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

Last updated: May 7, 2025
Sponsor: Inmunotek S.L.
Overall Status: Active - Recruiting

Phase

3

Condition

Common Cold

Allergy

Eye Disorders/infections

Treatment

Placebo subcutaneous

10,000 MG01 +10,000 T521

30,000 MG01 +10,000 T521

Clinical Study ID

NCT04898283
DMV02-SIT-026
  • Ages 12-65
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Written informed consent.

  2. Aged between 12 and 65, both genders

  3. Positive suggestive clinical history of intermittent or persistent moderate tosevere rhinitis /rhinoconjunctivitis according to ARIA classification, with orwithout moderate intermittent or persistent asthma,according to GEMA 5.0, due tograss and cupressaceae pollen.

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

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

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

  7. Women of childbearing potential participating in the trial, should commit to usingan appropriate method of contraception. Medically acceptable methods ofcontraception are intrauterine devices placed at least 3 months in advance, surgicalsterilization (for example, tubal ligation), barrier methods, or the use of oralcontraceptives.

  8. Subjects capable of complying with the dosing regimen.

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

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

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

Exclusion

Exclusion Criteria:

  1. Subjects with positive prick test to other aeroallergens except for sensitisation toepithelia with occasional exposure and symptoms.

  2. Subjects with positive prick test to other aeroallergens except for sensitisation topollen noncoseasonal with cupressus or grasses.

  3. Subjects who have received prior immunotherapy in the preceding 5 years for any ofthe allergens tested or a cross-reactive allergen or are currently receivingimmunotherapy with any allergen.

  4. Subjects in which immunotherapy may be subject to an absolute generalcontraindication according to the criteria of the Immunotherapy Committee of theSpanish Society of Allergy and Clinical Immunology and the European Allergy andClinical Immunology Immunotherapy Subcommittee.

  5. Subjects with severe or uncontrolled intermittent or persistent asthma, with an FEV1 <70% with respect to the reference value despite adequate pharmacological treatmentat the time of inclusion in the trial. Likewise, subjects with intermittent orpersistent rhinitis / rhinoconjunctivitis with severe symptoms in which thesuspension of oral or systemic antihistamine treatment is contraindicated.

  6. Subjects who have previously had a severe secondary reaction during the prick testdiagnostic skin test.

  7. Subjects treated with beta-blockers.

  8. Clinically unstable subjects at the time of inclusion in the trial (acute asthmaticexacerbation, respiratory infection, febrile process, acute urticaria, etc.).

  9. Subjects with active chronic urticaria, severe dermographism, severe atopicdermatitis, sunburn, active psoriasis with lesions in areas where skin tests will beperformed, or a history of hereditary angioedema.

  10. Subjects who have any pathology in which adrenaline administration iscontraindicated (hyperthyroidism, HTN, heart disease, etc.).

  11. Subjects with any other disease not related to moderate rhinoconjunctivitis orasthma, but potentially serious and that may interfere with treatment and follow-up (epilepsy, psychomotor disorder, uncontrolled diabetes, malformations, multioperatedpatients, kidney disease,).

  12. Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumor diseases or witha diagnosis of immunodeficiencies.

  13. Subject whose condition prevents from offering cooperation and/ or who has severepsychiatric disorders.

  14. Subjects with a known allergy to components of the investigational medicinal productother than the allergen.

  15. Subjects with lower respiratory diseases other than asthma such as emphysema orbronchiectasis.

  16. Subjects who are direct relatives of the researchers.

  17. Pregnant or lactating women.

Study Design

Total Participants: 180
Treatment Group(s): 3
Primary Treatment: Placebo subcutaneous
Phase: 3
Study Start date:
May 31, 2021
Estimated Completion Date:
October 31, 2026

Study Description

The multicenter study includes 180 subjects sensitised to cupressaceae and grass pollen, both male and female aged 12 to 65 years.

The double-blinded and placebo controlled treatment will last 18 months for each subject.

The primary endpoint of the trial will be the combined rhinitis/rhinoconjunctivitis symptom and medication score (RCSMS) which will be assessed using data collected in the Subject electronic Diary during the cupressaceae (January, February and March) and grass (May and June) pollen seasons.

Connect with a study center

  • Hospital Recoletas Felipe Ii

    Valladolid, Castilla Y León 47003
    Spain

    Active - Recruiting

  • Hospital Universitario Principe de Asturias

    Alcalá De Henares, Comunidad De Madrid 28806
    Spain

    Completed

  • Clínica Ojeda

    Madrid, Comunidad De Madrid 28006
    Spain

    Active - Recruiting

  • Clínica Privada Dres Ojeda

    Madrid, Comunidad De Madrid 28006
    Spain

    Active - Recruiting

  • Hospital Cruz Roja Madrid

    Madrid, Comunidad De Madrid 28003
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Comunidad De Madrid 28222
    Spain

    Site Not Available

  • Cedt de Tarancon

    Tarancon, Cuenca 16400
    Spain

    Site Not Available

  • Cedt de Tarancón

    Tarancón, Cuenca 16400
    Spain

    Active - Recruiting

  • Hospital U. Fundación Alcorcón

    Alcorcón, Madrid 28922
    Spain

    Active - Recruiting

  • Clínica Privada Murcia

    Murcia, Región De Murcia 30006
    Spain

    Site Not Available

  • Fundación Hospital Sant Pere Claver

    Barcelona, 08004
    Spain

    Site Not Available

  • Clínica privada Burgos

    Burgos, 09004
    Spain

    Site Not Available

  • Hospital Universitario de Burgos

    Burgos, 09006
    Spain

    Active - Recruiting

  • Hospital General de Villalba

    Collado-Villalba, 28400
    Spain

    Site Not Available

  • Clinica privada

    León, 24003
    Spain

    Site Not Available

  • CAP José Marva

    Madrid, 28020
    Spain

    Site Not Available

  • Centro Médico Iza (Clínica Privada Madrid)

    Madrid, 28760
    Spain

    Active - Recruiting

  • Centro médico Saluddia

    Madrid, 28522
    Spain

    Active - Recruiting

  • Clínica Privada

    Madrid, 28034
    Spain

    Site Not Available

  • Clínica Subiza

    Madrid, 28006
    Spain

    Site Not Available

  • Hospital Carlos III (antiguo CAP José Marva)

    Madrid, 28029
    Spain

    Site Not Available

  • Hospital Infanta Elena

    Madrid, 28342
    Spain

    Site Not Available

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Clinica privada

    Palencia, 34001
    Spain

    Active - Recruiting

  • Consulta Privada

    Palencia, 34001
    Spain

    Completed

  • Clinica privada

    Pamplona, 31006
    Spain

    Site Not Available

  • Hospital Clínico de Salamanca

    Salamanca, 37007
    Spain

    Site Not Available

  • Hospital General Universitario de Segovia

    Segovia, 40002
    Spain

    Site Not Available

  • Clinica Privada Soria

    Soria, 42005
    Spain

    Site Not Available

  • Clínica Privada

    Zaragoza, 50004
    Spain

    Site Not Available

  • Clínica Privada Zaragoza

    Zaragoza, 50004
    Spain

    Site Not Available

  • Hospital Nuestra Señora de Sonsoles

    Ávila, 05071
    Spain

    Site Not Available

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