Dose determination study of Phleum pratense allergenic extract for immunotherapy treatment, administered via sublingual route, standardized in TBU/mL.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Asac Pharmaceutical Inmunology S.A.

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Decision date (initial)

2026-04-14

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 of grass polen (Phleum pratense), 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 (both the rescue medication used spontaneously during follow-up and that administered after the nasal provocation test or skin prick test)
2. To determine the safety of the investigational treatment by considering local and/or systemic adverse reactions reported during the trial related to the investigational product, placebo, or study procedures (including those due to the nasal provocation test or skin prick test)
3. Evolution of specific IgE to Phleum pratense and major allergens ... between baseline and end of study. These determinations will be performed in a centralized laboratory (Echevarne Laboratory).
4. Evolution of Phleum pratense IgG4 at baseline prior to immunotherapy and at the end of the study. This determination will be performed in a centralized laboratory (Echevarne Laboratory).
5. Evolution of the Phleum pratense skin prick test between baseline and study completion
6. Independent analysis of each of the variables included in the assessment of the nasal provocation test results

Conditions and MedDRA coding

Allergic rhinitis/rhinoconjunctivitis caused by grass polen allergy

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Age between 12 and 50 years
2. Diagnosis of allergic rhinitis with/without conjunctivitis, with/without associated asthma. In patients with associated asthma at the time of recruitment, lung function must be FEV1 > 70% of predicted and FVC > 80% of predicted
3. Positive skin prick test to Phleum pratense or to a homologous grass allergen routinely used at the site, with a mean wheal diameter at least 5 mm greater than the negative control. The grass allergen used will be the one customarily employed by each site according to its clinical protocol. The skin test will be considered valid if performed no more than 6 months prior to inclusion in the study
4. Specific IgE determination to Phleum pratense or to the homologous allergen used at the site of at least 0.70 kU/L. This determination will be considered valid if performed no more than 6 months prior to inclusion. This value must be corroborated by the centralized study determination
5. Positive nasal provocation test result obtained with a maximum concentration of 1/10
6. Signed informed consent to participate in the study
7. In women of childbearing potential (considered fertile from menarche to post-menopause unless sterilized due to hysterectomy, bilateral salpingectomy, or bilateral oophorectomy), certainty of not being pregnant at study entry, which will be confirmed by a negative urine pregnancy test. In addition, a new pregnancy test must be performed at the end of treatment to confirm absence of pregnancy
8. No prior specific immunotherapy with Phleum pratense extracts or any related pollen within the last 5 years, and not receiving concomitant specific immunotherapy with Phleum pratense or any other allergen during the study period

Exclusion criteria 9

1. Sensitization (skin prick test and/or specific IgE) to perennial allergens (animal dander, environmental fungi, storage mites, or any other allergenic source depending on each participating site’s geographic location) that may interfere with the patient’s clinical evolution during follow-up. Tests and determinations performed within a maximum of 6 months prior to the inclusion visit will be considered valid. In the case of sensitization to animal dander, inclusion may be accepted provided that the patient has no habitual contact with such animals and that there is no possibility of this occurring during follow-up. Sensitization to pollens that overlap the grass season will not be considered an exclusion criterion, except when there is concomitant sensitization to Cupressus arizonica, ash, plane tree, and/or oak (considering results from the last 6 months or from the prick test performed in the study with supplied allergens) whose pollen seasons occur during the patient follow-up period
2. Nasal hyperreactivity, defined as a ≥15% reduction in Peak Nasal Inspiratory Flow (PNIF/PFIN) or an increase of 3 points in the symptom score compared with baseline during the nasal provocation test
3. Recent nasal/oral surgery (within 6 months or less; in the case of dental extractions, dental implants, or similar procedures, within the last 2 months).
4. Nasal septum perforation
5. Partially controlled or uncontrolled bronchial asthma according to GINA criteria. Exclusion criteria will include: FEV1 ≤ 70% of predicted and FVC ≤ 80% of predicted and Continuous use of asthma medication included in GINA levels 3, 4, or 5
6. Usual contraindications for allergen immunotherapy: Active or controlled neoplastic disease diagnosed within the last 5 years, Acute psychiatric pathology limiting the patient’s normal daily activity, Pregnancy and lactation
7. Chronic use of medication that prevents adequate analysis and follow-up during the study: antihistamines, oral and/or parenteral corticosteroids, membrane stabilizers (cromoglycates), antidepressants
8. Refusal to participate in the trial and to sign informed consent
9. Known allergy to components of the investigational product other than the study allergen

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 portable nasal inspiratory flow meter provided by the Sponsor, and the test will be considered positive if the reduction in NIPF is ≥ 40%. In addition, a clinical assessment will be performed based on the total sum of symptoms on a scoring scale with a maximum of 13 points.

Secondary endpoints 5

1. Determination of systemic and/or local adverse reactions associated with the trial, particularly those related to investigational product/placebo, and those due to the nasal provocation test or skin prick test.
2. Rescue medication used throughout the study in relation to the investigational product/placebo (this does not include any rescue medication that may be administered after the nasal provocation test or skin prick test).
3. Laboratory determinations of serum markers at baseline and end of study: Specific IgE to Phleum pratense and major allergens rPhl p1 + rPhl p5b., y Phleum pratense IgG4.
4. Phleum pratense skin prick test at baseline and end of study for comparative analysis
5. Independent analysis of each of the clinical variables included in the nasal provocation test scoring scale

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

Asac Pharmaceutical Inmunology S.A.

Contact name

Carmen Santos -actuando en nombre del Promotor

Public contact point

Organisation

Asac Pharmaceutical Inmunology S.A.

Contact name

Carmen Santos -actuando en nombre del Promotor

Third parties 1

Sponsor responsibilities

Article 77 compliance

Asac Pharmaceutical Inmunology S.A.

Article 77 implementation

Asac Pharmaceutical Inmunology S.A.

Locations

1 EU/EEA country · 10 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 9 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