drugset

drugset / Trial / NCT00410280

Study Evaluating the Effects of IMA-638 on Allergen-Induced Airway Responses in Subjects With Mild Atopic Asthma

NCT00410280 ↗

Phase 2 Completed 30 enrolled Pfizer

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Primary purpose of the protocol is to determine if IMA-638 prevents a mild asthma attack by a subject with mild asthma inhaling an allergen.

Timeline

Start: 2007-03
Primary completion: 2008-05
Completion: 2008-05

Outcome

Missed primary endpoint

registry IMA-638 2mg/kg vs Placebo; p = 0.0947; Mean Difference (Final Values) -6.44 (95% CI -14.04 to 1.15); ANOVA NCT00410280 ↗

registry IMA-638 2mg/kg vs Placebo; p = 0.2673; Mean Difference (Final Values) -4.24 (95% CI -11.84 to 3.35); ANOVA NCT00410280 ↗

Publications

Gauvreau GM, Boulet LP, Cockcroft DW, Fitzgerald JM, Carlsten C, Davis BE, Deschesnes F, Duong M, Durn BL, Howie KJ, Hui L, Kasaian MT, Killian KJ, Strinich TX, Watson RM, Y N, Zhou S, Raible D, O'Byrne PM. Effects of interleukin-13 blockade on allergen-induced airway responses in mild atopic asthma. Am J Respir Crit Care Med. 2011 Apr 15;183(8):1007-14. doi: 10.1164/rccm.201008-1210OC. Epub 2010 Nov 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Anrukinzumab	Monoclonal antibody	—	—

Indications