Clinical trials: completed, sponsored by CSL Behring
Asthma
A Clinical Study to Test the Safety, Exposure, and Pharmacodynamic Markers of CSL311 in Patients With Mild-to-moderate Asthma and in Healthy Volunteers
This is a phase 1, first-in-human (FIH), multi-center, randomized, double-blind, placebo-controlled study of CSL311 in patients with mild-to-moderate asthma.
- Trial name
- NCT04082754
- Testing
- Human beta common receptor antagonist monoclonal antibody
- Where
- 3 sites in Germany, United Kingdom
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- CSL Behring
Noncystic Fibrosis Bronchiectasis (NCFB)
Study to Assess CSL787 in Non-cystic Fibrosis Bronchiectasis (NCFB)
This study is a prospective, multicenter, randomized, double-blind, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and exploratory efficacy of nebulized CSL787 after…
- Trial name
- NCT04643587
- Testing
- CSL787
- Where
- 3 sites in Germany, United Kingdom
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- CSL Behring
Diabetic Kidney Disease (DKD)
Vascular Endothelial Growth Factor-B (VEGF-B) Blockade With the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease
This phase 2a, double-blind, randomized, placebo-controlled study will assess the efficacy, safety, tolerability, and pharmacokinetics (PK), of repeat doses of CSL346 in subjects with diabetic kidney disease (DKD) and albuminuria…
- Trial name
- NCT04419467
- Testing
- CSL346
- Where
- 37 sites in United States, Australia and 4 more
- Volunteers
- 114 people
- Sponsor
- CSL Behring
Healthy Volunteers
Effects of CSL324 in the Lung After Segmental Challenge
This is a phase 1b, randomized, double-blind, placebo-controlled study in healthy volunteers to investigate the antiinflammatory effect of pretreatment with CSL324 on response to a lipopolysaccharide (LPS) endotoxin challenge in…
- Trial name
- NCT05653713
- Testing
- CSL324
- Where
- Germany
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- CSL Behring
Sickle Cell Disease
Safety of Single Doses of CSL889 in Adult Patients With Sickle Cell Disease
This is a phase 1, first-in-human, multi-center, open-label, single dose cohort study to evaluate the safety and tolerability, pharmacokinetics (PK), exploratory pharmacodynamics (PD), and biomarkers of target engagement of…
- Trial name
- NCT04285827
- Testing
- CSL889
- Where
- 15 sites in United States, Netherlands and 1 more
- Volunteers
- 28 people
- Sponsor
- CSL Behring
Hereditary Angioedema
CSL312 (Garadacimab) in the Prevention of Hereditary Angioedema Attacks
This is a multicenter, double-blind, randomized, placebo-controlled, parallel-arm study to investigate the efficacy and safety of subcutaneous administration of CSL312 (garadacimab) in the prophylactic treatment of hereditary…
- Trial name
- NCT04656418
- Testing
- CSL312
- Where
- 28 sites in United States, Canada and 5 more
- Volunteers
- 64 people
- Sponsor
- CSL Behring
Hidradenitis Suppurativa, Palmoplantar Pustulosis
Safety and Pharmacokinetics of Repeat Doses of CSL324 in Subjects With Hidradenitis Suppurativa and Palmoplantar Pustulosis
Study CSL324_1002 will investigate the safety and pharmacokinetics of repeat doses of CSL324 in subjects with hidradenitis suppurativa and palmoplantar pustulosis.
- Trial name
- NCT03972280
- Testing
- Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibody
- Where
- 11 sites in Australia, Denmark and 1 more
- Volunteers
- 39 people
- Sponsor
- CSL Behring
Antibody-mediated Rejection in Kidney Transplant
Assess Burden of Disease Among Kidney Transplant Recipients With Chronic Active Antibody Mediated Rejection
This study investigates the burden of disease among kidney transplant recipients that have developed Chronic Active Antibody Mediated Rejection (caAMR) compared with kidney transplant recipients that have not developed caAMR
- Trial name
- NCT05452317
- Testing
- Chronic active AMR group, Non-Chronic active AMR group
- Where
- 3 sites in United States
- Volunteers
- 52 people
- Sponsor
- CSL Behring
Hereditary Angioedema
A Study to Investigate CSL312 in Subjects With Hereditary Angioedema (HAE)
This is a multicenter, randomized, placebo-controlled, parallel-arm, phase 2 study to investigate the clinical efficacy, pharmacokinetics, and safety of CSL312 as prophylaxis to prevent attacks in subjects with HAE.
