Effect of KB003 in Subjects With Asthma Inadequately Controlled by Corticosteroids
NCT ID: NCT01603277
Last Updated: 2015-02-02
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
160 participants
INTERVENTIONAL
2012-07-31
2014-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
GB001 in Adult Subjects With Moderate to Severe Asthma
NCT03683576
A Study to Evaluate the Safety and Tolerability of the Administration of MEDI-528 When Administered in Multiple Doses to Adults With Mild Persistent Asthma
NCT00507130
A Study to Evaluate the Effectiveness and Safety of MEDI-528 in Adults
NCT00968669
Clinical Trial of MG-K10 in Stage III of Moderate to Severe Asthma
NCT06837922
Efficacy and Safety Study of GSK3772847 in Subjects With Moderately Severe Asthma
NCT03207243
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Anti-GM-CSF Monoclonal Antibody 400mg
Anti-GM-CSF Monoclonal Antibody 400mg
Anti-GM-CSF Monoclonal Antibody 400mg
Normal Saline
Placebo
Normal Saline
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Anti-GM-CSF Monoclonal Antibody 400mg
Anti-GM-CSF Monoclonal Antibody 400mg
Placebo
Normal Saline
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Symptomatic asthma as defined by the Juniper Asthma Control Questionnaire
* Symptomatic asthma despite stable treatment with inhaled corticosteroids fluticasone or budesonide, or other corticosteroids, for at least 12 weeks
* Currently receiving inhaled long-acting beta agonist (LABA) or previously documented LABA intolerability or lack of responsiveness
* At least 2 exacerbations (no more than 6) in the previous 12 months that required systemic corticosteroids or at least a doubling of daily oral dose
Exclusion Criteria
* History of life-threatening asthma with admission to the intensive care unit requiring the use of mechanical ventilation within the past 12 months
* Use of any immunosuppressive or immunomodulatory agents within 12 weeks or an investigational agent within 4 weeks prior to Screening Visit
* History of any cardiovascular, neurological, hepatic, or renal condition
* History of smoking within the past 12 months
16 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Humanigen, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nestor A. Molfino, MD, MSc
Role: STUDY_CHAIR
KaloBios Pharmaceuticals, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Birmingham, Alabama, United States
Fullerton, California, United States
Granada Hills, California, United States
Los Angeles, California, United States
Rancho Mirage, California, United States
Sacramento, California, United States
San Jose, California, United States
Centennial, Colorado, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Waterbury, Connecticut, United States
Miami, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
Winter Park, Florida, United States
Duluth, Georgia, United States
Lawrenceville, Georgia, United States
Savannah, Georgia, United States
Lexington, Kentucky, United States
Ann Arbor, Michigan, United States
St Louis, Missouri, United States
Reno, Nevada, United States
Summit, New Jersey, United States
Winston-Salem, North Carolina, United States
Oklahoma City, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Warwick, Rhode Island, United States
Charleston, South Carolina, United States
Charleston, South Carolina, United States
Greenville, South Carolina, United States
Arlington, Texas, United States
Sugarland, Texas, United States
Milwaukee, Wisconsin, United States
Cairns, Queensland, Australia
Woolonggabba, Queensland, Australia
Bedford Park, South Australia, Australia
Woodville, South Australia, Australia
Box Hill, Victoria, Australia
Frankston, Victoria, Australia
Melbourne, Victoria, Australia
Nedlands, Western Australia, Australia
Marseille, , France
Montpellier, , France
Rennes, , France
Strasbourg, , France
Tours, , France
Bialystok, Podlaskie Voivodeship, Poland
Mrozy, Silesian Voivodeship, Poland
Wiłomin, Slaski, Poland
Biała Rawska, , Poland
Bydgoszcz, , Poland
Krakow, , Poland
Krakow, , Poland
Lodz, , Poland
Lublin, , Poland
Piasta, , Poland
Dnipropetrovsk, , Ukraine
Donetsk, , Ukraine
Kharkiv, , Ukraine
Kyiv, , Ukraine
Odesa, , Ukraine
Simferopol, , Ukraine
Vinnytsia, , Ukraine
Yalta, , Ukraine
Zaporizhzhya, , Ukraine
Wishaw, Lanarkshire, United Kingdom
Northwood, Middlesex, United Kingdom
Bradford, West Yorkshire, United Kingdom
Leeds, West Yorkshire, United Kingdom
Southampton, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Molfino NA, Kuna P, Leff JA, Oh CK, Singh D, Chernow M, Sutton B, Yarranton G. Phase 2, randomised placebo-controlled trial to evaluate the efficacy and safety of an anti-GM-CSF antibody (KB003) in patients with inadequately controlled asthma. BMJ Open. 2016 Jan 6;6(1):e007709. doi: 10.1136/bmjopen-2015-007709.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KB003-04
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.