Effect of KB003 in Subjects With Asthma Inadequately Controlled by Corticosteroids

NCT01603277 | Completed Phase 2 Results DMC

• 1 other identifier: KB003-04
• Study Type: interventional
• Target: 160
• Locations: 6 countries
• Sites: 70

Brief Summary

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

Conditions

Moderate-to-Severe Asthma

Keywords

Asthma; GM-CSF; Moderate-to-Severe Asthma

Outcome Measures

Primary Outcomes (1)

• Change in Percent Predicted FEV1 at Week 24

  Baseline to Week 24

Secondary Outcomes (3)

• 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

Study Arms (2)

Anti-GM-CSF Monoclonal Antibody 400mg

EXPERIMENTAL

Biological: Anti-GM-CSF Monoclonal Antibody 400mg

Normal Saline

PLACEBO COMPARATOR

Other: Placebo

Interventions

Anti-GM-CSF Monoclonal Antibody 400mg BIOLOGICAL

Anti-GM-CSF Monoclonal Antibody 400mg

Anti-GM-CSF Monoclonal Antibody 400mg

Placebo OTHER

Normal Saline

Normal Saline

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Humanigen, Inc.: lead

Study Sites (70)

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Birmingham, Alabama, 35216, United States

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Fullerton, California, 92835, United States

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Granada Hills, California, 91344, United States

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Los Angeles, California, 90025, United States

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Rancho Mirage, California, 92270, United States

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Sacramento, California, 95819, United States

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San Jose, California, 95117, United States

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Centennial, Colorado, 80112, United States

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Colorado Springs, Colorado, 80907, United States

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Denver, Colorado, 80206, United States

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Waterbury, Connecticut, 06708, United States

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Miami, Florida, 33136, United States

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Miami, Florida, 33171, United States

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Tampa, Florida, 33613, United States

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Winter Park, Florida, 32789, United States

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Duluth, Georgia, 30096, United States

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Lawrenceville, Georgia, 30046, United States

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Savannah, Georgia, 31405, United States

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Lexington, Kentucky, 40536, United States

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Ann Arbor, Michigan, 48109, United States

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St Louis, Missouri, 63110, United States

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Reno, Nevada, 89502, United States

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Summit, New Jersey, 07901, United States

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Winston-Salem, North Carolina, 27157, United States

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Oklahoma City, Oklahoma, 73120, United States

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Oklahoma City, Oklahoma, 73131, United States

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Warwick, Rhode Island, 02886, United States

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Charleston, South Carolina, 29407, United States

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Charleston, South Carolina, 29425, United States

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Greenville, South Carolina, 29615, United States

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Arlington, Texas, 76012, United States

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Sugarland, Texas, 77479, United States

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Milwaukee, Wisconsin, 53226, United States

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Cairns, Queensland, 4870, Australia

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Woolonggabba, Queensland, 4102, Australia

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Bedford Park, South Australia, 5042, Australia

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Woodville, South Australia, 5011, Australia

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Box Hill, Victoria, 3128, Australia

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Frankston, Victoria, 3199, Australia

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Melbourne, Victoria, 3050, Australia

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Nedlands, Western Australia, 6009, Australia

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Marseille, 13015, France

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Montpellier, 34295, France

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Rennes, 35033, France

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Strasbourg, 67091, France

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Tours, 37044, France

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Bialystok, Podlaskie Voivodeship, 15-010, Poland

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Mrozy, Silesian Voivodeship, 05-321, Poland

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Wiłomin, Slaski, 05-200, Poland

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Biała Rawska, 96-230, Poland

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Bydgoszcz, 85-079, Poland

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Krakow, 31-033, Poland

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Krakow, 31-159, Poland

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Lodz, 90-153, Poland

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Lublin, 20-089, Poland

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Piasta, 15-044, Poland

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Dnipropetrovsk, 49074, Ukraine

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Donetsk, 83099, Ukraine

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Kharkiv, 61124, Ukraine

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Kyiv, 03680, Ukraine

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Odesa, 65009, Ukraine

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Simferopol, 95043, Ukraine

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Vinnytsia, 21029, Ukraine

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Yalta, 98600, Ukraine

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Zaporizhzhya, 69035, Ukraine

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Wishaw, Lanarkshire, ML2 0DP, United Kingdom

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Northwood, Middlesex, HA6 2RN, United Kingdom

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Bradford, West Yorkshire, BD9 6RJ, United Kingdom

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Leeds, West Yorkshire, LS9 7TF, United Kingdom

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Southampton, SO16 6YD, United Kingdom

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Related Publications (1)

• Molfino NA, Kuna P, Leff JA, Oh CK, Singh D, Chernow M, Sutton B, Yarranton G. Phase 2, randomised placebo-controlled trial to evaluate the efficacy and safety of an anti-GM-CSF antibody (KB003) in patients with inadequately controlled asthma. BMJ Open. 2016 Jan 6;6(1):e007709. doi: 10.1136/bmjopen-2015-007709.

  PMID: 26739717 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Nestor Molfino, MD
• Organization: KaloBios Pharmaceuticals Inc.

nmolfino@kalobios.com

650-243-3100

Study Officials

• Nestor A. Molfino, MD, MSc

  KaloBios Pharmaceuticals, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2012
• First Posted: May 22, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: January 1, 2014
• Last Updated: February 2, 2015
• Results First Posted: February 2, 2015

Record last verified: 2015-01

Locations

PL (10); UA (9); GB (5); AU (8); FR (5); US (33)