Phase II Study to Evaluate the Efficacy of AMG 317

February 23, 2016 updated by: Amgen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

294

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • AMG 317 300 mg dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in frequency of rescue beta agonist use during week 12
Time Frame: 12 weeks
12 weeks
Change from baseline PEFR during week 12 (morning/evening, diurnal and inter-day variation)
Time Frame: 12 weeks
12 weeks
Change in pre and post bronchodilator FEV1 at week 12 from baseline
Time Frame: 12 weeks
12 weeks
Number of asthma symptom-free days
Time Frame: 16 weeks
16 weeks
Change from baseline in daily asthma symptoms during week 12
Time Frame: 12 weeks
12 weeks
Safety endpoints: number of asthma exacerbations, antibodies, adverse events, and change in ECG, labs and vital signs
Time Frame: 16 weeks
16 weeks
Change in AQLQ score at week 12 from baseline
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

February 15, 2007

First Submitted That Met QC Criteria

February 15, 2007

First Posted (Estimate)

February 19, 2007

Study Record Updates

Last Update Posted (Estimate)

March 23, 2016

Last Update Submitted That Met QC Criteria

February 23, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20060161

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Asthma

Clinical Trials on AMG 317 75 mg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe