Phase II Study of KB003 in Subjects with Asthma
Research type
Research Study
Full title
A Phase 2, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Safety, Tolerability, and Efficacy of KB003 in Subjects with Asthma Inadequately Controlled by Corticosteroids.
IRAS ID
106343
Contact name
Dinesh Saralaya
Sponsor organisation
KaloBios Pharmaceuticals, Inc.
Eudract number
2012-001791-11
Clinicaltrials.gov Identifier
Research summary
Asthma is a chronic inflammatory disease of the airways; symptoms include wheezing, coughing, chest tightness and shortness of breath. Approximately 300 million people worldwide are affected by asthma; this number is expected to increase by an additional 100 million by 2025. Inhaled corticosteroids are the mainstay of asthma therapy; however, certain asthmatic individuals show little or no benefit from existing corticosteroid therapies, even at high doses. These individuals have an urgent need for effective anti-inflammatory therapies. The purpose of this research study is to confirm observations from a previous single-dose asthma study and extend them to multiple doses in an asthmatic population having an unmet need. The main study objectives are to evaluate the effect of an investigational drug, KB003, on safety, tolerability, lung function and asthma symptoms in subjects with asthma inadequately controlled by corticosteroids. This is a randomised, double-blind, placebo-controlled, parallel-group, repeat-dose, Phase 2 study in subjects with asthma inadequately controlled by corticosteroids. From 20% to 40% of randomised subjects will be required to have been on oral corticosteroids for at least 12 weeks prior to screening and to have been on a stable dose and treatment regimen for at least 4 weeks prior to screening. Study assessments include, medical history, concomitant medication use, physical examination, vital signs, chest X-ray, clinical laboratories, PK testing in a subset of subjects, anti-KB003 antibody testing, electrocardiograms, monitoring for AEs and SAEs, lung function, asthma exacerbations, asthma control, asthma symptoms and rescue SABA use (Daily Diary) and biomarker testing. The study is sponsored by KaloBios Pharmaceuticals, Inc. The study will be conducted at approximately 65 sites in Europe, the US and Australia and will recruit males and females 16 to 75 years of age inclusive. The study will last approximately 25 months, however each subject??s participation may last approximately 36 weeks.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
12/WM/0226
Date of REC Opinion
31 Jul 2012
REC opinion
Favourable Opinion