Efficacy and Safety of SLIT in Patients With Rhinitis/RC With/Without Mild-moderate Asthma, Due to Dpt and/or Df

NCT07348302 | Recruiting Phase 3

• 1 other identifier: MM09-SLG-058
• Study Type: interventional
• Target: 736
• Locations: 4 countries
• Sites: 19

Brief Summary

The goal of this clinical trial is to learn if MM09 works to treat patients allergic to house mites, displaying rhinitis/rhinoconjunctivitis with or without mild to moderate asthma. It will also learn about the safety of MM09. The main questions it aims to answer are: Does MM09 reduce the symptoms and the need of rescue medication? What medical problems do participants have when inhaling MM09? Researchers will compare MM09 to a placebo (a look-alike substance that contains no drug) to see if MM09 works to treat rhinitis/rhinoconjunctivitis.

Conditions

Rhinitis; Rhinoconjunctivitis

Keywords

immunotherapy; sublingual; Quality of live; dust mites; Dermatophagoides pteronyssinus; Dermatophagoides farinae; moderate asthma; allergic rhinitis; Allergic asthma; House dust mite allergy; efficacy; safety

Outcome Measures

Primary Outcomes (1)

• RCSMS : Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score

  The RCMS corresponds to the sum of Rhinitis/Rhinoconjunctivitis Symptom Score (RSS) and Rhinitis/Rhinoconjunctivitis Medication Score (RMS). The daily RCSMS will be calculated as RCSMS (0-6) = RSS (0-3) + RMS (0-3) Higher scores mean a worse outcome.

  last 4 weeks of IMP treatment

Secondary Outcomes (5)

• RSS : Rhinitis/Rhinoconjunctivitis Symptom Score

  last 4 weeks of IMP treatment

• RMS : Rhinitis/Rhinoconjunctivitis Medication Score

  last 4 weeks of IMP treatment

• ASS : Asthma Symptom Score

  last 4 weeks of IMP treatment

• AMS: Asthma Medication Score

  last 4 weeks of IMP treatment

• ARSS: Asthma and Rhinitis/Rhinoconjunctivitis Symptom Score

  last 4 week of IMP treatment

Study Arms (2)

Control

PLACEBO COMPARATOR

Is a solution identical in composition to the active treatment, but without active ingredients

Biological: Allergen Immunotherapy Extract

Sublingual MM09

EXPERIMENTAL

Active substance

Biological: Allergen Immunotherapy Extract

Interventions

Allergen Immunotherapy Extract BIOLOGICAL

Sublingual spray, solution

Also known as: ORALTEK®

Control; Sublingual MM09

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:

• Participants who have signed and dated Informed Consent Form (ICF).
• Female or male aged 12 to 65 years, both included, at the time of signature of ICF.
• 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.
• 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.
• 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.
• 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.
• Participants capable of complying with dosage regimen.
• Participants owning a smartphone to register symptoms and medication consumption.
• 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):
• 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.
• 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.
• Participants not sensitized to moulds, cockroach, Blomia tropicalis or other geographically relevant mites (negative skin prick test or IgE \< 0.7 kU/L).
• 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.
• 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.

You may not qualify if:

• 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.
• 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)
• 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.
• 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.
• 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.
• Participants on treatment with β-blockers or angiotensin-converting enzyme (ACE) inhibitor.
• Participants on treatment with immunosuppressive or biological drugs.
• 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).
• Unstable participants who have suffered a respiratory tract infection and/or asthma exacerbation within 4 weeks prior to first screening visit (S1).
• Participants who have suffered chronic urticaria, severe anaphylaxis, or with hereditary angioedema history within 2 years prior to the first screening visit (S1).
• Participants having any contraindication for the use of adrenaline (e.g., hyperthyroidism, heart disease, or hypertension) according to the investigator's criteria.
• Participants with other severe diseases not related to allergic rhinitis or asthma that could interfere with the study treatment or the follow-up.
• Participants with severe and unresponsive to treatment autoimmune diseases (e.g., thyroiditis or lupus), tumoral diseases or immunodeficiencies.
• Participants that could not comply with the study protocol, according to the investigator's criteria, or have a serious mental illness.
• Participants with known allergy to any of the components of the study treatment other than study allergens.

Sponsors & Collaborators

• Inmunotek S.L.: lead

Study Sites (19)

Centro Médico Vitae

Nueve de Julio, Buenos Aires, 1650, Argentina

RECRUITING

Centro de Investigaciones Clínicas - Instituto de Especialidades de la Salud Rosario

Rosario, Santa Fe Province, 2000, Argentina

RECRUITING

Centro Respiratorio Infantil

Rosario, Santa Fe Province, 2000, Argentina

RECRUITING

Fundación CIDEA

Buenos Aires, 1121, Argentina

ACTIVE NOT RECRUITING

Hospital Italiano de Buenos Aires

Buenos Aires, 1199, Argentina

RECRUITING

Centro de Educación Medica de Investigaciones Clinicas "Norberto Quirno" (CEMIC)

Buenos Aires, 1431, Argentina

RECRUITING

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

The Third Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangzhou, 510080, China

RECRUITING

The First Affiliated Hospital, Sun Yat-sen University

Zhongshan, Guangzhou, 510080, China

NOT YET RECRUITING

The Third Xiangya Hospital of Central South University

Xiangya, Hunan, 410013, China

RECRUITING

Changzhou Third People's Hospital

Changzhou, Jiangsu, 213003, China

RECRUITING

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266005, China

RECRUITING

Eye & ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, 20032, China

RECRUITING

Tongji Hospital Tongji Medical College of HUST

Tongji, Wuhan, 430033, China

RECRUITING

Union Hospital Tongji Medical College of HUST

Huangzhou, China

RECRUITING

Unidade de Local de Saúde de Santo António, E.P.E.

Porto, 4050-651, Portugal

NOT YET RECRUITING

ULS Lezíria- Hospital Distrital de Santarém

Santarém, 2005-177, Portugal

NOT YET RECRUITING

Hospital IMED Benidorm

Benidorm, Alicante, 03503, Spain

RECRUITING

Hospital General Universitario Dr. Balmis

Alicante, 03010, Spain

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Rhinitis; Rhinitis, Allergic; Dust Mite Allergy

Interventions

Desensitization, Immunologic

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Rhinitis, Allergic, Perennial

Intervention Hierarchy (Ancestors)

Immunosuppression Therapy; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• Raquel Caballero

  Inmunotek S.L.

  STUDY CHAIR

Central Study Contacts

Raquel Caballero

CONTACT

+34 912 908 94; rcaballero@inmunotek.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, randomised, double-blind, placebo-controlled

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: January 16, 2026
• Study Start: April 2, 2025
• Primary Completion (Estimated): April 27, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PT (2); AR (6); ES (2); CN (9)