Clinical Trials Sponsored by Samsung Bioepis Co., Ltd.

Total 70 results

Samsung Bioepis Co., Ltd.

Completed

A Study to Compare SB15 (Proposed Aflibercept Biosimilar) to Eylea in Subjects With Neovascular Age-related Macular Degeneration (AMD)

Neovascular Age-related Macular Degeneration

Czechia, Estonia, Hungary, Korea, Republic of, Latvia, Poland, United States, Croatia, Japan, Russian Federation
Samsung Bioepis Co., Ltd.

Completed

A Study to Evaluate the Usability of the SB11 PFS in Subjects With Wet AMD or Macular Oedema Secondary to RVO

Macular Edema | Retinal Vein Occlusion | Neovascular Age-related Macular Degeneration

Poland
Samsung Bioepis Co., Ltd.

Completed

A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis

Postmenopausal Osteoporosis

Poland
Samsung Bioepis Co., Ltd.

Completed

Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Two Formulations of SB5 in Healthy Male Subjects

Healthy

Germany
Samsung Bioepis Co., Ltd.

Completed

A Phase I Study of SB26 in Healthy Volunteers

Healthy Volunteers

United States
Samsung Bioepis Co., Ltd.

Completed

Pharmacokinetic, Safety, Tolerability, Immunogenicity, and Pharmacodynamic Study of SB12 in Healthy Subjects

Healthy

Germany
Samsung Bioepis Co., Ltd.

Completed

Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB2 in Healthy Subjects

Healthy

Germany
Samsung Bioepis Co., Ltd.

Completed

Pharmacokinetics, Safety, and Tolerability Study of the Autoinjector and Pre-filled Syringe of SB4 in Healthy Male Subjects

Healthy

Netherlands
Samsung Bioepis Co., Ltd.

Completed

Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB3 in Healthy Male Subjects

Healthy

Germany
Samsung Bioepis Co., Ltd.

Recruiting

A Study to Compare the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Pembrolizumab (SB27, EU Sourced Keytruda, and US Sourced Keytruda) in Subjects With Stage II-IIIA NSCLC Following Complete Resection and Adjuvant Platinum-based Chemotherapy

Non-small Cell Lung Cancer Stage IIIA | Non-small Cell Lung Cancer Stage II

Korea, Republic of, Poland, Spain, Turkey
Samsung Bioepis Co., Ltd.

Completed

Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity Study of SB16 in Healthy Male Subjects

Healthy

France, United States
Samsung Bioepis Co., Ltd.

Completed

Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB4 in Healthy Male Subjects

Healthy

Germany
Samsung Bioepis Co., Ltd.

Completed

Pharmacokinetic, Safety, Tolerability, and Immunogenicity Study of SB8 in Healthy Male Subjects

Healthy

Belgium
Samsung Bioepis Co., Ltd.

Completed

A Study Comparing SB8 and Avastin® in Patients With Advanced Non-squamous Non-small Cell Lung Cancer

Lung Cancer | Non-small Cell Lung Cancer

Korea, Republic of, Germany, Hungary, Taiwan, Thailand, Georgia, Serbia, Poland, Romania, Ukraine, Spain, Belarus, Russian Federation
Samsung Bioepis Co., Ltd.

Completed

Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB5 in Healthy Subjects

Healthy

Germany
Samsung Bioepis Co., Ltd.

Completed

A Study to Compare the Effect of SB3 and Herceptin® in Women With HER2 Positive Breast Cancer

HER2 Positive Early or Locally Advanced Breast Cancer

Czechia
Samsung Bioepis Co., Ltd.

Completed

A Study Comparing SB4 to Enbrel® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

Rheumatoid Arthritis

Poland, United Kingdom
Samsung Bioepis Co., Ltd.

Completed

A Study Comparing SB5 to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

Rheumatoid Arthritis

Lithuania, Poland
Samsung Bioepis Co., Ltd.

