Actively Recruiting
Efficacy and Safety of SLIT in Patients With Rhinitis/RC With/Without Mild-moderate Asthma, Due to Dpt and/or Df
Led by Inmunotek S.L. · Updated on 2026-01-16
736
Participants Needed
19
Research Sites
221 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 and dated informed consent form
- Age between 12 and 65 years at consent
- Clinical history of intermittent or persistent moderate-to-severe rhinitis/rhinoconjunctivitis for at least 1 year caused by Dermatophagoides pteronyssinus and/or Dermatophagoides farinae
- Positive skin prick test with a wheal diameter ≥ 5 mm for Dermatophagoides pteronyssinus and/or Dermatophagoides farinae
- For women of childbearing age, negative serum pregnancy test and confirmed menstrual period before enrollment
- Women of childbearing age must use highly effective contraception during the trial and 1 month after treatment
- Ability to comply with dosage regimen
- Ownership of a smartphone for symptom and medication logging
- Not sensitized to other clinically relevant allergens or sensitized with specified conditions allowing inclusion
- No sensitization to moulds, cockroach, Blomia tropicalis, or other relevant mites
- Rhinitis/rhinoconjunctivitis symptom score ≥ 3 out of 6 for at least 10 days during baseline
- Specific IgE against Dermatophagoides pteronyssinus and/or Dermatophagoides farinae ≥ 3.5 kU/L
You will not qualify if you...
- Previous immunotherapy to tested allergens within 5 years or any desensitization in last 2 years
- Contraindications to allergen immunotherapy
- Asthma with FEV1 < 80% despite treatment
- Uncontrolled asthma or frequent/severe exacerbations
- Severe asthma on Step 4 or 5 treatment with poor control despite adherence
- Treatment with beta-blockers or ACE inhibitors
- Treatment with immunosuppressive or biological drugs
- Insufficient washout before allergen tests
- Respiratory infection or asthma exacerbation within 4 weeks before screening
- Chronic urticaria, severe anaphylaxis, or hereditary angioedema within 2 years
- Contraindications for adrenaline use
- Severe diseases unrelated to allergic rhinitis or asthma interfering with study
- Severe, treatment-unresponsive autoimmune diseases, tumors, or immunodeficiencies
- Inability to comply with protocol or serious mental illness
- Known allergy to study treatment components other than study allergens
- Nasal disease complications affecting evaluation
- Nasal surgery within 6 months prior or planned during study
- Oral lesions confounding safety assessment
- Use of antihistamines or corticosteroids for reasons other than allergic rhinitis symptoms
- Lower respiratory diseases other than asthma
- Breastfeeding or pregnant women
- Immediate family of investigator
- Participation in other clinical trials within 30 days
- History of serious systemic allergic reactions
- Expected major life changes during study
- Planned use of anti-mite bedding or similar during study
- Investigator-considered inappropriate for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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