NCT01385371

A Study of SCH 697243 in Participants With Grass Pollen Allergy Symptoms, With or Without Asthma (P08067)

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Grass (Phleum Pratense) Sublingual Tablet (SCH 697243) in Subjects Between 5 and 65 Years of Age, With a History of Grass Pollen-Induced Rhinoconjunctivitis, With or Without Asthma (Protocol No. P08067)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,501 (actual)
• Sponsor: ALK-Abelló A/S · Industry
• Sex: All
• Age: 5 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a study to evaluate the efficacy and safety of grass sublingual tablet (SCH 697243) versus placebo in the treatment of grass pollen-induced allergic hayfever symptoms. Participants will receive either the sublingual grass tablet or a placebo tablet during the study. It is expected that those participants receiving the active sublingual grass tablet will have less hayfever symptoms and need less medications to treat hayfever symptoms during the grass pollen season.

Conditions

• Rhinitis Allergic
• Conjunctivitis

Interventions

Type	Name	Description
BIOLOGICAL	Grass (Phleum pratense) pollen allergen extract	One dissolving tablet sublingually once daily
BIOLOGICAL	Placebo for SCH 697243	One dissolving tablet sublingually once daily

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2011-06-30
• Last updated: 2017-03-03
• Results posted: 2013-09-10