Phase II Study to Evaluate the Efficacy of AMG 317
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
1 other identifier
interventional
294
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 asthma
Started Mar 2007
Typical duration for phase_2 asthma
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2007
CompletedFirst Posted
Study publicly available on registry
February 19, 2007
CompletedStudy Start
First participant enrolled
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedMarch 23, 2016
February 1, 2016
1.5 years
February 15, 2007
February 23, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
12 weeks
Secondary Outcomes (7)
Change from baseline in frequency of rescue beta agonist use during week 12
12 weeks
Change from baseline PEFR during week 12 (morning/evening, diurnal and inter-day variation)
12 weeks
Change in pre and post bronchodilator FEV1 at week 12 from baseline
12 weeks
Number of asthma symptom-free days
16 weeks
Change from baseline in daily asthma symptoms during week 12
12 weeks
- +2 more secondary outcomes
Study Arms (4)
AMG 317 75 mg
EXPERIMENTAL75 subjects
Placebo Arm
PLACEBO COMPARATOR75 subjects
AMG 317 300 mg
EXPERIMENTAL75 subjects
AMG 317 150 mg
EXPERIMENTAL75 subjects
Interventions
150 mg SC once weekly injection
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Related Publications (2)
Meltzer EO, Busse WW, Wenzel SE, Belozeroff V, Weng HH, Feng J, Chon Y, Chiou CF, Globe D, Lin SL. Use of the Asthma Control Questionnaire to predict future risk of asthma exacerbation. J Allergy Clin Immunol. 2011 Jan;127(1):167-72. doi: 10.1016/j.jaci.2010.08.042. Epub 2010 Nov 18.
PMID: 21093024DERIVEDCorren J, Busse W, Meltzer EO, Mansfield L, Bensch G, Fahrenholz J, Wenzel SE, Chon Y, Dunn M, Weng HH, Lin SL. A randomized, controlled, phase 2 study of AMG 317, an IL-4Ralpha antagonist, in patients with asthma. Am J Respir Crit Care Med. 2010 Apr 15;181(8):788-96. doi: 10.1164/rccm.200909-1448OC. Epub 2010 Jan 7.
PMID: 20056900DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2007
First Posted
February 19, 2007
Study Start
March 1, 2007
Primary Completion
September 1, 2008
Study Completion
February 1, 2009
Last Updated
March 23, 2016
Record last verified: 2016-02