Actively Recruiting
Prospective Randomized Double-Blind Placebo-Controlled Trial to Evaluate Efficacy and Safety of Sublingual Immunotherapy MM09 in Patients With Rhinitis or Rhinoconjunctivitis With or Without Mild to Moderate Asthma Allergic to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae
Led by Inmunotek S.L. · Updated on 2026-01-16
736
Participants Needed
19
Research Sites
9 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate whether MM09, a sublingual immunotherapy, can help patients aged 12 to 65 with moderate-to-severe allergic rhinitis or rhinoconjunctivitis caused by house dust mites, with or without mild to moderate asthma. The trial is a phase III, randomized, double-blind, placebo-controlled study designed to assess if MM09 reduces symptoms and the need for rescue medications, while also monitoring safety. Participants will receive either the active MM09 sublingual spray or a placebo solution without the active ingredient. The treatment is given daily over 12 months. The study carefully compares the effects of MM09 against placebo to understand its impact on allergic rhinitis/rhinoconjunctivitis and asthma symptoms. During the study, participants will record symptoms and medication use via a smartphone app. Researchers will measure combined symptom and medication scores, as well as separate scores for rhinitis, rhinoconjunctivitis, and asthma symptoms and medication intake during the last four weeks of treatment. Safety and any medical problems from inhaling MM09 will be closely monitored throughout the trial, which lasts up to 12 months.
CONDITIONS
Brief Title
Efficacy and Safety of SLIT in Patients With Rhinitis/RC With/Without Mild-moderate Asthma, Due to Dpt and/or Df
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form.
- Male or female aged 12 to 65 years.
- Confirmed clinical history of moderate-to-severe rhinitis or rhinoconjunctivitis for at least 1 year, with or without mild-to-moderate controlled asthma.
- Positive skin prick test with a wheal diameter of 5 mm or more to house dust mite allergens Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.
- Women of childbearing age with negative pregnancy test and confirmed menstrual period, and committed to using highly effective contraception during the study and for 1 month after.
- Ability to comply with the dosage regimen.
- Ownership of a smartphone to record symptoms and medication use.
- Not sensitized to other clinically relevant allergens except occasional exposure to dander or endemic pollen under specific conditions.
- RCSMS score of 3 or higher recorded for at least 10 days during baseline evaluation.
- Specific IgE against house dust mite extract or molecular components with a value of 3.5 kU/L or higher.
You will not qualify if you...
- Previous immunotherapy to tested allergens in the last 5 years or any desensitization in the last 2 years.
- Contraindications to allergen-specific immunotherapy as per European Allergy and Clinical Immunology criteria.
- Asthma with FEV1 less than 80% despite treatment.
- Uncontrolled asthma or frequent exacerbations requiring oral corticosteroids or hospitalization.
- Severe asthma on high-level treatment with poor control.
- Treatment with beta-blockers, ACE inhibitors, immunosuppressive, or biological drugs.
- Recent respiratory infections or asthma exacerbations within 4 weeks before screening.
- History of chronic urticaria, severe anaphylaxis, or hereditary angioedema within 2 years.
- Contraindications for adrenaline use.
- Severe unrelated diseases, autoimmune diseases unresponsive to treatment, tumors, or immunodeficiencies.
- Serious mental illness or inability to comply with study protocol.
- Known allergy to study treatment components other than allergens.
- Nasal diseases or surgeries affecting evaluation.
- Oral lesions affecting safety assessment.
- Use of antihistamines or corticosteroids for conditions other than allergic rhinitis symptoms.
- Lower respiratory diseases other than asthma.
- Pregnant or breastfeeding women.
- Immediate family members of investigators.
- Participation in other clinical trials within 30 days before screening.
- History of serious systemic allergic reactions.
- Expected life changes affecting study participation.
- Plans to start anti-mite bedding or similar during the study.
- Considered inappropriate for the study by investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive sublingual immunotherapy or placebo daily as part of the study treatment for allergic rhinitis or rhinoconjunctivitis, with or without mild-to-moderate asthma.
Regular visits during treatment to monitor safety and efficacy
Trial Site Locations
Total: 19 locations
1
Centro Médico Vitae
Nueve de Julio, Buenos Aires, Argentina, 1650
Actively Recruiting
2
Centro de Investigaciones Clínicas - Instituto de Especialidades de la Salud Rosario
Rosario, Santa Fe Province, Argentina, 2000
Actively Recruiting
3
Centro Respiratorio Infantil
Rosario, Santa Fe Province, Argentina, 2000
Actively Recruiting
4
Fundación CIDEA
Buenos Aires, Argentina, 1121
Active, Not Recruiting
5
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina, 1199
Actively Recruiting
6
Centro de Educación Medica de Investigaciones Clinicas "Norberto Quirno" (CEMIC)
Buenos Aires, Argentina, 1431
Actively Recruiting
7
Beijing Tongren Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
8
The Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangzhou, China, 510080
Actively Recruiting
9
The First Affiliated Hospital, Sun Yat-sen University
Zhongshan, Guangzhou, China, 510080
Not Yet Recruiting
10
The Third Xiangya Hospital of Central South University
Xiangya, Hunan, China, 410013
Actively Recruiting
11
Changzhou Third People's Hospital
Changzhou, Jiangsu, China, 213003
Actively Recruiting
12
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266005
Actively Recruiting
13
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 20032
Actively Recruiting
14
Tongji Hospital Tongji Medical College of HUST
Tongji, Wuhan, China, 430033
Actively Recruiting
15
Union Hospital Tongji Medical College of HUST
Huangzhou, China
Actively Recruiting
16
Unidade de Local de Saúde de Santo António, E.P.E.
Porto, Portugal, 4050-651
Not Yet Recruiting
17
ULS Lezíria- Hospital Distrital de Santarém
Santarém, Portugal, 2005-177
Not Yet Recruiting
18
Hospital IMED Benidorm
Benidorm, Alicante, Spain, 03503
Actively Recruiting
19
Hospital General Universitario Dr. Balmis
Alicante, Spain, 03010
Active, Not Recruiting
Research Team
R
Raquel Caballero
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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