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RECRUITING
NCT04891237
PHASE3

Efficacy and Safety Evaluation for the Treatment of Allergy Against Grass and Olive Pollen

Sponsor: Inmunotek S.L.

View on ClinicalTrials.gov

Summary

Prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial of efficacy and safety with subcutaneous immunotherapy in patients with mild to moderate rhinitis / rhinoconjunctivitis with or without mild to moderate asthma sensitized to grasses and olive

Official title: A Randomized, Double-Blinded, Placebo-Controlled, Prospective, Multicenter CT to Evaluate Efficacy and Safety of Subcutaneous Immunotherapy in Subjects With Rhinitis With/Without Mild to Moderate Asthma Sensitized to Olive and Grass Pollen

Key Details

Gender

All

Age Range

12 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2021-06-14

Completion Date

2027-01

Last Updated

2025-05-07

Healthy Volunteers

No

Interventions

BIOLOGICAL

10,000 MG01 + 10,000 T517

Purified and polymerized with glutaraldehyde allergen extract, from a mixture of grasses (Phleum pratense, Holcus lanatus, Poa pratensis, Festuca pratensis, Lolium perenne and Dactylis glomerata) and Olea (Olea europaea), adsorbed on aluminum hydroxide. The other ingredients are: sodium chloride (0.9%), phenol (0.4%) and water for injections

BIOLOGICAL

30,000 MG01 + 10,000 T517

Purified and polymerized with glutaraldehyde allergen extract, from a mixture of grasses (Phleum pratense, Holcus lanatus, Poa pratensis, Festuca pratensis, Lolium perenne and Dactylis glomerata) and Olea (Olea europaea), adsorbed on aluminum hydroxide. The other ingredients are: sodium chloride (0.9%), phenol (0.4%) and water for injections

OTHER

Placebo

The same solution and presentation as the active treatment, but without active ingredients

Locations (32)

Cedt de Tarancón

Tarancón, Cuenca, Spain

Hospital Universitario Principe de Asturias

Alcalá de Henares, Madrid, Spain

Centro Médico Iza

Tres Cantos, Madrid, Spain

Hospital Infanta Elena

Valdemoro, Madrid, Spain

Hospital Clínico Universitario Virgen de Arrixaca

El Palmar, Murcia, Spain

Private Practice

Albacete, Spain

Hospital Ntra. Sra. de Sonsoles

Ávila, Spain

Clinica Dermatologica Y Alergia

Badajoz, Spain

Hospital Quironsalud Clideba

Badajoz, Spain

Hospital Universitario Dexeus

Barcelona, Spain

Clínica privada Barcelona

Barcelona, Spain

Hospital General Universitario Ciudad Real

Ciudad Real, Spain

Hospital Quironsalud Córdoba

Córdoba, Spain

Hospital Universitario Clínico San Cecilio

Granada, Spain

Hospital Universitario de Jaén

Jaén, Spain

Hospital Universitari Santa María

Lleida, Spain

Private practice

Madrid, Spain

Hospital Universitario Cruz Roja

Madrid, Spain

Clínica de Asma y Alergia en Madrid | CLÍNICA OJEDA

Madrid, Spain

Clínica Subiza

Madrid, Spain

Hospital Carlos Iii

Madrid, Spain

Hospital Universitario Rey Juan Carlos

Madrid, Spain

Hospital Quirónsalud Málaga

Málaga, Spain

Private Practice

Málaga, Spain

Private Practice

Murcia, Spain

Private Practice

Palencia, Spain

Hospital Universitario Infanta Cristina

Parla, Spain

Clínica privada Sevilla

Seville, Spain

Hospital Virgen Del Rocío

Seville, Spain

Hospital Viamed Santa Ángela de La Cruz

Seville, Spain

Private Practice

Toledo, Spain

Hospital Recoletas Felipe Ii

Valladolid, Spain