Allergic RhinoconjunctivitisPhase 1NCT02881879
Clinical Trial With Subcutaneous Immunotherapy in Depot Presentation in Patients With Allergic Rhinoconjunctivitis Sensitized to House Dust Mites
A Phase 1 study testing Allergovac depot DPT/DF (50:50) in people with Allergic Rhinoconjunctivitis, run by Roxall Medicina España S.A at 5 sites in Spain.
Trial summary
The aim of the study is to evaluate the safety and tolerability of subcutaneous immunotherapy (SCIT) with House Dust Mite (HDM) extract in patients with rhinoconjunctivitis with or without associated mild asthma and sensitized to HDM. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Allergic Rhinoconjunctivitis
- What is being tested?
- Allergovac depot DPT/DF (50:50)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 5 sitesSpain
- Study dates
- Jul 2016to Sep 2017
- Phase
- Phase 1
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients must sign the informed consent form
- Patients must be between 18 and 60 years of age
- Patients with perennial allergic rhinoconjunctivitis against HDM during a minimum of 1 year prior to study participation. Although allergic rhinoconjunctivitis is the pathology under study, the inclusion of patients with mild concomitant asthma is allowed (GINA 2015)
- Patients who obtained a prick test result ≥ 3 mm diameter to HDM. Positive and negative control of the test should give consistent results
- Patients with specific immunoglobulin E ≥ class 2 (CAP/PHADIA) to HDM
- Patients sensitized to HDM with clinically relevant symptoms in which treatment with HDM (50:50) vaccine is indicated
- Women of childbearing potential must have a negative urine pregnancy test at visit 1
- Women of childbearing potential must agree to use an appropriate contraception method during the study if they are sexually active
Who cannot join
- Patients who received immunotherapy in the previous 5 years for HDM or for any allergen with cross reactivity or patients that are currently receiving immunotherapy for any allergen
- Patients with severe asthma or forced expiratory volume in 1 second FEV1 < 70% even if the are pharmacologically controlled
- Polysensitized patients besides other airborne allergens Dermatophagoides pteronyssinus and Dermatophagoides farinae, which according to the investigator may present clinically relevant to those other airborne allergens while participating in this study
- Patients with: immunological, cardiac, renal or hepatic illnesses or any other medical condition that the investigator deems relevant so as to interfere with the study
- Patients with a previous history of anaphylaxis
- Patients with active chronic urticaria
Show all 12Show fewer
- Patients with active severe atopic eczema
- Patients who have participated in another clinical trial within 3 month prior to enrollment
- Patients under treatment with tricyclic antidepressives, phenothiazines, β- blockers, or Angiotensin Converting Enzyme Inhibitors (ACEI)
- Female patients who are pregnant or breast-feeding
- Patient who does not attend the visits
- Patient's lack of collaboration or refusal to participate
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Hospital Germans Triasl i Pujol
Badalona, Barcelona, 08916
Hospital de Bellvitge
Barcelona
Hospital de Basurto
Bilbao
Hospital de Valdecilla
Santander
Hospital Universitario de Araba
Vitoria-Gasteiz
About this study
Official title: An Open, Multicenter Clinical Trial With Subcutaneous Immunotherapy in Depot Presentation in Patients With Allergic Rhinoconjunctivitis Sensitized to House
The aim of the study is to evaluate the safety and tolerability of subcutaneous immunotherapy (SCIT) with House Dust Mite (HDM) extract in patients with rhinoconjunctivitis with or without associated mild asthma and sensitized to HDM. In addition,surrogate efficacy parameters will be evaluated: immunoglobulin level changes and skin reactivity.
It will be recruited 50 patients susceptible to receive SCIT with HDM extract along 5 participating spanish sites.
