Efficacy and Safety Evaluation for the Treatment of Allergy Against Mites
MM09-SIT-023
Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Clinical Trial With SCIT in Patients With Rhinitis/Rhinoconjunctivitis With or Without Mild to Moderate Asthma Sensitized to Dpt. and/or D. Farinae
2 other identifiers
interventional
150
1 country
32
Brief Summary
A double-blinded, placebo-controlled, prospective, multicenter randomized of 2 active treatment groups, compared to 1 placebo group, for the determination of the efficacy and safety of subcutaneous immunotherapy in patients with rhinitis/rhinoconjunctivitis with or without asthma, sensitised to Dermatophagoides pteronyssinus and /or Dermatophagoides farinae.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2020
Longer than P75 for phase_3
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2020
CompletedFirst Posted
Study publicly available on registry
June 17, 2020
CompletedStudy Start
First participant enrolled
October 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
May 13, 2025
May 1, 2025
6.2 years
June 10, 2020
May 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CSMS: Combined Symptoms and Medication Score
Evaluation of the number of symptoms and the consumption of medication for symptoms rhinitis / rhinoconjunctivitis of each subject during the trial, of the groups with each other and with respect to placebo.
12 months
Secondary Outcomes (7)
Medication-free days
12 months
Symptom-free days
12 months
Number of participants with treatment-related adverse events as assessed by MM09-SIT-023
12 months
Quality of life associated with asthma
12 months
Quality of life associated with rhinitis
12 months
- +2 more secondary outcomes
Study Arms (3)
Experimental:10,000 MM09
EXPERIMENTAL10,000 TU/mL of subcutaneous immunotherapy
Experimental: 30,000 MM09
EXPERIMENTAL30,000 TU/mL of subcutaneous immunotherapy
Placebo subcutaneous
PLACEBO COMPARATORThe same solution and presentation as the active treatment, but without any active ingredients.
Interventions
Purified allergenic extract, and adsorbed in aluminum hydroxide and polymerized with glutaraldehyde, mite mixture (Dermatophagoides pteronyssinus and Dermatophagoides farinae) with a concentration of 10,000 UT / mL
Purified allergenic extract, and adsorbed in aluminum hydroxide and polymerized with glutaraldehyde, mite mixture (Dermatophagoides pteronyssinus and Dermatophagoides farinae). The concentration is 30,000 UT / mL
The same solution and presentation as the active treatment, but without active ingredients.
Eligibility Criteria
You may qualify if:
- Written informed consent.
- Age between 12 and 65, both genders.
- Subjects with a confirmed clinical history of inhalant allergy (intermittent or persistent moderate-severe rhinitis and/or rhinoconjunctivitis according to the ARIA classification with or without intermittent or persistent mild-moderate controlled asthma according to the GEMA 5.0 definition) caused by allergy to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. The diagnosis of asthma will be valid from 12 months prior to signing the informed consent.
- Subjects with a positive skin prick-test wheal size \>5 mm higher diameter due to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. The positive and negative control of the test should give consistent results. The results will be valid 12 months prior to the signing of the informed consent.
- Specific immunoglobulin E against house dust mites \>3,5 KU/mL (InmunoCAP® o Immulite), for the complete extract of Dermatophagoides pteronyssinus and / or for Dermatophagoides farinae or for some of the molecular components of these allergenic sources
- Subjects should preferably be monosensitized to the study allergens. In case of subjects sensitized to other aeroallergens, only those with the following characteristics may be included in the study:
- Subjects with positive skin test to Blomia tropicalis and Lepidoglyphus destructor, whose specific IgE values do not exceed or equal the values for the study allergens. The maximum specific IgE value for these allergens is 3.5 KU/L.
- Subjects with positive skin tests to epithelia, as long as they present occasional exposure and symptomatology.
- Subjects with positive skin tests to pollens, whose specific IgE values do not exceed or equal the values of the allergens in the study and who do not present exacerbations during the pollen season. The maximum value of specific IgE for these allergens is 17.5 KU/L.
- Subjects with negative skin test for fungi
- Women of childbearing age (from menarche) must present a urine pregnancy test with a negative result at the time of joining the trial, before the first administration of the IMP.
- Women of childbearing age participating in the trial must agree to use an appropriate method of contraception, meaning any act, device, or medication to prevent conception or viable pregnancy, during the trial if they are sexually active.
- Subjects with a diagnosis of asthma according to the GEMA 5.0 guideline.
- Subjects capable of complying with the dosing regimen.
- Subjects who own an smartphone for symptom registration and medication
You may not qualify if:
- Subjects who have received previous immunotherapy in the previous 5 years to dander, fungi, and mites.
- Subjects in whom 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 presented a serious secondary reaction during the performance of diagnostic skin tests using the prick test.
- Subjects under treatment with β-blockers.
- Subjects with chronic active urticaria, severe dermographism, severe atopic dermatitis, sunburn, active psoriasis with lesions in areas where skin prick test will be performed, or a history of hereditary angioedema.
