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RecruitingNCT04891237Updated May 7, 2025

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

A Phase 3 interventional study of 10,000 MG01 + 10,000 T517 and 30,000 MG01 + 10,000 T517 in Rhinitis, Allergic, Rhinoconjunctivitis and Asthma, Allergic, sponsored by Inmunotek S.L.. Recruiting at 32 sites in Spain. Open to participants aged 12 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-05-07.

Sponsored by Inmunotek S.L. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
12 Years to 65 Years
Sex
All
01

Study 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

Read the detailed description

Double blind, multicenter, parallel, placebo controlled study. It includes 180 subjects sensitised to olea and grass pollen with mild to moderate rhinitis / rhinoconjunctivitis with or without mild to moderate asthma, from 12 to 65 years of age. Medication treatment during 1 year. The main outcome: CSMS

02

Conditions studied

  • Rhinitis, Allergic
  • Rhinoconjunctivitis
  • Asthma, Allergic

Keywords

  • Rhinitis/ Rhinoconjunctivitis
  • Mild to moderate asthma
  • Allergy
  • Grasses
  • Olea
03

Who can participate

Ages eligible
12 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Subject who has signed the informed consent.
  2. Subjects of both sexes aged between 12 and 65 years.
  3. Subjects with confirmed clinical history of inhalational allergy (rhinitis and / or moderate-severe intermittent or persistent rhinoconjunctivitis according to the ARIA classification with or without intermittent or persistent controlled mild-moderate asthma according to the GEMA 5.0 classification caused by grass and olive allergy. The diagnosis of asthma will be valid from 12 months prior to signing the informed consent
  4. Subjects with a positive prick test (higher papule diameter ≥ 5 mm) to a standardized extract of pollen from grasses (Phleum pratense, Holcus lanatus, Dactylis glomerata, Poa pratensis, Festuca elatior, Lolium perenne), or one of the components of the mixture and an olive extract.
  5. Specific IgE (CAP or Immulite) against a mixture of grasses or against one of the components of the mixture of grasses, preferably Phleum pratense and olive or one of the molecular components of allergenic sources with a value > 3,5 KU / L.
  6. Women of childbearing age (from menarche) should submit a urine pregnancy test with a negative result at the time of joining the trial.
  7. Women of childbearing potential, and men 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.
  8. Subjects capable of complying with the dosage regimen.
  9. Subjects who have a smartphone to record symptoms and medication.
  10. 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
  11. 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

Exclusion criteria

Exclusion Criteria:

  1. Subjects polysensitized to other aeroallergens with the exception of epithelia with occasional exposure and symptoms
  2. Subjects polysensitized to other aeroallergens with the exception non-seasonal pollens with grasses and olive
  3. Subjects who have received prior immunotherapy in the preceding 5 years to any aeroallergens.
  4. Subjects in which immunotherapy may be subject to an absolute general contraindication according to the criteria of the Immunotherapy Committee of the Spanish Society of Allergy and Clinical Immunology and the European Allergy and Clinical Immunology Immunotherapy Subcommittee.
  5. Subjects with severe or uncontrolled persistent asthma, with an FEV1 \<70% with respect to the reference value despite adequate pharmacological treatment at the time of inclusion in the trial. Likewise, subjects with intermittent or persistent rhinitis / rhinoconjunctivitis with severe symptoms in which the suspension of oral or systemic antihistamine treatment is contraindicated.
  6. Subjects who have previously presented a serious secondary reaction during the performance of diagnostic skin tests using the prick test.
  7. Subjects under treatment with ß-blockers.
  8. Clinically unstable subjects at the time of enrolment in the trial (acute asthma exacerbation, respiratory infection, feverish process, acute urticaria, etc.).
  9. Subjects with active chronic urticaria, severe dermographism, severe atopic dermatitis, sunburns, active psoriasis with lesions in areas where skin tests will be performed, or a history of hereditary angioedema.
  10. Subjects who have any pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, HT, heart disease, etc.).
  11. Subjects with some other disease not related to moderate rhinoconjunctivitis or asthma, but of potential severity and that may interfere with treatment and follow-up (epilepsy, psychomotor disorder, uncontrolled diabetes, malformations, multiple operations, kidney disease,).
  12. Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumor diseases or with a diagnosis of immunodeficiencies.
  13. Subject whose condition prevents him / her from offering cooperation and who has severe psychiatric disorders.
  14. Subjects with a known allergy to other investigational drug components other than the allergen.
  15. Subjects with diseases of the lower respiratory tract other than asthma such as emphysema or bronchiectasis.
  16. Subjects who are direct relatives of the researchers.
  17. Pregnant or lactating women.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    10,000 MG01 + 10,000 T517

