Double-blind, Multiple Dose Study in Subjects With Mild Atopic Asthma
This study is currently recruiting participants.
Verified September 2012 by Amgen
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01405963
First received: July 21, 2011
Last updated: September 28, 2012
Last verified: September 2012
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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 ]
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | March 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01405963
Contacts
| Contact: Amgen Call Center | 866-572-6436 |
Locations
| Canada, Alberta | |
| Research Site | Recruiting |
| Calgary, Alberta, Canada, T2N 4Z6 | |
| Canada, British Columbia | |
| Research Site | Recruiting |
| Vancouver, British Columbia, Canada, V5Z 1M9 | |
| Canada, Ontario | |
| Research Site | Recruiting |
| Hamilton, Ontario, Canada, L8N 3Z5 | |
| Canada, Quebec | |
| Research Site | Recruiting |
| Sainte-Foy, Quebec, Canada, G1V 4G5 | |
| Canada, Saskatchewan | |
| Research Site | Recruiting |
| Saskatoon, Saskatchewan, Canada, S7N 0W8 | |
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
No publications provided
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT01405963 History of Changes |
| Other Study ID Numbers: | 20101183 |
| Study First Received: | July 21, 2011 |
| Last Updated: | September 28, 2012 |
| 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 May 16, 2013