ClinicalTrials.gg
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

From the registry’s dates

  • Primary completion was expected by Jan 2026, 10 months ago, but the record still lists the study as recruiting.
  • Started Jun 2021; still recruiting 5 years 4 months later.
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

In context

Rhinitis, Allergic

717 studies on the registry are indexed under Rhinitis, Allergic; 94 are open to participants now.

This study's planned enrollment of 180 is above the median of 68 across 552 interventional studies indexed under Rhinitis, Allergic.

Browse Rhinitis, Allergic studies →

Lead sponsor

Inmunotek S.L. is the lead sponsor of 26 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Subject who has signed the .
  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 , and men participating in the trial, should commit to using an appropriate method of . 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 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 \<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 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 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.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

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

06

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

07

Study locations

22 of 32 sites recruiting
  • Hospital Universitario Principe de Asturias
    Alcalá De Henares, Comunidad De Madrid 28805, Spain
    Completed

    Not enrolling at this site — choose another above.

  • Cedt de Tarancón
    Tarancon, Cuenca 16400, Spain
    Recruiting
    • ANTONIO MORENO FERNÁNDEZ, MD · Principal investigator
  • Centro Médico Iza
    Tres Cantos, Madrid 28760, Spain
    Recruiting
    • Diana Pérez Alzate · Contact
    • Diana Pérez Alzate, MD · Principal investigator
  • Hospital Infanta Elena
    Valdemoro, Madrid 28342, Spain
    Recruiting
    • FRANCISCO JAVIER RUIZ HORNILLOS, DM · Principal investigator
  • Hospital Clínico Universitario Virgen de Arrixaca
    El Palmar, Murcia 30120, Spain
    Recruiting
    • PAOLA CARRILLO, DM · Principal investigator
  • Private Practice
    Albacete, 02003, Spain
    Withdrawn

    Not enrolling at this site — choose another above.

  • Clinica Dermatologica Y Alergia
    Badajoz, 06001, Spain
    Recruiting
    • Irán Sánchez Ramos, MD · Principal investigator
  • Hospital Quironsalud Clideba
    Badajoz, 06011, Spain
    Recruiting
    • Silvia Sánchez, MD · Principal investigator
  • Hospital Universitario Dexeus
    Barcelona, 08028, Spain
    Recruiting
    • Elena Botey Faraudo, MD · Principal investigator
  • Clínica privada Barcelona
    Barcelona, 08172, Spain
    Withdrawn

    Not enrolling at this site — choose another above.

  • Hospital General Universitario Ciudad Real
    Ciudad Real, 13005, Spain
    Recruiting
    • Carmen García, MD · Principal investigator
  • Hospital Quironsalud Córdoba
    Córdoba, 14004, Spain
    Recruiting
    • Ignacio García Nuñez, MD · Principal investigator
  • Hospital Universitario Clínico San Cecilio
    Granada, 18016, Spain
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Hospital Universitario de Jaén
    Jaén, 23007, Spain
    Recruiting
    • 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
  • Hospital Universitari Santa María
    Lleida, 25198, Spain
    Recruiting
    • Eva Alcoceba Borrás, MD · Principal investigator
  • Private practice
    Madrid, 28001, Spain
    Withdrawn

    Not enrolling at this site — choose another above.

  • Hospital Universitario Cruz Roja
    Madrid, 28003, Spain
    Recruiting
    • 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
  • Clínica de Asma y Alergia en Madrid | CLÍNICA OJEDA
    Madrid, 28006, Spain
    Recruiting
    • Pedro Ojeda, MD · Principal investigator
    • David Baquero, MD · Sub investigator
  • Clínica Subiza
    Madrid, 28006, Spain
    Recruiting
    • Javier Subiza Garrido-Lestache, MD · Principal investigator
    • Concepción Barjau Buj, MD · Sub investigator
  • Hospital Carlos Iii
    Madrid, 28029, Spain
    Completed

    Not enrolling at this site — choose another above.

  • Hospital Universitario Rey Juan Carlos
    Madrid, 28933, Spain
    Withdrawn

    Not enrolling at this site — choose another above.

  • Private Practice
    Murcia, Spain
    Recruiting
    • Antonio Carbonell, MD · Principal investigator
    • Yulia Petryk Petryk, MD · Sub investigator
  • Hospital Quirónsalud Málaga
    Málaga, 29004, Spain
    Recruiting
    • Leticia Herrero, DM · Principal investigator
  • Private Practice
    Málaga, Spain
    Recruiting
    • Manuel Barceló, DM · Principal investigator
  • Private Practice
    Palencia, 34001, Spain
    Completed

    Not enrolling at this site — choose another above.

  • Hospital Universitario Infanta Cristina
    Parla, 28981, Spain
    Recruiting
    • Aurora Losada, MD · Principal investigator
  • Clínica privada Sevilla
    Sevilla, 41005, Spain
    Withdrawn

    Not enrolling at this site — choose another above.

  • Hospital Virgen Del Rocío
    Sevilla, 41013, Spain
    Recruiting
    • 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
  • Hospital Viamed Santa Ángela de La Cruz
    Sevilla, 41014, Spain
    Recruiting
    • MÓNICA DONADO NORTES, MD · Principal investigator
  • Private Practice
    Toledo, 45005, Spain
    Withdrawn

    Not enrolling at this site — choose another above.

  • Hospital Recoletas Felipe Ii
    Valladolid, 47003, Spain
    Recruiting
    • Alicia Alonso, DM · Principal investigator
  • Hospital Ntra. Sra. de Sonsoles
    Ávila, 05004, Spain
    Recruiting
    • Sara Acero, MD · Principal investigator
08

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

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2021 (actual). Primary completion is estimated for Jan 2026, 55 months after the start.

Of 31 industry-sponsored phase 3 interventional studies under Rhinitis, Allergic, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 41. This study's planned 55 months is above that.

Counting every sponsor, half of 41 studies reached it within 13 months; a quarter within 6 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 30, 2021
First posted
May 18, 2021
StartActual
Jun 14, 2021
Primary completionEst.
Jan 2026
CompletionEst.
Jan 2027
Last update
May 7, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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