    10,000 TU/mL of MG01 + 10,000 TU/mL of T517 of subcutaneous immunotherapy

    Biological: 10,000 MG01 + 10,000 T517

  • Experimental
    30,000 MG01 + 10,000 T517

    30,000 TU/mL of MG01 + 10,000 TU/mL of T517 of subcutaneous immunotherapy

    Biological: 30,000 MG01 + 10,000 T517

  • Placebo comparator
    Placebo subcutaneous

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

    Other: Placebo

Interventions

  • Biological10,000 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

    Also known as: Grasses and olea 10,000

  • Biological30,000 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

    Also known as: Grasses and olea

  • OtherPlacebo

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

05

What researchers measure

Primary outcomes

  1. CSMS: Combined Symptoms and Medication Score

    Overall score of symptoms and medication throughout the trial. The minimum score is cero and maximum six, per day

    Time frame: 12 months

Secondary outcomes

  1. Medication-free days

    Number of days that the subjects need no medication

    Time frame: 12 months

  2. Symptom-free days

    Number of days that the subjects have no symptom

    Time frame: 12 months

  3. Asthmatic exacerbations

    Time elapsed until the first appearance of asthmatic exacerbations

    Time frame: 12 months

  4. Visual Analogue Scale (VAS)

    Visual Analogue Scale in which the subject has to indicate in a straight line of 10cm how he/she feels regarding to his allergy symptoms. Being left side very bad and right side very well

    Time frame: 12 months

  5. Quality of life rhinitis test

    Quality of life rhinitis test (ESPRINT-15)

    Time frame: 12 months

  6. Quality of life asthma test

    Control of asthma by Asthma Control Quality questionnaire

    Time frame: 12 months

  7. Health resources

    For each patient, the number of times that due to allergy symptoms has done the following will be counted: Have visited the GP, Have made an unscheduled visit to the specialist, Has gone to the emergency room, Has been hospitalized, Have needed to contact the doctor by phone

    Time frame: 12 months

  8. Immunological parameters

    Analyses of total and specific IgE, specific Ig G4

    Time frame: 12 months

  9. Security parameters

    Global rate and severity of AE per administration and per subject

    Time frame: 12 months

  10. Adverse Reactions

    Local and systemic reactions and any medication administered for the treatment of AR

