Phase II Trial With Subcutaneous Immunotherapy in Patients Sensitized to Phleum Pratense

Summary

Based on EMA (European Medicines Agency) new guidelines on the clinical development of products for immunotherapy for the treatment of allergic diseases the aim of this study is to establish a dose-response relationship for clinical efficacy of Phleum pratense pollen extract subcutaneous vaccine.

Conditions

• Allergic Rhinoconjunctivitis

Interventions

BIOLOGICAL

Allergovac Depot

Increasing dosages till the maintenance dose of 0.25 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.

BIOLOGICAL

Allergovac Depot

Increasing dosages till the maintenance dose of 0.5 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.

BIOLOGICAL

Allergovac Depot

Increasing dosages till the maintenance dose of 1SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.

BIOLOGICAL

Allergovac Depot

Increasing dosages till the maintenance dose of 2 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.

BIOLOGICAL

Allergovac Depot

Increasing dosages till the maintenance dose of 4SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.

BIOLOGICAL

Placebo

Increasing volumes of placebo. Afterwards, 3 maintenance doses are given at 4-weekly intervals.

Sponsors & Collaborators

• Roxall Medicina España S.A

  lead INDUSTRY

Principal Investigators

• Emilio Alvarez Cuesta, MD · Hospital Universitario Ramón y Cajal

• Santiago Quirce, MD · Hospital Universitario La Paz

• Matilde Rodríguez, MD · Hospital Universitario Puerta de Hierro

• José Manuel Zubeldia, MD · Hospital Universitario Gregorio Marañón

• Carmen Panizo, MD · Hospital Ntra. Sra. del Prado

• João Fonseca, MD · Instituto CUF Porto

• José Luís Plácido, MD · Centro Hospitalar de S. João

• José Alberto Ferreira, MD · Centro Hospitalar Gaia/Espinho

• Celso Pereira, MD · Hospital da Universidade de Coimbra

• Filipe Inácio, MD · Centro Hospitalar de Setúbal - Hospital de São Bernardo

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-10-31

Primary Completion

2013-04-30

Completion

2013-04-30

Countries

• Portugal
• Spain

Study Locations