Efficacy and Safety Study of RAGWITEK™ (MK-3641) in Children With Ragweed-Induced Rhinoconjunctivitis With or Without Asthma (MK-3641-008)

Summary

The purpose of this study is to assess the efficacy and safety of short ragweed pollen allergen extract (MK-3641, SCH 039641, RAGWITEK™) sublingual immunotherapy tablets in children aged 5 to 17 years with ragweed-induced allergic rhinitis/rhinoconjunctivitis with or without asthma. The primary hypothesis of this study is that administration of short ragweed pollen allergen extract sublingual immunotherapy tablets to children 5 to 17 years of age, compared with placebo, will result in a significant reduction in the combination of rhinoconjunctivitis symptoms and medication use over the peak ragweed season (RS).

Timeline

Start

2015-07-20

Primary completion

2018-11-09

Completion

2018-11-19

Outcome

Met primary endpoint

registry analysis (superiority test); Short Ragweed Pollen Allergen Extract vs Placebo; p < 0.001 NCT02478398 ↗

registry Mean Difference (Final Values) -2.73 (95% CI -3.45 to -2.00) NCT02478398 ↗

Publications

• Ellis AK, Gagnon R, Bernstein DI, Nolte H. Randomized controlled trial of ragweed sublingual immunotherapy tablet in the subpopulation of Canadian children and adolescents with allergic rhinoconjunctivitis. Allergy Asthma Clin Immunol. 2021 Dec 9;17(1):127. doi: 10.1186/s13223-021-00626-2.
• Fortescue R, Kew KM, Leung MST. Sublingual immunotherapy for asthma. Cochrane Database Syst Rev. 2020 Sep 14;9(9):CD011293. doi: 10.1002/14651858.CD011293.pub3.
• Field K, Blaiss MS. Sublingual Versus Subcutaneous Immunotherapy for Allergic Rhinitis: What Are the Important Therapeutic and Real-World Considerations? Curr Allergy Asthma Rep. 2020 Jun 16;20(9):45. doi: 10.1007/s11882-020-00934-4.
• Nolte H, Bernstein DI, Nelson HS, Ellis AK, Kleine-Tebbe J, Lu S. Efficacy and Safety of Ragweed SLIT-Tablet in Children with Allergic Rhinoconjunctivitis in a Randomized, Placebo-Controlled Trial. J Allergy Clin Immunol Pract. 2020 Jul-Aug;8(7):2322-2331.e5. doi: 10.1016/j.jaip.2020.03.041. Epub 2020 Apr 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Short ragweed pollen allergen extract	Protein / enzyme biologic	12 unknown	Other
Background	Loratadine	Small molecule	5 mg	Oral
Background	Loratadine	Small molecule	10 mg	Oral
Background	Mometasone furoate	Other / unclassified	50 ug	Intranasal
Background	Mometasone furoate	Other / unclassified	100 ug	Intranasal
Background	Olopatadine	Other / unclassified	0.1 %	Other
Background	Salbutamol	Unknown	90 ug	Inhaled
Background	Salbutamol	Unknown	100 ug	Inhaled
Background	Self-injectable epinephrine	Unknown	0.15 mg	Intramuscular
Background	Self-injectable epinephrine	Unknown	0.3 mg	Intramuscular

Indications