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

Efficacy and Safety Assessment of a Subcutaneous Immunotherapy (Beltavac®) With Polymerized Allergenic Extract From House Dust Mites in Patients With Allergic Rhinitis/Rhinoconjuntivitis

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

Study Overview

• Status: Recruiting
• Conditions: House Dust Mite Allergy
• Intervention / Treatment: Biological: House dust mites allergoid from Dermatophagoides pteronyssinus and Dermatophagoides farinae; Biological: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 350
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Inma Buendia; Phone Number: +34 608 933 618; Email: inmaculadabuendia@probeltepharma.es

Study Locations

• Spain
  • Barcelona, Spain
    • Recruiting
    • Hospital De Bellvitge
    • Contact: Teresa Dordal, MD
  • Barcelona, Spain
    • Recruiting
    • Hospital Germans Trias i Pujol
    • Contact: Albert Roger, MD
    • Principal Investigator: Albert Roger
  • Barcelona, Spain
    • Recruiting
    • Fundacion Sanitaria Sant Pere Claver
    • Contact: Helena Hermida, MD
    • Principal Investigator: Helena Hermida, MD
  • Barcelona, Spain
    • Recruiting
    • Hospital infantil Vall d Hebron
    • Contact: Teresa Garriga, MD
    • Principal Investigator: Teresa Garriga
  • Barcelona, Spain
    • Recruiting
    • Hospital Val d ' Hebron
    • Contact: Victoria Cardona, MD
    • Principal Investigator: Victoria Cardona, MD
  • Castelló, Spain
    • Recruiting
    • Hospital General de Castellon
    • Contact: J.V. Castelló Carrascosa
  • Murcia, Spain
    • Withdrawn
    • Hospital Virgen de la Arrixaca
  • Sevilla, Spain
    • Recruiting
    • Hospital Virgen Macarena
    • Contact: Pilar Lara de la Rosa
    • Principal Investigator: Pilar Lara de la Rosa
  • Sevilla, Spain
    • Recruiting
    • Hospital de Fatima
    • Contact: J.L. Pérez Formoso
  • Valencia, Spain
    • Recruiting
    • Hospital Clínico Universitario de Valencia
    • Contact: Enrique Burches, MD
    • Principal Investigator: Enrique Burches
  • Valencia, Spain
    • Recruiting
    • Hospital Politecnico de la Fé
    • Contact: Miguel Angel Diaz, MD
    • Principal Investigator: Miguel Angel Diaz, MD
  • Alicante
    • Orihuela, Alicante, Spain
      • Recruiting
      • Hospital Vega Baja
      • Contact: Angel Ferrer
      • Principal Investigator: Angel Ferrer
  • Canarias
    • Santa Cruz De Tenerife, Canarias, Spain
      • Withdrawn
      • Hospital de Canarias
  • Castellón
    • Castellón De La Plana, Castellón, Spain
      • Recruiting
      • Hospital de la Plana
      • Contact: David El Qutob, MD
      • Principal Investigator: David El -Qutob, MD
  • Málaga
    • Malaga, Málaga, Spain
      • Recruiting
      • Hospital Regional de Málaga
      • Contact: M J Torres
      • Principal Investigator: M J Torres, MD
  • Navarra
    • Pamplona, Navarra, Spain
      • Recruiting
      • Complejo Hospitalario de Navarra
      • Contact: Ana Tabar Purroy, MD
      • Principal Investigator: Ana Tabar Purroy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 65 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Active substance; House dust mites allergoid from Dermatophagoides pteronyssinus and Dermatophagoides farinae solution administered by the subcutaneous route for 12 months using a rush schedule	Biological: House dust mites allergoid from Dermatophagoides pteronyssinus and Dermatophagoides farinae; The vaccine will be administered according to a rush schedule meaning one administration each month for 1 year
PLACEBO_COMPARATOR: Placebo; Saline solution administered by the subcutaneous route for 12 months using a rush schedule	Biological: Placebo; The vaccine will be administered according to a rush schedule meaning one administration each month for 1 year

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The combined nasal symptom and medication score	The symptoms assessed are: itchy nose, sneezing, runny nose, and blocked nose (all rated from 0-3). The medication score is 1 for oral and/or topical antihistamines, 2 for intranasal corticosteroids, and 3 for oral corticosteroids. The scores from the nasal symptoms are added and divided by 4 to a total daily symptom score from 0-3.Final score range from 0 to 6, higher score meaning a worse outcome.	12 months of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score of the nasal symptoms scale	Symptoms assessed are: itchy nose, sneezing, runny nose, and blocked nose (all rated from 0-3). Final score range from 0 to 3, higher score meaning worse outcome.	12 months of treatment
Score of the specific medication scale	The medication score is 1 for oral and/or topical antihistamines, 2 for intranasal corticosteroids, and 3 for oral corticosteroids. Final score range from 0 to 3, higher score meaning worse outcome.	12 months of treatment.
Percentage of days without symptoms or medication	Percentage of days with a zero value for symptom and medication recorded in the patient digital diary	12 months of treatment
VAS score (completed by the patient and the investigator)	Visual analogue score from 0 (no symptoms) to 100mm (serious symptoms) to assess global symptoms of allergy	12 months of treatment.
RCAT questionnaire	Rhinitis Control Assessment Test. Score from 6 (poor control) to 30 (good control)	12 months of treatment.
Mini-RQLQ questionnaires	Mini-Rhinoconjunctivitis Quality of Life Questionnaire	12 months of treatment.
Values in serum of specific IgE and IgG4	Specific IgE and IgG4 to DPT and total DF, Der p1 and Der p2, Der p23, Der f1, Der f2	12 months of treatment.
Number of local and systemic reactions.	Number of local and systemic reaccions associated with the treatment	13 months of study follow up
Cost-effectiveness analysis	Number days/ visits related to allergy	13 months of study follow up
The combined asthma symptom and medication score	The symptoms assessed are: symptoms during the day, symptoms during the night and physical activity limitations (all rated from 0-3). The medication score is 1 for inhalated corticoids (low dose) , 2 for inhalated corticosteroids associated with LABA, and 3 for inhalated corticosteroids medium dosis associated with LABA. The scores from the symptoms are added and divided by 3 to a total daily symptom score from 0-3. The total daily medication score ranges from 0-3.	12 months of treatment
PEF	Peak expiratory flow measured with a Smart Peak Flow device	12 months of treatment
ACT questionnaire	Asthma Control Test Questionnaire to assess the control of asthma in asthmatic patients	12 months of treatment

Collaborators and Investigators

• Sponsor: Probelte Pharma S.L.U.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 17, 2022
• Primary Completion (ANTICIPATED): February 1, 2024
• Study Completion (ANTICIPATED): February 1, 2024

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: May 24, 2022
• First Posted (ACTUAL): May 27, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: PRO-ACAROS-2018-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No