Evaluation of Subcutaneous Immunotherapy with Polymerized Allergen Extracts of Dermatophagoides in Allergic Rhinoconjunctivitis Patients
- Trial ID
- 2024-516893-31-01
- Protocol
- PRO-RCT-ACAROS-2018
- Sponsor
- Probelte Pharma S.L.
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to evaluate the **efficacy** of subcutaneous rush immunotherapy with Beltavac® over a 12-month period in treating allergic rhinitis in patients sensitized to house dust mites. This is clinically relevant as allergic rhinitis is a common condition that significantly impacts patients' quality of life, and effective treatment options are essential for managing symptoms and improving patient outcomes.
Secondary objectives include:
- Assessing the efficacy of Beltavac® in controlling **rhinoconjunctivitis**.
- Evaluating its global efficacy on allergic symptoms.
- Assessing its safety profile.
- Evaluating its effect on patients' quality of life.
- Assessing its impact on serum levels of specific **immunoglobulins**.
- Conducting an economic assessment of its clinical effect.
Participants
The clinical trial focuses on individuals diagnosed with **allergic rhinoconjunctivitis** due to exposure to house dust mites. The study population includes both male and female participants, aged between 12 and 65 years. Participants are required to have moderate or severe symptoms of persistent rhinitis, with or without asthma that is well or partially controlled. The trial does not involve a vulnerable population. The sponsor has not provided information regarding the total number of participants. Participants were selected based on their sensitization to Dermatophagoides pteronyssinus or Dermatophagoides farinae, confirmed by a positive prick test and a specific IgE value. Lifestyle considerations such as diet and physical activity are not specified. Key inclusion criteria include the ability to complete an electronic patient record and, for women of childbearing potential, the use of contraception. The trial aims to assess the efficacy of subcutaneous rush immunotherapy with Beltavac® over a 12-month period.
Plans and Procedures
The clinical trial is designed to evaluate the **efficacy** and safety of subcutaneous immunotherapy using Beltavac with polymerized allergenic extract from house dust mites in patients with **allergic rhinoconjunctivitis**. This is a randomized, double-blind, placebo-controlled trial, with a duration of 12 months. Participants will be randomly assigned to receive either the active treatment or a placebo, which is a saline solution without the allergenic extract. The trial will involve a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on specific criteria, including age, symptom severity, and confirmation of sensitization to house dust mites.
Following the screening phase, eligible participants will enter the treatment phase, which includes regular follow-up visits to monitor progress and collect data on primary and secondary endpoints. The primary endpoint is the score on the combined scale of nasal symptoms and specific medication, recorded daily by participants. Secondary endpoints include scores on nasal and ocular symptom scales, medication use, and the percentage of days without symptoms or medication. The end-of-study visit will occur at the conclusion of the 12-month treatment period, where final assessments will be conducted.
Participant involvement is expected to last for the entire 12-month duration of the trial, with conditions for early termination including withdrawal of consent, non-compliance with study procedures, or adverse events that warrant discontinuation. The trial aims to provide comprehensive data on the long-term effects of the immunotherapy, contributing valuable insights into the management of allergic rhinoconjunctivitis due to house dust mite exposure.
Treatment
The clinical trial involves the administration of **BELTAVAC** with polymerized extract from Dermatophagoides, which is an **injectable aqueous solution**. The active substance in this experimental medication is a **mixture of allergen extracts** of Dermatophagoides pteronyssinus and Dermatophagoides farinae, polymerized with glutaraldehyde. This formulation is designed for subcutaneous injection. The maximum daily dose is 0.5 ml, and the treatment is administered over a period of 12 months. The pharmaceutical form is specifically tailored for subcutaneous administration, ensuring the controlled release of the allergenic extracts. Participant compliance is monitored through regular follow-ups and dose adjustments as necessary to maintain the efficacy and safety of the treatment.
In addition to the experimental treatment, a **placebo** is used as a comparator in the study. The placebo, known as Beltavac Polymerized placebo, is a saline solution devoid of the allergenic extract. It is administered in the same manner as the experimental treatment, via subcutaneous injection, to maintain the study's double-blind design. The placebo is crucial for assessing the true efficacy of the BELTAVAC treatment by providing a baseline for comparison. Compliance with the placebo administration is similarly monitored to ensure the integrity of the trial results.
Efficacy
The efficacy of the subcutaneous immunotherapy with Beltavac® for treating **allergic rhinitis** will be assessed using a combination of primary and secondary endpoints. The primary endpoint is the score on the combined scale of nasal symptoms and specific medication (CSMS4), which patients will complete daily in their online patient card over 4-week periods throughout the year of follow-up. Secondary endpoints include the 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), and the percentage of days without symptoms or medication.
Data collection will involve patient-reported outcomes, with patients required to maintain an electronic patient record. The assessment will occur repeatedly during the trial, allowing for a comprehensive evaluation of symptom improvement and medication usage over time. The trial is designed to last for 12 months, with efficacy parameters being measured at regular intervals to ensure a robust analysis of the treatment's impact on allergic rhinitis symptoms.
Inclusion and Exclusion Criteria
Inclusion Criteria
- 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.
- 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
- 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.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Spain | Recruiting | 17 Jan 2022 | 250 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
Beltavac Polymerized placebo. It is a saline solution without the allergenic extract | Placebo | N/A | — | — | — | N/A |
BELTAVAC with polymerized extract From Dermatophagoides | Test | INJECTABLE AQUEOUS SOLUTION | SUBCUTANEOUS INJECTION | 0.5 | 12 | PRD9441128 |