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Sublingual MM09 for dust-mite–triggered rhinitis and rhinoconjunctivitis in people aged 12–65 with or without mild-to-moderate asthma

Prospective, Randomised, DBPC, Multicenter Clinical Trial to Evaluate Efficacy and Safety of Sublingual Immunotherapy in Patients With Rhinitis/Rhinoconjunctivitis With or Without Mild to Moderate Asthma, Allergic to Dpt and/or Df

Phase 3 Interventional Inmunotek S.L. · NCT07348302

This trial will test whether daily sublingual MM09 reduces symptoms and the need for rescue medication in people aged 12–65 who have rhinitis or rhinoconjunctivitis caused by dust mites, with or without mild-to-moderate asthma.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment736 (estimated)
Ages12 Years to 65 Years
SexAll
SponsorInmunotek S.L. Industry-sponsored
Drugs / interventionsimmunotherapy
Locations19 sites (Nueve de Julio, Buenos Aires and 18 other locations)
Trial IDNCT07348302 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial comparing sublingual MM09 (30,000 TU/mL) to placebo over 12 months in participants aged 12–65 with dust-mite–driven moderate-to-severe allergic rhinitis or rhinoconjunctivitis, with or without controlled mild-to-moderate asthma. Eligible participants must have a clinical history of at least one year of symptoms and a positive skin prick test to Dermatophagoides pteronyssinus and/or D. farinae. The study will track symptom scores, rescue medication use, and safety/adverse events to determine clinical benefit and tolerability. Multiple sites in Argentina will enroll and follow participants under blinded conditions.

Who should consider this trial

Good fit: Ideal candidates are people aged 12–65 with at least one year of moderate-to-severe rhinitis or rhinoconjunctivitis due to Dermatophagoides pteronyssinus and/or D. farinae, confirmed by a positive skin prick test, and who may have controlled mild-to-moderate asthma.

Not a fit: Patients without confirmed dust-mite allergy, those with severe or uncontrolled asthma, significant comorbidities, or those outside the 12–65 age range are unlikely to benefit from this intervention in the trial.

Why it matters

Potential benefit: If successful, MM09 could reduce allergy symptoms and lower the need for rescue medications, improving quality of life for people with dust-mite allergic rhinitis or rhinoconjunctivitis.

How similar studies have performed: Sublingual immunotherapy for dust-mite allergy has shown benefit in prior clinical trials, but this specific MM09 formulation is being tested here in a late-phase confirmatory trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Participants who have signed and dated Informed Consent Form (ICF).
2. Female or male aged 12 to 65 years, both included, at the time of signature of ICF.
3. Participants with confirmed clinical history of inhalation allergy with intermittent or persistent moderate-severe rhinitis/ rhinoconjunctivitis according to the ARIA classification(1) of at least 1 year of duration (treated with anti-allergic medication) with or without mild-moderate controlled intermittent or persistent asthma according to the definition of GINA 2022(2) caused by Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.
4. Participants with positive skin prick test and a wheal major diameter ≥ 5 mm to a standardized allergen extract of Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.
5. Women of childbearing age (i.e., following menarche and until postmenopause, defined as no menses for 12 months without an alternative medical cause, or non-subject to permanent sterilisation methods, such as hysterectomy, bilateral salpingectomy and bilateral oophorectomy) must have a serum pregnancy test negative result, and a confirmed menstrual period before enrolling the study.
6. Women of childbearing age must commit to using a highly effective contraception method during the trial and up to 1 month after the end of treatment with the investigational medicinal product (IMP). Such methods include: combined (estrogen and progestogen containing) hormonal, contraception. associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device, intrauterine hormone-releasing system, male condom, diaphragm used with spermicide, bilateral tubal occlusion, vasectomized partner or sexual abstinence.
7. Participants capable of complying with dosage regimen.
8. Participants owning a smartphone to register symptoms and medication consumption.
9. Participants not sensitized to any other clinically relevant allergen or sensitized with the following characteristics (sensitization to other allergens will be assessed through skin prick test in Europe and LATAM and through IgE levels in China):

   1. Participants sensitized to dander (with a positive skin prick test for dander or IgE ≥ 0.35 kU/L), provided that they have occasional exposure and symptoms.
   2. Participants sensitized to endemic pollen (with a positive skin prick test or IgE ≥0.35 kU/L) will be scheduled to be included so that the pollen season does not coincide with the Baseline Evaluation Period nor with one month before and after the Main Evaluation Period. In LATAM, grass sensitized participants will not be included.
10. Participants not sensitized to moulds, cockroach, Blomia tropicalis or other geographically relevant mites (negative skin prick test or IgE \< 0.7 kU/L).
11. Participants with a RCSMS ≥ 3 out of 6 recorded for at least 10 days during the baseline evaluation period, corresponding to moderate-to-severe allergic rhinitis/rhinoconjunctivitis.
12. Participants with specific IgE against a complete extract of D. pteronyssinus and / or D. farinae or any of the molecular components of allergenic sources with a value ≥ 3.5kU/L.

