Efficacy and Safety Assessment of Beltavac® With Polymerized Extract of HDM

House Dust Mite Allergy Clinical Trial

— PROACAROS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05395689
• Other study ID #: PRO-ACAROS-2018-01
• Status: Recruiting
• Phase: Phase 3
• Start date: January 17, 2022
• Est. completion date: February 2024

Study information

• Verified date: May 2022
• Source: Probelte Pharma S.L.U.
• Contact: Inma Buendia
• Phone: +34 608 933 618
• Email: inmaculadabuendia[@]probeltepharma.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• House Dust Mite Allergy

Intervention

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
The vaccine will be administered according to a rush schedule meaning one administration each month for 1 year

Locations

Country	Name	City	State
Spain	Fundacion Sanitaria Sant Pere Claver	Barcelona
Spain	Hospital de Bellvitge	Barcelona
Spain	Hospital Germans Trias i Pujol	Barcelona
Spain	Hospital infantil Vall d Hebron	Barcelona
Spain	Hospital Val d ' Hebron	Barcelona
Spain	Hospital General de Castellón	Castelló
Spain	Hospital de la Plana	Castellón De La Plana	Castellón
Spain	Hospital Regional de Málaga	Malaga	Málaga
Spain	Hospital Virgen de la Arrixaca	Murcia
Spain	Hospital Vega Baja	Orihuela	Alicante
Spain	Complejo Hospitalario de Navarra	Pamplona	Navarra
Spain	Hospital de Canarias	Santa Cruz De Tenerife	Canarias
Spain	Hospital de Fatima	Sevilla
Spain	Hospital Virgen Macarena	Sevilla
Spain	Hospital Clinico Universitario de Valencia	Valencia
Spain	Hospital Politecnico de la Fé	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Probelte Pharma S.L.U.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.
Secondary	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
Secondary	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.
Secondary	RCAT questionnaire	Rhinitis Control Assessment Test. Score from 6 (poor control) to 30 (good control)	12 months of treatment.
Secondary	Mini-RQLQ questionnaires	Mini-Rhinoconjunctivitis Quality of Life Questionnaire	12 months of treatment.
Secondary	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.
Secondary	Number of local and systemic reactions.	Number of local and systemic reaccions associated with the treatment	13 months of study follow up
Secondary	Cost-effectiveness analysis	Number days/ visits related to allergy	13 months of study follow up
Secondary	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
Secondary	PEF	Peak expiratory flow measured with a Smart Peak Flow device	12 months of treatment
Secondary	ACT questionnaire	Asthma Control Test Questionnaire to assess the control of asthma in asthmatic patients	12 months of treatment