Efficacy and Safety Assessment of Beltavac® With Polymerized Extract of HDM (PROACAROS)

Probelte Pharma

Status and phase: Enrolling; Phase 3

Conditions: House Dust Mite Allergy

Treatments: Biological: Placebo; Biological: House dust mites allergoid from Dermatophagoides pteronyssinus and Dermatophagoides farinae

Study type: Interventional

Funder types: Industry

Identifiers

NCT05395689

PRO-ACAROS-2018-01

Details and patient eligibility

About

The trial is performed to assess efficacy and safety of Beltavac with polymerized extract of house dust mites in allergic Rhinoconjunctivitis associated or not with asthma

Enrollment: 350 estimated patients

Sex: All

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent, signed and duly dated.
• Man or woman between 12 and 65 years old (both included).
• Patient with moderate or severe symptoms of persistent rhinitis according to the ARIA Guide, associated or not with well or partially controlled asthma according to the GEMA 5.0 Guide.
• Confirmation of sensitization to DPT or DF with a positive prick test (mean papule diameter greater than or equal to 3 mm) with a commercial standardized allergenic extract and a serum extract-specific IgE value of class 3 or higher (> 3.5 kU / L) within the 6 months prior to the study.
• Negative pregnancy test.
• Nasal symptom and medication combined scale score ≥ 1.5 during the screening phase.

Exclusion criteria

• Concomitant sensitization to allergens other than dust mites if clinically relevant symptoms are anticipated that may interfere with study evaluation periods at the discretion of the investigator.
• Poorly controlled asthma according to the GEMA 5.0 guideline
• Severe asthma, that is, those who during the last months have controlled their asthma according to therapeutic step 5-6 of the GEMA 5.0 guideline.
• Autoimmune diseases or immunodeficiency.
• Malignant neoplasms, serious cardiovascular disease, serious mental illness or other relevant chronic diseases that may interfere with the results of the study.
• Clinical history of anaphylaxis with cardio / respiratory symptoms.
• Hypersensitivity to any of the excipients of the investigational product.
• Immunosuppressive medication during the last 6 months before the inclusion of patients and until the end of the study.
• Treatment with beta-blockers during the study.
• Patients who have previously received immunotherapy with allergenic dust mite extract or other extracts and have failed within the last 5 years.
• Patients with immunotherapy with allergens other than dust mites during the study period.
• Patients who receive any other vaccine one week before the start of treatment or awaiting the second dose of vaccine against COVID-19.
• Pregnant or nursing patients.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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350 participants in 2 patient groups, including a placebo group

Active substance

Experimental group

Description:

House dust mites allergoid from Dermatophagoides pteronyssinus and Dermatophagoides farinae solution administered by the subcutaneous route for 12 months using a rush schedule

Treatment:

Biological: House dust mites allergoid from Dermatophagoides pteronyssinus and Dermatophagoides farinae

Placebo

Placebo Comparator group

Description:

Saline solution administered by the subcutaneous route for 12 months using a rush schedule

Treatment:

Biological: Placebo