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Dose determination study of a mix of Dermatophagoides allergenic extracts (pteronyssinus and farinae) for immunotherapy treatment, administered via sublingual route, standardized in TBU/mL.
EU CTIS ID: 2025-521522-15-00
What this study is testing
To determine the most effective dose of the allergen extract mix of Dermatophagoides pteronyssinus and Dermatophagoides farinae, for immunotherapeutic treatment administered via sublingual route, standardized in TBU/mL, without compromising patient safety.
- 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
- Age between 14 and 50 years.
- Diagnosis of allergic rhinitis with or without conjunctivitis, with or without associated asthma. In patients with associated asthma at the time of recruitment, FEV₁ must be >70% of predicted and FVC >80% of predicted
- Positive skin prick test results to D. pteronyssinus and D. farinae, with a mean wheal diameter at least 5 mm greater than the negative control. The skin prick test is considered valid if performed within 12 months prior to study inclusion
- Specific IgE to D. pteronyssinus and D. farinae ≥ 0.70 kU/L. This determination is considered valid if performed within 6 months prior to study inclusion
- Positive result in the nasal provocation test using a maximum concentration of 1/10
- Signed informed consent to participate in the study
You likely can't join if
- Sensitization (by skin prick test and/or specific IgE) to perennial allergens (animal dander, environmental fungi, storage mites), or any other allergen source (according to the geographical location of each participating center), that could interfere with the patient's clinical course during the follow-up period of this clinical trial. Tests and determinations performed within a maximum of 6 months prior to the inclusion visit will be considered valid
- Sensitization (by skin prick test and/or specific IgE) to seasonal allergens that, due to their particular seasonal characteristics and their geographical prevalence in the location of the participating centers, could interfere with the clinical course of enrolled patients during the study period. Tests and determinations performed within a maximum of 6 months prior to the inclusion visit will be considered valid.
- Recent nasal/oral surgery (within the last 6 months, and within the last 2 months in the case of dental extractions, dental implants, or similar procedures).
- Nasal septum perforation.
- Partially controlled or uncontrolled bronchial asthma according to GINA criteria. The following will be considered exclusion criteria: • FEV₁ ≤ 70% of predicted, and • FVC ≤ 80% of predicted, and • Continuous use of asthma medication corresponding to GINA treatment steps 3, 4, or 5.
- Usual contraindications for allergen immunotherapy: • Active or controlled neoplastic disease, or a diagnosis of neoplastic disease within the last 5 years. • Acute psychiatric disorder that significantly limits the patient’s daily functioning. • Pregnancy and breastfeeding.
See the full eligibility criteria
Who can join
- Age between 14 and 50 years.
- Diagnosis of allergic rhinitis with or without conjunctivitis, with or without associated asthma. In patients with associated asthma at the time of recruitment, FEV₁ must be >70% of predicted and FVC >80% of predicted
- Positive skin prick test results to D. pteronyssinus and D. farinae, with a mean wheal diameter at least 5 mm greater than the negative control. The skin prick test is considered valid if performed within 12 months prior to study inclusion
- Specific IgE to D. pteronyssinus and D. farinae ≥ 0.70 kU/L. This determination is considered valid if performed within 6 months prior to study inclusion
- Positive result in the nasal provocation test using a maximum concentration of 1/10
- Signed informed consent to participate in the study
- For women of childbearing potential (defined as the time from menarche to postmenopause, unless rendered sterile by hysterectomy, bilateral salpingectomy, or bilateral oophorectomy): confirmation of non-pregnancy at the time of study entry, verified by a negative urine pregnancy test. An additional pregnancy test will be performed at the end of treatment to confirm absence of pregnancy
- No previous or concomitant allergen immunotherapy with Dermatophagoides extract or with any other allergen during the study period
What rules you out
- Sensitization (by skin prick test and/or specific IgE) to perennial allergens (animal dander, environmental fungi, storage mites), or any other allergen source (according to the geographical location of each participating center), that could interfere with the patient's clinical course during the follow-up period of this clinical trial. Tests and determinations performed within a maximum of 6 months prior to the inclusion visit will be considered valid
- Sensitization (by skin prick test and/or specific IgE) to seasonal allergens that, due to their particular seasonal characteristics and their geographical prevalence in the location of the participating centers, could interfere with the clinical course of enrolled patients during the study period. Tests and determinations performed within a maximum of 6 months prior to the inclusion visit will be considered valid.
- Recent nasal/oral surgery (within the last 6 months, and within the last 2 months in the case of dental extractions, dental implants, or similar procedures).
- Nasal septum perforation.
- Partially controlled or uncontrolled bronchial asthma according to GINA criteria. The following will be considered exclusion criteria: • FEV₁ ≤ 70% of predicted, and • FVC ≤ 80% of predicted, and • Continuous use of asthma medication corresponding to GINA treatment steps 3, 4, or 5.
- Usual contraindications for allergen immunotherapy: • Active or controlled neoplastic disease, or a diagnosis of neoplastic disease within the last 5 years. • Acute psychiatric disorder that significantly limits the patient’s daily functioning. • Pregnancy and breastfeeding.
- Chronic use of medications that may interfere with proper analysis and monitoring during the study: antihistamines, oral and/or parenteral corticosteroids, mast cell stabilizers (e.g., cromoglycates), antidepressants
- Refusal to participate in the trial or to sign the informed consent form.
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, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
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.