Double-blind, Multiple Dose Study of Tezepelumab (AMG 157) in Adults With Mild Atopic Asthma

Summary

The purpose of this study is to assess the late and early asthmatic response after an allergen inhalation challenge in adults with mild atopic asthma after receiving multiple doses of tezepelumab (AMG 157), as well as the safety, tolerability, immunogenicity, and pharmacokinetics of multiple doses of tezepelumab in adults with mild atopic asthma.

Timeline

Start

2011-10-31

Primary completion

2013-04-05

Completion

2013-04-05

Outcome

Mixed primary results

registry analysis (other test); Placebo vs Tezepelumab 700 mg; p = 0.09; Treatment Difference 7.65 (95% CI -1.30 to 16.60); ANCOVA NCT01405963 ↗

registry analysis (other test); Placebo vs Tezepelumab 700 mg; p = 0.02; Treatment Difference 9.91 (95% CI 1.59 to 18.23); ANCOVA NCT01405963 ↗

registry analysis (other test); Placebo vs Tezepelumab 700 mg; p = 0.11; Treatment Difference -4.35 (95% CI -9.80 to 1.10); ANCOVA NCT01405963 ↗

Publications

• Gauvreau GM, O'Byrne PM, Boulet LP, Wang Y, Cockcroft D, Bigler J, FitzGerald JM, Boedigheimer M, Davis BE, Dias C, Gorski KS, Smith L, Bautista E, Comeau MR, Leigh R, Parnes JR. Effects of an anti-TSLP antibody on allergen-induced asthmatic responses. N Engl J Med. 2014 May 29;370(22):2102-10. doi: 10.1056/NEJMoa1402895. Epub 2014 May 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tezepelumab	Monoclonal antibody	700 mg	Intravenous

Indications