Clinical Trials Sponsored by Biovis d.o.o.

Total 547 results

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
Nutrition Institute, Slovenia
Slovenian Research Agency; Valens Int. d.o.o., Slovenija; Community Health Centre...

Completed

The Effect of Content of Barley Beta-glucans in Bread on Postprandial Blood Sugar (ARRS-bGL-01)

Glycemic Index

Slovenia
Stealth BioTherapeutics Inc.
Charite University, Berlin, Germany; SCIRENT Clinical Research and Science...

Completed

A Study to Evaluate the Effects of 4 Weeks Treatment With Subcutaneous Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Preserved Ejection Fraction

Chronic Heart Failure

Germany, Serbia
Ionis Pharmaceuticals, Inc.

Not yet recruiting

ATTUNE: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intrathecally-Administered ION440 in Participants With Methyl CpG Binding Protein 2 (MECP2) Duplication Syndrome (MDS)

Methyl CpG Binding Protein 2 (MECP2) Duplication Syndrome
Ionis Pharmaceuticals, Inc.

Recruiting

A Study to Evaluate the Safety and Efficacy of ION373 in Patients With Alexander Disease (AxD)

Alexander Disease

United States, United Kingdom, Australia, Canada, Israel, Italy, Japan, Netherlands
Ionis Pharmaceuticals, Inc.

Active, not recruiting

An Extension Study of Donidalorsen (IONIS-PKK-LRx) in Participants With Hereditary Angioedema

Hereditary Angioedema

Netherlands, United States
Ionis Pharmaceuticals, Inc.

Completed

A Study Comparing Two Subcutaneous Formulations: Vial and Autoinjector (AI) With Olezarsen, at Two Dose Levels, in Healthy Adult Participants

Healthy Participants

United States
Ionis Pharmaceuticals, Inc.

Active, not recruiting

PrProfile: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ION717.

Prion Disease

Spain, United States, Israel, Germany, Japan, Canada
Ionis Pharmaceuticals, Inc.

Completed

Extension Study Assessing Long Term Safety and Efficacy of IONIS-TTR Rx in Familial Amyloid Polyneuropathy (FAP)

Amyloidosis | Familial Amyloid Polyneuropathy | FAP | TTR | Transthyretin

United States, Spain, Argentina, Brazil, France, Germany, Italy, Portugal, United Kingdom
Ionis Pharmaceuticals, Inc.

Completed

Safety and Tolerability Study of ISIS EIF4E Rx in Combination With Docetaxel and Prednisone (CRPC)

Castrate-Resistant Prostate Cancer

United States, Puerto Rico, Hungary, Romania, Russian Federation, Poland
Ionis Pharmaceuticals, Inc.

Completed

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS-MAPTRx in Patients With Mild Alzheimer's Disease

Mild Alzheimer's Disease

United Kingdom, Netherlands, Germany, Sweden, Canada, Finland
Covis Pharma S.à.r.l.

Completed

Comparison Between Systemic Exposure to Ciclesonide Nasal Spray, Ciclesonide HFA Nasal Aerosol and Orally Inhaled Ciclesonide (BY9010/M1-422)

Allergic Rhinitis

United States
Ionis Pharmaceuticals, Inc.

Completed

A Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx, an Antisense Inhibitor Administered Subcutaneously to Hypertensive Participants With Controlled Blood Pressure

Mild Hypertension

United States
Ionis Pharmaceuticals, Inc.

Terminated

A Study to Assess the Safety, Tolerability, and Efficacy of ION-827359 in Participants With Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD) With Chronic Bronchitis (CB)

Chronic Obstructive Pulmonary Disease | Chronic Bronchitis

Germany, Czechia, Hungary, United Kingdom
Ionis Pharmaceuticals, Inc.

Completed

Addition of ISIS 14803 to Therapy With Peginterferon and Ribavirin for Chronic Hepatitis C (HCV) Patients Not Responding Adequately to the Two Drugs

Hepatitis C, Chronic

United States
Ionis Pharmaceuticals, Inc.

