AzTrials
AzTrials

Rhinitis, AllergicPhase 3NCT04898283

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

A Phase 3 study testing 10,000 MG01 +10,000 T521 and 30,000 MG01 +10,000 T521 in people with Rhinitis, Allergic and Rhinoconjunctivitis, run by Inmunotek S.L. at 27 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

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. Read more about this study

Who is it for?
Ages 12 to 65 years
What is being tested?
10,000 MG01 +10,000 T521 and 30,000 MG01 +10,000 T521
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
27 sitesSpain
Study dates
31 May 2021to Oct 2026
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

  • 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.
Show all 11Show fewer
  • 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.

Who cannot join

  • Subjects with positive prick test to other aeroallergens except for sensitisation to epithelia with occasional exposure and symptoms.
  • Subjects with positive prick test to other aeroallergens except for sensitisation to pollen noncoseasonal with cupressus or grasses.
  • Subjects who have received prior immunotherapy in the preceding 5 years for any of the allergens tested or a cross-reactive allergen or are currently receiving immunotherapy with any allergen.
  • 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 intermittent or 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 had a severe secondary reaction during the prick test diagnostic skin test.
Show all 17Show fewer
  • Subjects treated with beta-blockers.
  • Clinically unstable subjects at the time of inclusion in the trial (acute asthmatic exacerbation, respiratory infection, febrile process, acute urticaria, etc.).
  • Subjects with active chronic urticaria, severe dermographism, severe atopic dermatitis, sunburn, 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 adrenaline administration is contraindicated (hyperthyroidism, HTN, heart disease, etc.).
  • Subjects with any other disease not related to moderate rhinoconjunctivitis or asthma, but potentially serious and that may interfere with treatment and follow-up (epilepsy, psychomotor disorder, uncontrolled diabetes, malformations, multioperated patients, kidney disease,).
  • Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumor diseases or with a diagnosis of immunodeficiencies.
  • Subject whose condition prevents from offering cooperation and/ or who has severe psychiatric disorders.
  • Subjects with a known allergy to components of the investigational medicinal product other than the allergen.
  • Subjects with lower respiratory diseases other than asthma such as emphysema or bronchiectasis.
  • Subjects who are direct relatives of the researchers.
  • Pregnant or lactating women.

Trial locations and contacts

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

Miguel Casanovas, MD PhD contact

+34 912908942 ext. 0034

mcasanovas@inmunotek.com

Raquel Caballero contact

+34 607600638

rcaballero@inmunotek.com

27 sites in 1 country

Spain27 sites, 16 recruiting

  • Hospital Universitario Principe de Asturias

    Alcalá de Henares, Madrid, 28806

    Completed

  • Hospital U. Fundación Alcorcón

    Alcorcón, Madrid, 28922

    Mª Dolores Alonso Díaz de Durana, +34 916219400, mdolores.alonso@salud.madrid.org

    Mª Dolores Alonso Díaz de Durana, MD

    Recruiting

  • Hospital Nuestra Señora de Sonsoles

    Ávila, 05071

    Sara Acero Sainz, MD, +34 920 358 000, sacero@saludcastillayleon.es

    Sara Acero Sainz, MD

    Not yet recruiting

  • Fundación Hospital Sant Pere Claver

    Barcelona, 08004

    Withdrawn

  • Clínica privada Burgos

    Burgos, 09004

    Withdrawn

  • Hospital Universitario de Burgos

    Burgos, 09006

    Laura Manzanedo, MD, +34 947281800, lmanzanedo@saludcastillayleon.es

    Natalia Sofía Perea Lam, MD

    Recruiting

  • Hospital General de Villalba

    Collado Villalba, 28400

    Ignacio Esteban Gorgojo, MD, +34 658 934 085, igestebang@gmail.com

    Not yet recruiting

  • Clinica privada

    León, 24003

    Withdrawn

  • Hospital Cruz Roja Madrid

    Madrid, Madrid, 28003

    Jose Julio Laguna, MD, +34 914538300, josejuliolaguna@gmail.com

    Jose Julio Laguna, MD

    Recruiting

  • Clínica Privada Dres Ojeda

    Madrid, Madrid, 28006

    Pedro Ojeda, MD, +34 915623262, pedro.ojeda@clinicaojeda.es

    Pedro Ojeda, MD

    Recruiting

  • Clínica Subiza

    Madrid, 28006

    Active, not recruiting

  • Hospital Carlos III (antiguo CAP José Marva)

