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RECRUITING
NCT04898283
PHASE3

Efficacy and Safety Evaluation of the Treatment of Allergy Against Cupressaceae and Grasses.

Sponsor: Inmunotek S.L.

View on ClinicalTrials.gov

Summary

A Randomized, Double-Blinded, Placebo-Controlled, Prospective, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous Immunotherapy in Patients With Rhinitis/Rhinoconjunctivitis With or Without Mild to Moderate Asthma Sensitized to cupressaceae and grasses.

Official title: Prospective, Multicentre, Doubleblind, Placebo-controlled RCT to Evaluate Efficacy and Safety With SC Immunotherapy in Patients With Rhinitis/Rhinoconjunctivitis With or Without Mild to Moderate Asthma Sensitised to Grasses and Cupressaceae

Key Details

Gender

All

Age Range

12 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2021-05-31

Completion Date

2026-10

Last Updated

2025-05-13

Healthy Volunteers

No

Interventions

BIOLOGICAL

10,000 MG01 +10,000 T521

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 cupressaceae (Juniperus oxycedrus), 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 T521

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

OTHER

Placebo subcutaneous

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

Locations (27)

Hospital Recoletas Felipe Ii

Valladolid, Castille and León, Spain

Cedt de Tarancón

Tarancón, Cuenca, Spain

Hospital Universitario Principe de Asturias

Alcalá de Henares, Madrid, Spain

Hospital U. Fundación Alcorcón

Alcorcón, Madrid, Spain

Hospital Cruz Roja Madrid

Madrid, Madrid, Spain

Clínica Privada Dres Ojeda

Madrid, Madrid, Spain

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain

Clínica Privada Murcia

Murcia, Murcia, Spain

Hospital Nuestra Señora de Sonsoles

Ávila, Spain

Fundación Hospital Sant Pere Claver

Barcelona, Spain

Clínica privada Burgos

Burgos, Spain

Hospital Universitario de Burgos

Burgos, Spain

Hospital General de Villalba

Collado Villalba, Spain

Clinica privada

León, Spain

Clínica Subiza

Madrid, Spain

Hospital Carlos III (antiguo CAP José Marva)

Madrid, Spain

Clínica Privada

Madrid, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain

Hospital Infanta Elena

Madrid, Spain

Centro médico Saluddia

Madrid, Spain

Centro Médico Iza (Clínica Privada Madrid)

Madrid, Spain

Consulta Privada

Palencia, Spain

Hospital Clínico de Salamanca

Salamanca, Spain

Hospital General Universitario de Segovia

Segovia, Spain

Clinica Privada Soria

Soria, Spain

Clínica Privada

Zaragoza, Spain