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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04891237
Other study ID # DMV03-SIT-027
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date June 14, 2021
Est. completion date January 2026

Study information

Verified date December 2023
Source Inmunotek S.L.
Contact Miguel Casanovas
Phone 912908942
Email mcasanovas@inmunotek.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 180
Est. completion date January 2026
Est. primary completion date October 2025
Accepts healthy volunteers No
Gender All
Age group 12 Years to 65 Years
Eligibility 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: 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.

Study Design


Intervention

Biological:
10,000 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
30,000 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
Other:
Placebo
The same solution and presentation as the active treatment, but without active ingredients

Locations

Country Name City State
Spain Private Practice Albacete
Spain Hospital Universitario Principe de Asturias Alcalá De Henares Comunidad De Madrid
Spain Clinica Dermatologica Y Alergia Badajoz
Spain Hospital Universitario Dexeus Barcelona
Spain Hospital Quironsalud Córdoba Córdoba
Spain Hospital Clínico Universitario Virgen de Arrixaca El Palmar Murcia
Spain Hospital Universitario Clínico San Cecilio Granada
Spain Hospital Universitario de Jaén Jaén
Spain Hospital Universitari Santa María Lleida
Spain Cap José Marvá Madrid
Spain Clínica de Asma y Alergia en Madrid | CLÍNICA OJEDA Madrid
Spain Clínica Subiza Madrid
Spain Hospital Universitario Cruz Roja Madrid
Spain Hospital Universitario Rey Juan Carlos Madrid
Spain Private practice Madrid
Spain Hospital Quirónsalud Málaga Málaga
Spain Private Practice Málaga
Spain Private Practice Murcia
Spain Private Practice Palencia
Spain Hospital Viamed Santa Ángela de La Cruz Sevilla
Spain Hospital Virgen Del Rocío Sevilla
Spain Cedt de Tarancón Tarancon Cuenca
Spain Private Practice Toledo
Spain Centro Médico Iza Tres Cantos Madrid
Spain Hospital Infanta Elena Valdemoro Madrid
Spain Hospital Recoletas Felipe Ii Valladolid

Sponsors (1)

Lead Sponsor Collaborator
Inmunotek S.L.

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 12 months
Secondary Medication-free days Number of days that the subjects need no medication 12 months
Secondary Symptom-free days Number of days that the subjects have no symptom 12 months
Secondary Asthmatic exacerbations Time elapsed until the first appearance of asthmatic exacerbations 12 months
Secondary 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 12 months
Secondary Quality of life rhinitis test Quality of life rhinitis test (ESPRINT-15) 12 months
Secondary Quality of life asthma test Control of asthma by Asthma Control Quality questionnaire 12 months
Secondary 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
12 months
Secondary Immunological parameters Analyses of total and specific IgE, specific Ig G4 12 months
Secondary Security parameters Global rate and severity of AE per administration and per subject 12 months
Secondary Adverse Reactions Local and systemic reactions and any medication administered for the treatment of AR 12 months
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