    Madrid, 28029

    Withdrawn

  • Clínica Privada

    Madrid, 28034

    Withdrawn

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

    David González de Olano, MD, +34 913368000, dgolano@yahoo.es

    David González de Olano, MD

    Not yet recruiting

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040

    Diana Betancor Pérez, MD, +34 915504800, diana.betancor@quironsalud.es

    Diana Betancor Pérez, MD

    Recruiting

  • Hospital Infanta Elena

    Madrid, 28342

    Francisco Javier Ruiz Hornillos, MD, +34 918948410, jrornillod@gmail.com

    Francisco Javier Ruiz Hornillos, MD

    Not yet recruiting

  • Centro médico Saluddia

    Madrid, 28522

    Beatriz Huertas Barbudo, MD, +34 917372953, huertasb@gmail.com

    Beatriz Huertas Barbudo, MD

    Recruiting

  • Centro Médico Iza (Clínica Privada Madrid)

    Madrid, 28760

    Diana Victoria Pérez Alzate, MD, +34 918046602, dianatoria@hotmail.com

    Diana Pérez, MD

    Recruiting

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222

    Ángel Luis Villalón, MD, +34 911916000, anluvillalon@yahoo.es

    Ángel Luis Villalón García, MD

    Not yet recruiting

  • Clínica Privada Murcia

    Murcia, Murcia, 30006

    Antonio Carbonell Martínez, MD, +34 968238621, med018934@gmail.com

    Antonio Carbonell Martínez, MD

    Not yet recruiting

  • Consulta Privada

    Palencia, 34001

    Completed

  • Hospital Clínico de Salamanca

    Salamanca, 37007

    Active, not recruiting

  • Hospital General Universitario de Segovia

    Segovia, 40002

    María Mercedes Fuentes Cuesta, MD PhD, +34 629 870 557, fuentescuesta@yahoo.es

    María Mercedes Fuentes Cuesta, MD PhD

    Not yet recruiting

  • Clinica Privada Soria

    Soria, 42005

    Withdrawn

  • Cedt de Tarancón

    Tarancón, Cuenca, 16400

    Antonio Moreno Fernández, MD, +34 918925373, doctorertony@hotmail.com

    Antonio Moreno Fernández, MD

    Recruiting

  • Hospital Recoletas Felipe Ii

    Valladolid, Castille and León, 47003

    Alicia Alonso, MD, +34 983358000, aliciaalonsogomez@gmail.com

    Alicia Alonso, MD

    Recruiting

  • Clínica Privada

    Zaragoza, 50004

    Withdrawn

Other trials in Spain

About this study

Official title: 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

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.

Read the detailed 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.

Being tested
10,000 MG01 +10,000 T521, 30,000 MG01 +10,000 T521, Placebo subcutaneous
Keywords
Rhinitis/ Rhinoconjunctivitis, Mild to moderate asthma, Allergy, Immunotherapy, Grass, cupressaceae
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 T521Biological

    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 cupressaceae (Juniperus oxycedrus), adsorbed on aluminum hydroxide. The other ingredients are: sodium chloride (0.9%), phenol (0.4%) and water for injections

  • 30,000 MG01 +10,000 T521Biological

    Purified allergen extract polymerized with glutaraldehyde, from a mixture of grasses (Phleum pratense, Holcus lanatus, Poa pratensis, Festuca pratensis, Lolium perenne and Dactylis glomerata) and cupressaceae (Juniperus oxycedrus), adsorbed on aluminum hydroxide. The other ingredients are: sodium chloride (0.9%), phenol (0.4%) and water for injections.

