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Phase II Study to Evaluate the Efficacy of AMG 317

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00436670
First received: February 15, 2007
Last updated: April 9, 2009
Last verified: April 2009
  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 2

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, 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
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

  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
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: NCT00436670

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: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00436670     History of Changes
Other Study ID Numbers: 20060161
Study First Received: February 15, 2007
Last Updated: April 9, 2009
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

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

ClinicalTrials.gov processed this record on November 20, 2014