Actively Recruiting
Efficacy and Safety Evaluation for the Treatment of Allergy Against Mites
Led by Inmunotek S.L. · Updated on 2025-05-13
150
Participants Needed
32
Research Sites
321 weeks
Total Duration
On this page
Sponsors
I
Inmunotek S.L.
Lead Sponsor
B
BioClever 2005 S.L.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety Evaluation for the Treatment of Allergy Against Mites
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent.
- Age between 12 and 65 years, any gender.
- Confirmed history of moderate to severe rhinitis and/or rhinoconjunctivitis caused by Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.
- Diagnosis of mild to moderate asthma controlled according to GEMA 5.0, valid from 12 months before consent.
- Positive skin prick test with wheal size >5 mm for Dermatophagoides pteronyssinus and/or Dermatophagoides farinae within 12 months before consent.
- Specific IgE >3.5 KU/mL for house dust mites or their molecular components.
- Preferably monosensitized to study allergens; limited sensitization to specific other aeroallergens with defined IgE thresholds.
- Negative skin test for fungi.
- Women of childbearing age must have a negative urine pregnancy test before first treatment.
- Women of childbearing age must agree to use contraception during the trial if sexually active.
- Ability to comply with dosing regimen.
- Owning a smartphone for symptom and medication recording.
You will not qualify if you...
- Previous immunotherapy for dander, fungi, or mites within last 5 years.
- Absolute contraindications to immunotherapy as defined by allergy societies.
- Persistent severe or uncontrolled asthma with FEV1 <70% despite treatment.
- Severe rhinitis/rhinoconjunctivitis where oral or systemic antihistamines are contraindicated.
- History of serious reactions to diagnostic skin prick tests.
- Current treatment with beta-blockers.
- Clinical instability at inclusion (e.g., asthma exacerbation, respiratory infection, fever, acute urticaria).
- Chronic active urticaria, severe dermographism, severe atopic dermatitis, sunburn, active psoriasis on testing areas, or hereditary angioedema.
- Other severe diseases interfering with treatment or follow-up (epilepsy, psychomotor impairment, uncontrolled diabetes, nephropathy, etc.).
- Autoimmune diseases, tumors, or immunodeficiencies.
- Serious mental illness or inability to cooperate.
- Allergy to components of the investigational product other than the mite allergens.
- Lower respiratory diseases other than asthma (e.g., emphysema, bronchiectasis).
- Direct relatives of the investigator.
- Pregnant or breastfeeding women.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 32 locations
1
Hospital Provincial de Conxo
Santiago de Compostela, A Coruña, Spain, 15706
Actively Recruiting
2
IMED Elche
Elche, Alicante, Spain, 03203
Actively Recruiting
3
Hospital Universitario de Torrevieja
Torrevieja, Alicante, Spain, 03186
Actively Recruiting
4
Clinica Tecma
Valencia, Alzira, Spain, 46600
Completed
5
Clinica Virgen del Rosario
Algeciras, Cadiz, Spain
Active, Not Recruiting
6
Hospital HLA Jerez Puerta Sur
Jerez de la Frontera, Cádiz, Spain, 11408
Withdrawn
7
Hospital Dr. Peset
Valencia, España, Spain, 46017
Actively Recruiting
8
Hospital General Universitario Santa Maria de Rosell
Cartagena, Murcia, Spain, 30203
Withdrawn
9
Hospital Rivera Povisa
Vigo, Pontevedra, Spain, 36211
Active, Not Recruiting
10
Hospital General Universitario Dr. Balmis
Alicante, Spain, 03010
Actively Recruiting
11
Hospital Universitario San Juan de Alicante
Alicante, Spain, 03550
Actively Recruiting
12
Clínica Dermatológica y Alergia
Badajoz, Spain, 06001
Actively Recruiting
13
Hospital Quironsalud Clideba
Badajoz, Spain, 06011
Actively Recruiting
14
Hospital Sant Pere Claver
Barcelona, Spain, 08004
Actively Recruiting
15
Clínica Corachan
Barcelona, Spain, 08017
Actively Recruiting
16
Hospital Universitari Dexeus
Barcelona, Spain, 08028
Actively Recruiting
17
Cenvi Medic
Barcelona, Spain, 08036
Actively Recruiting
18
Allergocenter
Barcelona, Spain
Active, Not Recruiting
19
Clinica privada
Bilbao, Spain
Withdrawn
20
Centro Médico ASISA Dr. Lobatón
Cadiz, Spain, 11008
Actively Recruiting
21
Centro Médico Puerto
Cadiz, Spain
Actively Recruiting
22
Hospital Quiron Salud Córdoba
Córdoba, Spain
Actively Recruiting
23
Hospital Polusa
Lugo, Spain, 27004
Actively Recruiting
24
Clinica privada
Málaga, Spain, 29001
Actively Recruiting
25
Hospital Comarcal de Melilla
Melilla, Spain, 52005
Actively Recruiting
26
Clinica Privada
Murcia, Spain, 36006
Not Yet Recruiting
27
Alergocantabria
Santander, Spain
Actively Recruiting
28
Hospital Quiron Infanta Luisa
Seville, Spain, 41010
Actively Recruiting
29
Clinica Lanuza
Valencia, Spain, 46003
Actively Recruiting
30
Hospital Universitario Y Politecnico La Fe
Valencia, Spain, 46026
Actively Recruiting
31
Clinica IMED
Valencia, Spain, 46100
Withdrawn
32
Hospital de Sagunto
Valencia, Spain, 46520
Withdrawn
Research Team
M
Miguel Casanovas, MD PhD
CONTACT
R
Raquel Caballero, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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