Effect of KB003 in Subjects With Asthma Inadequately Controlled by Corticosteroids

Moderate-to-Severe Asthma Clinical Trial

— KB003-04  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01603277
• Other study ID #: KB003-04
• Status: Completed
• Phase: Phase 2
• First received: May 16, 2012
• Last updated: January 30, 2015
• Start date: July 2012
• Est. completion date: January 2014

Study information

• Verified date: January 2015
• Source: KaloBios Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: January 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Moderate-to-Severe Asthma

Intervention

Biological:
• Anti-GM-CSF Monoclonal Antibody 400mg
Anti-GM-CSF Monoclonal Antibody 400mg

Other:
• Placebo
Normal Saline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
KaloBios Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  France,  Poland,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Percent Predicted FEV1 at Week 24		Baseline to Week 24	No
Secondary	To Evaluate the Efficacy of KB003 as Measured by Asthma Exacerbation Rate		Week 24	No
Secondary	To Evaluate the Effect of KB003 on Peak Expiratory Flow (PEF)		Week 24	No
Secondary	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	Yes