AzTrials
AzTrials

Rhinitis, AllergicPhase 3NCT04891237

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

A Phase 3 study testing 10,000 MG01 + 10,000 T517 and 30,000 MG01 + 10,000 T517 in people with Rhinitis, Allergic and Rhinoconjunctivitis, run by Inmunotek S.L. at 32 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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 more about this study

Who is it for?
Ages 12 to 65 years
What is being tested?
10,000 MG01 + 10,000 T517 and 30,000 MG01 + 10,000 T517
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
32 sitesSpain
Study dates
14 Jun 2021to Jan 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Subject who has signed the informed consent.
  • Subjects of both sexes aged between 12 and 65 years.
  • 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
  • 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.
  • 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.
  • Women of childbearing age (from menarche) should submit a urine pregnancy test with a negative result at the time of joining the trial.
Show all 11Show fewer
  • 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.
  • Subjects capable of complying with the dosage regimen.
  • Subjects who have a smartphone to record symptoms 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

Who cannot join

  • Subjects polysensitized to other aeroallergens with the exception of epithelia with occasional exposure and symptoms
  • Subjects polysensitized to other aeroallergens with the exception non-seasonal pollens with grasses and olive
  • Subjects who have received prior immunotherapy in the preceding 5 years to any aeroallergens.
  • 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.
  • 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.
  • Subjects who have previously presented a serious secondary reaction during the performance of diagnostic skin tests using the prick test.
Show all 17Show fewer
  • Subjects under treatment with ß-blockers.
  • Clinically unstable subjects at the time of enrolment in the trial (acute asthma exacerbation, respiratory infection, feverish process, acute urticaria, etc.).
  • 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.
  • Subjects who have any pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, HT, heart disease, etc.).
  • 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,).
  • Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumor diseases or with a diagnosis of immunodeficiencies.
  • Subject whose condition prevents him / her from offering cooperation and who has severe psychiatric disorders.
  • Subjects with a known allergy to other investigational drug components other than the allergen.
  • Subjects with diseases of the lower respiratory tract other than asthma such as emphysema or bronchiectasis.
  • Subjects who are direct relatives of the researchers.
  • Pregnant or lactating women.