Recruiting

A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer

Non-small Cell Lung Cancer Stage IV

Georgia, India, Romania, Spain, Japan, Thailand, Bosnia and Herzegovina, Germany, Malaysia, Philippines
Samsung Bioepis Co., Ltd.

Completed

A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria

Paroxysmal Nocturnal Hemoglobinuria

Korea, Republic of, Taiwan, Malaysia, Thailand, Romania, India, Mexico, Ukraine
Samsung Bioepis Co., Ltd.

Terminated

A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC

Breast Neoplasms

Ukraine, Romania, Russian Federation, France, Bulgaria, Czechia, Poland
Samsung Bioepis Co., Ltd.

Completed

A Study to Compare SB17 (Proposed Ustekinumab Biosimilar) to Stelara® in Subject With Moderate to Severe Plaque Psoriasis

Psoriasis | Moderate to Severe Plaque Psoriasis

Czechia, Estonia, Hungary, Korea, Republic of, Latvia, Lithuania, Poland, Ukraine
Samsung Bioepis Co., Ltd.

Completed

A Study to Compare SB17 (Proposed Ustekinumab Biosimilar) to European Union (EU) Sourced Stelara and United States of America (US) Sourced Stelara in Healthy Subjects

Healthy

France
Samsung Bioepis Co., Ltd.

Completed

A Study to Compare SB11 (Proposed Ranibizumab Biosimilar) to Lucentis in Subjects With Neovascular Age-related Macular Degeneration (AMD)

Age-Related Macular Degeneration

Korea, Republic of, United States, India, Germany, Hungary, United Kingdom, Czechia, Poland, Russian Federation
Samsung Bioepis Co., Ltd.

Completed

An Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Poland
Samsung Bioepis Co., Ltd.

Completed

Pharmacokinetics, Safety, and Tolerability Study of the Pen and PFS of SB5 in Healthy Subjects

Healthy

Belgium, New Zealand
Samsung Bioepis Co., Ltd.

Completed

An Multicentre Clinical Study to Evaluate the Usability and Safety of the Autoinjector and Pre-filled Syringe of SB4 in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Poland
Samsung Bioepis Co., Ltd.

Completed

A Study Comparing SB2 to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

Rheumatoid Arthritis

Bulgaria, Lithuania
Biogen
Samsung Bioepis Co., Ltd.

Completed

Observational Study to Evaluate the Real-Life Effectiveness of Benepali Following Transition From Enbrel (BENEFIT)

Rheumatoid Arthritis | Axial Spondyloarthritis

Germany
Samsung Bioepis Co., Ltd.
Organon and Co

Completed

Pharmacokinetics, Efficacy, Safety, and Immunogenicity of SB5 Versus Humira in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Plaque Psoriasis

Czechia, Lithuania, Poland, Bulgaria
University of Leeds
Samsung Bioepis Co., Ltd.

Not yet recruiting

Targeted Treatment Early With Etanercept + Methotrexate vs.T2T Care for DMARD-naïve Early RA Patients Based on naïve T-cell Stratification (TEEMS)

Rheumatoid Arthritis

United Kingdom
Institut fuer Frauengesundheit
Samsung Bioepis Co., Ltd.

Recruiting

Neoadjuvant Ontruzant (SB3) in Patients With HER2-positive Early Breast Cancer: An Open-Label (NeoON) (NeoON)

Breast Cancer | Breast Neoplasms | HER2-positive Breast Cancer | Breast Cancer Female

Germany
Samsung Pharmaceutical Co., Ltd.

Not yet recruiting

GV1001 Subcutaneous for the Treatment of Moderate to Severe Alzheimer's Disease(AD)

Moderate to Severe Alzheimer's Disease
Samsung Pharmaceutical Co., Ltd.

Unknown

A Phase III Study to Assess the Efficacy and Safety of GV1001-Gem/Cap vs Gem/Cap in Pancreatic Cancer Patients

Pancreatic Cancer

Korea, Republic of
Samsung Medical Center
Medipost Co Ltd.