    Time frame: 12 months

06

Study locations

22 of 32 sites recruiting
  • Hospital Universitario Principe de Asturias
    Alcalá De Henares, Comunidad De Madrid 28805, Spain
    Completed
  • Cedt de Tarancón
    Tarancon, Cuenca 16400, Spain
    • ANTONIO MORENO FERNÁNDEZ, MD · Principal investigator
    Recruiting
  • Centro Médico Iza
    Tres Cantos, Madrid 28760, Spain
    • Diana Pérez Alzate · Contact
    • Diana Pérez Alzate, MD · Principal investigator
    Recruiting
  • Hospital Infanta Elena
    Valdemoro, Madrid 28342, Spain
    • FRANCISCO JAVIER RUIZ HORNILLOS, DM · Principal investigator
    Recruiting
  • Hospital Clínico Universitario Virgen de Arrixaca
    El Palmar, Murcia 30120, Spain
    • PAOLA CARRILLO, DM · Principal investigator
    Recruiting
  • Private Practice
    Albacete, 02003, Spain
    Withdrawn
  • Clinica Dermatologica Y Alergia
    Badajoz, 06001, Spain
    • Irán Sánchez Ramos, MD · Principal investigator
    Recruiting
  • Hospital Quironsalud Clideba
    Badajoz, 06011, Spain
    • Silvia Sánchez, MD · Principal investigator
    Recruiting
  • Hospital Universitario Dexeus
    Barcelona, 08028, Spain
    • Elena Botey Faraudo, MD · Principal investigator
    Recruiting
  • Clínica privada Barcelona
    Barcelona, 08172, Spain
    Withdrawn
  • Hospital General Universitario Ciudad Real
    Ciudad Real, 13005, Spain
    • Carmen García, MD · Principal investigator
    Recruiting
  • Hospital Quironsalud Córdoba
    Córdoba, 14004, Spain
    • Ignacio García Nuñez, MD · Principal investigator
    Recruiting
  • Hospital Universitario Clínico San Cecilio
    Granada, 18016, Spain
    Active, not recruiting
  • Hospital Universitario de Jaén
    Jaén, 23007, Spain
    • Manuel Alcántara Villar, MD · Principal investigator
    • Carmen Laura Cañada Porta, MD · Sub investigator
    • María Antonia Navarrete del Pimo, MD · Sub investigator
    • Miriam Bermúdez Bejarano, MD · Sub investigator
    • Alicia López Guerrero, MD · Sub investigator
    Recruiting
  • Hospital Universitari Santa María
    Lleida, 25198, Spain
    • Eva Alcoceba Borrás, MD · Principal investigator
    Recruiting
  • Private practice
    Madrid, 28001, Spain
    Withdrawn
  • Hospital Universitario Cruz Roja
    Madrid, 28003, Spain
    • JOSE JULIO LAGUNA, MD · Principal investigator
    • Cosmin Boteau, MD · Sub investigator
    • Maria Luisa Sánchez, MD · Sub investigator
    • Rosario González, MD · Sub investigator
    • Inmaculada Piorno, MD · Sub investigator
    Recruiting
  • Clínica de Asma y Alergia en Madrid | CLÍNICA OJEDA
    Madrid, 28006, Spain
    • Pedro Ojeda, MD · Principal investigator
    • David Baquero, MD · Sub investigator
    Recruiting
  • Clínica Subiza
    Madrid, 28006, Spain
    • Javier Subiza Garrido-Lestache, MD · Principal investigator
    • Concepción Barjau Buj, MD · Sub investigator
    Recruiting
  • Hospital Carlos Iii
    Madrid, 28029, Spain
    Completed
  • Hospital Universitario Rey Juan Carlos
    Madrid, 28933, Spain
    Withdrawn
  • Private Practice
    Murcia, Spain
    • Antonio Carbonell, MD · Principal investigator
    • Yulia Petryk Petryk, MD · Sub investigator
    Recruiting
  • Hospital Quirónsalud Málaga
    Málaga, 29004, Spain
    • Leticia Herrero, DM · Principal investigator
    Recruiting
  • Private Practice
    Málaga, Spain
    • Manuel Barceló, DM · Principal investigator
    Recruiting
  • Private Practice
    Palencia, 34001, Spain
    Completed
  • Hospital Universitario Infanta Cristina
    Parla, 28981, Spain
    • Aurora Losada, MD · Principal investigator
    Recruiting
  • Clínica privada Sevilla
    Sevilla, 41005, Spain
    Withdrawn
  • Hospital Virgen Del Rocío
    Sevilla, 41013, Spain
    • Joaquín Quiralte Enriquez, MD · Principal investigator
    • Yolanda Puente Crespo, MD · Sub investigator
    • María del Robledo Ávila Castellano, MD · Sub investigator
    • Carmen Rodríguez Pozo, Nurse · Sub investigator
    • Esteban Romero Rueda, Nurse · Sub investigator
    Recruiting
  • Hospital Viamed Santa Ángela de La Cruz
    Sevilla, 41014, Spain
    • MÓNICA DONADO NORTES, MD · Principal investigator
    Recruiting
  • Private Practice
    Toledo, 45005, Spain
    Withdrawn
  • Hospital Recoletas Felipe Ii
    Valladolid, 47003, Spain
    • Alicia Alonso, DM · Principal investigator
    Recruiting
  • Hospital Ntra. Sra. de Sonsoles
    Ávila, 05004, Spain
    • Sara Acero, MD · Principal investigator
    Recruiting
07

References and documents

Publications

  • Subiza J, Feliu A, Subiza JL, Uhlig J, Fernandez-Caldas E. Cluster immunotherapy with a glutaraldehyde-modified mixture of grasses results in an improvement in specific nasal provocation tests in less than 2.5 months of treatment. Clin Exp Allergy. 2008 Jun;38(6):987-94. doi: 10.1111/j.1365-2222.2008.02995.x. Epub 2008 Apr 25. PubMed 18445082 ↗
  • Klimek L, Uhlig J, Mosges R, Rettig K, Pfaar O. A high polymerized grass pollen extract is efficacious and safe in a randomized double-blind, placebo-controlled study using a novel up-dosing cluster-protocol. Allergy. 2014 Dec;69(12):1629-38. doi: 10.1111/all.12513. Epub 2014 Oct 6. PubMed 25130503 ↗
  • Guzman-Fulgencio M, Caballero R, Lara B, Mena M, Tejera M, Sastre A, Subiza JL, Fernandez-Caldas E, Casanovas M. Safety of immunotherapy with glutaraldehyde modified allergen extracts in children and adults. Allergol Immunopathol (Madr). 2017 Mar-Apr;45(2):198-207. doi: 10.1016/j.aller.2016.08.008. Epub 2016 Dec 7. PubMed 27939406 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT04891237
Lead sponsor
Inmunotek S.L.
Responsible party
Sponsor
First posted
May 18, 2021
Start date
Jun 14, 2021
Primary completion
Jan 2026 (estimated)
Completion
Jan 2027 (estimated)
Last update
May 7, 2025

Study contacts

Miguel Casanovas
Contact
mcasanovas@inmunotek.com
912908942 ext. 0034
Raquel Caballero
Contact
rcaballero@inmunotek.com
607600638 ext. 34
Irán Sánchez
study chair · Private Site

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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