- Trial name
- NCT03712228
- Testing
- Factor XIIa antagonist monoclonal antibody
- Where
- 16 sites in United States, Australia and 3 more
- Volunteers
- 44 people
- Sponsor
- CSL Behring
Healthy Participants
A Study to Compare the Pharmacokinetics of CSL312 Administered by Prefilled Syringe Assembled to Autoinjector to the Pharmacokinetics Administered by Prefilled Syringe Assembled to Needle Safety Device in Healthy Subjects
This is an open-label, parallel-group, phase 1, single center study to assess the relative bioavailability of CSL312 administered subcutaneously via a prefilled syringe assembled to an autoinjector compared to a prefilled syringe…
- Trial name
- NCT05306275
- Testing
- CSL312
- Where
- United States
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- CSL Behring
Healthy Volunteers
A Study to Assess the Pharmacokinetics and Safety of CSL312 in Healthy Japanese and Caucasian Adults
This will be a 2- part, phase 1, open-label, single center, single ascending dose study to investigate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of subcutaneous (SC) and intravenous (IV)…
- Trial name
- NCT04580654
- Testing
- CSL312
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- CSL Behring
Healthy
Pharmacokinetics and Safety of Subcutaneous CSL324 in Healthy Japanese and White Subjects
Study CSL324_1003 is a single center, randomized, double-blind, placebo-controlled study designed to characterize and compare the PK properties and safety of a single subcutaneous dose of CSL324 in healthy Japanese and White…
- Trial name
- NCT04570267
- Testing
- CSL324
- Where
- Australia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- CSL Behring
Hemophilia B
A Safety and Efficacy Extension Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B
This study will examine the long-term safety and efficacy of rIX-FP for the control and prevention of bleeding episodes in children and adults with severe hemophilia B.
- Trial name
- NCT02053792
- Testing
- rIX-FP
- Where
- 42 sites in United States, Australia and 13 more
- Volunteers
- 97 people
- Sponsor
- CSL Behring
Hemophilia B
Trial of AAV5-hFIX in Severe or Moderately Severe Hemophilia B
This study evaluates how safe gene therapy treatment with AAV5-hFIX is in adult patients with severe or moderately severe hemophilia B and severe bleeding type.
- Trial name
- NCT02396342
- Testing
- AAV5-hFIX
- Where
- 7 sites in Denmark, Germany and 1 more
- Volunteers
- 10 people
- Sponsor
- CSL Behring
Coronavirus Disease 2019 (COVID-19)
Treatment With CSL312 in Adults With Coronavirus Disease 2019 (COVID-19)
This is a prospective, phase 2, multicenter, randomized, double blind, placebo controlled, parallel group study to assess the safety and efficacy of CSL312 administered intravenously, in combination with standard of care (SOC)…
- Trial name
- NCT04409509
- Testing
- Garadacimab, Factor XIIa Antagonist Monoclonal Antibody
- Where
- 14 sites in United States
- Volunteers
- 124 people
- Sponsor
- CSL Behring
Rheumatoid Arthritis
Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to Methotrexate
The purpose of this study is to determine the effective dose of BMS-945429 in subjects with inadequate response to Methotrexate in the treatment of moderate to severe Rheumatoid Arthritis.
- Trial name
- NCT01373151
- Testing
- BMS-945429, Methotrexate
- Where
- 100 sites in United States, Argentina and 17 more
- Volunteers
- 418 people
- Sponsor
- CSL Behring
Arthritis, Psoriatic
Psoriatic Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to NSAIDs or Non-biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) Therapy
The purpose of this study is to characterize the safety, efficacy and dose response of BMS-945429 in subjects with active Psoriatic Arthritis and an inadequate response to Nonsteroidal anti-inflammatory drugs (NSAIDs) and…
- Trial name
- NCT01490450
- Testing
- BMS-945429
- Where
- 49 sites in United States, Argentina and 11 more
- Volunteers
- 165 people
- Sponsor
- CSL Behring
Hemophilia A, Severe Hemophilia A
An Open-label Safety and Efficacy Study of Recombinant FVIII in Patients With Severe Hemophilia A
This multicenter, open-label, phase 3 extension study will investigate the safety and efficacy of rVIII-SingleChain for prophylaxis and on-demand treatment of bleeding episodes in at least 200 previously treated patients (PTPs)…
- Trial name
- NCT02172950
- Testing
- rVIII-SingleChain
- Where
- 64 sites in United States, Australia and 23 more
- Volunteers
- 246 people
- Sponsor
- CSL Behring
Hemorrhage
An Observational Cohort Study to Investigate the Risk of Thromboembolic Events in Patients Receiving Kcentra® or Plasma to Reverse Vitamin K Antagonist (VKA) Therapy in the Setting of Acute Major Bleeding
This observational cohort study is designed to obtain product safety information from the routine clinical setting within large, diverse, community-based populations.
- Trial name
- NCT02319460
- Testing
- Kcentra®, Plasma
- Where
- United States
- Volunteers
- 2,238 people
- Sponsor
- CSL Behring
Rheumatoid Arthritis
Phase IIB Dose Ranging Study in Subjects With Moderate to Severe Rheumatoid Arthritis
The primary purpose of this study is to identify an appropriate dose of study medication.
- Trial name
- NCT02015520
- Testing
- Clazakizumab
- Where
- 55 sites in United States, Argentina and 7 more
- Volunteers
- 143 people
- Sponsor
- CSL Behring