CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 445 enrolled
Drug / intervention
5-grass mix SLIT-drops +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04881461
NCT04881461Phase 3Completed

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

ALK-Abelló A/S·interventional·Posted May 11, 2021·Updated Dec 16, 2024

In Brief

A Phase 3 clinical trial evaluating 5-grass mix SLIT-drops and Placebo for Allergy. Completed, enrolled 445 participants across 48 sites in 6 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAllergy
CountriesCzechia, Estonia, France, Latvia, Lithuania, Poland
CollaboratorsSyneos Health

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedMay 11, 2021
Enrollment StartMay 10, 2021
Primary CompletionSep 26, 2023
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 5.1 years ago

Interventions

5-grass mix SLIT-dropsdrug

Sublingual allergy immunotherapy drops, for daily administration

Placebodrug

Placebo