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

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.

Study Overview

• Status: Recruiting
• Conditions: Rhinitis, Allergic; Rhinoconjunctivitis; Asthma, Allergic
• Intervention / Treatment: Biological: 10,000 MM09; Biological: 30,000 MM09; Biological: Placebo subcutaneous

Detailed Description

Double blind, multicenter, parallel placebo controlled study. It includes 150 subjects sensitised to mites, from 12 to 65 years of age. Medication treatment of 1 year. The main outcome: CSMS

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Miguel Casanovas, MD PhD; Phone Number: +34916510010; Email: mcasanovas@inmunotek.com
• Study Contact Backup: Name: Raquel Caballero, MD; Phone Number: +34607600638; Email: rcaballero@inmunotek.com

Study Locations

• Spain
  • Alicante, Spain, 03010
    • Recruiting
    • Hospital General Universitario Dr. Balmis
    • Contact: Teodoriked Jimenez, MD; Phone Number: 965 93 30 00; Email: teodorikez@gmail.com
  • Alicante, Spain, 03550
    • Recruiting
    • Hospital Universitario San Juan de Alicante
    • Contact: Mónica Antón, MD; Phone Number: 965 16 94 00; Email: manton.girones@hotmail.com
  • Badajoz, Spain, 06001
    • Recruiting
    • Clínica Dermatológica y Alergia
    • Contact: Irán Sánchez Ramos, MD; Phone Number: 924220562; Email: iran120@hotmail.com
    • Principal Investigator: Irán Sánchez, MD
  • Badajoz, Spain, 06011
    • Recruiting
    • Hospital Quironsalud Clideba
    • Contact: Silvia Sánchez, MD; Phone Number: 924 22 90 50; Email: silviasanvega@hotmail.es
  • Barcelona, Spain, 08028
    • Recruiting
    • Hospital Universitari Dexeus
    • Contact: Elena Botey, MD; Phone Number: 932274747; Email: elena.botey@gmail.com
    • Sub-Investigator: Begoña Navarro, md
  • Barcelona, Spain
    • Active, not recruiting
    • Allergocenter
  • Barcelona, Spain, 08004
    • Recruiting
    • Hospital Sant Pere Claver
    • Contact: Helena Hermida, MD; Phone Number: 934 42 39 03; Email: hhermida@pereclaver.org
  • Barcelona, Spain, 08017
    • Recruiting
    • Clínica Corachan
    • Contact: César Alías, MD; Phone Number: 932545800; Email: cesar.alias@xij.gencat.cat
    • Principal Investigator: César Alías, MD
  • Barcelona, Spain, 08036
    • Recruiting
    • Cenvi Medic
    • Contact: Mario Tubella Martín, MD; Phone Number: 934108895; Email: lmtubella@hotmail.com
    • Principal Investigator: Mario Tubella Martín, DM
  • Bilbao, Spain
    • Withdrawn
    • Clinica privada
  • Cadiz, Spain, 11008
    • Recruiting
    • Centro Médico ASISA Dr. Lobatón
    • Principal Investigator: Francisco Moreno, DM
    • Contact: Francisco Moreno, MD; Phone Number: +34956 29 21 00; Email: dr.moreno@drlobaton.com
  • Cadiz, Spain
    • Recruiting
    • Centro Médico Puerto
    • Contact: Mª José Pereira González, MD; Phone Number: 916748081; Email: mjpereirag@yahoo.es
    • Principal Investigator: Mª José Pereira González, MD
  • Córdoba, Spain
    • Recruiting
    • Hospital Quiron Salud Córdoba
    • Principal Investigator: Ignacio Garcia Núñez, MD
    • Contact: Ignacio García Núñez, MD; Phone Number: 957410000; Email: h62ganui@hotmail.com
  • Lugo, Spain, 27004
    • Recruiting
    • Hospital Polusa
    • Contact: Joaquín Martín, MD; Phone Number: 982222854; Email: joaquin.martin@yahoo.es
    • Principal Investigator: Joaquín Martín, MD
  • Melilla, Spain, 52005
    • Recruiting
    • Hospital Comarcal de Melilla
    • Contact: Arturo Ruiz, MD; Phone Number: 952 67 00 00; Email: aruizsanfrancisco@gmail.com
  • Murcia, Spain, 36006
    • Not yet recruiting
    • Clinica privada
    • Contact: Yulia Petryk, MD; Phone Number: 968238621; Email: yuliapetrik1991@gmail.com
  • Málaga, Spain, 29001
    • Recruiting
    • Clinica privada
    • Contact: Manuel Barceló, MD; Phone Number: 952120102; Email: informacion@doctorbarcelo.com
    • Principal Investigator: Manuel Barceló Muñoz, MD
  • Santander, Spain
    • Recruiting
    • Alergocantabria
    • Contact: Miguel Ángel Añó, MD; Phone Number: 942760777; Email: asma_rinitis_dermatitis@hotmail.com
    • Principal Investigator: Miguel Ángel Añó, MD
  • Sevilla, Spain, 41010
    • Recruiting
    • Hospital Quiron Infanta Luisa
    • Contact: María Antonia Ortega Camarero, MD; Phone Number: 954 33 01 00; Email: ortegamed@gmail.com
  • Valencia, Spain, 46026
    • Recruiting
    • Hospital Universitario y Politécnico La Fe
    • Contact: Miguel Tortajada, MD; Phone Number: 961 24 40 00; Email: tortajadamig@gmail.com
  • Valencia, Spain, 46003
    • Recruiting
    • Clinica Lanuza
    • Contact: Amparo Lanuza, MD; Phone Number: 963923099; Email: amparo@clinicalanuza.com
  • Valencia, Spain, 46100
    • Withdrawn
    • Clinica IMED
  • Valencia, Spain, 46520
    • Withdrawn
    • Hospital de Sagunto
  • A Coruña
    • Santiago De Compostela, A Coruña, Spain, 15706
      • Recruiting
      • Hospital Provincial de Conxo
      • Contact: Carmen Vidal, MD; Phone Number: +34 981 95 15 00; Email: carmen.vidal.pan@sergas.es
