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Study of an Allergy Injection for House Dust Mite Allergy in People with Allergic Rhinitis or Eye Allergies.
EU CTIS ID: 2026-526105-15-00
What this study is testing
To evaluate the effectiveness of treatment for allergic rhinitis/rhinoconjunctivitis due to sensitization to Dermatophagoides pteronyssinus, Dermatophagoides farinae and Blomia tropicalis
- Therapeutic confirmatory (Phase III)
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
- 1. Written informed consent, duly signed and dated.
- 10. Asthma Control Test (ACT) score >19 (only for asthma patients).
- 11. Forced expiratory volume in one second (FEV1) ≥80% (only for asthma patients).
- 2. Male or female between 12 and 65 years of age (inclusive).
- 3. Patient with moderate to severe symptoms of persistent rhinitis according to the ARIA Guidelines (3), with or without associated asthma controlled according to the GINA 2025 guidelines (steps 1-3).
- 4. Medical history of allergic rhinitis/rhinoconjunctivitis requiring symptomatic treatment for at least one year.
You likely can't join if
- 1. Concomitant sensitization to allergens other than dust mites (i.e., pollens, animal dander, or other perennial allergens) if clinically relevant symptoms are anticipated that could interfere with the study evaluation periods.
- 10. Patients receiving immunotherapy with allergens other than dust mites during the study period.
- 11. Patients receiving any other vaccine within one week prior to the start of treatment.
- 12. Pregnant or breastfeeding patients.
- 2. Mild to severe persistent asthma, partially controlled or uncontrolled according to GINA 2025 guidelines (5).
- 3. Autoimmune diseases or immunodeficiency.
See the full eligibility criteria
- 1. Written informed consent, duly signed and dated.
- 10. Asthma Control Test (ACT) score >19 (only for asthma patients).
- 11. Forced expiratory volume in one second (FEV1) ≥80% (only for asthma patients).
- 2. Male or female between 12 and 65 years of age (inclusive).
- 3. Patient with moderate to severe symptoms of persistent rhinitis according to the ARIA Guidelines (3), with or without associated asthma controlled according to the GINA 2025 guidelines (steps 1-3).
- 4. Medical history of allergic rhinitis/rhinoconjunctivitis requiring symptomatic treatment for at least one year.
- 5. Confirmation of sensitization to BT and DPT or DF with a positive prick test (mean diameter of the wheal greater than or equal to 3 mm) using a standardized commercial allergen extract and a serum extract-specific IgE level of class 3 or higher (>3.5 kU/L) within the 6 months prior to the study.
- 6. For women of childbearing potential, use of contraception for at least one month prior to the visit and a commitment to continue using it throughout the trial period.
- 7. Patients who are willing and able to complete an electronic patient record during the screening period (4 weeks) and during the treatment period (12 weeks).
- 8. Negative pregnancy test.
- 9. Patients with a mean rhinitis symptom score (RSS) ≥ 2 during the screening period.
- 1. Concomitant sensitization to allergens other than dust mites (i.e., pollens, animal dander, or other perennial allergens) if clinically relevant symptoms are anticipated that could interfere with the study evaluation periods.
- 10. Patients receiving immunotherapy with allergens other than dust mites during the study period.
- 11. Patients receiving any other vaccine within one week prior to the start of treatment.
- 12. Pregnant or breastfeeding patients.
- 2. Mild to severe persistent asthma, partially controlled or uncontrolled according to GINA 2025 guidelines (5).
- 3. Autoimmune diseases or immunodeficiency.
- 4. Malignant neoplasms, serious cardiovascular diseases, serious mental illnesses, or other relevant chronic diseases that could interfere with the study results.
- 5. History of anaphylaxis with cardiorespiratory symptoms.
- 6. Hypersensitivity to any of the excipients in the investigational product.
- 7. Immunosuppressive medication (e.g., cyclosporine A, azathioprine, omalizumab, mepolizumab, benralizumab, reslizumab, dupilumab) during the 6 months prior to patient enrollment and until the end of the study.
- 8. Treatment with beta-blockers during the study.
- 9. Patients who have received allergen immunotherapy that has failed within the last 5 years.
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, 0-17 years, 18-64 years, 65+ 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.