NCT04881461

A Study in Adults With Grass Pollen-induced Rhinoconjunctivitis

A Randomised, Parallel-group, Double-blind, Placebo-controlled Phase III Trial Assessing the Efficacy and Safety of 5-grass Mix SLIT-drops in Adults With Grass Pollen-induced Rhinoconjunctivitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 445 (actual)
• Sponsor: ALK-Abelló A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a 2 year clinical study to compare 5-grass mix SLIT-drops with placebo in relieving grass pollen-induced rhinoconjunctivitis symptoms and in use of symptom-relieving medication during the second grass pollen season (peak grass pollen season, PGPS) The study will collect health-related quality of life data in the groups treated with 5-grass mix SLIT-drops or with placebo during the first and second PGPS. The trial medication used is already approved to treat allergic rhinitis caused by grass pollen in adults in several countries.

Detailed description

This trial is a 2 year, parallel-group, double-blind, placebo-controlled phase III trial to evaluate efficacy and safety of the 5-grass mix SLIT-drops in adults with grass pollen-induced rhinoconjunctivitis with or without asthma. Approximately 440 adults will be enrolled in the trial and will receive the 5-grass mix SLIT-drops or placebo. The trial is conducted in several European countries.

Conditions

• Allergy

Interventions

Type	Name	Description
DRUG	5-grass mix SLIT-drops	Sublingual allergy immunotherapy drops, for daily administration
DRUG	Placebo	Placebo

Timeline

• Start date: 2021-05-10
• Primary completion: 2023-09-26
• Completion: 2023-09-26
• First posted: 2021-05-11
• Last updated: 2024-12-16
• Results posted: 2024-12-16

Locations

48 sites across 6 countries: Czechia, Estonia, France, Latvia, Lithuania, Poland