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

A Randomized Placebo-Controlled Safety and Pharmacodynamic Study of KB002, an Anti-GM-CSF Monoclonal Antibody, in Patients with Persistent Symptomatic Asthma

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000554460

Enrollment

Registered

2007-10-29

Start date

2008-01-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to look at the safety and effectiveness of a drug called KB002. KB002 is a monoclonal antibody which specifically target parts of the immune system that lead to inflammation, which can contribute to asthma. This study will help decide if KB002 may be safe at reducing the symptoms of asthma.

Interventions

200mL infusion of 5.0mg/kg KB002 in 0.9% sodium chloride over 1 hour

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

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

Outcome results