A study to look at the safety, tolerability and effect of KB003 in people with asthma.
- Conditions
- Asthma inadequately controlled by corticosteroidsMedDRA version: 14.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2012-001791-11-GB
- Lead Sponsor
- KaloBios Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 150
1. Written and signed informed consent from subject (or assent from legal guardian if under 18 years of age, or legal representative if applicable) prior to any study-specific assessments, and permission to use protected health information in accordance with regional regulations.
2. Males or females aged 16 to 75 years inclusive at Screening Visit.
3. Females of childbearing potential may participate if they have a negative pregnancy test, are nonlactating, and agree to practice a highly effective birth control method (e.g., abstinence, combination barrier and spermicide, hormonal) for the duration of
the study.
4. Physician diagnosis of asthma established for at least 2 years prior to Screening Visit.
5. Symptomatic asthma defined as having an ACQ score =1.5 at Screening and Randomization Visits.
6. Symptomatic asthma despite chronic treatment with inhaled corticosteroids =500 µg/day fluticasone (dry powder or hydrofluoroalkane [HFA] inhaler) or budesonide, or equivalent doses of other inhaled corticosteroids, for at least 12 weeks prior to Screening Visit. A stable dose is required for at least 4 weeks prior
to Screening Visit.
7. For the subset of subjects taking oral corticosteroids, asthma is symptomatic despite treatment with =7.5 mg of prednisolone per day for at least 12 weeks prior to screening. A stable dose is required for at least 4 weeks prior to Screening Visit.
8. Currently receiving LABA. Subjects not receiving LABA must have documented LABA intolerability or lack of responsiveness to LABA.
9. FEV1 from 40% to 80% of the predicted value at Screening and Randomization Visits.
10. At Screening or Randomization visits, demonstrated FEV1 bronchodilator response of =12% (i.e., reversibility) from baseline measurements 15 to 30 minutes after SABA administration.
11. 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 for 3 or more days.
12. Weight from 40 to 125 kg at Screening Visit.
13. Ability to perform spirometry tests according to protocol-specified standards as indicated in the Spirometry Manual.
14. Chest X-ray (CXR) within 12 months of Screening Visit with no evidence of clinically significant abnormality. For subjects who have had an intervening significant cardiac or pulmonary event, a post-event CXR should be obtained.
15. Ability to understand and comply with study requirements including study visits, diary completion. and daily peak flow measurements, as demonstrated during the run-in period.
Are the trial subjects under 18? yes
Number of subjects for this age range: 5
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 117
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 28
1. Acute asthma worsening (defined as requiring emergency room visit, hospitalization, urgent care, physician visit, or change in asthma medications) or lower respiratory tract infection requiring the use of antibiotics within 4 weeks prior to Screening Visit.
2. History of life-threatening asthma, with admission to the intensive care unit requiring the use of mechanical ventilation, within the past 12 months.
3. Use of any immunosuppressive or immunomodulatory agents within 12 weeks or use of an investigational agent within 4 weeks prior to Screening Visit.
4. History of any cardiovascular, neurological, hepatic, renal, or other medical condition that in the Investigator’s opinion may interfere with the interpretation of data or the subject’s participation in the study.
5. History of cigarette or marijuana smoking within the 12 months prior to screening, a >10 pack-year history, or a positive test for nicotine (cotinine).
6. History of alcohol or drug abuse that in the opinion of the Investigator would preclude appropriate compliance with study procedures.
7. Omalizumab (Xolair) therapy within 12 weeks prior to Screening Visit.
8. History of malignancy within the last 5 years. Basal or squamous cell skin carcinoma adequately treated is allowed.
9. Known immunodeficiency including but not limited to human immunodeficiency virus (HIV) infection.
10. Pre-existing lung disease other than asthma that in the Investigator’s opinion may interfere with the interpretation of data or the subject’s participation in the study.
11. Known history of tuberculosis, chronic fungal infection (e.g., histoplasmosis, coccidioidomycosis), or hepatitis C.
12. Prior allergic reaction to a monoclonal antibody. Mild to moderate infusion reactions that are transient and easily treated with medications are allowed.
13. Inability to give consent/assent or unwillingness or inability to comply with study procedures.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method