AMG 853 Phase 2 Study in Subjects With Inadequately Controlled Asthma

Amgen

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: Placebo; Drug: AMG 853

Study type: Interventional

Funder types: Industry

Identifiers

NCT01018550

20080615

Details and patient eligibility

About

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.

Enrollment: 397 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

397 participants in 2 patient groups, including a placebo group

AMG 853

Experimental group

Treatment:

Drug: AMG 853

Drug: AMG 853

Drug: AMG 853

Drug: AMG 853

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo