Clinical trials: Eosinophilic Asthma
Severe Uncontrolled Asthma
PK/PD and Long Term Safety Study of Benralizumab in Children With Severe Eosinophilic Asthma
This study will evaluate the PK, PD and long-term safety of Benralizumab administered subcutaneously in 30 children aged 6 to 11 years with severe eosinophilic asthma.
- Trial name
- TATE (NCT04305405)
- Testing
- Benralizumab
- Where
- 15 sites in United States, Japan
- Volunteers
- 30 people
- Sponsor
- AstraZeneca
Respiratory System Agents, Anti-Asthmatic Agents
Study to Evaluate Safety and Efficacy of Benralizumab in Subjects With Hypereosinophilic Syndrome
Background: Eosinophils are white blood cells that help fight infections. High eosinophil levels can damage people s organs, causing hypereosinophilic syndrome (HES).
- Conditions
- Respiratory System Agents, Anti-Asthmatic Agents, Hematologic Diseases, Leukocyte Disorders
- Trial name
- HESIL5R (NCT02130882)
- Testing
- benralizumab
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Asthma
Efficacy, Safety, and Tolerability of Dupilumab in Patients With Persistent Moderate to Severe Eosinophilic Asthma
Primary Objective: To investigate the effects of Dupilumab (SAR231893/REGN668) administered subcutaneously (SC) once weekly (qw) for 12 weeks as compared to placebo on reducing the incidence of asthma exacerbation in participants…
- Trial name
- NCT01312961
- Testing
- Dupilumab, Fluticasone/Salmeterol combination therapy, Fluticasone monotherapy
- Where
- 50 sites in United States
- Volunteers
- 104 people
- Sponsor
- Sanofi
Asthma
Efficacy and Safety Study of Mepolizumab Adjunctive Therapy in Participants With Severe Eosinophilic Asthma on Markers of Asthma Control
This is a multi-centre, placebo-controlled, double-blind, parallel-group study to evaluate the efficacy and safety of mepolizumab adjunctive therapy in participants with severe eosinophilic asthma on markers of asthma control.
- Trial name
- NCT02281318
- Testing
- Mepolizumab, SOC
- Where
- 144 sites in United States, Argentina and 17 more
- Volunteers
- 556 people
- Sponsor
- GlaxoSmithKline
Eosinophilic Asthma
Study to Evaluate the Efficacy and Safety of Reslizumab Treatment in Patients With Moderate to Severe Asthma
The primary objective of the study is to characterize the efficacy of reslizumab treatment, at a dosage of 3.0 milligrams per kilogram (mg/kg) every 4 weeks for a total of 4 doses, in improving pulmonary function in relation to…
- Trial name
- NCT01508936
- Testing
- Reslizumab
- Where
- 66 sites in United States
- Volunteers
- 511 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Asthma
Study to Evaluate Efficacy and Safety of Benralizumab in Reducing Oral Corticosteroid Use in Adult Patients With Severe Asthma
This is a study designed to evaluate efficacy and safety of Benralizumab in reducing the Oral Corticosteroid (OCS) use in adult patients with severe asthma who are receiving OCS with or without additional asthma controller…
- Trial name
- PONENTE (NCT03557307)
- Testing
- Benralizumab
- Where
- 144 sites in United States, Argentina and 15 more
- Volunteers
- 598 people
- Sponsor
- AstraZeneca
Asthma, Severe Eosinophilic Asthma
A Study to Assess the Reduction of Daily Maintenance ICS/LABA Treatment Towards Anti-Inflammatory Reliever Treatment in Patients With Severe Eosinophilic Asthma Treated With Benralizumab
This is a multicentre, randomised, open-label, parallel-group, active-controlled, phase IV study to assess the reduction of daily Symbicort® maintenance to anti-inflammatory reliever treatment only in participants with severe…
- Trial name
- NCT04159519
- Testing
- Symbicort®, Fasenra®, Ventolin®
- Where
- 23 sites in France, Germany and 2 more
- Volunteers
- 170 people
- Sponsor
- AstraZeneca
Asthma
A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype
This study will assess whether switching participants who have benefitted from mepolizumab or benralizumab to GSK3511294 (Depemokimab) is non-inferior to maintaining current treatment on the annualized rate of clinically…
- Trial name
- NIMBLE (NCT04718389)
- Testing
- GSK3511294 (Depemokimab), Mepolizumab, Benralizumab
- Where
- 397 sites in United States, Australia and 19 more
- Volunteers
- 1,717 people
- Sponsor
- GlaxoSmithKline
Asthma
GB001 in Adult Subjects With Moderate to Severe Asthma
A randomized, double-blind, placebo-controlled, dose-ranging, multi-center study to evaluate the efficacy and safety of GB001 when added to standard-of care (SOC) asthma maintenance therapy in adults with moderate to severe…
- Trial name
- NCT03683576
- Testing
- GB001
- Where
- 117 sites in United States, Austria and 9 more
- Volunteers
- 481 people
- Sponsor
- GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.
Asthma
AZD1419 Ph2a Study
Ph2a study planned to be run at approximately 16-18 sites in 4 EU countries (Denmark, Hungary, Poland and Sweden) enrolling approximately 170 patients to ensure 70 randomized patients with eosinophilic, moderate to severe asthma.
