Efficacy and Safety of Several Doses of Viaskin Peanut in Adults and Children With Peanut Allergy

Summary

The objectives of this dose-finding study for the treatment of peanut allergy are: * To determine the efficacy of 3 doses of Viaskin Peanut (50 mcg ,100 mcg and 250 mcg peanut protein per patch) to significantly desensitize peanut-allergic subjects to peanut after 12 months of treatment. * To evaluate the safety of a long-term treatment with Viaskin Peanut.

Timeline

Start

2012-08

Primary completion

2014-07

Completion

2014-07

Outcome

Met primary endpoint

registry analysis (superiority test); Viaskin Peanut 250 μg vs Placebo; p = 0.0108; Relative risk 2.00 (95% CI 1.18 to 3.38); Fisher Exact NCT01675882 ↗

paper In this dose-ranging trial of peanut-allergic patients, the 250-μg peanut patch resulted in significant treatment response vs placebo patch following 12 months of therapy. PMID 29136445 ↗

Publications

• Lewis MO, Brown-Whitehorn TF, Cianferoni A, Rooney C, Spergel JM. Peanut-allergic patient experiences after epicutaneous immunotherapy: peanut consumption and impact on QoL. Ann Allergy Asthma Immunol. 2019 Jul;123(1):101-103. doi: 10.1016/j.anai.2019.04.006. Epub 2019 Apr 10. No abstract available.
• Sampson HA, Shreffler WG, Yang WH, Sussman GL, Brown-Whitehorn TF, Nadeau KC, Cheema AS, Leonard SA, Pongracic JA, Sauvage-Delebarre C, Assa'ad AH, de Blay F, Bird JA, Tilles SA, Boralevi F, Bourrier T, Hebert J, Green TD, Gerth van Wijk R, Knulst AC, Kanny G, Schneider LC, Kowalski ML, Dupont C. Effect of Varying Doses of Epicutaneous Immunotherapy vs Placebo on Reaction to Peanut Protein Exposure Among Patients With Peanut Sensitivity: A Randomized Clinical Trial. JAMA. 2017 Nov 14;318(18):1798-1809. doi: 10.1001/jama.2017.16591.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Viaskin Peanut	Protein / enzyme biologic	50 ug	Other
Subject	Viaskin Peanut	Protein / enzyme biologic	100 ug	Other
Subject	Viaskin Peanut	Protein / enzyme biologic	250 ug	Other

Indications