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

NCT04898283 | Recruiting Phase 3

• 1 other identifier: DMV02-SIT-026
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 27

Brief 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.

Conditions

Rhinitis, Allergic; Rhinoconjunctivitis; Asthma, Allergic

Keywords

Rhinitis/ Rhinoconjunctivitis; Mild to moderate asthma; Allergy; Immunotherapy; Grass; cupressaceae

Outcome Measures

Primary Outcomes (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.

  18 months

Secondary Outcomes (17)

• Symptom free days

  18 months

• Medication free days

  18 months

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

  18 months

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

  18 months

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

  18 months

Study Arms (3)

10,000 MG01 + 10,000 T521

EXPERIMENTAL

10,000 TU/mL of MG01 + 10,000 TU/mL of T521 of subcutaneous immunotherapy

Biological: 10,000 MG01 +10,000 T521

30,000 MG01 + 10,000 T521

EXPERIMENTAL

30,000 TU/mL of MG01 + 10,000 TU/mL of T521 of subcutaneous immunotherapy

Biological: 30,000 MG01 +10,000 T521

Placebo subcutaneous

PLACEBO COMPARATOR

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

Other: Placebo subcutaneous

Interventions

10,000 MG01 +10,000 T521 BIOLOGICAL

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

10,000 MG01 + 10,000 T521

30,000 MG01 +10,000 T521 BIOLOGICAL

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.

30,000 MG01 + 10,000 T521

Placebo subcutaneous OTHER

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

Placebo subcutaneous

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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 who have previously had a severe secondary reaction during the prick test diagnostic skin test.
• Subjects treated with beta-blockers.
• 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.

Sponsors & Collaborators

• Inmunotek S.L.: lead

Study Sites (27)

Hospital Recoletas Felipe Ii

Valladolid, Castille and León, 47003, Spain

RECRUITING

Cedt de Tarancón

Tarancón, Cuenca, 16400, Spain

RECRUITING

Hospital Universitario Principe de Asturias

Alcalá de Henares, Madrid, 28806, Spain

COMPLETED

Hospital U. Fundación Alcorcón

Alcorcón, Madrid, 28922, Spain

RECRUITING

Hospital Cruz Roja Madrid

Madrid, Madrid, 28003, Spain

RECRUITING

Clínica Privada Dres Ojeda

Madrid, Madrid, 28006, Spain

RECRUITING

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

NOT YET RECRUITING

Clínica Privada Murcia

Murcia, Murcia, 30006, Spain

NOT YET RECRUITING

Hospital Nuestra Señora de Sonsoles

Ávila, 05071, Spain

NOT YET RECRUITING

Fundación Hospital Sant Pere Claver

Barcelona, 08004, Spain

WITHDRAWN

Clínica privada Burgos

Burgos, 09004, Spain

WITHDRAWN

Hospital Universitario de Burgos

Burgos, 09006, Spain

RECRUITING

Hospital General de Villalba

Collado Villalba, 28400, Spain

NOT YET RECRUITING

Clinica privada

León, 24003, Spain

WITHDRAWN

Clínica Subiza

Madrid, 28006, Spain

ACTIVE NOT RECRUITING

Hospital Carlos III (antiguo CAP José Marva)

Madrid, 28029, Spain

WITHDRAWN

Clínica Privada

Madrid, 28034, Spain

WITHDRAWN

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

NOT YET RECRUITING

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

RECRUITING

Hospital Infanta Elena

Madrid, 28342, Spain

NOT YET RECRUITING

Centro médico Saluddia

Madrid, 28522, Spain

RECRUITING

Centro Médico Iza (Clínica Privada Madrid)

Madrid, 28760, Spain

RECRUITING

Consulta Privada

Palencia, 34001, Spain

COMPLETED

Hospital Clínico de Salamanca

Salamanca, 37007, Spain

ACTIVE NOT RECRUITING

Hospital General Universitario de Segovia

Segovia, 40002, Spain

NOT YET RECRUITING

Clinica Privada Soria

Soria, 42005, Spain

WITHDRAWN

Clínica Privada

Zaragoza, 50004, Spain

WITHDRAWN

Related Publications (2)

• 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.

  PMID: 27939406 BACKGROUND

• 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.

  PMID: 33498057 BACKGROUND

MeSH Terms

Conditions

Rhinitis, Allergic; Asthma; Hypersensitivity

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Immune System Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Pedro Ojeda, MD

  Clínica privada Dres Ojeda

  STUDY DIRECTOR

Central Study Contacts

Miguel Casanovas, MD PhD

CONTACT

+34 912908942; mcasanovas@inmunotek.com

Raquel Caballero

CONTACT

+34 607600638; rcaballero@inmunotek.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: During the trial, both the investigator and the included subjects will be unaware of the treatment each subject is receiving. The person in charge of data analysis will also not know the treatment assigned to each subject until the database has been closed. So that neither the subject nor the investigator knows what treatment each subject is receiving, all the trial medication is identical in terms of outer packaging and appearance.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, multicentre, parallel-group study

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: May 24, 2021
• Study Start: May 31, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (27)