Phase II Study to Evaluate the Efficacy of AMG 317

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00436670
• Other study ID #: 20060161
• Status: Completed
• Phase: Phase 2
• First received: February 15, 2007
• Last updated: April 9, 2009
• Start date: March 2007
• Est. completion date: February 2009

Study information

• Verified date: April 2009
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 294
• Est. completion date: February 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Biological:
• AMG 317 75 mg
75 mg SC weekly injection
• AMG 317 150 mg
150 mg SC once weekly injection
• AMG 317 300 mg
300 mg weekly SC injection
• Placebo
Placebo SC once weekly injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change from baseline in frequency of rescue beta agonist use during week 12		12 weeks	No
Secondary	Change from baseline PEFR during week 12 (morning/evening, diurnal and inter-day variation)		12 weeks	No
Secondary	Change in pre and post bronchodilator FEV1 at week 12 from baseline		12 weeks	No
Secondary	Number of asthma symptom-free days		16 weeks	No
Secondary	Change from baseline in daily asthma symptoms during week 12		12 weeks	No
Secondary	Safety endpoints: number of asthma exacerbations, antibodies, adverse events, and change in ECG, labs and vital signs		16 weeks	Yes
Secondary	Change in AQLQ score at week 12 from baseline		12 weeks	No

External Links

•   AmgenTrials clinical trials website