A Study to Evaluate the Dosing of AMG 827 for Subjects With Inadequately Controlled Asthma

October 29, 2021 updated by: Amgen

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Determine the Safety and Efficacy of AMG 827 in Subjects With Inadequately Controlled Asthma

The purpose of this study is to determine if AMG 827 is effective compared to placebo as measured by change in Asthma Control Questionnaire (ACQ) composite scores.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

315

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Feldbach, Austria
        • Research Site
      • Hallein, Austria
        • Research Site
      • Wien, Austria
        • Research Site
  • Belgium
      • Bruxelles, Belgium
        • Research Site
      • Leuven, Belgium
        • Research Site
      • Liege, Belgium
        • Research Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Research Site
    • Ontario
      • Ottawa, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
  • Finland
      • Helsinki, Finland
        • Research Site
      • Jyväskylä, Finland
        • Research Site
      • Turku, Finland
        • Research Site
  • Hungary
      • Edeleny, Hungary
        • Research Site
      • Matrahaza, Hungary
        • Research Site
      • Tatabanya, Hungary
        • Research Site
      • Torokbalint, Hungary
        • Research Site
      • Zalaegerszeg - Pozva, Hungary
        • Research Site
  • Korea, Republic of
      • Bucheon-si, Korea, Republic of
        • Research Site
      • Seoul, Korea, Republic of
        • Research Site
      • Suwon, Korea, Republic of
        • Research Site
  • Netherlands
      • Rotterdam, Netherlands
        • Research Site
  • Poland
      • Bialystok, Poland
        • Research Site
      • Chodziez, Poland
        • Research Site
      • Gdansk, Poland
        • Research Site
      • Wroclaw, Poland
        • Research Site
  • Russian Federation
      • Moscow, Russian Federation
        • Research Site
      • Saint Petersburg, Russian Federation
        • Research Site
  • United States
    • California
      • Encinitas, California, United States
        • Research Site
      • Huntington Beach, California, United States
        • Research Site
      • Los Angeles, California, United States
        • Research Site
      • San Diego, California, United States
        • Research Site
      • Stockton, California, United States
        • Research Site
    • Colorado
      • Colorado Springs, Colorado, United States
        • Research Site
    • Georgia
      • Stockbridge, Georgia, United States
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States
        • Research Site
    • Massachusetts
      • North Dartmouth, Massachusetts, United States
        • Research Site
    • Missouri
      • Saint Louis, Missouri, United States
        • Research Site
    • Montana
      • Bozeman, Montana, United States
        • Research Site
    • Nebraska
      • Bellevue, Nebraska, United States
        • Research Site
    • New Jersey
      • Skillman, New Jersey, United States
        • Research Site
    • New York
      • Rockville Centre, New York, United States
        • Research Site
    • North Carolina
      • High Point, North Carolina, United States
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States
        • Research Site
    • Oregon
      • Lake Oswego, Oregon, United States
        • Research Site
      • Medford, Oregon, United States
        • Research Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • Research Site
    • Texas
      • Dallas, Texas, United States
        • Research Site
      • El Paso, Texas, United States
        • Research Site
    • Wisconsin
      • Madison, Wisconsin, United States
        • Research Site

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:

  • Men or women 18 to 65 years of age
  • Percent of predicted FEV1 ≥ 50% and ≤ 80%
  • At least 12% reversibility over pre-bronchodilator FEV1
  • Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000 µg/day fluticasone powder or equivalent
  • Ongoing asthma symptoms with ACQ composite score ≥ 1.5 points

Exclusion Criteria:

  • Respiratory infection within 4 weeks of screening visit or 1 week of baseline visit
  • History of chronic obstructive pulmonary disease or other chronic pulmonary condition other than asthma
  • Any uncontrolled or clinically significant systemic disease (eg, uncontrolled diabetes, 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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive the matching placebo administered as subcutaneous (SC) injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
Drug: Placebo
SC injection.
Experimental: AMG 827 140 mg
Participants will receive AMG 140 mg administered as SC injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
Drug: AMG 827
SC injection.
Experimental: AMG 827 210 mg
Participants will receive AMG 210 mg administered as SC injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
Drug: AMG 827
SC injection.
Experimental: AMG 827 280 mg
Participants will receive AMG 280 mg administered as SC injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
Drug: AMG 827
SC injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Asthma Control Questionnaire (ACQ) Composite Scores to Week 12
Time Frame: Baseline and Week 12

The ACQ is an instrument used in clinical research and practice to evaluate asthma control/impairment.

