NCT02661854

Dose Finding for the Treatment of Rhinitis/Rhinoconjunctivitis Against Mite Allergy

Double Blind, Placebo-controlled, Dose Finding, Prospective, Multicenter Clinical Trial for the Treatment of Rhinitis/Rhinoconjunctivitis Against a Mixture of Dermatophagoides Pteronyssinus and Dermatophagoides Farinae Allergen Extract

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 186 (actual)
• Sponsor: Inmunotek S.L. · Industry
• Sex: All
• Age: 12 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 mite allergy

Detailed description

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

Conditions

• Rhinitis
• Rhinoconjunctivitis

Interventions

Type	Name	Description
BIOLOGICAL	MM09 Mannosylated 5.000 subcutaneous	Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 5.000 MTU (Mannosylated Therapeutic Units)/ml subcutaneous
BIOLOGICAL	MM09 Mannosylated 10.000 subcutaneous	Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 10.000 MTU (Mannosylated Therapeutic Units)/ml subcutaneous
BIOLOGICAL	MM09 Mannosylated 30.000 subcutaneous	Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 30.000 MTU (Mannosylated Therapeutic Units)/ml subcutaneous
BIOLOGICAL	MM09 Mannosylated 50.000 subcutaneous	Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 50.000 MTU (Mannosylated Therapeutic Units)/ml subcutaneous
BIOLOGICAL	MM09 Mannosylated 5.000 sublingual	Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 5.000 MTU (Mannosylated Therapeutic Units)/ml sublingual
BIOLOGICAL	MM09 Mannosylated 10.000 sublingual	Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 10.000 MTU (Mannosylated Therapeutic Units)/ml sublingual
BIOLOGICAL	MM09 Mannosylated 30.000 sublingual	Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 30.000 MTU (Mannosylated Therapeutic Units)/ml sublingual
BIOLOGICAL	MM09 Mannosylated 50.000 sublingual	Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 50.000 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: 2016-06-21
• Primary completion: 2020-07-01
• Completion: 2020-07-01
• First posted: 2016-01-25
• Last updated: 2020-03-11

Locations

14 sites across 1 country: Spain