Study of an Allergy Injection for House Dust Mite Allergy in People with Allergic Rhinitis or Eye Allergies.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Probelte Pharma S.L.

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11], Diseases [C] - Disorders of Environmental Origin [C21]

Decision date (initial)

2026-07-08

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Probelte Pharma

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To evaluate the effectiveness of treatment for allergic rhinitis/rhinoconjunctivitis due to sensitization to Dermatophagoides pteronyssinus, Dermatophagoides farinae and Blomia tropicalis

Secondary objectives 5

1. To evaluate the effect on the treatment of allergic rhinoconjunctivitis due to sensitization to dust mites.
2. To evaluate the overall effect on allergy symptoms.
3. To evaluate the effect on rhinitis control.
4. To evaluate the effect on quality of life.
5. To evaluate the effect on serum levels of specific immunoglobulins

Conditions and MedDRA coding

Allergic rhinitis/rhinoconjunctivitis due to house dust mites exposure

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. 1. Written informed consent, duly signed and dated.
2. 2. Male or female between 12 and 65 years of age (inclusive).
3. 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. 4. Medical history of allergic rhinitis/rhinoconjunctivitis requiring symptomatic treatment for at least one year.
5. 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. 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. 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. 8. Negative pregnancy test.
9. 9. Patients with a mean rhinitis symptom score (RSS) ≥ 2 during the screening period.
10. 10. Asthma Control Test (ACT) score >19 (only for asthma patients).
11. 11. Forced expiratory volume in one second (FEV1) ≥80% (only for asthma patients).

Exclusion criteria 12

1. 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.
2. 2. Mild to severe persistent asthma, partially controlled or uncontrolled according to GINA 2025 guidelines (5).
3. 3. Autoimmune diseases or immunodeficiency.
4. 4. Malignant neoplasms, serious cardiovascular diseases, serious mental illnesses, or other relevant chronic diseases that could interfere with the study results.
5. 5. History of anaphylaxis with cardiorespiratory symptoms.
6. 6. Hypersensitivity to any of the excipients in the investigational product.
7. 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. 8. Treatment with beta-blockers during the study.
9. 9. Patients who have received allergen immunotherapy that has failed within the last 5 years.
10. 10. Patients receiving immunotherapy with allergens other than dust mites during the study period.
11. 11. Patients receiving any other vaccine within one week prior to the start of treatment.
12. 12. Pregnant or breastfeeding patients.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Combined score of nasal symptoms and specific allergy medication (CSMR4) completed by the patient daily in the patient's electronic record in 4-week periods prior to visits 1 and 7 and 8-week periods prior to visit 13.

Secondary endpoints 9

1. Rhinitis Symptoms Score
2. Specific Medication Scale score.
3. Nasal and Ocular Symptom Scale score.
4. Combined score of nasal, ocular, and medication symptoms (CSMR6).
5. Percentage of days without symptoms or medication.
6. Visual analogue scale score on visits 1, 7 and 13 by the patient and investigator.
7. RCAT questionnaire score on visits 1, 7 and 13.
8. Specific rhinitis questionnaire score (mini-RQLQ) at visits 1, 7 and 13.
9. Specific serum values ​​of IgE and IgG4 specific to Blomia, DPT and DF total, Der p1 and Der p2, Der p23, Der f1, Der f2 and Blo t5 at visits 0, 7 and 13.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Probelte Pharma S.L.

Sponsor organisation

Probelte Pharma S.L.

Address

Calle Antonio Belmonte Abellan 7

City

Murcia

Postcode

30100

Country

Spain

Scientific contact point

Organisation

Probelte Pharma S.L.

Contact name

Inmaculada Buendía

Public contact point

Organisation

Probelte Pharma S.L.

Contact name

Inmaculada Buendía

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications