Back to results

Phase II Study to Evaluate the Efficacy of AMG 317

Primary Purpose

Asthma

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

AMG 317 75 mg

AMG 317 150 mg

AMG 317 300 mg

Placebo

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Allergy, IL-13, IL-4, IL-4R

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

AMG 317 75 mg

Placebo Arm

AMG 317 300 mg

AMG 317 150 mg

Arm Description

75 subjects

Outcomes

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.

Secondary Outcome Measures

Change from baseline in frequency of rescue beta agonist use during week 12

Change from baseline PEFR during week 12 (morning/evening, diurnal and inter-day variation)

Change in pre and post bronchodilator FEV1 at week 12 from baseline

Number of asthma symptom-free days

Change from baseline in daily asthma symptoms during week 12

Safety endpoints: number of asthma exacerbations, antibodies, adverse events, and change in ECG, labs and vital signs

Change in AQLQ score at week 12 from baseline

Full Information

NCT ID

NCT00436670

First Posted

February 15, 2007

Last Updated

February 23, 2016

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT00436670

Brief Title

Phase II Study to Evaluate the Efficacy of AMG 317

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amgen

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Asthma, Allergy, IL-13, IL-4, IL-4R

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

294 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AMG 317 75 mg

Arm Type

Experimental

Arm Description

75 subjects

Arm Title

Placebo Arm

Arm Type

Placebo Comparator

Arm Description

75 subjects

Arm Title

AMG 317 300 mg

Arm Type

Experimental

Arm Description

75 subjects

Arm Title

AMG 317 150 mg

Arm Type

Experimental

Arm Description

75 subjects

Intervention Type

Biological

Intervention Name(s)

AMG 317 75 mg

Intervention Description

75 mg SC weekly injection

Intervention Type

Biological

Intervention Name(s)

AMG 317 150 mg

Other Intervention Name(s)

AMG 317 300 mg dose

Intervention Description

150 mg SC once weekly injection

Intervention Type

Biological

Intervention Name(s)

AMG 317 300 mg

Intervention Description

300 mg weekly SC injection

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

Placebo SC once weekly injection

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Change from baseline in frequency of rescue beta agonist use during week 12

Time Frame

12 weeks

Title

Change from baseline PEFR during week 12 (morning/evening, diurnal and inter-day variation)

Time Frame

12 weeks

Title

Change in pre and post bronchodilator FEV1 at week 12 from baseline

Time Frame

12 weeks

Title

Number of asthma symptom-free days

Time Frame

16 weeks

Title

Change from baseline in daily asthma symptoms during week 12

Time Frame

12 weeks

Title

Safety endpoints: number of asthma exacerbations, antibodies, adverse events, and change in ECG, labs and vital signs

Time Frame

16 weeks

Title

Change in AQLQ score at week 12 from baseline

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Organizational Affiliation

Amgen

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

21093024

Citation

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.

Results Reference

derived

PubMed Identifier

20056900

Citation

Corren 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.

Results Reference

derived

Links:

URL

http://www.amgentrials.com

Description

AmgenTrials clinical trials website

Learn more about this trial

Phase II Study to Evaluate the Efficacy of AMG 317

We'll reach out to this number within 24 hrs