A Phase IIa Study of Subcutaneous AER 001 on Antigen Challenge In Atopic Asthmatic Subjects (28 Day Study)

Phase 2 Completed 24 enrolled Aerovance, Inc. Quintiles, Inc. · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a single center, double-blind, randomised parallel group design study to investigate the effects of AER 001 on the late phase asthmatic resonse in asthmatic subjects. AER 001 is to be administered subcutaneously (25 mg, once daily) for 28 days. The asthmatic subjects will be challenged with allergen both before and after AER 001 treatment (at screen and at Day 28). The primary outcome will be late phase sthmatic response (the max drop in FEV1 from 4-10 hours after an allergen challenge).

Timeline

Start: 2005-01
Primary completion: —
Completion: 2005-05

Outcome

Missed primary endpoint

paper difference 6%, 95% CI -4.37 to 16.32; p=0.243 PMID 17950857 ↗

Publications

Wenzel S, Wilbraham D, Fuller R, Getz EB, Longphre M. Effect of an interleukin-4 variant on late phase asthmatic response to allergen challenge in asthmatic patients: results of two phase 2a studies. Lancet. 2007 Oct 20;370(9596):1422-31. doi: 10.1016/S0140-6736(07)61600-6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	pitrakinra	Protein / enzyme biologic	25 mg	Subcutaneous