RhinoconjunctivitisPhase 1NCT02477917
A Multicenter, Open Trial With Subcutaneous Immunotherapy (SCIT) in Patients With Rhinoconjunctivitis Sensitized to Parietaria Judaica
A Phase 1 study testing Allergovac depot with Parietaria judaica pollen extract in people with Rhinoconjunctivitis, run by Roxall Medicina España S.A at 4 sites in Spain.
Trial summary
The study was designed according to the draft of allergenic product regulation published by Spanish Regulatory Agency. The aim of the study is to evaluate the safety and tolerability of subcutaneous immunotherapy with Parietaria judaica pollen extract in patients with rhinoconjunctivitis with or without associated… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rhinoconjunctivitis
- What is being tested?
- Allergovac depot with Parietaria judaica pollen extract
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 4 sitesSpain
- Study dates
- May 2015to Mar 2016
- 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 seasonal allergic rhinoconjunctivitis against Parietaria judaica during a minimum of 2 years prior to study participation. Although allergic rhinoconjunctivitis is the pathology under study, the inclusion of patients with mild concomitant asthma is allowed (GINA 2013).
- Patients who obtained a prick test result ≥ 3 mm diameter to Parietaria judacia. Positive and negative control of the test should give consistent results.
- Patients with specific immunoglobulin E ≥ class 2 (CAP/PHADIA) to Parietaria judaica.
- Patients sensitized to Parietaria judaica with clinically relevant symptoms in which treatment with Parietaria judaica 100% vaccine is indicated.
- Women of childbearing potential must have a negative urine pregnancy test at Screening visit/Visit 0.
- 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 Parietaria judaica or fo rany allergen with cross reactivity or patients that are currently receiving immunotherapy for any allergen.
- Patients with severe asthma or forzed expiratoy volumen in 1 second FEV1< 70% even if the are pharmacologically controlled .
- 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 chronic urticaria,
- Patients with moderate to severe atopic dermatitis
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- Patients who have participated in another clinical trial within 3 month prior to enrolment.
- 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
4 sites in 1 country.
Spain4 sites
Hospital de Manises
Manises, Valencia
Hospital Vega Baja
Orihuela, Alicante, 03314
Hosptal de Sagunto
Sagunto, Valencia, 46520
Hospital Universitario y Politécnico La Fe
Valencia, 46026
About this study
Official title: A Multicenter, Open Clinical Trial With Subcutaneous Immunotherapy in Depot in Patients With Rhinoconjunctivitis Sensitized to Parietaria Judaica
The study was designed according to the draft of allergenic product regulation published by Spanish Regulatory Agency. The aim of the study is to evaluate the safety and tolerability of subcutaneous immunotherapy with Parietaria judaica pollen extract in patients with rhinoconjunctivitis with or without associated mild asthma. In addition, surrogate efficacy parameters will be evaluated: immunoglobulin level changes and skin reactivity.
Read the detailed description
Parietaria judaica is a weed widespread throughout the Mediterranean área. Prevalence of sensitization to Parietaria judaica's pollen is very high in the Mediterranean areas, reaching 41.4% among allergic patients on the Spanish Mediterranean coast.
The study has been designed as an open trial which will be conducted in 4 Spanish sites.
- Conditions
- Rhinoconjunctivitis
- Being tested
- Allergovac depot with Parietaria judaica pollen extract
- Keywords
- allergy, SCIT
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allergovac depot with Parietaria judaica pollen extractBiological
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 | Experimental | Allergovac depot with Parietaria judaica pollen extract Receives: Biological: Allergovac depot with Parietaria judaica pollen extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and severity of adverse reactions as a measure of Safety and tolerability
Measured: across 17 weeks treatment period
Secondary outcomes (2)
Immunoglobulin changes from baseline
Measured: At baseline and 1 week after last administered dose
Skin reactivity changes from baseline
Measured: At baseline and 1 week after last administered dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 51 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
- NCT02477917
- Sponsor's protocol ID
- BIA-PAR-DEPOT
- Status last verified
- Apr 2017
- First submitted
- 1 Jun 2015
- Last updated
- 1 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open Clinical Trial With Subcutaneous Immunotherapy in Depot in Patients With Rhinoconjunctivitis Sensitized to Parietaria Judaica
- ClinicalTrials.gov ID
- NCT02477917
- Acronym / sponsor ID
- BIA-PAR-DEPOT
- Conditions
- Rhinoconjunctivitis
- Keywords
- allergy, SCIT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Roxall Medicina España S.AIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 23 Jun 2015 (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 study was designed according to the draft of allergenic product regulation published by Spanish Regulatory Agency. The aim of the study is to evaluate the safety and tolerability of subcutaneous immunotherapy with Parietaria judaica pollen extract in patients with rhinoconjunctivitis with or without associated mild asthma. In addition, surrogate efficacy parameters will be evaluated: immunoglobulin level changes and skin reactivity.
Detailed description
Parietaria judaica is a weed widespread throughout the Mediterranean área. Prevalence of sensitization to Parietaria judaica's pollen is very high in the Mediterranean areas, reaching 41.4% among allergic patients on the Spanish Mediterranean coast.
The study has been designed as an open trial which will be conducted in 4 Spanish sites.
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 | Experimental | Biological: Allergovac depot with Parietaria judaica pollen extractAllergovac depot with Parietaria judaica pollen extract |
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 seasonal allergic rhinoconjunctivitis against Parietaria judaica during a minimum of 2 years prior to study participation. Although allergic rhinoconjunctivitis is the pathology under study, the inclusion of patients with mild concomitant asthma is allowed (GINA 2013).
- Patients who obtained a prick test result ≥ 3 mm diameter to Parietaria judacia. Positive and negative control of the test should give consistent results.
- Patients with specific immunoglobulin E ≥ class 2 (CAP/PHADIA) to Parietaria judaica.
Key exclusion criteria (11 listed)
- Patients who received immunotherapy in the previous 5 years for Parietaria judaica or fo rany allergen with cross reactivity or patients that are currently receiving immunotherapy for any allergen.
- Patients with severe asthma or forzed expiratoy volumen in 1 second FEV1< 70% even if the are pharmacologically controlled .
- 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 chronic urticaria,
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 with Parietaria judaica pollen extractSubcutaneous 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 |
Primary outcome
Number and severity of adverse reactions as a measure of Safety and tolerability
Time frame: across 17 weeks treatment period
2 secondary outcomes
Immunoglobulin changes from baseline
Time frame: At baseline and 1 week after last administered dose
Skin reactivity changes from baseline
Time frame: At baseline and 1 week after last administered dose
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 1 May 2017.
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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
4 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 with Parietaria judaica pollen extract in people with Rhinoconjunctivitis, run by Roxall Medicina España S.A at 4 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 11 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 1 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Number and severity of adverse reactions as a measure of Safety and tolerability (time frame: across 17 weeks treatment period). 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 1 May 2017.