It is a validated composite score that assesses disease control by evaluating 7 questions: night time awakenings, asthma symptoms upon awakening, activity limitation, shortness of breath, wheeze frequency, short-acting bronchodilator use, and forced expiratory volume in 1 second (FEV1).

The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/limitation) scale. The total score is obtained by adding the value from each question and dividing by the number of questions. Higher scores indicates worsening of condition and a negative change from baseline indicates improvement.
Baseline and Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Pre- and Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: Baseline and Week 12
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. FEV1 was performed both pre and post-administration of bronchodilator treatment at Baseline and Week 12.
Baseline and Week 12
Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) to Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Change From Baseline in the Frequency of Rescue Short Acting β-Agonist (SABA) Use to Week 12
Time Frame: Baseline to Week 12
Participants recorded SABA use for 1 week prior to randomization (baseline) and the average number of days recorded was subtracted from average days of SABA use across 12 week intervention period.
Baseline to Week 12
Change From Baseline in Daily Asthma Symptom Score to Week 12
Time Frame: Baseline and Week 12

Participants recorded their daily asthma symptoms in their electronic diaries (Ediary). It included 7 questions: frequency of night time awakening, time awake at night, wheezing, shortness of breath, cough, chest tightness and activity limitation.

Daily asthma symptoms score is the sum of 7 individual scores (with the total score ranging from 0-21).

Higher scores indicates worsening of condition and a negative change from baseline indicates improvement.
Baseline and Week 12
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score at Week 12
Time Frame: Baseline and Week 12

The AQLQ is the most commonly used asthma specific instrument and includes evaluations of both symptom and quality of life measures. The 32-item instrument measures 4 domains affected by asthma including activity limitations, emotional function, exposure to environmental stimuli, and symptoms (Mitchell EA et al, 1997, Juniper et al, 1994, Christie MJ et al, 1993, Juniper et al, 1993).

Participants were asked to recall their experiences during the last 2 weeks and to respond to each question on a 7-point scale (7=no impairment, 1=severe impairment). The overall score = mean of the responses to the 32 questions.

Higher scores indicate "better quality of life" and a positive change from baseline indicates improved symptoms.
Baseline and Week 12
Proportion of Asthma Symptom-free Days
Time Frame: Up to Week 12

Asthma symptom-free days were defined as a participant having a score of zero in their daily asthma symptom score. Asthma symptom-free days without SABA use were defined as a participant having a score of zero in their daily asthma symptom score and no SABA use.

The proportion of asthma symptom-free days was calculated as the number of asthma symptom-free days over the number of days in the double-blind treatment period (12 weeks).
Up to Week 12
Time to Maximum Observed Concentration (Tmax) of AMG 827 at Week 8 to 10
Time Frame: Week 8 (days 60 and 64), and pre-dose on Week 10
Week 8 (days 60 and 64), and pre-dose on Week 10
Maximum Observed Concentration (Cmax) of AMG 827 at Week 8 to 10
Time Frame: Week 8 (days 60 and 64), and pre-dose on Week 10
Week 8 (days 60 and 64), and pre-dose on Week 10
Area Under the Concentration-time Curve During the Dosing Interval (AUCtau) of AMG 827 at Week 8 to 10
Time Frame: Week 8 (days 60 and 64), and pre-dose on Week 10
Week 8 (days 60 and 64), and pre-dose on Week 10

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 (Actual)

October 4, 2010

Primary Completion (Actual)

December 21, 2011

Study Completion (Actual)

December 21, 2011

Study Registration Dates

First Submitted

August 5, 2010

First Submitted That Met QC Criteria

September 9, 2010

First Posted (Estimate)

September 10, 2010

Study Record Updates

Last Update Posted (Actual)

November 26, 2021

Last Update Submitted That Met QC Criteria

October 29, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20090203

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.

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