- Trial name
- INCONTRO (NCT02898662)
- Testing
- AZD1419
- Where
- 15 sites in Denmark, Hungary and 2 more
- Volunteers
- 81 people
- Sponsor
- AstraZeneca
Asthma
An Open-Label Extension Study of GSK3511294 (Depemokimab) in Participants Who Were Previously Enrolled in 206713 (NCT04719832) or 213744 (NCT04718103)
The purpose of this open-label 12-month extension study is to continue to characterize the long-term safety, efficacy and immunogenic profile of GSK3511294 (Depemokimab) in participants with severe asthma with an eosinophilic…
- Trial name
- AGILE (NCT05243680)
- Testing
- GSK3511294 (Depemokimab)
- Where
- 137 sites in United States, Australia and 12 more
- Volunteers
- 641 people
- Sponsor
- GlaxoSmithKline
Eosinophilic Asthma
Proof of Concept Study to Investigate Etokimab (ANB020) Activity in Adult Participants With Severe Eosinophilic Asthma
This is a proof of concept study designed to assess the effects of a single intravenous dose of etokimab compared to placebo in adult participants with severe eosinophilic asthma.
- Trial name
- NCT03469934
- Testing
- Etokimab
- Where
- 7 sites in United States, United Kingdom
- Volunteers
- 25 people
- Sponsor
- AnaptysBio, Inc.
Eosinophilic Asthma
Changes in Gene Transcription and Immunophenotypes Following Mepolizumab Treatment for Asthma
The purpose of this study is to identify differentially expressed gene transcripts after initiation of mepolizumab in individuals with severe eosinophilic asthma (SEA).
- Trial name
- NCT05002621
- Testing
- Observational
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Mayo Clinic
Eosinophilic Asthma
Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Reslizumab (3.0 mg/kg) as Treatment for Patients (12 Through 75 Years of Age) With Eosinophilic Asthma
The primary objective of the study is to evaluate the long-term safety of reslizumab at a dosage of 3.0 mg/kg every 4 weeks for approximately 24 months in pediatric and adult patients with eosinophilic asthma as assessed by…
- Trial name
- NCT01290887
- Testing
- Reslizumab
- Where
- 219 sites in United States, Argentina and 29 more
- Volunteers
- 1,052 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Asthma
Study of Mepolizumab Safety Syringe in Asthmatics
This study is aimed to assess the correct real-world use of a safety syringe for the repeat self-administration of mepolizumab SC.
- Trial name
- NCT03021304
- Testing
- Mepolizumab
- Where
- 15 sites in United States, Canada and 3 more
- Volunteers
- 56 people
- Sponsor
- GlaxoSmithKline
Asthma
A Phase 3a, Repeat Dose, Open-label, Long-term Safety Study of Mepolizumab in Asthmatic Subjects
This is a multi-center, open-label, long-term study of subcutaneously (SC) administered mepolizumab 100mg in addition to standard of care (SOC), in subjects with severe eosinophilic asthma.
- Trial name
- NCT02135692
- Testing
- Mepolizumab, SOC
- Where
- 114 sites in United States, Argentina and 16 more
- Volunteers
- 339 people
- Sponsor
- GlaxoSmithKline
Nasal Polyposis, Eosinophilic Chronic Rhinosinusitis
Efficacy and Safety Study of Benralizumab in Patient With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps (ORCHID)
This is a randomized, double-blind, placebo-controlled, parallel-group, international, multicenter, Phase 3 study to evaluate the efficacy and safety of repeat dosing of benralizumab 30 mg administered subcutaneously (SC) versus…
- Trial name
- ORCHID (NCT04157335)
- Testing
- Benralizumab 30 mg
- Where
- 116 sites in United States, Argentina and 15 more
- Volunteers
- 295 people
- Sponsor
- AstraZeneca
Eosinophils, Asthma
A Study of Reslizumab in Patients 12 Years of Age and Older With Severe Eosinophilic Asthma
This is a multicenter, open-label (OL) extension study to obtain additional long-term safety data for subcutaneous (sc) administration of reslizumab treatment administered at a fixed dose of 110 mg in patients 12 years of age and…
- Trial name
- NCT03052725
- Testing
- reslizumab
- Where
- 134 sites in United States, Belgium and 11 more
- Volunteers
- 391 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Asthma
Efficacy and Safety Study of Mepolizumab 100 Milligram (mg) Subcutaneous (SC) in Indian Participants Aged Greater Than or Equal to (>=) 18 Years With Severe Eosinophilic Asthma
Mepolizumab is a humanized monoclonal antibody (IgG1, kappa) that blocks interleukin- 5 (IL-5) thus inhibits production and survival of eosinophils.
- Trial name
- PRISM (NCT04276233)
- Testing
- Mepolizumab, Salbutamol
- Where
- 14 sites in India
- Volunteers
- 100 people
- Sponsor
- GlaxoSmithKline
Asthma
Omalizumab to Mepolizumab Switch Study in Severe Eosinophilic Asthma Patients
Mepolizumab is an anti-interleukin-5 ( IL-5) monoclonal antibody that neutralizes IL-5 and reduces eosinophil counts in both sputum and blood.
- Trial name
- NCT02654145
- Testing
- Mepolizumab 100mg SC, Albuterol/salbutamol MDIs, Omalizumab
- Where
- 53 sites in United States, Argentina and 7 more
- Volunteers
- 145 people
- Sponsor
- GlaxoSmithKline