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

Summary

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

Conditions

• Rhinitis
• Rhinoconjunctivitis

Interventions

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

Sponsors & Collaborators

• Inmunotek S.L.

  lead INDUSTRY

Principal Investigators

• Mª Dolores Hernández, PhD; MD

• Pilar Alba, PhD; MD

• Carmen Pérez, PhD; MD

• Javier Montoro, PhD; MD

• Antonio de Mateo, PhD; MD

• David El-Qutob, PhD; MD

• Javier Fernández, PhD; MD

• Vicente Jover, PhD; MD

• Isabel Flores, PhD; MD

• Mónica Antón, PhD; MD

• Carmen Andreu, PhD; MD

• Luis Angel Navarro, PhD; MD

• Ángel Ferrer

• Antonio Nieto, PhD; MD

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-06-21

Primary Completion

2020-07-31

Completion

2020-07-31

Countries

• Spain

Study Locations