  • Alicante
    • Elche, Alicante, Spain, 03203
      • Recruiting
      • IMED Elche
      • Contact: Eugenia Margarita Campos, MD; Phone Number: 966915151; Email: eumarcampos@hotmail.com
      • Principal Investigator: Eugenia Margarita Campos, MD
    • Torrevieja, Alicante, Spain, 03186
      • Recruiting
      • Hospital Universitario de Torrevieja
      • Contact: Dorimar Brugaletta, MD; Phone Number: 965 69 55 00; Email: dorimarbrugaletta@yahoo.com
  • Alzira
    • Valencia, Alzira, Spain, 46600
      • Completed
      • Clinica Tecma
  • Cadiz
    • Algeciras, Cadiz, Spain
      • Active, not recruiting
      • Clinica Virgen del Rosario
  • Cádiz
    • Jerez De La Frontera, Cádiz, Spain, 11408
      • Withdrawn
      • Hospital HLA Jerez Puerta Sur
  • España
    • Valencia, España, Spain, 46017
      • Recruiting
      • Hospital Dr. Peset
      • Contact: Mª Carmen Pérez Francés, MD; Phone Number: +34963975150; Email: carmenfrances29@gmail.com
  • Murcia
    • Cartagena, Murcia, Spain, 30203
      • Withdrawn
      • Hospital General Universitario Santa Maria de Rosell
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36211
      • Active, not recruiting
      • Hospital Rivera Povisa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 with persistent severe or uncontrolled asthma, with an FEV1<70% of baseline despite adequate pharmacological treatment at the time of inclusion in the trial. Also subjects with intermittent or persistent rhinitis/rhinoconjunctivitis with severe symptoms in whom oral or systemic antihistamine therapy is contraindicated.
• 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.
• Clinically unstable subjects at the time of inclusion in the trial (acute asthma exacerbation, respiratory infection, feverish process, acute urticaria, etc.).
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental:10,000 MM09; 10,000 TU/mL of subcutaneous immunotherapy	Biological: 10,000 MM09; 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
Experimental: Experimental: 30,000 MM09; 30,000 TU/mL of subcutaneous immunotherapy	Biological: 30,000 MM09; 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
Placebo Comparator: Placebo subcutaneous; The same solution and presentation as the active treatment, but without any active ingredients.	Biological: Placebo subcutaneous; The same solution and presentation as the active treatment, but without active ingredients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication-free days	Number of days that the subjects need no medication	12 months
Symptom-free days	Number of days that the subjects have no symptom	12 months
Quality of life associated with rhinitis	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).	12 months
Number of participants with treatment-related adverse events as assessed by MM09-SIT-023	Comparison between the beginning and end of the trial and among active groups and placebo	12 months
Quality of life associated with asthma	The quality of life associated with asthma will be measured following the GINA questionnaire. The GINA questionnaire consists of 4 questions. In questions 1-4, patients recall their experience during the last 4 weeks and answer using YES or NO. The interpretation of the answers is as follows: Well-controlled: None of the answers are YES Partly controlled: 1 - 2 answers are YES Uncontrolled: 3-4 answers are YES	12 months
Visual Analogue Scale (VAS)	Visual Analogue Scale in which the subject has to indicate how he/she feels regarding to his allergy symptoms at the moment from 1 to 10. Being 1 very bad and 10 very well.	12 months
Immunological parameters	Analyses of total IgE and specific IgA,IgG and IgG4	12 months

Collaborators and Investigators

• Sponsor: Inmunotek S.L.
• Collaborators: BioClever 2005 S.L.
• Investigators: Study Director: Francisco Moreno, MD, Centro Médico ASISA

Publications and helpful links

General Publications

• 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.
• Yepes-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.
• Cardona 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.
• Bousquet 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.
• Branco 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 10, 2020
• First Submitted That Met QC Criteria: June 15, 2020
• First Posted (Actual): June 17, 2020

Study Record Updates

• Last Update Posted (Actual): May 13, 2025
• Last Update Submitted That Met QC Criteria: May 7, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Allergy; Immunotherapy; Mites; Rhinitis/ Rhinoconjunctivitis; Mild to moderate asthma
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Eye Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Nose Diseases; Otorhinolaryngologic Diseases; Conjunctival Diseases; Asthma; Conjunctivitis; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: MM09-SIT-023; 2018-004262-34 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No