NCT02654223

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

Double Blind, Placebo-controlled, Dose Finding, Prospective, Multicenter Clinical Trial for the Treatment of Rhinitis/Rhinoconjunctivitis Against Grass Pollen Allergy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Inmunotek S.L. · Industry
• Sex: All
• Age: 14 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Double blind placebo-controlled study. The subjects will receive medication during 4 months.

Conditions

• Rhinitis
• Rhinoconjunctivitis

Interventions

Type	Name	Description
BIOLOGICAL	MG56 Mannosylated 500 subcutaneous	Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 500 mTU (Mannosylated Therapeutic Units)/ml subcutaneous
BIOLOGICAL	MG56 Mannosylated 1000 subcutaneous	Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 1000 mTU (Mannosylated Therapeutic Units)/ml subcutaneous
BIOLOGICAL	MG56 Mannosylated 3000 subcutaneous	Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 3000 mTU (Mannosylated Therapeutic Units)/ml subcutaneous
BIOLOGICAL	MG56 Mannosylated 5000 subcutaneous	Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 5000 mTU (Mannosylated Therapeutic Units)/ml subcutaneous
BIOLOGICAL	MG56 Mannosylated 500 sublingual	Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 500 mTU (Mannosylated Therapeutic Units)/ml sublingual
BIOLOGICAL	MG56 Mannosylated 1000 sublingual	Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 1000 mTU (Mannosylated Therapeutic Units)/ml sublingual
BIOLOGICAL	MG56 Mannosylated 3000 sublingual	Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 3000 mTU (Mannosylated Therapeutic Units)/ml sublingual
BIOLOGICAL	MG56 Mannosylated 5000 sublingual	Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 5000 mTU (Mannosylated Therapeutic Units)/ml sublingual
BIOLOGICAL	Subcutaneous placebo	Comparison between placebo and active group
BIOLOGICAL	Sublingual placebo	Comparison between placebo and active group

Timeline

• Start date: 2015-12-30
• Primary completion: 2021-11-01
• Completion: 2021-11-01
• First posted: 2016-01-13
• Last updated: 2022-01-27

Locations

12 sites across 1 country: Spain