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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 15, 2007

Last Updated Date

April 9, 2009

Start Date ^ICMJE

March 2007

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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.

Change History

Complete list of historical versions of study NCT00436670 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

The secondary objectives are to evaluate the efficacy of AMG 317 as measured by change in pre- and post-bronchodilator FEV1.
To evaluate the efficacy of AMG 317 as measured by change in morning and evening peak expiratory flow rate (PEFR)
To evaluate the efficacy of AMG 317 as measured by change in diurnal and inter-day variation of PEFR
To evaluate the efficacy of AMG 317 as measured by change in use of rescue beta-agonist
To evaluate the efficacy of AMG 317 as measured by change in average daily symptoms
To evaluate the efficacy of AMG 317 as measured by change in symptom-free days
To evaluate the efficacy of AMG 317 as measured by change in Asthma Quality Life of Questionnaire (AQLQ).

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Phase II Study to Evaluate the Efficacy of AMG 317

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Biological: AMG 317 75 mg
75 mg SC weekly injection
Biological: AMG 317 150 mg
150 mg SC once weekly injection

Other Name: AMG 317 300 mg dose
Biological: AMG 317 300 mg
300 mg weekly SC injection
Biological: Placebo
Placebo SC once weekly injection

Study Arm (s)

Experimental: AMG 317 75 mg
75 subjects

Intervention: Biological: AMG 317 75 mg
Placebo Comparator: Placebo Arm
75 subjects

Intervention: Biological: Placebo
Experimental: AMG 317 300 mg
75 subjects

Intervention: Biological: AMG 317 300 mg
Experimental: AMG 317 150 mg
75 subjects

Intervention: Biological: AMG 317 150 mg

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

294

Completion Date

February 2009

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00436670

Other Study ID Numbers ^ICMJE

20060161

Has Data Monitoring Committee

Not Provided

Responsible Party

Global Development Leader, Amgen Inc.

Study Sponsor ^ICMJE

Amgen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Amgen

Information Provided By

Amgen

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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