Not yet recruiting

Exploratory Efficacy Study of NEUROSTEM® in Subjects Who Control Group of NEUROSTEM®

Alzheimer's Disease

Korea, Republic of
Samsung Medical Center
Medipost Co Ltd.

Active, not recruiting

Follow-Up Study of Safety and Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia

Bronchopulmonary Dysplasia

Korea, Republic of
Samsung Medical Center
Pharmicell Co., Ltd.

Unknown

The STem Cell Application Researches and Trials In NeuroloGy-2 (STARTING-2) Study (STARTING-2)

Stroke, Ischemic

Korea, Republic of
Samsung Medical Center
GENECAST Co., Ltd.

Recruiting

Practical Usability of EGFR Mutation Detection in ctDNA From Resectable NSCLC

Lung Neoplasms

Korea, Republic of
Samsung Medical Center
Medipost Co Ltd.

Unknown

Umbilical Cord Blood-derived Mesenchymal Stem Cells for the Treatment of Steroid-refractory Acute or Chronic Graft-versus-host-disease (GVHD-MSC)

Graft-Versus-Host Disease | GVHD | Disorder Related to Transplantation | Allogeneic Hematopoietic Transplant

Korea, Republic of
Kangbuk Samsung Hospital
Daewoong Pharmaceutical Co. LTD.

Recruiting

Long-term Effects of Flash Glucose Monitoring System in Patients With Gestational Diabetes (GDMLIBRE)

Gestational Diabetes Mellitus in Pregnancy

Korea, Republic of
Samsung Medical Center
Ono Pharmaceutical Co. Ltd

Unknown

Neoadjuvant Nivolumab for Operable Esophageal Carcinoma

Esophageal Squamous Cell Carcinoma

Korea, Republic of
Kangbuk Samsung Hospital
Hana Pharm Co., Ltd.

Completed

Quality of Recovery of Remimazolam Versus Sevoflurane in Transurethral Bladder Resection.

Quality of Recovery

Korea, Republic of
Samsung Medical Center
Taewoong Medical Co., Ltd.

Unknown

Efficacy and Safety of a Covered Self-expandable Dual-layered Metallic Mesh Stent (UVENTA) in Ureteral Obstruction (UVENTA)

Ureteral Obstruction

Korea, Republic of
Samsung Medical Center
Hanmi Pharmaceutical co., ltd.

Active, not recruiting

Usual Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin on Coronary Atherosclerotic Plaque (Rosuzet-IVUS)

Coronary Artery Disease

Korea, Republic of
Samsung Medical Center
SK Chemicals Co., Ltd.

Withdrawn

Resting-state Functional Connectivity Changes During Migraine Treatment

Migraine Disorders

Korea, Republic of
Samsung Medical Center
Dong-A Pharmaceutical Co., Ltd.

Unknown

Effect of Zydena (Udenafil) on Cerebral Blood Flow and Peripheral Blood Viscosity (SMCZN01)

Vascular Dementia | Subcortical Vascular Dementia

Korea, Republic of
Samsung Medical Center
Daiichi Sankyo Korea Co., Ltd.

Completed

Effect of Pravastatin in the Subjects With Prediabetes or Early Diabetes

Diabetes Mellitus | Prediabetic State

Korea, Republic of
KIMJisun
Kuhnil Pharmaceutical Co., Ltd.

Unknown

Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease

Parkinson's Disease
Samsung Medical Center
Dong-A ST Co., Ltd.

Unknown

The Efficacy and Safety of Udenafil in Patients With Erectile Dysfunction After Bilateral Nerve-sparing Radical Prostatectomy (DA8159_EDP_IIT)

Prostate Cancer With Radical Prostatectomy
Samsung Medical Center
Dong-A ST Co., Ltd.

Unknown

Naftopidil 75mg for Improving Clearance of Urinary Stones

Kidney Calculi | Ureter Calculi

Korea, Republic of

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