House Dust Mite AllergyPhase 3PROACAROSNCT05395689
Efficacy and Safety Assessment of Beltavac® With Polymerized Extract of HDM
A Phase 3 study testing House dust mites allergoid from Dermatophagoides pteronyssinus and Dermatophagoides farinae in people with House Dust Mite Allergy, run by Probelte Pharma S.L.U. at 18 sites in Spain.
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 Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- House Dust Mite Allergy
- What is being tested?
- House dust mites allergoid from Dermatophagoides pteronyssinus and Dermatophagoides farinae
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 18 sitesSpain
- Study dates
- 17 Jan 2022to Jun 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
18 sites in 1 country.
18 sites in 1 country
Spain18 sites, 16 recruiting
- Recruiting
Fundacion Sanitaria Sant Pere Claver
Barcelona
Helena Hermida, MD
Helena Hermida, MD
- Recruiting
Hospital de Bellvitge
Barcelona
Teresa Dordal, MD
- Recruiting
Hospital Germans Trias i Pujol
Barcelona
Albert Roger, MD
Albert Roger
- Recruiting
Hospital infantil Vall d Hebron
Barcelona
Teresa Garriga, MD
Teresa Garriga
- Recruiting
Hospital Val d ' Hebron
Barcelona
Victoria Cardona, MD
Victoria Cardona, MD
- Recruiting
Hospital General de Castellón
Castelló
J.V. Castelló Carrascosa
- Recruiting
Hospital de la Plana
Castellon, Castellón
David El Qutob, MD
David El -Qutob, MD
- Recruiting
Hospital General de Granollers
Granollers, Barcelona
Patricia Martinez Lezcano, MD
- Recruiting
Hospital Regional de Málaga
Málaga, Málaga
M J Torres
M J Torres, MD
- Withdrawn
Hospital Virgen de la Arrixaca
Murcia
- Recruiting
Hospital Vega Baja
Orihuela, Alicante
Angel Ferrer
Angel Ferrer
- Recruiting
Complejo Hospitalario de Navarra
Pamplona, Navarre
Ana Tabar Purroy, MD
Ana Tabar Purroy
- Withdrawn
Hospital de Canarias
Santa Cruz de Tenerife, Canary Islands
- Recruiting
Hospital de Fatima
Seville
J.L. Pérez Formoso
- Recruiting
Hospital Virgen Macarena
Seville
Pilar Lara de la Rosa
Pilar Lara de la Rosa
- Recruiting
Hospital Clinico Universitario de Valencia
Valencia
Enrique Burches, MD
Enrique Burches
- Recruiting
Hospital Politecnico de la Fé
Valencia
Miguel Angel Diaz, MD
Miguel Angel Diaz, MD
- Recruiting
Hospital Universitario Infantil de la Fé
Valencia
Miguel Tortajada, MD
About this study
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
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
- Conditions
- House Dust Mite Allergy
- Being tested
- House dust mites allergoid from Dermatophagoides pteronyssinus and Dermatophagoides farinae, Placebo
- Medical subject headings
- Dust Mite Allergy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
House dust mites allergoid from Dermatophagoides pteronyssinus and Dermatophagoides farinaeBiological
The vaccine will be administered according to a rush schedule meaning one administration each month for 1 year
PlaceboBiological
The vaccine will be administered according to a rush schedule meaning one administration each month for 1 year
| Study group | Role | What they receive |
|---|---|---|
| Active substance | Experimental | House dust mites allergoid from Dermatophagoides pteronyssinus and Dermatophagoides farinae solution administered by the subcutaneous route for 12 months using a rush schedule Receives: Biological: House dust mites allergoid from Dermatophagoides pteronyssinus and Dermatophagoides farinae |
| Placebo | Placebo comparator | Saline solution administered by the subcutaneous route for 12 months using a rush schedule Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months of treatment
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 12 months of treatment.
RCAT questionnaire
Rhinitis Control Assessment Test. Score from 6 (poor control) to 30 (good control)
Measured: 12 months of treatment.
Mini-RQLQ questionnaires
Mini-Rhinoconjunctivitis Quality of Life Questionnaire
Measured: 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
Measured: 12 months of treatment.
Number of local and systemic reactions.
Number of local and systemic reaccions associated with the treatment
Measured: 13 months of study follow up
Cost-effectiveness analysis
Number days/ visits related to allergy
Measured: 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.
Measured: 12 months of treatment
PEF
Peak expiratory flow measured with a Smart Peak Flow device
Measured: 12 months of treatment
ACT questionnaire
Asthma Control Test Questionnaire to assess the control of asthma in asthmatic patients
Measured: 12 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start17 Jan 2022
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for House Dust Mite AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Probelte Pharma S.L.U.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05395689
- Sponsor's protocol ID
- PRO-ACAROS-2018-01
- Acronym
- PROACAROS
- Status last verified
- Jul 2024
- First submitted
- 19 May 2022
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05395689
- Acronym / sponsor ID
- PROACAROS / PRO-ACAROS-2018-01
- Conditions
- House Dust Mite Allergy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Probelte Pharma S.L.U.Industry (pharma, biotech, devices)
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active substance | Experimental | Biological: House dust mites allergoid from Dermatophagoides pteronyssinus and Dermatophagoides farinaeHouse dust mites allergoid from Dermatophagoides pteronyssinus and Dermatophagoides farinae solution administered by the subcutaneous route for 12 months using a rush schedule |
| Placebo | Placebo comparator | Biological: PlaceboSaline solution administered by the subcutaneous route for 12 months using a rush schedule |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| House dust mites allergoid from Dermatophagoides pteronyssinus and Dermatophagoides farinaeThe vaccine will be administered according to a rush schedule meaning one administration each month for 1 year | Biological | Active substance |
| PlaceboThe vaccine will be administered according to a rush schedule meaning one administration each month for 1 year | Biological | Placebo |
Primary outcome
The combined nasal symptom and medication score
Time frame: 12 months of treatment
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 secondary outcomes
Score of the nasal symptoms scale
Time frame: 12 months of treatment
Score of the specific medication scale
Time frame: 12 months of treatment.
Percentage of days without symptoms or medication
Time frame: 12 months of treatment
VAS score (completed by the patient and the investigator)
Time frame: 12 months of treatment.
RCAT questionnaire
Time frame: 12 months of treatment.
Mini-RQLQ questionnaires
Time frame: 12 months of treatment.
Values in serum of specific IgE and IgG4
Time frame: 12 months of treatment.
Number of local and systemic reactions.
Time frame: 13 months of study follow up
Cost-effectiveness analysis
Time frame: 13 months of study follow up
The combined asthma symptom and medication score
Time frame: 12 months of treatment
PEF
Time frame: 12 months of treatment
ACT questionnaire
Time frame: 12 months of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing House dust mites allergoid from Dermatophagoides pteronyssinus and Dermatophagoides farinae in people with House Dust Mite Allergy, run by Probelte Pharma S.L.U. at 18 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Inma Buendia (+34 608 933 618, inmaculadabuendia@probeltepharma.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The combined nasal symptom and medication score (time frame: 12 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024.