  • Placebo subcutaneousOther

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

Study groups in NCT04898283
Study groupRoleWhat they receive
10,000 MG01 + 10,000 T521Experimental10,000 TU/mL of MG01 + 10,000 TU/mL of T521 of subcutaneous immunotherapy
Receives: Biological: 10,000 MG01 +10,000 T521
30,000 MG01 + 10,000 T521Experimental30,000 TU/mL of MG01 + 10,000 TU/mL of T521 of subcutaneous immunotherapy
Receives: Biological: 30,000 MG01 +10,000 T521
Placebo subcutaneousPlacebo comparatorThe same solution and presentation as the active treatment, but without active ingredients.
Receives: Other: Placebo subcutaneous

What is being measured

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

  1. RCSMS: Combined Symptoms and Medication Score of rhinitis. Combined symptom and medication score in rhinitis/rhinoconjunctivitis (RCSMS)

    Evaluation of the number of symptoms and the consumption of medication necessary for the control of such symptoms in rhinitis / rhinoconjunctivitis of each subject during the pollen season and pollen peak of cupressaceae (January, February and March) and grasses (May and June), of the groups with each other and with respect to placebo.

    Measured: 18 months

Secondary outcomes (17)

  1. Symptom free days

    The number of days during the trial period that the subject was free of symptoms related to the study pathologies (both rhinitis/rhinoconjunctivitis and asthma) shall be counted for each subject.

    Measured: 18 months

  2. Medication free days

    The number of days during the trial period that the subject has not taken any medication for symptom (both rhinitis/rhinoconjunctivitis and asthma) relief shall be counted for each subject.

    Measured: 18 months

  3. Symptom score in rhinitis/rhinoconjunctivitis (RSS) during pollen season and pollen peak of grasses and cupressaceae

    The rhinitis/rhinoconjunctivitis-related symptom score shall be counted throughout the trial period for each subject.

    Measured: 18 months

  4. Medication score in rhinitis/rhinoconjunctivitis (RMS) during pollen season and pollen peak of grasses and cupressaceae

    The rhinitis/rhinoconjunctivitis-related medication score will be counted throughout the trial period for each subject.

    Measured: 18 months

  5. Combined symptom and medication score (ACSMS) during pollen season and pollen peak of grasses and cupressaceae

    The combined asthma-related symptom score (ASS) and asthma-related medication score (AMS) shall be counted throughout the trial period for each subject.

    The ACSMS shall range from 0 to 6.

    Measured: 18 months

  6. Asthma symptom score (ASS) during pollen season and pollen peak of grasses and cupressaceae

    The asthma-related symptom score shall be counted throughout the trial period for each subject. The symptoms are as follows: coughing, wheezing or whistling, choking or suffocating sensation, chest tightness

    The assessment criteria for each symptom shall be as follows:

    0 = No symptoms (no obvious symptoms).

    1. = Mild (trivial; the symptom is clearly present but not bothersome).
    2. = Moderate (annoying, but not disabling or intolerable).
    3. = Severe (disabling and/or intolerable). The asthma symptom score (ASS) will be the sum of the 4 asthma symptoms divided by 4. The final score will vary from 0 to 3.

    Measured: 18 months

  7. Asthma Medication Score (AMS) during pollen season and pollen peak of grasses and cupressaceae

    The asthma-related medication score will be counted throughout the trial period for each subject. The medication will be scored based on the therapeutic step in which the drugs are included in the GEMA 5.0 and GINA 2020 guidelines. The scoring approach is detailed in the article entitled 'Combination of Allergic Asthma Symptom and Medication Scores in Allergen Immunotherapy Trials: A Proposal'

    Measured: 18 months

  8. Asthma and rhinitis/rhinoconjunctivitis symptom score (ARSS) during pollen season and pollen peak of grasses and cupressaceae

    The asthma-related (ASS) and rhinitis/rhinoconjunctivitis (RSS) symptom scores shall be counted throughout the trial period for each subject.

    The ARSS shall range from 0 to 6.

    Measured: 18 months

  9. Asthma and rhinitis/rhinoconjunctivitis medication score (ARMS) during pollen season and pollen peak of grasses and cupressaceae

    The asthma-related medication score (AMS) and rhinitis/rhinoconjunctivitis score (RMS) shall be counted throughout the trial period for each subject.