Read more
Primary endpoint of the study is to assess the safety and tolerability of subcutaneous immunotherapy in depot presentation and quick pattern in patients with rhinoconjunctivitis with or without mild asthma sensitized to house dust mites
Secondary objective is to evaluate the indirect immunotherapy efficacy through the measurement of immunoglobulin level changes and cutaneous reactivity
Read the detailed description
The aim of present clinical trial is to go deeper into the safety of the vaccine of mixture of DPT and DF (50:50). Although this is the first clinical trial to date to be performed with this vaccine, there have been two clinical trials with the same formulation and DPT 100% as active ingredient( NºEudraCT: 2009-016277-15 and NºEudraCT: 2011-004583-30). Given that there is a remarkable cross-reactivity between the DPT and DF mites, the results of the two clinical trials conducted to date with subcutaneous depot vaccine with Dermatophagoides pteronyssinus 100% extract mite, are very significant
- Conditions
- Allergic Rhinoconjunctivitis
- Being tested
- Allergovac depot DPT/DF (50:50)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allergovac depot DPT/DF (50:50)Biological
Subcutaneous immunotherapy in depot presentation in a rapid dose escalation scheme: 6 weekly dose increasing injections at the initiation phase plus 3 maintenance monthly injections
| Study group | Role | What they receive |
|---|---|---|
| Allergovac depot with HDM extract | Experimental | Extract of mixture of Dermatophagoides pteronyssinus and Dermatophagoides farinae (50:50) adsorbed onto aluminum hydroxide 0.33%. Receives: Biological: Allergovac depot DPT/DF (50:50) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Measured: From date inform consent is signed until the date the treatment is completed, assessed up to 5 months
Secondary outcomes (2)
Immunoglobulin level changes
Measured: Prior starting the treatment (baseline) versus one week after the last dose is administered (final visit)
Skin prick test reactivity
Measured: Prior starting the treatment (baseline) versus one week after the last dose is administered (final visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinoconjunctivitisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roxall Medicina España S.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Araitz Landeta, Study chair, Roxall Medicina España S.A
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881879
- Sponsor's protocol ID
- BIA-HDMD-101
- Status last verified
- Oct 2017
- First submitted
- 29 Jul 2016
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Multicenter Clinical Trial With Subcutaneous Immunotherapy in Depot Presentation in Patients With Allergic Rhinoconjunctivitis Sensitized to House
- ClinicalTrials.gov ID
- NCT02881879
- Acronym / sponsor ID
- BIA-HDMD-101
- Conditions
- Allergic Rhinoconjunctivitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Roxall Medicina España S.AIndustry (pharma, biotech, devices)
- Study start
- Jul 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 29 Aug 2016 (estimated)
- 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 aim of the study is to evaluate the safety and tolerability of subcutaneous immunotherapy (SCIT) with House Dust Mite (HDM) extract in patients with rhinoconjunctivitis with or without associated mild asthma and sensitized to HDM. In addition,surrogate efficacy parameters will be evaluated: immunoglobulin level changes and skin reactivity.
It will be recruited 50 patients susceptible to receive SCIT with HDM extract along 5 participating spanish sites.
Primary endpoint of the study is to assess the safety and tolerability of subcutaneous immunotherapy in depot presentation and quick pattern in patients with rhinoconjunctivitis with or without mild asthma sensitized to house dust mites
Secondary objective is to evaluate the indirect immunotherapy efficacy through the measurement of immunoglobulin level changes and cutaneous reactivity
Detailed description
The aim of present clinical trial is to go deeper into the safety of the vaccine of mixture of DPT and DF (50:50). Although this is the first clinical trial to date to be performed with this vaccine, there have been two clinical trials with the same formulation and DPT 100% as active ingredient( NºEudraCT: 2009-016277-15 and NºEudraCT: 2011-004583-30). Given that there is a remarkable cross-reactivity between the DPT and DF mites, the results of the two clinical trials conducted to date with subcutaneous depot vaccine with Dermatophagoides pteronyssinus 100% extract mite, are very significant
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allergovac depot with HDM extract | Experimental | Biological: Allergovac depot DPT/DF (50:50)Extract of mixture of Dermatophagoides pteronyssinus and Dermatophagoides farinae (50:50) adsorbed onto aluminum hydroxide 0.33%. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients must sign the informed consent form
- Patients must be between 18 and 60 years of age
- Patients with perennial allergic rhinoconjunctivitis against HDM during a minimum of 1 year prior to study participation. Although allergic rhinoconjunctivitis is the pathology under study, the inclusion of patients with mild concomitant asthma is allowed (GINA 2015)
- Patients who obtained a prick test result ≥ 3 mm diameter to HDM. Positive and negative control of the test should give consistent results
- Patients with specific immunoglobulin E ≥ class 2 (CAP/PHADIA) to HDM
Key exclusion criteria (12 listed)
- Patients who received immunotherapy in the previous 5 years for HDM or for any allergen with cross reactivity or patients that are currently receiving immunotherapy for any allergen
- Patients with severe asthma or forced expiratory volume in 1 second FEV1 < 70% even if the are pharmacologically controlled
- Polysensitized patients besides other airborne allergens Dermatophagoides pteronyssinus and Dermatophagoides farinae, which according to the investigator may present clinically relevant to those other airborne allergens while participating in this study
- Patients with: immunological, cardiac, renal or hepatic illnesses or any other medical condition that the investigator deems relevant so as to interfere with the study
- Patients with a previous history of anaphylaxis
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 |
|---|---|---|
| Allergovac depot DPT/DF (50:50)Subcutaneous immunotherapy in depot presentation in a rapid dose escalation scheme: 6 weekly dose increasing injections at the initiation phase plus 3 maintenance monthly injections | Biological | Allergovac depot with HDM extract |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: From date inform consent is signed until the date the treatment is completed, assessed up to 5 months
2 secondary outcomes
Immunoglobulin level changes
Time frame: Prior starting the treatment (baseline) versus one week after the last dose is administered (final visit)
Skin prick test reactivity
Time frame: Prior starting the treatment (baseline) versus one week after the last dose is administered (final visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
- Individual participant dataSharing planned: No
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Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
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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.
Araitz Landeta study chair
Roxall Medicina España S.A
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Allergovac depot DPT/DF (50:50) in people with Allergic Rhinoconjunctivitis, run by Roxall Medicina España S.A at 5 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 8 inclusion and 12 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: finished, as of the sponsor's last update on 20 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: From date inform consent is signed until the date the treatment is completed, assessed up to 5 months). 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 20 Oct 2017.