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

January 30, 2015 updated by: Humanigen, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Cairns, Queensland, Australia, 4870
      • Woolonggabba, Queensland, Australia, 4102
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
      • Woodville, South Australia, Australia, 5011
    • Victoria
      • Box Hill, Victoria, Australia, 3128
      • Frankston, Victoria, Australia, 3199
      • Melbourne, Victoria, Australia, 3050
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
  • France
      • Marseille, France, 13015
      • Montpellier, France, 34295
      • Rennes, France, 35033
      • Strasbourg, France, 67091
      • Tours, France, 37044
  • Poland
      • Biala Rawska, Poland, 96-230
      • Bydgoszcz, Poland, 85-079
      • Krakow, Poland, 31-159
      • Krakow, Poland, 31-033
      • Lodz, Poland, 90-153
      • Lublin, Poland, 20-089
      • Piasta, Poland, 15-044
    • Podlaskie
      • Bialystok, Podlaskie, Poland, 15-010
    • Slaski
      • Wilomin, Slaski, Poland, 05-200
    • Slaskie
      • Mrozy, Slaskie, Poland, 05-321
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49074
      • Donetsk, Ukraine, 83099
      • Kharkiv, Ukraine, 61124
      • Kyiv, Ukraine, 03680
      • Odessa, Ukraine, 65009
      • Simferopol, Ukraine, 95043
      • Vinnytsya, Ukraine, 21029
      • Yalta, Ukraine, 98600
      • Zaporizhzhya, Ukraine, 69035
  • United Kingdom
      • Southampton, United Kingdom, SO16 6YD
    • Lanarkshire
      • Wishaw, Lanarkshire, United Kingdom, ML2 0DP
    • Middlesex
      • Northwood, Middlesex, United Kingdom, HA6 2RN
    • West Yorkshire
      • Bradford, West Yorkshire, United Kingdom, BD9 6RJ
      • Leeds, West Yorkshire, United Kingdom, LS9 7TF
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
    • California
      • Fullerton, California, United States, 92835
      • Granada Hills, California, United States, 91344
      • Los Angeles, California, United States, 90025
      • Rancho Mirage, California, United States, 92270
      • Sacramento, California, United States, 95819
      • San Jose, California, United States, 95117
    • Colorado
      • Centennial, Colorado, United States, 80112
      • Colorado Springs, Colorado, United States, 80907
      • Denver, Colorado, United States, 80206
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
    • Florida
      • Miami, Florida, United States, 33136
      • Miami, Florida, United States, 33171
      • Tampa, Florida, United States, 33613
      • Winter Park, Florida, United States, 32789
    • Georgia
      • Duluth, Georgia, United States, 30096
      • Lawrenceville, Georgia, United States, 30046
      • Savannah, Georgia, United States, 31405
    • Kentucky
      • Lexington, Kentucky, United States, 40536
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
    • Missouri
      • St. Louis, Missouri, United States, 63110
    • Nevada
      • Reno, Nevada, United States, 89502
    • New Jersey
      • Summit, New Jersey, United States, 07901
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
      • Oklahoma City, Oklahoma, United States, 73131
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
    • South Carolina
      • Charleston, South Carolina, United States, 29425
      • Charleston, South Carolina, United States, 29407
      • Greenville, South Carolina, United States, 29615
    • Texas
      • Arlington, Texas, United States, 76012
      • Sugarland, Texas, United States, 77479
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Percent Predicted FEV1 at Week 24
Time Frame: Baseline to Week 24
Baseline to Week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
To Evaluate the Efficacy of KB003 as Measured by Asthma Exacerbation Rate
Time Frame: Week 24
Week 24
To Evaluate the Effect of KB003 on Peak Expiratory Flow (PEF)
Time Frame: Week 24
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
Time Frame: Week 24
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Humanigen, Inc.

Investigators

  • Study Chair: Nestor A. Molfino, MD, MSc, KaloBios Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

May 16, 2012

First Submitted That Met QC Criteria

May 18, 2012

First Posted (Estimate)

May 22, 2012

Study Record Updates

Last Update Posted (Estimate)

February 2, 2015

Last Update Submitted That Met QC Criteria

January 30, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KB003-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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