Double-blind, Multiple Dose Study in Subjects With Mild Atopic Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01405963
First received: July 21, 2011
Last updated: September 16, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to assess the late asthmatic response, safety and tolerability of AMG 157 following multiple intravenous (IV) dose administration in subjects with mild atopic asthma.


Condition Intervention Phase
Asthma
Drug: AMG 157 Matching Placebo
Drug: AMG 157
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 157 in Subjects With Mild Atopic Asthma

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Evaluate late asthmatic response, as measured by area under the curve (AUC) in the forced expiratory volume (FEV1) in 1 sec btwn 3 & 7 hrs after an allergen inhalation challenge in mild atopic asthmatic subjects [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Evaluate late asthmatic response, as measured by the max percentage fall in the forced expiratory volume (FEV1) in 1 sec btwn 3 & 7 hrs after an allergen inhalation challenge in mild atopic asthmatic subjects [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate early asthmatic response, as measured by area under the curve (AUC) in forced expiratory volume (FEV1) in 1 sec btwn 0 & 2 hrs after an allergen inhalation challenge in mild atopic asthmatic subjects [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Evaluate early asthmatic response, as measured by the max percentage fall in forced expiratory volume (FEV1) in 1 sec btwn 0 & 2 hrs after an allergen inhalation challenge in mild atopic asthmatic subjects [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]
  • Measure the area under the plasma concentration curve versus time of AMG 157 after multiple dose administration in subjects with mild atopic asthma [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Examine the number of adverse events per subject, after multiple dose administration of AMG 157 in subjects with mild atopic asthma [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 31
Study Start Date: September 2011
Study Completion Date: June 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Arm
One dose level of AMG 157 administered as multiple IV doses in subjects with mild atopic asthma.
Drug: AMG 157
One dose level of AMG 157 administered as multiple IV doses in subjects with mild atopic asthma.
Placebo Comparator: Placebo Arm
Placebo comparator administered as a multiple IV doses in subjects with mild atopic asthma
Drug: AMG 157 Matching Placebo
Matching placebo administered as multiple IV doses in subjects with mild atopic asthma

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects with history of mild atopic asthma between 18 and 60 years-of-age
  • Body mass index (BMI) between 18 and 35 kg/m2
  • Normal or clinically acceptable physical examination (PE), clinical laboratory values, and ECG; clinically acceptable PE includes history of mild atopic asthma
  • Used only inhaled short-acting β2-agonists infrequently to treat asthma
  • No current exposure to allergens to which subject experiences asthmatic responses
  • No other lung disease, exacerbations of asthma or lower respiratory tract infections for at least 6 weeks prior to screening
  • Positive skin prick test to common aeroallergens at screening
  • Additional inclusion criteria apply

Exclusion Criteria:

  • History or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion;
  • History or current medical conditions that are contraindicated for methacholine challenge, such as myocardial infarction or stroke within previous 3 months, known cardiac disease, uncontrolled hypertension and aortic or cerebral aneurysm
  • Evidence of active or suspected bacterial, viral, fungal or parasitic infections within past 6 weeks
  • Subject has know type I/II diabetes
  • History of residential exposure to tuberculosis or has a positive PPD or QuantiFERON test within 4 weeks before randomization
  • Subject who has history of malignancy of any type within 5 years prior to enrollment
  • Subjects tested positive for drugs/alcohol or nicotine use at screening
  • Subjects tested positive for HIV, Hep B or Hep C
  • Additional exclusion criteria apply
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01405963

Locations
Canada, Alberta
Research Site
Calgary, Alberta, Canada, T2N 4Z6
Canada, British Columbia
Research Site
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
Research Site
Hamilton, Ontario, Canada, L8N 3Z5
Canada, Quebec
Research Site
Sainte-Foy, Quebec, Canada, G1V 4G5
Canada, Saskatchewan
Research Site
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided by Amgen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01405963     History of Changes
Other Study ID Numbers: 20101183
Study First Received: July 21, 2011
Last Updated: September 16, 2013
Health Authority: Canada: Health Canada

Keywords provided by Amgen:
Amgen
AMG 157
Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on October 16, 2014