- Subjects with any other disease not related to moderate rhinoconjunctivitis or asthma, but of potential severity and that may interfere with treatment and follow-up (epilepsy, psychomotor impairment, uncontrolled diabetes, malformations, multiple surgeries, nephropathy).
- 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/or who has serious mental illness.
- Subjects with a known allergy to other components of the investigational medicinal product other than the allergen.
- Subjects with diseases of the lower respiratory tract other than asthma such as emphysema or bronchiectasis.
- Direct investigator's relatives.
- Pregnant women or breastfeeding women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Inmunotek S.L.lead
- BioClever 2005 S.L.collaborator
Study Sites (32)
Hospital Provincial de Conxo
Santiago de Compostela, A Coruña, 15706, Spain
IMED Elche
Elche, Alicante, 03203, Spain
Hospital Universitario de Torrevieja
Torrevieja, Alicante, 03186, Spain
Clinica Tecma
Valencia, Alzira, 46600, Spain
Clinica Virgen del Rosario
Algeciras, Cadiz, Spain
Hospital HLA Jerez Puerta Sur
Jerez de la Frontera, Cádiz, 11408, Spain
Hospital Dr. Peset
Valencia, España, 46017, Spain
Hospital General Universitario Santa Maria de Rosell
Cartagena, Murcia, 30203, Spain
Hospital Rivera Povisa
Vigo, Pontevedra, 36211, Spain
Hospital General Universitario Dr. Balmis
Alicante, 03010, Spain
Hospital Universitario San Juan de Alicante
Alicante, 03550, Spain
Clínica Dermatológica y Alergia
Badajoz, 06001, Spain
Hospital Quironsalud Clideba
Badajoz, 06011, Spain
Hospital Sant Pere Claver
Barcelona, 08004, Spain
Clínica Corachan
Barcelona, 08017, Spain
Hospital Universitari Dexeus
Barcelona, 08028, Spain
Cenvi Medic
Barcelona, 08036, Spain
Allergocenter
Barcelona, Spain
Clinica privada
Bilbao, Spain
Centro Médico ASISA Dr. Lobatón
Cadiz, 11008, Spain
Centro Médico Puerto
Cadiz, Spain
Hospital Quiron Salud Córdoba
Córdoba, Spain
Hospital Polusa
Lugo, 27004, Spain
Clinica privada
Málaga, 29001, Spain
Hospital Comarcal de Melilla
Melilla, 52005, Spain
Clinica Privada
Murcia, 36006, Spain
Alergocantabria
Santander, Spain
Hospital Quiron Infanta Luisa
Seville, 41010, Spain
Clinica Lanuza
Valencia, 46003, Spain
Hospital Universitario Y Politecnico La Fe
Valencia, 46026, Spain
Clinica IMED
Valencia, 46100, Spain
Hospital de Sagunto
Valencia, 46520, Spain
Related Publications (5)
Piacentini GL, Vicentini L, Mazzi P, Chilosi M, Martinati L, Boner AL. Mite-antigen avoidance can reduce bronchial epithelial shedding in allergic asthmatic children. Clin Exp Allergy. 1998 May;28(5):561-7. doi: 10.1046/j.1365-2222.1998.00260.x.
PMID: 9645592BACKGROUNDYepes-Nunez JJ, Gomez C, Espinoza Y, Cardona R. [The impact of subcutaneous immunotherapy with Dermatophagoides farinae and Dermatophagoides pteronyssinus on the quality of life of patients with allergic rhinitis and asthma]. Biomedica. 2014 Apr-Jun;34(2):282-90. doi: 10.1590/S0120-41572014000200014. Spanish.
PMID: 24967933BACKGROUNDCardona R, Lopez E, Beltran J, Sanchez J. Safety of immunotherapy in patients with rhinitis, asthma or atopic dermatitis using an ultra-rush buildup. A retrospective study. Allergol Immunopathol (Madr). 2014 Mar-Apr;42(2):90-5. doi: 10.1016/j.aller.2012.07.005. Epub 2012 Dec 20.
PMID: 23265265BACKGROUNDBousquet J, Hejjaoui A, Clauzel AM, Guerin B, Dhivert H, Skassa-Brociek W, Michel FB. Specific immunotherapy with a standardized Dermatophagoides pteronyssinus extract. II. Prediction of efficacy of immunotherapy. J Allergy Clin Immunol. 1988 Dec;82(6):971-7. doi: 10.1016/0091-6749(88)90133-9.
PMID: 3204255BACKGROUNDBranco Ferreira M, Spinola Santos A, Pereira Santos MC, Palma Carlos ML, Pereira Barbosa MA, Palma Carlos AG. Efficacy and safety of specific immunotherapy with a modified mite extract. Allergol Immunopathol (Madr). 2005 Mar-Apr;33(2):80-5. doi: 10.1157/13072918.
PMID: 15808114BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Francisco Moreno, MD
Centro Médico ASISA
Central Study Contacts
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
Study Record Dates
First Submitted
June 10, 2020
First Posted
June 17, 2020
Study Start
October 6, 2020
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
May 13, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share