Evaluation of the Efficacy and Safety of Subcutaneous Immunotherapy (Beltavac®) with Polymerized Allergenic Extract of House Dust Mite Mixture in Patients with Allergic Rhinitis/Rhinoconjunctivitis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Probelte Pharma S.L.

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years

Gender

Male and Female

Therapeutic area

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

Trial duration

31 Jan 2022 → ongoing

Decision date (initial)

2024-10-18

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Probelte Pharma S.L.U

External identifiers

EU CT number

2024-516893-31-01

EudraCT number

2018-003427-11

ClinicalTrials.gov

NCT05395689

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To assess the efficacy of the subcutaneous rush immunotherapy with Beltavac® for 12 months for treating HDM-sensitized allergic rhinitis

Secondary objectives 6

1. To assess the efficacy of Beltavac® in controlling rhinoconjunctivitis.
2. To assess its global efficacy on allergic symptoms.
3. To assess its safety.
4. To assess its effect on patients’ quality of life
5. To assess its effect on the serum levels of specific immunoglobulins
6. To perform an economic assessment of its clinical effect

Conditions and MedDRA coding

Allergic rhinoconjunctivitis due to exposure of house dust mites

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. For the screening phase. 1. Written informed consent, signed and dated. 2. Male or female between 12 and 65 years of age (both included). 3. Patient with moderate or severe symptoms of persistent rhinitis according to the ARIA Guide (Figure 1) associated or not with asthma well or partially controlled according to the GEMA Guide 5.0. (Figure 2). 4. Confirmation of sensitization to DPT or DF with a positive prick test (mean diameter of the wheal greater than or equal to 3 mm) with a standardized commercial allergenic extract and a serum extract-specific IgE value of class 3 or higher (>3.5 kU/L) within 6 months prior to the study. 5. For women with the possibility of pregnancy, use of contraception for at least 1 month prior to the visit and commitment to continue using it during the period of participation in the trial. 6. Patients who are willing and able to complete an electronic patient record during the 4-week screening period.
2. For the treatment phase 1. Negative pregnancy test. 2. Combined symptom and medication score (ESMR4) ≥ 1.5 during the screening phase. 3. Patients willing and able to complete an electronic patient record for a 12-week period during the treatment phase. 4. Asthma Control Test (ACT) score >19 (for asthmatic patients only). 5. PEF value >80% of personal best at the time of the visit (for asthmatic patients only).

Exclusion criteria 1

1. 1. Concomitant sensitization to allergens other than dust mites in case clinically relevant symptoms are expected that may interfere with the evaluation periods of the study (4 weeks before visits V1, V7, V10 and V13) according to the investigator's criteria. Clarification: The inclusion/exclusion of patients sensitized to other perennial allergens (other than Dermatophagoides), such as storage mites and fungi, will be evaluated by the PI and agreed with the scientific committee of the trial based on the clinical and IgE values ​​of each patient. 2. Poorly controlled asthma according to the GEMA 5.0 guide (Figure 2). 3. Severe asthma, that is, those who have controlled their asthma during the last few months according to therapeutic step 5-6 of the GEMA 5.0 Guide. 4. Autoimmune diseases or immunodeficiency. 5. Malignant neoplasms, severe cardiovascular diseases, severe mental illnesses or other relevant chronic diseases that may interfere with the results of the study. 6. Clinical history of anaphylaxis with cardio/respiratory symptoms. 7. Hypersensitivity to any of the excipients of the investigational product. 8. Immunosuppressive medication (e.g. cyclosporine A, azathioprine, omalizumab, mepolizumab, benralizumab, reslizumab, dupilumab) during the last 6 months prior to patient inclusion and until the end of the study. 9. Treatment with beta-blockers during the study. 10. Patients who have previously received immunotherapy with dust mite allergen extract or other extracts and who have failed during the last 5 years. 11. Patients with immunotherapy with allergens other than dust mites during the study period. 12. Patients who receive any other vaccine one week before starting treatment or waiting for the second dose of the COVID-19 vaccine. 13. Pregnant or breastfeeding patients.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Score on the combined scale of nasal symptoms and specific medication (CSMS4) of allergy completed by the patient daily in his/her online patient card in periods of 4 weeks repeatedly during the year of follow-up.

Secondary endpoints 1

1. - Nasal symptom scale score (SS4). - Specific medication scale score (MS). - Nasal and ocular symptom scale score (SS6) - Combined nasal, ocular symptom and medication scale score (CSMS6). - Percentage of days without symptoms or medication.

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 Jiménez

Public contact point

Organisation

Probelte Pharma S.L.

Contact name

Inmaculada Buendía Jiménez

Locations

1 EU/EEA country · 16 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 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