Exclusion Criteria:

1. Participants who have received previous immunotherapy to any of the tested allergen during the last 5 years or any desensitization process in the last 2 years (e.g., oral immunotherapy \[OIT\], milk, or egg) before the second screening visit (S2), or currently receiving immunotherapy with any other allergen.
2. Those cases in which allergen-specific immunotherapy (AIT) would be a contraindication according to the criteria of European Allergy and Clinical Immunology Immunotherapy Subcommittee.(3)
3. Asthmatic participants with forced expiratory volume in the first second (FEV1) \<80% (following at least a 6-hour washout of short-acting beta2 agonists \[SABA\] and 12-hour washout of long-acting beta2 agonists \[LABA\]) despite pharmacological treatment by the time of enrolment.
4. Participants with uncontrolled asthma, according to GINA 2022,(2) asthma with poor symptom control (frequent symptoms or reliever use, activity limited by asthma, night waking due to asthma) and/or frequent exacerbations (≥2/year) requiring oral corticosteroids (OCS), or serious exacerbations (≥1/year) requiring hospitalization.
5. Participants with severe asthma, according to GINA 2022,(2) on Step 4 or 5 treatment, who had poor symptom control and had good adherence and inhaler technique.
6. Participants on treatment with β-blockers or angiotensin-converting enzyme (ACE) inhibitor.
7. Participants on treatment with immunosuppressive or biological drugs.
8. Participants who had not had a long enough washout/withdrawal period at the first screening visit (S1) according to criteria in the study protocol (See Table 6 in section 9.5.3) before undergoing allergen diagnostic tests (skin prick test or IgE analysis).
9. Unstable participants who have suffered a respiratory tract infection and/or asthma exacerbation within 4 weeks prior to first screening visit (S1).
10. Participants who have suffered chronic urticaria, severe anaphylaxis, or with hereditary angioedema history within 2 years prior to the first screening visit (S1).
11. Participants having any contraindication for the use of adrenaline (e.g., hyperthyroidism, heart disease, or hypertension) according to the investigator's criteria.
12. Participants with other severe diseases not related to allergic rhinitis or asthma that could interfere with the study treatment or the follow-up.
13. Participants with severe and unresponsive to treatment autoimmune diseases (e.g., thyroiditis or lupus), tumoral diseases or immunodeficiencies.
14. Participants that could not comply with the study protocol, according to the investigator's criteria, or have a serious mental illness.
15. Participants with known allergy to any of the components of the study treatment other than study allergens.
16. Participants who had a complication(s) of any nasal disease (including nasal polyp, nasal septal deviation, and hypertrophic rhinitis, drug-induced rhinitis and/or non-allergic rhinitis) affecting an appropriate evaluation of the efficacy and/or safety, according to investigator's criteria.
17. Participants who had a nasal surgery within 6 months prior to the first screening visit (S1) or have programmed or anticipated nasal surgery during the trial period.
18. Participants with a lesion in the oral cavity that could confound the safety profile of the study treatment, according to the investigator's criteria.
19. Participants who required treatment with antihistamines and/or corticosteroids for other purposes than alleviating symptoms of allergic rhinitis (except temporal use for diseases such as common colds).
20. Participants with lower respiratory tract diseases different from asthma as emphysema, bronchiectasis, or chronic obstructive pulmonary disease.
21. Breastfeeding or pregnant women.
22. Participants who are immediate family members of the investigator.
23. Concurrent participation in other clinical trials or previous participation within 30 days prior to the first screening visit (S1).
24. Participants with history of serious systemic reactions, including food, Hymenoptera venom, medications, etc.
25. Participants expected to have marked changes (e.g., moving) in the circumstances of life during the study.
26. Participants who plan to start using anti-mite bedding or similar equipment during the study.
27. Participants who are considered inappropriate for the study, according to the investigator criteria.

Where this trial is running

Nueve de Julio, Buenos Aires and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions RhinitisRhinoconjunctivitisimmunotherapysublingualQuality of livedust mitesDermatophagoides pteronyssinusDermatophagoides farinae
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.