AMG 853 Phase 2 Study in Subjects With Inadequately Controlled Asthma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

397 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-03-31

Brief Summary

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The primary objective is to determine if AMG 853 is effective compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) composite symptoms scores from baseline to week 12.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AMG 853

Group Type EXPERIMENTAL

AMG 853

Intervention Type DRUG

AMG 853 5 mg (BID)

AMG 853

Intervention Type DRUG

AMG 853 200 mg (QD)

AMG 853

Intervention Type DRUG

AMG 853 25 mg (BID)

AMG 853

Intervention Type DRUG

AMG 853 100 mg (BID)

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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AMG 853

AMG 853 5 mg (BID)

Intervention Type DRUG

AMG 853

AMG 853 200 mg (QD)

Intervention Type DRUG

AMG 853

AMG 853 25 mg (BID)

Intervention Type DRUG

AMG 853

AMG 853 100 mg (BID)

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males or females 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 or equivalent.
* Ongoing asthma symptoms with ACQ score ≥ 1.5 points

Exclusion Criteria

* History of chronic obstructive pulmonary disease or other chronic pulmonary condition other than asthma
* Any uncontrolled, clinically significant systemic disease
* Respiratory infection within 4 weeks of the screening visit

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No