Evaluating a new treatment for allergies to certain trees and grasses
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
Run by Inmunotek S.L. · NCT04898283 · Data updated 2026-11-12
This study is testing a new allergy treatment for people aged 12 to 65 who are sensitive to certain tree and grass pollens to see if it can help reduce their allergy symptoms.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 12 Years to 65 Years |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | Inmunotek S.L. Industry-sponsored |
| Drugs / interventions | immunotherapy |
| Locations | 27 sites (Valladolid, Castille and León and 26 other locations) |
| Status | Recruiting |
| Started | May 31, 2021 |
| Main results expected | October 2026 |
| Study ends | October 2026 |
| Registry record updated | May 13, 2025 |
| Trial ID | NCT04898283 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 12 to 65 with a clinical history of moderate to severe rhinitis/rhinoconjunctivitis and/or mild to moderate asthma due to grass and cupressaceae pollen.
✕Probably not a fit
Patients who do not have a positive skin prick test or specific IgE levels for the targeted allergens may not benefit from this treatment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial is a randomized, double-blinded, placebo-controlled study designed to assess the efficacy and safety of subcutaneous immunotherapy in patients aged 12 to 65 who are sensitized to cupressaceae and grass pollen. The study will involve 180 participants and will last for 18 months, during which their rhinitis and asthma symptoms will be monitored through an electronic diary. The primary endpoint is the combined rhinitis/rhinoconjunctivitis symptom and medication score, evaluated during peak pollen seasons.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce allergy symptoms and improve quality of life for patients with rhinitis and asthma triggered by specific pollen.
How similar studies have gone: Previous studies have shown promising results with similar immunotherapy approaches for allergic rhinitis and asthma, indicating potential for success in this trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Written informed consent. 2. Aged between 12 and 65, both genders 3. 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. 4. 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. 5. Specific IgE \> 3,5 KU/L , against grass (preferably Phleum pratense) and cupressaceae pollen (InmunoCAP® o Immulite). 6. Women of childbearing age (from menarche) must present a urine pregnancy test with a negative result at the time of joining the trial. 7. 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. 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 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: 1. Subjects with positive prick test to other aeroallergens except for sensitisation to epithelia with occasional exposure and symptoms. 2. Subjects with positive prick test to other aeroallergens except for sensitisation to pollen noncoseasonal with cupressus or grasses. 3. 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. 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 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. 6. Subjects who have previously had a severe secondary reaction during the prick test diagnostic skin test. 7. Subjects treated with beta-blockers. 8. Clinically unstable subjects at the time of inclusion in the trial (acute asthmatic exacerbation, respiratory infection, febrile process, acute urticaria, etc.). 9. 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. 10. Subjects who have any pathology in which adrenaline administration is contraindicated (hyperthyroidism, HTN, heart disease, etc.). 11. 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,). 12. Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumor diseases or with a diagnosis of immunodeficiencies. 13. Subject whose condition prevents from offering cooperation and/ or who has severe psychiatric disorders. 14. Subjects with a known allergy to components of the investigational medicinal product other than the allergen. 15. Subjects with lower respiratory diseases other than asthma such as emphysema or bronchiectasis. 16. Subjects who are direct relatives of the researchers. 17. Pregnant or lactating women.
Where it's running
-
Hospital Recoletas Felipe Ii
Valladolid, Castille and León, Spain Recruiting -
Cedt de Tarancón
Tarancón, Cuenca, Spain Recruiting -
Hospital U. Fundación Alcorcón
Alcorcón, Madrid, Spain Recruiting -
Hospital Cruz Roja Madrid
Madrid, Madrid, Spain Recruiting -
Clínica Privada Dres Ojeda
Madrid, Madrid, Spain Recruiting -
Hospital Universitario de Burgos
Burgos, Spain Recruiting
Show 21 more locations
-
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain Recruiting -
Centro médico Saluddia
Madrid, Spain Recruiting -
Centro Médico Iza (Clínica Privada Madrid)
Madrid, Spain Recruiting -
Hospital Universitario Principe de Asturias
Alcalá de Henares, Madrid, Spain Completed -
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain Not yet recruiting -
Clínica Privada Murcia
Murcia, Murcia, Spain Not yet recruiting -
Hospital Nuestra Señora de Sonsoles
Ávila, Spain Not yet recruiting -
Fundación Hospital Sant Pere Claver
Barcelona, Spain Withdrawn -
Clínica privada Burgos
Burgos, Spain Withdrawn -
Hospital General de Villalba
Collado Villalba, Spain Not yet recruiting -
Clinica privada
León, Spain Withdrawn -
Clínica Subiza
Madrid, Spain Active not recruiting -
Hospital Carlos III (antiguo CAP José Marva)
Madrid, Spain Withdrawn -
Clínica Privada
Madrid, Spain Withdrawn -
Hospital Universitario Ramón y Cajal
Madrid, Spain Not yet recruiting -
Hospital Infanta Elena
Madrid, Spain Not yet recruiting -
Consulta Privada
Palencia, Spain Completed -
Hospital Clínico de Salamanca
Salamanca, Spain Active not recruiting -
Hospital General Universitario de Segovia
Segovia, Spain Not yet recruiting -
Clinica Privada Soria
Soria, Spain Withdrawn -
Clínica Privada
Zaragoza, Spain Withdrawn
Study contacts
- Study coordinator: Miguel Casanovas, MD PhD
- Email: mcasanovas@inmunotek.com
- Phone: +34 912908942
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Evaluating a treatment for allergies to grass and olive pollen
This study is testing a new allergy treatment for people aged 12 to 65 who have reactions to grass and olive pollen to see if it can help reduce their symptoms.
-
Evaluating a treatment for allergies to dust mites
This study is testing a new allergy treatment for people aged 12 to 65 who are sensitive to dust mites to see if it can help reduce their allergy and asthma symptoms over a year.
-
PollenVax for mugwort pollen allergy
This Phase 2 study tests PollenVax, a quick-course subcutaneous immunotherapy, in adults with mugwort pollen–triggered allergic rhinitis.
-
Sublingual MM09 for dust-mite–triggered rhinitis and rhinoconjunctivitis in people aged 12–65 with or without mild-to-moderate asthma
This trial will test whether daily sublingual MM09 reduces symptoms and the need for rescue medication in people aged 12–65 who have rhinitis or rhinoconjunctivitis caused by dust mites, with or without mild-to-moderate asthma.
-
Evaluating air purifiers for improving allergic rhinitis symptoms
This study is testing whether using a special air purifier can help adults with moderate to severe allergies feel better compared to using a fake air purifier.
-
Assessing the impact of airway allergic diseases on children's and parents' quality of life
This study looks at how having asthma or allergies affects the quality of life for children and their parents, comparing those getting special treatment to those on regular care.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.