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

Summary

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

Conditions

• Rhinitis
• Rhinoconjunctivitis

Interventions

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

Sponsors & Collaborators

• Inmunotek S.L.

  lead INDUSTRY

Principal Investigators

• Javier Subiza, PhD; MD · Clinica Subliza

• Carmen Diéguez, PhD; MD · Hospital Universitario 12 de Octubre

• Pedro Ojeda, PhD; MD · Clínica Ojeda

• Javier Ruiz Hornillos, PhD; MD · Hospital Universitario Infanta Elena

• Matilde Domínguez, PhD; MD · Hospital Universitario Puerta de Hierro

• Emilio Solano, MD · Hospital Universitario Ramón y Cajal

• Antonio Moreno · Clínica Atlas

• Pedro Guardia · Hospital Universitario Virgen Macarena

• Agustín Orovigt · Hospital Viamed Santa Ángela de la Cruz

• Alberto Caso · Hospital San Agustín

• Alicia Alonso · Clínica Alianza Médica

• Amparo Conde · Hospital Nisa Sevilla Aljarafe

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

14 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-12-30

Primary Completion

2021-11-30

Completion

2021-11-30

Countries

• Spain

Study Locations