    The ARMS shall range from 0 to 6.

    Measured: 18 months

  10. Combined symptom and medication score in asthma and rhinitis/rhinoconjunctivitis (ARCSMS) during pollen season and pollen peak of grasses and cupressaceae

    The combined asthma-related symptom and medication score (ACSMS) and rhinitis/rhinoconjunctivitis (RCSMS) shall be counted throughout the trial period for each subject.

    The ARCSMS shall range from 0 to 12.

    Measured: 18 months

  11. Asthmatic exacerbations

    Time to first occurrence of asthmatic exacerbation, number, duration and severity will be analysed.

    Measured: 18 months

  12. 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 (0) = very bad and right side (10) = very well

    Measured: 18 months

  13. Immunological parameters

    Total IgE, specific IgE and specific IgG4 are analysed during screening and final visit.

    The determination of grasses shall be carried out on Phleum pratense. The determination of immunological parameters shall be carried out by analysis of the whole or total extract and not by molecular components.

    Measured: 18 months

  14. Quality of life associated with asthma (ACQ-6)

    The quality of life associated with asthma will be measured following the ACQ questionnaire.

    The ACQ questionnaire consists of 6 questions (ACQ-6). In questions 1-6, patients recall their experience during the last 7 days and answer using a scale of 7 points (from 0 = fully controlled to 6 = extremely poorly controlled). The questionnaire score is the mean of the 6 responses (ACQ-6).

    The interpretation of the scores is as follows:

    Less than or equal to 0.75: Adequate control of asthma From 0.75 to 1.50: Partially controlled asthma More than 1.50: Inadequate asthma control

    Measured: 18 months

  15. Quality of life associated with rhinitis (ESPRINT-15)

    The quality of life associated with rhinitis will be measured following the test ESPRINT-15.

    The scoring of the questionnaire will be carried out as follows: The global sum of the scores (ranging from "0 = nothing has bothered me" to "6 = it has bothered me a lot") of the 14 items plus the score given in the general questionnaire (ranging from "0 = Excellent" to "4 = Bad"). This sum is divided by the total number of items (15 items).

    The interpretation of the scores is between 0 (low impact) and 6 (high impact).

    Measured: 18 months

  16. Health resource consumption

    Counting the Health resource consumption related to the study pathology: visits to specialists, telephone calls, test and analyses.

    Recording of health resource consumption will be carried out at all study visits, from screening to final visit or additional final visit, if applicable.

    Measured: 18 months

  17. Safety parameters

    Number of participants with treatment-related adverse events as assessed by T521+MG01-SIT026.

    Comparison between the beginning and end of the trial and among active groups and placebo

    Measured: 18 months

Timeline

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

  1. First posted24 May 2021
  2. Study start31 May 2021
  3. Primary completionOct 2026 (estimated)
  4. Study completionOct 2026 (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
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
NCT04898283
Sponsor's protocol ID
DMV02-SIT-026
Status last verified
May 2025
First submitted
4 Jan 2021
Last updated
13 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

  • Caballero R, Grau A, Javaloyes G, Del Pozo S, Leon MA, Romero M, Casanovas M. Combination of Allergic Asthma Symptom and Medication Scores in Allergen Immunotherapy Trials: A Proposal. Int Arch Allergy Immunol. 2021;182(7):571-573. doi: 10.1159/000513543. Epub 2021 Jan 26. No abstract available.

    PubMed 33498057

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 10,000 MG01 +10,000 T521 and 30,000 MG01 +10,000 T521 in people with Rhinitis, Allergic and Rhinoconjunctivitis, run by Inmunotek S.L. at 27 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 13 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 27 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, MD PhD (+34 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?

RCSMS: Combined Symptoms and Medication Score of rhinitis. Combined symptom and medication score in rhinitis/rhinoconjunctivitis (RCSMS) (time frame: 18 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 NCT04898283, which also lists 2 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 13 May 2025.

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

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in