Phase II Study to Evaluate the Efficacy of AMG 317
This study has been completed.
Sponsor:
Amgen
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00436670
First received: February 15, 2007
Last updated: April 9, 2009
Last verified: April 2009
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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 |
Resource links provided by NLM:
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 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 Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013