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

Who is this study for? Patients with rhinitis with or without mild to moderate asthma sensitized to cupressaceae and grasses
What treatments are being studied? Subcutaneous Immunotherapy
Status: Recruiting
Location: See all (27) locations...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 65
Healthy Volunteers: f
View:

• Written informed consent.

• Aged between 12 and 65, both genders

• Positive suggestive clinical history of intermittent or persistent moderate to severe rhinitis /rhinoconjunctivitis according to ARIA classification, with or without moderate intermittent or persistent asthma,according to GEMA 5.0, due to grass and cupressaceae pollen.

• Subjects with a positive skin prick-test (wheal size \>5 mm diameter) to a standardized mixed extract of grass pollen (Phleum pratense, Holcus lanatus, Dactylis glomerata, Poa pratensis, Festuca elatior, Lolium perenne) or to one of the molecular components of the mixture and to a cupressaceae extract. In addition, the largest diameter of the papules must be greater than or equal to that of the histamine.

• Specific IgE \> 3,5 KU/L , against grass (preferably Phleum pratense) and cupressaceae pollen (InmunoCAP® o Immulite).

• Women of childbearing age (from menarche) must present a urine pregnancy test with a negative result at the time of joining the trial.

• Women of childbearing potential participating in the trial, should commit to using an appropriate method of contraception. Medically acceptable methods of contraception are intrauterine devices placed at least 3 months in advance, surgical sterilization (for example, tubal ligation), barrier methods, or the use of oral contraceptives.

• Subjects capable of complying with the dosing regimen.

• Subjects who own a smartphone for symptom registration and medication.

⁃ Subjects with a negative prick test to coestational pollens. In the case specific IgE is available, the result should be \<3,5 kU/L and without relevant symptomatology

⁃ Subjects with a negative prick test to other aeroallergens (dust mites, epitheliums and fungus). In the case specific IgE is available, the result should be \<3,5 kU/L and without relevant symptomatology.

Locations
Other Locations
Spain
Hospital Universitario Principe de Asturias
COMPLETED
Alcalá De Henares
Hospital U. Fundación Alcorcón
RECRUITING
Alcorcón
Hospital Nuestra Señora de Sonsoles
NOT_YET_RECRUITING
Ávila
Fundación Hospital Sant Pere Claver
WITHDRAWN
Barcelona
Clínica privada Burgos
WITHDRAWN
Burgos
Hospital Universitario de Burgos
RECRUITING
Burgos
Hospital General de Villalba
NOT_YET_RECRUITING
Collado-villalba
Clinica privada
WITHDRAWN
León
Centro Médico Iza (Clínica Privada Madrid)
RECRUITING
Madrid
Centro médico Saluddia
RECRUITING
Madrid
Clínica Privada
WITHDRAWN
Madrid
Clínica Privada Dres Ojeda
RECRUITING
Madrid
Clínica Subiza
ACTIVE_NOT_RECRUITING
Madrid
Hospital Carlos III (antiguo CAP José Marva)
WITHDRAWN
Madrid
Hospital Cruz Roja Madrid
RECRUITING
Madrid
Hospital Infanta Elena
NOT_YET_RECRUITING
Madrid
Hospital Universitario Fundación Jiménez Díaz
RECRUITING
Madrid
Hospital Universitario Ramón y Cajal
NOT_YET_RECRUITING
Madrid
Hospital Universitario Puerta de Hierro
NOT_YET_RECRUITING
Majadahonda
Clínica Privada Murcia
NOT_YET_RECRUITING
Murcia
Consulta Privada
COMPLETED
Palencia
Hospital Clínico de Salamanca
ACTIVE_NOT_RECRUITING
Salamanca
Hospital General Universitario de Segovia
NOT_YET_RECRUITING
Segovia
Clinica Privada Soria
WITHDRAWN
Soria
Cedt de Tarancón
RECRUITING
Tarancón
Hospital Recoletas Felipe Ii
RECRUITING
Valladolid
Clínica Privada
WITHDRAWN
Zaragoza
Contact Information
Primary
Miguel Casanovas, MD PhD
mcasanovas@inmunotek.com
+34 912908942
Backup
Raquel Caballero
rcaballero@inmunotek.com
+34 607600638
Time Frame
Start Date: 2021-05-31
Estimated Completion Date: 2026-10
Participants
Target number of participants: 180
Treatments
Experimental: 10,000 MG01 + 10,000 T521
10,000 TU/mL of MG01 + 10,000 TU/mL of T521 of subcutaneous immunotherapy
Experimental: 30,000 MG01 + 10,000 T521
30,000 TU/mL of MG01 + 10,000 TU/mL of T521 of subcutaneous immunotherapy
Placebo_comparator: Placebo subcutaneous
The same solution and presentation as the active treatment, but without active ingredients.
Authors
Izaskun Leanizbarrutia De Bizkarralegorra
Sponsors
Leads: Inmunotek S.L.

This content was sourced from clinicaltrials.gov

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