Phase II Study to Evaluate the Efficacy of AMG 317 - Full Text View

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00436670

Purpose

A Multi-center, Randomized, Placebo, Multi-Dose study to evaluate the efficacy of AMG 317 compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) symptom scores from baseline to week 12.

Condition	Intervention	Phase
Asthma	Biological: AMG 317 75 mg Biological: AMG 317 150 mg Biological: AMG 317 300 mg Biological: Placebo	Phase II

MedlinePlus related topics: Asthma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Phase 2 Study to Determine the Safety and Efficacy of AMG 317 in Subjects With Moderate to Severe Asthma

Further study details as provided by Amgen:

Primary Outcome Measures:

The primary objective is to evaluate the efficacy of AMG 317 compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) symptom scores from baseline to week 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in frequency of rescue beta agonist use during week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change from baseline PEFR during week 12 (morning/evening, diurnal and inter-day variation) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change in pre and post bronchodilator FEV1 at week 12 from baseline [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Number of asthma symptom-free days [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Change from baseline in daily asthma symptoms during week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Safety endpoints: number of asthma exacerbations, antibodies, adverse events, and change in ECG, labs and vital signs [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
Change in AQLQ score at week 12 from baseline [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	294
Study Start Date:	March 2007
Study Completion Date:	February 2009
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
AMG 317 75 mg: Experimental 75 subjects	Biological: AMG 317 75 mg 75 mg SC weekly injection
Placebo Arm: Placebo Comparator 75 subjects	Biological: Placebo Placebo SC once weekly injection
AMG 317 300 mg: Experimental 75 subjects	Biological: AMG 317 300 mg 300 mg weekly SC injection
AMG 317 150 mg: Experimental 75 subjects	Biological: AMG 317 150 mg 150 mg SC once weekly injection

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males or females 18 to 65 years of age at the time of screening
Baseline percent of predicted FEV1 ≥ 50% to ≤ 80% at screening
At least 12% reversibility over baseline FEV1 with beta agonist inhalation, which can be demonstrated in the office or documented by medical record within the past 12 months
Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000 µg/day fluticasone or equivalent. Stable ICS dose for ≥ 30 days before screening and dose expected to remain stable during treatment with investigational agent. Must have used ICS for at least the last 3 consecutive months before screening
If receiving allergen immunotherapy, a stable dose for > 3 months before screening and anticipated to remain stable for the duration of the study
Positive to skin prick or RAST
Ongoing asthma symptoms with ACQ score at screening and baseline ≥ 1.5 points
Nonsmoker or ex-smoker with < 10 pack-years (eg, 1 pack per day for 10 years) who stopped ≥ 1 year ago

Exclusion Criteria:

Acute asthma exacerbation requiring emergency room (ER) treatment or hospitalization within 3 months
History of endotracheal intubation for asthma-related exacerbation within 3 years of screening
Respiratory illness within 4 weeks of screening
History of chronic obstructive pulmonary disease (COPD) or other chronic pulmonary condition other than asthma
Received long-acting beta agonist, theophylline, inhaled anticholinergics, oral beta 2 agonists, or cromolyn therapeutics within 1 week of first run-in visit.
Leukotriene antagonists within 2 weeks before first run-in visit
Oral or parenteral corticosteroids within 6 weeks before first run-in visit
Live/attenuated vaccinations within 4 weeks of screening or during the study
Any uncontrolled, clinically significant systemic disease (eg, chronic renal failure, uncontrolled hypertension, liver disease)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00436670

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20060161
Study First Received:	February 15, 2007
Last Updated:	April 9, 2009
ClinicalTrials.gov Identifier:	NCT00436670 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by Amgen:

Asthma
Allergy
IL-13
IL-4
IL-4R

Study placed in the following topic categories:

Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Bronchial Diseases

Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

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

Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on May 07, 2009