Completed

ISIS 2302-CS27, A 6-Week, Placebo-Controlled Clinical Study to Evaluate the Effectiveness of Alicaforsen (ISIS 2302) in Patients With Mild to Moderate Active Ulcerative Colitis.

Ulcerative Colitis

United States
Ionis Pharmaceuticals, Inc.

Completed

ISIS 2302-CS22, A 6-Week, Active-Controlled Clinical Study to Evaluate the Effectiveness of Alicaforsen (ISIS 2302) in Patients With Mild to Moderate Active Ulcerative Colitis

Ulcerative Colitis

United States
Ionis Pharmaceuticals, Inc.

Completed

ISIS 104838, an Inhibitor of Tumor Necrosis Factor, for Active Rheumatoid Arthritis

Rheumatoid Arthritis

United States, Canada
Ionis Pharmaceuticals, Inc.

Completed

Alicaforsen (ISIS 2302) in Patients With Active Crohn's Disease

Crohn's Disease

Poland, Spain, Belgium, Germany, Czechia, Italy
Ionis Pharmaceuticals, Inc.

Completed

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ION904

Healthy Volunteers

Canada
Ionis Pharmaceuticals, Inc.

Completed

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Donidalorsen (IONIS-PKK-LRx) Administered Subcutaneously to Healthy Volunteers

Healthy Volunteers

Canada
Ionis Pharmaceuticals, Inc.

Completed

A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of IONIS FXI-LRx in up to 84 Healthy Volunteers

Healthy Participants

Canada
Ionis Pharmaceuticals, Inc.

Completed

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISIS-APO(a)Rx in Participants With High Lipoprotein(a)

Elevated Lipoprotein(a)

Netherlands, United Kingdom, Denmark, Germany, Canada
Ionis Pharmaceuticals, Inc.

Completed

Efficacy and Safety of Inotersen in Familial Amyloid Polyneuropathy

Amyloidosis | Familial Amyloid Polyneuropathy | FAP | TTR | Transthyretin

New Zealand, United States, Spain, Argentina, Brazil, France, Germany, Italy, Portugal, United Kingdom
Ionis Pharmaceuticals, Inc.

Completed

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ionis AGT-LRx in Healthy Volunteers

Healthy Volunteers

Canada
Ionis Pharmaceuticals, Inc.

Completed

A Safety, Tolerability, PK, and PD Study of Once Weekly ISIS-FGFR4RX SC in Obese Patients (FGFR4-CS2)

Obesity

United States
Ionis Pharmaceuticals, Inc.

Completed

Study to Evaluate the Effect of ISIS GCGRRx on Hepatic Lipid and Glycogen Content in Type 2 Diabetes

Type 2 Diabetes

Austria
Ionis Pharmaceuticals, Inc.

Completed

Safety, Tolerability and Efficacy of ISIS-GCCRRx in Type 2 Diabetes

Type 2 Diabetes Mellitus

Canada, Romania, South Africa
Ionis Pharmaceuticals, Inc.

Completed

Safety, Tolerability, and Efficacy of ISIS-PTP1BRx in Type 2 Diabetes

Type 2 Diabetes Mellitus | Obese

Argentina, Canada, South Africa
Biovo Technologies Ltd

Unknown

Performance Evaluation of AirWay Medix Closed Suction System Compared With a Standard Closed Suction System

Endotracheal Tube | Mechanical Ventilation

Israel
BioMS Technology Corp.

Terminated

Efficacy and Safety of MBP8298 in Subjects With Secondary Progressive Multiple Sclerosis (MAESTRO-03)

Multiple Sclerosis, Secondary Progressive
Pasche, Boris, M.D.

No longer available

Low Levels of Electromagnetic Fields to Treat Advanced Cancer (ADLG3)

Cancer
Ionis Pharmaceuticals, Inc.

Completed

Safety, Tolerability, and Activity of ISIS 113715 in People With Type 2 Diabetes Mellitus Who Have Not Received Prior Treatment

Type 2 Diabetes Mellitus

Russian Federation, Poland
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

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