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Effect of KB003 in Subjects With Asthma Inadequately Controlled by Corticosteroids (KB003-04)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01603277
Recruitment Status : Completed
First Posted : May 22, 2012
Results First Posted : February 2, 2015
Last Update Posted : February 2, 2015
Sponsor:
Information provided by (Responsible Party):
Humanigen, Inc.

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

Condition or disease Intervention/treatment Phase
Moderate-to-Severe Asthma Biological: Anti-GM-CSF Monoclonal Antibody 400mg Other: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : July 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Anti-GM-CSF Monoclonal Antibody 400mg Biological: Anti-GM-CSF Monoclonal Antibody 400mg
Anti-GM-CSF Monoclonal Antibody 400mg
Placebo Comparator: Normal Saline Other: Placebo
Normal Saline


Outcome Measures
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Primary Outcome Measures :
  1. Change in Percent Predicted FEV1 at Week 24 [ Time Frame: Baseline to Week 24 ]

Secondary Outcome Measures :
  1. To Evaluate the Efficacy of KB003 as Measured by Asthma Exacerbation Rate [ Time Frame: Week 24 ]
  2. To Evaluate the Effect of KB003 on Peak Expiratory Flow (PEF) [ Time Frame: Week 24 ]
  3. To Evaluate the Safety and Tolerability of KB003 as Measured by Frequency and Severity of AEs, Clinical Safety, Laboratory Abnormalities and Chest Radiographic Assessments [ Time Frame: Week 24 ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01603277


Locations
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Sponsors and Collaborators
Humanigen, Inc.
Investigators
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Study Chair: Nestor A. Molfino, MD, MSc KaloBios Pharmaceuticals, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Humanigen, Inc.
ClinicalTrials.gov Identifier: NCT01603277    
Other Study ID Numbers: KB003-04
First Posted: May 22, 2012    Key Record Dates
Results First Posted: February 2, 2015
Last Update Posted: February 2, 2015
Last Verified: January 2015
Keywords provided by Humanigen, Inc.:
Asthma
GM-CSF
Moderate-to-Severe Asthma
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
 Hypersensitivity
Immune System Diseases
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs