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Rhinitis, AllergicPhase 3MM09-SIT-023NCT04435990

Efficacy and Safety Evaluation for the Treatment of Allergy Against Mites

A Phase 3 study testing 10,000 MM09 and 30,000 MM09 in people with Rhinitis, Allergic and Rhinoconjunctivitis, run by Inmunotek S.L. at 32 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 12 to 65 years
What is being tested?
10,000 MM09 and 30,000 MM09
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
32 sitesSpain
Study dates
6 Oct 2020to Dec 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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:
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  • 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

Who cannot join

  • 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.).
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  • 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.

Trial locations and contacts

32 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Miguel Casanovas, MD PhD contact

+34916510010

mcasanovas@inmunotek.com

Raquel Caballero, MD contact

+34607600638

rcaballero@inmunotek.com

32 sites in 1 country

Spain32 sites, 23 recruiting

  • Clinica Virgen del Rosario

    Algeciras, Cadiz

    Active, not recruiting

  • Hospital General Universitario Dr. Balmis

    Alicante, 03010

    Teodoriked Jimenez, MD, 965 93 30 00, teodorikez@gmail.com

    Recruiting

  • Hospital Universitario San Juan de Alicante

    Alicante, 03550

    Mónica Antón, MD, 965 16 94 00, manton.girones@hotmail.com

    Recruiting

  • Clínica Dermatológica y Alergia

    Badajoz, 06001

    Irán Sánchez Ramos, MD, 924220562, iran120@hotmail.com

    Irán Sánchez, MD

    Recruiting

  • Hospital Quironsalud Clideba

    Badajoz, 06011

    Silvia Sánchez, MD, 924 22 90 50, silviasanvega@hotmail.es

    Recruiting

  • Hospital Sant Pere Claver

    Barcelona, 08004

    Helena Hermida, MD, 934 42 39 03, hhermida@pereclaver.org

    Recruiting

  • Clínica Corachan

    Barcelona, 08017

    César Alías, MD, 932545800, cesar.alias@xij.gencat.cat

    César Alías, MD

    Recruiting

  • Hospital Universitari Dexeus

    Barcelona, 08028

    Elena Botey, MD, 932274747, elena.botey@gmail.com

    Begoña Navarro, md

    Recruiting

  • Cenvi Medic

    Barcelona, 08036

    Mario Tubella Martín, MD, 934108895, lmtubella@hotmail.com

    Mario Tubella Martín, DM

    Recruiting

  • Allergocenter

    Barcelona

    Active, not recruiting

  • Clinica privada

    Bilbao

    Withdrawn

  • Centro Médico ASISA Dr. Lobatón

    Cadiz, 11008

    Francisco Moreno, MD, +34956 29 21 00, dr.moreno@drlobaton.com

    Francisco Moreno, DM

    Recruiting

  • Centro Médico Puerto

    Cadiz

    Mª José Pereira González, MD, 916748081, mjpereirag@yahoo.es

    Mª José Pereira González, MD

    Recruiting

  • Hospital General Universitario Santa Maria de Rosell

    Cartagena, Murcia, 30203

    Withdrawn

  • Hospital Quiron Salud Córdoba

    Córdoba

    Ignacio García Núñez, MD, 957410000, h62ganui@hotmail.com

    Ignacio Garcia Núñez, MD

    Recruiting

  • IMED Elche

    Elche, Alicante, 03203

    Eugenia Margarita Campos, MD, 966915151, eumarcampos@hotmail.com

    Eugenia Margarita Campos, MD

    Recruiting

  • Hospital HLA Jerez Puerta Sur

    Jerez de la Frontera, Cádiz, 11408

    Withdrawn

  • Hospital Polusa

    Lugo, 27004

    Joaquín Martín, MD, 982222854, joaquin.martin@yahoo.es

    Joaquín Martín, MD

    Recruiting

  • Clinica privada

    Málaga, 29001

    Manuel Barceló, MD, 952120102, informacion@doctorbarcelo.com

    Manuel Barceló Muñoz, MD

    Recruiting

  • Hospital Comarcal de Melilla

    Melilla, 52005

    Arturo Ruiz, MD, 952 67 00 00, aruizsanfrancisco@gmail.com

    Recruiting

  • Clinica Privada

    Murcia, 36006

    Yulia Petryk, MD, 968238621, yuliapetrik1991@gmail.com

    Not yet recruiting

  • Alergocantabria

    Santander

    Miguel Ángel Añó, MD, 942760777, asma_rinitis_dermatitis@hotmail.com

    Miguel Ángel Añó, MD

    Recruiting

  • Hospital Provincial de Conxo

    Santiago de Compostela, A Coruña, 15706

    Carmen Vidal, MD, +34 981 95 15 00, carmen.vidal.pan@sergas.es

    Recruiting

  • Hospital Quiron Infanta Luisa

    Seville, 41010

    María Antonia Ortega Camarero, MD, 954 33 01 00, ortegamed@gmail.com

    Recruiting

  • Hospital Universitario de Torrevieja

    Torrevieja, Alicante, 03186

    Dorimar Brugaletta, MD, 965 69 55 00, dorimarbrugaletta@yahoo.com

    Recruiting

  • Clinica Tecma

    Valencia, Alzira, 46600

    Completed

  • Hospital Dr. Peset

    Valencia, España, 46017

    Mª Carmen Pérez Francés, MD, +34963975150, carmenfrances29@gmail.com

    Recruiting

  • Clinica Lanuza

    Valencia, 46003

    Amparo Lanuza, MD, 963923099, amparo@clinicalanuza.com

    Recruiting

  • Hospital Universitario Y Politecnico La Fe

    Valencia, 46026

    Miguel Tortajada, MD, 961 24 40 00, tortajadamig@gmail.com

    Recruiting

  • Clinica IMED

    Valencia, 46100

    Withdrawn

  • Hospital de Sagunto

    Valencia, 46520

    Withdrawn

  • Hospital Rivera Povisa

    Vigo, Pontevedra, 36211

    Active, not recruiting

Other trials in Spain

About this study

Official title: 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.

Read the 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

Being tested
10,000 MM09, 30,000 MM09, Placebo subcutaneous
Keywords
Rhinitis/ Rhinoconjunctivitis, Mild to moderate asthma, Allergy, Immunotherapy, Mites
Medical subject headings
Rhinitis, Allergic, Asthma, Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 10,000 MM09Biological

    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

  • 30,000 MM09Biological

    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 subcutaneousBiological

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

Study groups in NCT04435990
Study groupRoleWhat they receive
Experimental:10,000 MM09Experimental10,000 TU/mL of subcutaneous immunotherapy
Receives: Biological: 10,000 MM09
Experimental: 30,000 MM09Experimental30,000 TU/mL of subcutaneous immunotherapy
Receives: Biological: 30,000 MM09
Placebo subcutaneousPlacebo comparatorThe same solution and presentation as the active treatment, but without any active ingredients.
Receives: Biological: Placebo subcutaneous

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (7)

  1. Medication-free days

    Number of days that the subjects need no medication

    Measured: 12 months

  2. Symptom-free days

    Number of days that the subjects have no symptom

    Measured: 12 months

  3. 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

    Measured: 12 months

  4. 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

    Measured: 12 months

  5. 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).

    Measured: 12 months

  6. 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.

    Measured: 12 months

  7. Immunological parameters

    Analyses of total IgE and specific IgA,IgG and IgG4

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2020
  2. Study start6 Oct 2020
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, double-blind, placebo-controlled, multi centre, parallel-group study
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04435990
Sponsor's protocol ID
MM09-SIT-023
Other IDs
2018-004262-34, 2018
Acronym
MM09-SIT-023
Status last verified
May 2025
First submitted
10 Jun 2020
Last updated
13 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 9645592

  • 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.

    PubMed 24967933

  • 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.

    PubMed 23265265

  • 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.

    PubMed 3204255

  • 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.

    PubMed 15808114

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 10,000 MM09 and 30,000 MM09 in people with Rhinitis, Allergic and Rhinoconjunctivitis, run by Inmunotek S.L. at 32 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Miguel Casanovas, MD PhD (+34916510010, mcasanovas@inmunotek.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CSMS: Combined Symptoms and Medication Score (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04435990, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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