AMG 853 Phase 2 Study in Subjects With Inadequately Controlled Asthma

Amgen397 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

397

Conditions

Asthma

Interventions

AMG 853DRUG

AMG 853 5 mg (BID)

AMG 853DRUG

AMG 853 200 mg (QD)

AMG 853DRUG

AMG 853 25 mg (BID)

AMG 853

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.