Effect of KB003 in Subjects With Asthma Inadequately Controlled by Corticosteroids

Study Overview
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Brief Summary
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This study will evaluate the safety, tolerability and efficacy of a single dose level of KB003 in subjects with inadequately controlled asthma.

Official Title
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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

Conditions
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Moderate-to-Severe Asthma

Intervention / Treatment
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* Biological: Anti-GM-CSF Monoclonal Antibody 400mg
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: A diagnosis of asthma established for at least 2 years 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 Key Exclusion Criteria: Acute asthma worsening (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. 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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anti-GM-CSF Monoclonal Antibody 400mg<br> | Biological: Anti-GM-CSF Monoclonal Antibody 400mg<br>* Anti-GM-CSF Monoclonal Antibody 400mg<br>|
| Placebo Comparator: Normal Saline<br> | Other: Placebo<br>* Normal Saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Percent Predicted FEV1 at Week 24 |  | Baseline to Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Evaluate the Efficacy of KB003 as Measured by Asthma Exacerbation Rate |  | Week 24 | 
| To Evaluate the Effect of KB003 on Peak Expiratory Flow (PEF) |  | Week 24 | 
| To Evaluate the Safety and Tolerability of KB003 as Measured by Frequency and Severity of AEs, Clinical Safety, Laboratory Abnormalities and Chest Radiographic Assessments |  | Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, GM-CSF, Moderate-to-Severe Asthma