NCT06744335 | D1843R00359 — Prospective Observational Multicenter Study of Patients With AH and CKD Markers in Kazakhstan (PROGRESS-CKD) | COMPLETED |
| Baxdrostat/dapagliflozin | Hypertension | Phase 3 | NCT06742723 | BaxDuo-Pacific — A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure | RECRUITING |
| AZD0120 - Regimen 1 | SEP | Phase 1 | NCT07224373 | ZENITH — An Open-label Study of AZD0120 in Adults With Multiple Sclerosis | RECRUITING |
| Anifrolumab | Lupus | Phase 4 | NCT06594068 | PRIMULA Lac — Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users | RECRUITING |
| Anifrolumab | Lupus | À vérifier | NCT07330245 | DAHLIA — Achievement of LLDAS5 in Patients With Systemic Lupus Erythematosus Treated With Anifrolumab. | RECRUITING |
| Anifrolumab | Lupus | Phase 3 | NCT07430306 | SUNFLOWER — A Study to Evaluate the Treatment Outcomes of Subcutaneous Anifrolumab in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus | RECRUITING |
| AZD5492 | Lupus | Phase 1 | NCT06916806 | TITAN — A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD5492 in Adult Participants With Systemic Lupus Erythematosus or Idiopathic Inflammatory Myopathies or Rheumatoid Arthritis. | RECRUITING |
| Rilvegostomig | Cancer | Phase 3 | NCT06627647 | A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Locally Advanced or Metastatic Non-Squamous NSCLC | RECRUITING |
| Anifrolumab | Lupus | Phase 3 | NCT05835310 | BLOSSOM — An Efficacy and Safety Study of Intravenous Anifrolumab to Treat Systemic Lupus Erythematosus in Pediatric Participants | RECRUITING |
| MG Cohort — A Study in Patients With Myasthenia Gravis in China | Myasthénie | À vérifier | NCT06700616 | MG Cohort — A Study in Patients With Myasthenia Gravis in China | ACTIVE_NOT_RECRUITING |
| Medi-546 | Lupus | Phase 3 | NCT04877691 | Tulip SC — Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus | ACTIVE_NOT_RECRUITING |
| Surovatamig | Lupus | Phase 1 | NCT07201558 | ASSURO — Study Evaluating Safety, Tolerability, PK/PD of Surovatamig in Adult RA or SLE Participants | RECRUITING |
| Anifrolumab | Lupus | Phase 3 | NCT05138133 | IRIS — Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis | ACTIVE_NOT_RECRUITING |
| Epidemiological Study of Treatment Approaches in AChR-Antibody Positive Generalized Myasthenia Gravis in Russia | Myasthénie | À vérifier | NCT07247279 | Epidemiological Study of Treatment Approaches in AChR-Antibody Positive Generalized Myasthenia Gravis in Russia | RECRUITING |
| Anifrolumab | Lupus | Phase 3 | NCT07751848 | LOTUS — A Study of Outcomes in Chinese Patients Treated With Anifrolumab Who Have Active Mod-severe Systemic Lupus Erythematosus | RECRUITING |
| Anifrolumab | Lupus | À vérifier | NCT06795893 | The Anifrolumab PRIM Program | RECRUITING |
| AZD0120 | Lupus | Phase 1/2 | NCT06897930 | A Study to Investigate the Safety, Tolerability, and Efficacy of AZD0120 in Adults With Refractory SLE | RECRUITING |
| Anifrolumab | Lupus | À vérifier | NCT07000110 | SIMA — Anifrolumab Malignancy and Serious Infections Study | RECRUITING |
| Rilvegostomig | Cancer | Phase 3 | NCT06692738 | A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) | RECRUITING |
| IV Rilvegostomig | Parkinson | Phase 1 | NCT07161414 | ARTEMIDE-subQ — A Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Rilvegostomig in Adult Participants With Advanced Solid Tumors Previously Treated With Standard of Care Therapy | RECRUITING |
| Trastuzumab deruxtecan | Parkinson | Phase 3 | NCT06989112 | DE-01 — DESTINY-Endometrial01: A Phase III Study of Trastuzumab Deruxtecan Plus Rilvegostomig or Pembrolizumab as First-Line Treatment of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR) Endometrial Cancer | RECRUITING |
| Prophyl C — National Survey on Hypertension in Cardiologic Private Practice | Hypertension | À vérifier | NCT00695175 | Prophyl C — National Survey on Hypertension in Cardiologic Private Practice | COMPLETED |
| Ravulizumab | Myasthénie | À vérifier | NCT06909253 | MG-ARCADIA — Ravulizumab Treatment Outcomes in Patients With Generalized Myasthenia Gravis | RECRUITING |
Publications
10| Molécule | Indication / population | Titre | Journal | Date |
|---|---|---|---|---|
| Trastuzumab deruxtecan | Redefining first-line standards: The role of next-generation HER2-Targeted therapies in HER2-positive metastatic breast cancer. | Biochimica et biophysica acta. Reviews on cancer | ||
| Trastuzumab deruxtecan | An intrinsically hydrophilic linker enables a stable, high-DAR exatecan-based HER2 ADC with potent antitumor activity. | European journal of medicinal chemistry | ||
| Medi-546 | SLE-DAS enables an accurate definition of severe lupus disease activity: derivation and validation in a post hoc study of anifrolumab phase II and III studies. | Lupus science & medicine | ||
| Surovatamig | T-cell engaging antibodies for B-cell lymphomas. | Seminars in hematology | ||
| IV Rilvegostomig | TROPION-Lung12: A phase 3 study of adjuvant datopotamab deruxtecan and rilvegostomig in ctDNA-positive or high-risk pathology stage I non-small cell lung cancer. | The Journal of thoracic and cardiovascular surgery | ||
| IV Rilvegostomig | TROPION-Lung10: a phase 3 study of datopotamab deruxtecan and rilvegostomig in patients with treatment-naïve locally advanced or metastatic nonsquamous non-small cell lung cancer with high PD-L1 expression and without actionable genomic alterations. | Frontiers in oncology | ||
| Rilvegostomig | Correction: TROPION-Lung10: a phase 3 study of datopotamab deruxtecan and rilvegostomig in patients with treatment-naïve locally advanced or metastatic nonsquamous non-small cell lung cancer with high PD-L1 expression and without actionable genomic alterations. | Frontiers in oncology | ||
| Rilvegostomig | Rilvegostomig for Metastatic Non-Small-Cell Lung Cancer: A First-In-Human Phase I/II Clinical Study. | Clinical cancer research : an official journal of the American Association for Cancer Research | ||
| Trastuzumab deruxtecan | Dynamic HER2 reassessment and precision sequencing after trastuzumab in HER2-positive advanced gastric cancer. | ESMO gastrointestinal oncology | ||
| Trastuzumab deruxtecan | Small Triple-Negative and HER2-Positive Early Breast Cancer: Upfront Surgery or Neoadjuvant Chemotherapy? | Cancers |