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Phase II Study to Evaluate the Efficacy of AMG 317

This study has been completed.
Information provided by (Responsible Party):
Amgen Identifier:
First received: February 15, 2007
Last updated: February 23, 2016
Last verified: February 2016
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
Biological: AMG 317 75 mg
Biological: AMG 317 150 mg
Biological: AMG 317 300 mg
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 ]

Secondary Outcome Measures:
  • Change from baseline in frequency of rescue beta agonist use during week 12 [ Time Frame: 12 weeks ]
  • Change from baseline PEFR during week 12 (morning/evening, diurnal and inter-day variation) [ Time Frame: 12 weeks ]
  • Change in pre and post bronchodilator FEV1 at week 12 from baseline [ Time Frame: 12 weeks ]
  • Number of asthma symptom-free days [ Time Frame: 16 weeks ]
  • Change from baseline in daily asthma symptoms during week 12 [ Time Frame: 12 weeks ]
  • Safety endpoints: number of asthma exacerbations, antibodies, adverse events, and change in ECG, labs and vital signs [ Time Frame: 16 weeks ]
  • Change in AQLQ score at week 12 from baseline [ Time Frame: 12 weeks ]

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
Experimental: AMG 317 75 mg
75 subjects
Biological: AMG 317 75 mg
75 mg SC weekly injection
Placebo Comparator: Placebo Arm
75 subjects
Biological: Placebo
Placebo SC once weekly injection
Experimental: AMG 317 300 mg
75 subjects
Biological: AMG 317 300 mg
300 mg weekly SC injection
Experimental: AMG 317 150 mg
75 subjects
Biological: AMG 317 150 mg
150 mg SC once weekly injection
Other Name: AMG 317 300 mg dose


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00436670

Sponsors and Collaborators
Study Director: MD Amgen
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Amgen Identifier: NCT00436670     History of Changes
Other Study ID Numbers: 20060161
Study First Received: February 15, 2007
Last Updated: February 23, 2016

Keywords provided by Amgen:

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases processed this record on April 28, 2017