Phase II Study to Evaluate the Efficacy of AMG 317

Phase 2

Completed

• Conditions: Asthma
• Interventions: Biological: AMG 317 150 mg; Biological: AMG 317 75 mg; Biological: Placebo; Biological: AMG 317 300 mg

• Registration Number: NCT00436670
• Lead Sponsor: Amgen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-02-15
• Study First Submitted QC: 2007-02-15
• Study First Posted: 2007-02-19
• Study Start: 2007-03
• Primary Completion: 2008-09
• Study Completion: 2009-02
• Status Verified: 2016-02
• Disposition First Submitted: 2016-02-23
• Disposition First Submitted QC: 2016-02-23
• Last Update Submitted: 2016-02-23
• Disposition First Posted: 2016-03-23
• Last Update Posted: 2016-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 294

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AMG 317 150 mg	AMG 317 150 mg	75 subjects
AMG 317 75 mg	AMG 317 75 mg	75 subjects
Placebo Arm	Placebo	75 subjects
AMG 317 300 mg	AMG 317 300 mg	75 subjects

Primary Outcome Measures

Name	Time	Method
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.	12 weeks

Secondary Outcome Measures

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