Clinical trial NCT01603277: Effect of KB003 in Subjects With Asthma Inadequately Controlled by Corticosteroids
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Moderate-to-Severe Asthma
Keywords: Asthma
GM-CSF
Moderate-to-Severe Asthma
Lead sponsor: Humanigen, Inc.
Sponsor class: INDUSTRY
First posted: 2012-05-22
Enrollment: 160
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Change in Percent Predicted FEV1 at Week 24
timeFrame: Baseline to Week 24
Secondary outcomes:
measure: To Evaluate the Efficacy of KB003 as Measured by Asthma Exacerbation Rate
timeFrame: Week 24
measure: To Evaluate the Effect of KB003 on Peak Expiratory Flow (PEF)
timeFrame: Week 24
measure: To Evaluate the Safety and Tolerability of KB003 as Measured by Frequency and Severity of AEs, Clinical Safety, Laboratory Abnormalities and Chest Radiographic Assessments
timeFrame: Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Fullerton
country: United States
state: California
city: Granada Hills
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Rancho Mirage
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Jose
country: United States
state: California
city: Centennial
country: United States
state: Colorado
city: Colorado Springs
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Waterbury
country: United States
state: Connecticut
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Winter Park
country: United States
state: Florida
city: Duluth
country: United States
state: Georgia
city: Lawrenceville
country: United States
state: Georgia
city: Savannah
country: United States
state: Georgia
city: Lexington
country: United States
state: Kentucky
city: Ann Arbor
country: United States
state: Michigan
city: St. Louis
country: United States
state: Missouri
city: Reno
country: United States
state: Nevada
city: Summit
country: United States
state: New Jersey
city: Winston-Salem
country: United States
state: North Carolina
city: Oklahoma City
country: United States
state: Oklahoma
city: Oklahoma City
country: United States
state: Oklahoma
city: Warwick
country: United States
state: Rhode Island
city: Charleston
country: United States
state: South Carolina
city: Charleston
country: United States
state: South Carolina
city: Greenville
country: United States
state: South Carolina
city: Arlington
country: United States
state: Texas
city: Sugarland
country: United States
state: Texas
city: Milwaukee
country: United States
state: Wisconsin
city: Cairns
country: Australia
state: Queensland
city: Woolonggabba
country: Australia
state: Queensland
city: Bedford Park
country: Australia
state: South Australia
city: Woodville
country: Australia
state: South Australia
city: Box Hill
country: Australia
state: Victoria
city: Frankston
country: Australia
state: Victoria
city: Melbourne
country: Australia
state: Victoria
city: Nedlands
country: Australia
state: Western Australia
city: Marseille
country: France
city: Montpellier
country: France
city: Rennes
country: France
city: Strasbourg
country: France
city: Tours
country: France
city: Bialystok
country: Poland
state: Podlaskie
city: Mrozy
country: Poland
state: Slaskie
city: Wilomin
country: Poland
state: Slaski
city: Biala Rawska
country: Poland
city: Bydgoszcz
country: Poland
city: Krakow
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Piasta
country: Poland
city: Dnipropetrovsk
country: Ukraine
city: Donetsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Odessa
country: Ukraine
city: Simferopol
country: Ukraine
city: Vinnytsya
country: Ukraine
city: Yalta
country: Ukraine
city: Zaporizhzhya
country: Ukraine
city: Wishaw
country: United Kingdom
state: Lanarkshire
city: Northwood
country: United Kingdom
state: Middlesex
city: Bradford
country: United Kingdom
state: West Yorkshire
city: Leeds
country: United Kingdom
state: West Yorkshire
city: Southampton
country: United Kingdom
Study officials:
affiliation: KaloBios Pharmaceuticals, Inc.
name: Nestor A. Molfino, MD, MSc
role: STUDY_CHAIR
References:
citation: 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.