Efficacy and Long-Term Safety of Ragweed (Ambrosia Artemisiifolia) Sublingual Tablet (SCH 39641) in Adults With a History of Ragweed-Induced Rhinoconjunctivitis With or Without Asthma (Study P05234)

Summary

This study will evaluate the efficacy and safety of ragweed sublingual tablet (SCH 39641/MK-3641/Amb a 1-U) compared with placebo in participants with ragweed-induced rhinoconjunctivitis over a one-year period. It is expected that ragweed allergic participants on one of the active arms of the trial will have decreased allergic rhinoconjunctivitis symptoms and require less allergy rescue medications during ragweed pollen season.

Timeline

Start

2009-09

Primary completion

2011-05

Completion

2011-05

Outcome

Met primary endpoint

registry SCH 39641 6 Amb a 1-U vs Placebo; p = 0.0113; Mean Difference (Final Values) -1.58 (95% CI -2.80 to -0.36); ANOVA NCT00770315 ↗

registry SCH 39641 12 Amb a 1-U vs Placebo; p = 0.0015; Mean Difference (Final Values) -2.04 (95% CI -3.30 to -0.79); ANOVA NCT00770315 ↗

Publications

• Results Creticos PS, Maloney J, Bernstein DI, Casale T, Kaur A, Fisher R, Liu N, Murphy K, Nekam K, Nolte H. Randomized controlled trial of a ragweed allergy immunotherapy tablet in North American and European adults. J Allergy Clin Immunol. 2013 May;131(5):1342-9.e6. doi: 10.1016/j.jaci.2013.03.019.
• Christensen LH, Ipsen H, Nolte H, Maloney J, Nelson HS, Weber R, Lund K. Short ragweeds is highly cross-reactive with other ragweeds. Ann Allergy Asthma Immunol. 2015 Dec;115(6):490-495.e1. doi: 10.1016/j.anai.2015.09.016. Epub 2015 Oct 21.
• Kim H, Waserman S, Hebert J, Blaiss M, Nelson H, Creticos P, Kaur A, Maloney J, Li Z, Nolte H. Efficacy and safety of ragweed sublingual immunotherapy in Canadian patients with allergic rhinoconjunctivitis. Allergy Asthma Clin Immunol. 2014 Nov 10;10(1):55. doi: 10.1186/1710-1492-10-55. eCollection 2014.
• Nolte H, Amar N, Bernstein DI, Lanier BQ, Creticos P, Berman G, Kaur A, Hebert J, Maloney J. Safety and tolerability of a short ragweed sublingual immunotherapy tablet. Ann Allergy Asthma Immunol. 2014 Jul;113(1):93-100.e3. doi: 10.1016/j.anai.2014.04.018. Epub 2014 May 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ambrosia artemisiifolia allergen extract	Protein / enzyme biologic	1.5 unknown	Other
Subject	Ambrosia artemisiifolia allergen extract	Protein / enzyme biologic	6 unknown	Other
Subject	Ambrosia artemisiifolia allergen extract	Protein / enzyme biologic	12 unknown	Other

Indications