Effect of KB003 in Subjects With Asthma Inadequately Controlled by Corticosteroids

Phase 2

Completed

• Conditions: Moderate-to-Severe Asthma
• Interventions: Other: Placebo; Biological: Anti-GM-CSF Monoclonal Antibody 400mg

• Registration Number: NCT01603277
• Lead Sponsor: Humanigen, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-16
• Study First Submitted QC: 2012-05-18
• Study First Posted: 2012-05-22
• Study Start: 2012-07
• Primary Completion: 2013-07
• Study Completion: 2014-01
• Status Verified: 2015-01
• Results First Submitted: 2015-01-12
• Results First Submitted QC: 2015-01-30
• Last Update Submitted: 2015-01-30
• Results First Posted: 2015-02-02
• Last Update Posted: 2015-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline	Placebo	-
Anti-GM-CSF Monoclonal Antibody 400mg	Anti-GM-CSF Monoclonal Antibody 400mg	-

Primary Outcome Measures

Name	Time	Method
Change in Percent Predicted FEV1 at Week 24	Baseline to Week 24

Secondary Outcome Measures

Name	Time	Method
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