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

This study is currently recruiting participants.
Verified April 2013 by KaloBios Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
KaloBios Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01603277
First received: May 16, 2012
Last updated: April 12, 2013
Last verified: April 2013
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Asthma Steroids
U.S. FDA Resources

Further study details as provided by KaloBios Pharmaceuticals:

Primary Outcome Measures:
  • Evaluate the effect of KB003 on lung function in subjects with asthma inadequately controlled by corticosteroids, as measured by change in percent predicted FEV1 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the efficacy of KB003 as measured by asthma exacerbation rate [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • To evaluate the effect of KB003 on peak expiratory flow (PEF) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: July 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01603277

Contacts
Contact: Josh Pelham 650-243-3125 jpelham@kalobios.com

  Show 52 Study Locations
Sponsors and Collaborators
KaloBios Pharmaceuticals
Investigators
Study Chair: Nestor A. Molfino, MD, MSc KaloBios Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: KaloBios Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01603277     History of Changes
Other Study ID Numbers: KB003-04
Study First Received: May 16, 2012
Last Updated: April 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by KaloBios Pharmaceuticals:
Asthma
GM-CSF
Moderate-to-Severe Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
 Immune System Diseases
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013