AMG 853 Phase 2 Study in Subjects With Inadequately Controlled Asthma

A Randomized, Double-Blind, Placebo Controlled, Multiple Dose Phase 2 Study to Determine the Safety and Efficacy of AMG 853 in Subjects With Inadequately Controlled Asthma

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01018550

Enrollment

397

Registered

2009-11-23

Start date

2009-10-31

Completion date

2011-03-31

Last updated

2016-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Brief summary

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.

Interventions

DRUGAMG 853

AMG 853 5 mg (BID)

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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.	Baseline to Week 12

Secondary

Measure	Time frame
Evaluate the efficacy of AMG 853 as measured by use of rescue short-acting β-agonist (SABA)	Baseline to Week 12
Evaluate the efficacy of AMG 853 as measured by daily symptom score (aggregate/night and individual symptoms; and symptom free days)	Baseline to Week 12
Evaluate the efficacy of AMG 853 as measured by pre- and post-bronchodilator forced expiratory volume in 1 second (FEV1)	Baseline to Week 12
Evaluate the efficacy of AMG 853 as measured by AM and PM peak expiratory flow rate (PEFR)	Baseline to Week 12
Evaluate the efficacy of AMG 853 as measured by asthma quality of life questionnaire (AQLQ)	Baseline to Week 12

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026