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BIOLOGICAL STANDARDISATION OF ALLERGENIC EXTRACTS OF MITES TO DETERMINE BIOLOGICAL ACTIVITY (IN HEP UNITS) IN SENSITIVISED PATIENTS.
EU CTIS ID: 2024-513834-40-01
What this study is testing
The main objective is to evaluate in vivo the concentration of allergenic extracts of mites (Dermatophagoides pteronyssinus, Dermatophagoides farinae, Blomia tropicalis and Lepidoglyphus destructor) that cause a papule of a size equivalent to that produced by a solution of histamine dihydrochloride at 10 mg/ml. Standardize mite allergenic extracts in biological units.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- The age of the patients will range between 18 and 65 years, both inclusive.
- Patient who has provided informed consent to participate in the study.
- Previous medical history supporting the diagnosis of allergy
- Demonstrated sensitization to allergens (at least to one of the following allergens: Dermatophagoides pteronyssinus, Dermatophagoides farinae, Blomia tropicalis, and Lepidoglyphus destructor responsible for the patient's clinical symptoms) through: - Skin prick test (Prick test), with a positivity criterion when the largest diameter of the wheal obtained with a standardized commercial extract is ≥ 3 mm compared to the negative control. - Specific IgE serum to the allergen equal to or greater than 3.5 kUA/L (CAP). Both the skin prick test and the specific IgE will be valid if performed within the 18 months prior to study inclusion.
- Negative pregnancy test in urine for potentially fertile women (fertile is understood from menarche to postmenopause, unless sterilized due to hysterectomy, bilateral salpingectomy, and bilateral oophorectomy).
You likely can't join if
- Having received previous immunotherapy treatment during the 5 years prior to study inclusion with an allergenic extract of any type of mites.
- Uncontrolled severe diseases that may increase the risk to the safety of patients participating in this study.
- Patients with a history of severe reactions during previous skin tests.
- Patients receiving anti-IgE, anti-IL 5, anti-IL 4 or IL-13 biological therapy, or anti-eosinophil (Omalizumab, Dupilumab, Benralizumab, Reslizumab, Mepolizumab) or have been receiving it in the last 6 months.
- Simultaneous participation in another clinical trial.
- Pregnant or breastfeeding women.
See the full eligibility criteria
- The age of the patients will range between 18 and 65 years, both inclusive.
- Patient who has provided informed consent to participate in the study.
- Previous medical history supporting the diagnosis of allergy
- Demonstrated sensitization to allergens (at least to one of the following allergens: Dermatophagoides pteronyssinus, Dermatophagoides farinae, Blomia tropicalis, and Lepidoglyphus destructor responsible for the patient's clinical symptoms) through: - Skin prick test (Prick test), with a positivity criterion when the largest diameter of the wheal obtained with a standardized commercial extract is ≥ 3 mm compared to the negative control. - Specific IgE serum to the allergen equal to or greater than 3.5 kUA/L (CAP). Both the skin prick test and the specific IgE will be valid if performed within the 18 months prior to study inclusion.
- Negative pregnancy test in urine for potentially fertile women (fertile is understood from menarche to postmenopause, unless sterilized due to hysterectomy, bilateral salpingectomy, and bilateral oophorectomy).
- Having received previous immunotherapy treatment during the 5 years prior to study inclusion with an allergenic extract of any type of mites.
- Uncontrolled severe diseases that may increase the risk to the safety of patients participating in this study.
- Patients with a history of severe reactions during previous skin tests.
- Patients receiving anti-IgE, anti-IL 5, anti-IL 4 or IL-13 biological therapy, or anti-eosinophil (Omalizumab, Dupilumab, Benralizumab, Reslizumab, Mepolizumab) or have been receiving it in the last 6 months.
- Simultaneous participation in another clinical trial.
- Pregnant or breastfeeding women.
- Having taken oral H1 antihistamines (first or second generation) in the 7 days prior to study inclusion
- Psychiatric disorder that prevents adequate compliance with the immunotherapy program. If taking psychiatric medication that interferes with the diagnostic test (e.g., tricyclic antidepressants), it should not be discontinued to be included in the study.
- Use of beta-blockers or any medication contraindicating the use of adrenaline. If the drug is necessary to preserve the patient's health, it should not be discontinued to be included in the study.
- Chronic use of oral corticosteroids, or oral or parenteral corticosteroid use in repeated and intermittent regimens (> 10 mg/day of prednisone or equivalent).
- Dermographism, lesions, and/or any cutaneous pathology (including dermatitis and urticaria) affecting the area where skin tests are performed.
- Hypersensitivity to any component of the skin prick test
- Treatment with pimecrolimus and/or topical corticosteroids in the area where skin tests are performed in the last 21 days prior to study inclusion
- Clinically relevant immune system diseases, both autoimmune and immunodeficiencies, at the investigator's discretion
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.