Trial locations and contacts

32 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Miguel Casanovas contact

912908942 ext. 0034

mcasanovas@inmunotek.com

Raquel Caballero contact

607600638 ext. 34

rcaballero@inmunotek.com

32 sites in 1 country

Spain32 sites, 22 recruiting

  • Private Practice

    Albacete, 02003

    Withdrawn

  • Hospital Universitario Principe de Asturias

    Alcalá de Henares, Madrid, 28805

    Completed

  • Hospital Ntra. Sra. de Sonsoles

    Ávila, 05004

    Sara Acero, MD

    Recruiting

  • Clinica Dermatologica Y Alergia

    Badajoz, 06001

    Irán Sánchez Ramos, MD

    Recruiting

  • Hospital Quironsalud Clideba

    Badajoz, 06011

    Silvia Sánchez, MD

    Recruiting

  • Hospital Universitario Dexeus

    Barcelona, 08028

    Elena Botey Faraudo, MD

    Recruiting

  • Clínica privada Barcelona

    Barcelona, 08172

    Withdrawn

  • Hospital General Universitario Ciudad Real

    Ciudad Real, 13005

    Carmen García, MD

    Recruiting

  • Hospital Quironsalud Córdoba

    Córdoba, 14004

    Ignacio García Nuñez, MD

    Recruiting

  • Hospital Clínico Universitario Virgen de Arrixaca

    El Palmar, Murcia, 30120

    PAOLA CARRILLO, DM

    Recruiting

  • Hospital Universitario Clínico San Cecilio

    Granada, 18016

    Active, not recruiting

  • Hospital Universitario de Jaén

    Jaén, 23007

    Manuel Alcántara Villar, MD

    Carmen Laura Cañada Porta, MD

    Recruiting

  • Hospital Universitari Santa María

    Lleida, 25198

    Eva Alcoceba Borrás, MD

    Recruiting

  • Private practice

    Madrid, 28001

    Withdrawn

  • Hospital Universitario Cruz Roja

    Madrid, 28003

    JOSE JULIO LAGUNA, MD

    Cosmin Boteau, MD

    Recruiting

  • Clínica de Asma y Alergia en Madrid | CLÍNICA OJEDA

    Madrid, 28006

    Pedro Ojeda, MD

    David Baquero, MD

    Recruiting

  • Clínica Subiza

    Madrid, 28006

    Javier Subiza Garrido-Lestache, MD

    Concepción Barjau Buj, MD

    Recruiting

  • Hospital Carlos Iii

    Madrid, 28029

    Completed

  • Hospital Universitario Rey Juan Carlos

    Madrid, 28933

    Withdrawn

  • Hospital Quirónsalud Málaga

    Málaga, 29004

    Leticia Herrero, DM

    Recruiting

  • Private Practice

    Málaga

    Manuel Barceló, DM

    Recruiting

  • Private Practice

    Murcia

    Antonio Carbonell, MD

    Yulia Petryk Petryk, MD

    Recruiting

  • Private Practice

    Palencia, 34001

    Completed

  • Hospital Universitario Infanta Cristina

    Parla, 28981

    Aurora Losada, MD

    Recruiting

  • Clínica privada Sevilla

    Seville, 41005

    Withdrawn

  • Hospital Virgen Del Rocío

    Seville, 41013

    Joaquín Quiralte Enriquez, MD

    Yolanda Puente Crespo, MD

    Recruiting

  • Hospital Viamed Santa Ángela de La Cruz

    Seville, 41014

    MÓNICA DONADO NORTES, MD

    Recruiting

  • Cedt de Tarancón

    Tarancón, Cuenca, 16400

    ANTONIO MORENO FERNÁNDEZ, MD

    Recruiting

  • Private Practice

    Toledo, 45005

    Withdrawn

  • Centro Médico Iza

    Tres Cantos, Madrid, 28760

    Diana Pérez Alzate

    Diana Pérez Alzate, MD

    Recruiting

  • Hospital Infanta Elena

    Valdemoro, Madrid, 28342

    FRANCISCO JAVIER RUIZ HORNILLOS, DM

    Recruiting

  • Hospital Recoletas Felipe Ii

    Valladolid, 47003

    Alicia Alonso, DM

    Recruiting

Other trials in Spain

About this study

Official title: A Randomized, Double-Blinded, Placebo-Controlled, Prospective, Multicenter CT to Evaluate Efficacy and Safety of Subcutaneous Immunotherapy in Subjects With Rhinitis With/Without Mild to Moderate Asthma Sensitized to Olive and Grass Pollen

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

Being tested
10,000 MG01 + 10,000 T517, 30,000 MG01 + 10,000 T517, Placebo
Keywords
Rhinitis/ Rhinoconjunctivitis, Mild to moderate asthma, Allergy, Grasses, Olea
Medical subject headings
Rhinitis, Allergic, Asthma, Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 10,000 MG01 + 10,000 T517Biological

    Also called Grasses and olea 10,000

    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

  • 30,000 MG01 + 10,000 T517Biological

    Also called Grasses and olea

    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

  • PlaceboOther

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

Study groups in NCT04891237
Study groupRoleWhat they receive
10,000 MG01 + 10,000 T517Experimental10,000 TU/mL of MG01 + 10,000 TU/mL of T517 of subcutaneous immunotherapy
Receives: Biological: 10,000 MG01 + 10,000 T517
30,000 MG01 + 10,000 T517Experimental30,000 TU/mL of MG01 + 10,000 TU/mL of T517 of subcutaneous immunotherapy
Receives: Biological: 30,000 MG01 + 10,000 T517
Placebo subcutaneousPlacebo comparatorThe same solution and presentation as the active treatment, but without active ingredients.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months

Secondary outcomes (10)

  1. Medication-free days

    Number of days that the subjects need no medication

    Measured: 12 months

  2. Symptom-free days

    Number of days that the subjects have no symptom

    Measured: 12 months

  3. Asthmatic exacerbations

    Time elapsed until the first appearance of asthmatic exacerbations

    Measured: 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

    Measured: 12 months

  5. Quality of life rhinitis test

    Quality of life rhinitis test (ESPRINT-15)

    Measured: 12 months

  6. Quality of life asthma test

    Control of asthma by Asthma Control Quality questionnaire

    Measured: 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

    Measured: 12 months

  8. Immunological parameters

    Analyses of total and specific IgE, specific Ig G4

    Measured: 12 months

  9. Security parameters

    Global rate and severity of AE per administration and per subject

    Measured: 12 months

  10. Adverse Reactions

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2021
  2. Study start14 Jun 2021
  3. Primary completionJan 2026 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, randomized, double-blind, placebo-controlled, multicentre, parallel-group study
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04891237
Sponsor's protocol ID
DMV03-SIT-027
Status last verified
May 2025
First submitted
30 Apr 2021
Last updated
7 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 10,000 MG01 + 10,000 T517 and 30,000 MG01 + 10,000 T517 in people with Rhinitis, Allergic and Rhinoconjunctivitis, run by Inmunotek S.L. at 32 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Miguel Casanovas (912908942 ext. 0034, mcasanovas@inmunotek.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CSMS: Combined Symptoms and Medication Score (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04891237, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025; AzTrials last refreshed its copy on 26 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in