Dose Finding for the Treatment of Rhinitis/Rhinoconjunctivitis Against Grass Pollen Allergy

Phase 2 Completed 180 enrolled Inmunotek S.L.

RandomizedParallel-groupDouble-blindScreening

Summary

The purpose of the study is to evaluate the more efficient dose for the treatment of rhinitis/rhinoconjunctivitis against grass pollen allergy

Timeline

Start: 2015-12-30
Primary completion: 2021-11
Completion: 2021-11

Outcome

Met primary endpoint

paper Significant differences over placebo were observed at doses of 3,000 mTU/mL (p=0.049 for SL, p=0.015 for SC) and 5,000 mTU/mL (p=0.011 for SL, p=0.015 for SC). PMID 38989287 ↗

Publications

Ojeda P, Barjau MC, Subiza J, Moreno A, Ojeda I, Solano E, Alonso A, Caballero R, Del Pozo S, Gomez-Perosanz M, Sanchez-Trincado JL, Benito-Villalvilla C, Angelina A, Soria I, Reche PA, Palomares O, Subiza JL, Casanovas M. Grass pollen allergoids conjugated with mannan for subcutaneous and sublingual immunotherapy: a dose-finding study. Front Immunol. 2024 Jun 26;15:1431351. doi: 10.3389/fimmu.2024.1431351. eCollection 2024.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MG56 Mannosylated	Unknown	500 unknown	Subcutaneous
Subject	MG56 Mannosylated	Unknown	1000 unknown	Subcutaneous
Subject	MG56 Mannosylated	Unknown	3000 unknown	Subcutaneous
Subject	MG56 Mannosylated	Unknown	5000 unknown	Subcutaneous