Safety and pharmacodynamics of KB002, an anti granulocyte monocyte colony stimulating factor (GM-CSF) monoclonal antibody, in patients with persistent symptomatic asthma

Completed

• Conditions: Persistent symptomatic asthma; Respiratory - Asthma

• Registration Number: ACTRN12607000554460
• Lead Sponsor: Kalobios Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-10-29
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Aged 18 – 75 years inclusive at screening 2. Males and females. Females of childbearing age may participate only if they have a negative pregnancy test, are non-lactating, and agree to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for the duration of the study 3. An established diagnosis of asthma for at least 2 years at screening 4. Astthma control questionaire score of >0.75 at screening 5. Have persistent asthma as defined as being symptomatic despite being treated with >/= 500 µg/day beclomethasone (BDP) equivalent of inhaled and/or >/= 7.5mg prednisolone equivalent oral corticosteroids

Exclusion Criteria

1. Acute asthma attack or lower respiratory tract infection within 1 month prior to baseline (Day 0)
2. History of life threatening asthma with admission to the intensive care unit requiring the use of mechanical ventilation within the past three years
3. History of any cardiovascular, neurological, hepatic, renal, or other medical conditions that in the Investigator’s opinion may interfere with the interpretation of data or the patient’s participation in the study
4. History of smoking within the past year or a greater than 20 pack year history of smoking
5. History of alcohol or drug abuse
6. Omalizumab (Xolair) therapy within 2 months prior to baseline (Day 0)
7. Participation in another research trial within 1 month prior to baseline (Day 0)
8. Inability to give consent and/or unwillingness/inability to comply with study procedures

Study & Design

• Study Type: Interventional
• Study Design: Not specified