Dose determination study of a mix of Dermatophagoides allergenic extracts (pteronyssinus and farinae) for immunotherapy treatment, administered via sublingual route, standardized in TBU/mL.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Asac Pharmaceutical Inmunology S.A., Advanced Outcomes Research S.L.

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

5 Nov 2025 → ongoing

Decision date (initial)

2025-09-17

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

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.

Secondary objectives 6

1. Assessment of rescue medication use in relation to the investigational product/placebo (excluding any rescue medication administered following the nasal provocation test or skin prick test).
2. To assess the safety of the investigational treatment by considering both systemic and local adverse reactions reported during the trial that are related to the investigational product/placebo (excluding adverse reactions resulting from the nasal provocation test or skin prick test).
3. Evaluation of the evolution of specific IgE to Dermatophagoides pteronyssinus, Dermatophagoides farinae, and the major allergens Der p 1 and Der p 2, from baseline to the end of the study. These assessments will be performed at a centralized laboratory (Echevarne Laboratory).
4. Evaluation of Dermatophagoides-specific IgG4 levels at baseline prior to immunotherapy and at the end of the study. This assessment will be performed at a centralized laboratory (Echevarne Laboratory).
5. Evaluation of the evolution of skin prick test responses to Dermatophagoides pteronyssinus and Dermatophagoides farinae from baseline to the end of the study.
6. Independent analysis of each variable included in the assessment of the nasal provocation test outcomes.

Conditions and MedDRA coding

Allergic rhinitis/rhinoconjunctivitis caused by dust mite allergy

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Age between 14 and 50 years.
2. 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
3. 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
4. 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
5. Positive result in the nasal provocation test using a maximum concentration of 1/10
6. Signed informed consent to participate in the study
7. 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
8. No previous or concomitant allergen immunotherapy with Dermatophagoides extract or with any other allergen during the study period

Exclusion criteria 8

1. 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
2. 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.
3. 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).
4. Nasal septum perforation.
5. 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.
6. 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.
7. 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
8. Refusal to participate in the trial or to sign the informed consent form.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The individual response of each recruited subject to the nasal provocation test (NPT). To objectively assess the response, the change in Nasal Inspiratory Peak Flow (NIPF) will be measured using a rhinomanometer provided by the sponsor, and the response will be considered positive if the NIPF decreases by ≥ 40%. In addition, a clinical assessment will be performed based on the total sum of symptom scores on a 13-point scale.

Secondary endpoints 5

1. Assessment of rescue medication use throughout the study in relation to the investigational product/placebo.
2. Evaluation of adverse reactions occurring during the patient follow-up period specified in the study.
3. Analytical determinations of serum markers (specific IgE to Dermatophagoides pteronyssinus, Dermatophagoides farinae, Der p1 and Der p2; and IgG4 to Dermatophagoides) at baseline and at the end of the study.
4. Assessment of the primary wheal resulting from skin prick tests with Dermatophagoides pteronyssinus and Dermatophagoides farinae at baseline and at the end of the study: the primary wheal will be calculated as the mean of the two diameters ([largest diameter + smallest diameter] / 2). Subsequently, the group mean will be calculated based on the results of each enrolled subject, to allow for comparative analysis between groups.
5. Evaluation of all individual variables from the scoring scale used in the nasal provocation test.

Investigational products

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

Test 3

Placebo 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Asac Pharmaceutical Inmunology S.A.

Sponsor organisation

Asac Pharmaceutical Inmunology S.A.

Address

Calle Capricornio 3-5

City

Alicante

Postcode

03006

Country

Spain

Scientific contact point

Organisation

Advanced Outcomes Research S.L.

Contact name

Dra. Carmen Santos

Public contact point

Organisation

Advanced Outcomes Research S.L.

Contact name

Dra. Carmen Santos

Advanced Outcomes Research S.L.

Sponsor organisation

Advanced Outcomes Research S.L.

Address

Calle De Tarragona 84-90 Esc C 2ª-7

City

Barcelona

Postcode

08015

Country

Spain

Scientific contact point

Organisation

Advanced Outcomes Research S.L.

Contact name

Carmen Santos Coca

Public contact point

Organisation

Advanced Outcomes Research S.L.

Contact name

Carmen Santos Coca

Sponsor responsibilities

Article 77 compliance

Asac Pharmaceutical Inmunology S.A.

Locations

1 EU/EEA country · 13 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

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

Documents 8 files

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

Application history

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