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AMG 853 Phase 2 Study in Subjects With Inadequately Controlled Asthma

Amgen logo

Amgen

Status and phase

Completed
Phase 2

Conditions

Asthma

Treatments

Drug: AMG 853
Drug: Placebo

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
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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