A Study to Evaluate the Dosing of AMG 827 for Subjects With Inadequately Controlled Asthma

Amgen

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: AMG 827; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01199289

20090203

Details and patient eligibility

About

The purpose of this study is to determine if AMG 827 is effective compared to placebo as measured by change in Asthma Control Questionnaire (ACQ) composite scores.

Enrollment: 315 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men or women 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 powder or equivalent
• Ongoing asthma symptoms with ACQ composite score ≥ 1.5 points

Exclusion criteria

• Respiratory infection within 4 weeks of screening visit or 1 week of baseline visit
• History of chronic obstructive pulmonary disease or other chronic pulmonary condition other than asthma
• Any uncontrolled or clinically significant systemic disease (eg, uncontrolled diabetes, liver disease)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

315 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants will receive the matching placebo administered as subcutaneous (SC) injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10.

Treatment:

Drug: Placebo

AMG 827 140 mg

Experimental group

Description:

Participants will receive AMG 140 mg administered as SC injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10.

Treatment:

Drug: AMG 827

AMG 827 210 mg

Experimental group

Description:

Participants will receive AMG 210 mg administered as SC injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10.

Treatment:

Drug: AMG 827

AMG 827 280 mg

Experimental group

Description:

Participants will receive AMG 280 mg administered as SC injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10.

Treatment:

Drug: AMG 827