Allergic RhinoconjunctivitisPhase 2NCT01564017
Dose-response Study With Subcutaneous Immunotherapy of an Standardized Dermatophagoides Pteronyssinus (DPT) Extract
A Phase 2 study testing Allergovac depot in people with Allergic Rhinoconjunctivitis, run by Roxall Medicina España S.A at 12 sites in Spain.
Trial summary
As part of the registration plan of our products and after performing a Phase I study the present trial has been designed to compare the efficacy of 5 different doses of subcutaneous immunotherapy in depot presentation. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 12 sitesSpain
- Study dates
- May 2012to May 2013
- Phase
- Phase 2
- 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 produced by Dermatophagoides pteronyssinus during at least 2 years prior to participating in the study. Although the pathology being studied is allergic rhinoconjunctivitis, patients who have concomitant mild or moderate asthma may be included.
- Patients who have had a skin prick test result greater or equal to 3 mm in diameter against Dermatophagoides pteronyssinus.
- Patients who have specific Immunoglobulin E (IgE) greater or equal to class 2 (CAP/PHADIA) to Dermatophagoides pteronyssinus.
- Patients will preferably be monosensitized to Dermatophagoides pteronyssinus. Polysensitized patients may only be included in the study if their other sensitizations are produced by:
Show all 11Show fewer
- Pollens whose season period does not overlap with the study treatment or, if overlap, whose specific IgE levels are less than class 2.
- Perennial allergens with specific IgE levels less than class 2.
- Allergens that do not cohabit with the patient or whose environmental levels are not high enough to produce symptoms during the study period.
- Women of child-bearing potential must have a negative urine pregnancy test at the time they begin the study.
- Furthermore, women of child-bearing potential must agree to use adequate contraceptive methods during this study if they are sexually active.
Who cannot join
- Patients with stable and continued use of medication to treat their allergic condition during the 2 weeks prior to their inclusion in the study.
- Patients sensitized and with specific IgE levels greater or equal to class 2 to other perennial or seasonal allergens clinically relevant including other mites unless they are cross reactive with Dermatophagoides pteronyssinus.
- Patients who have received immunotherapy in the 5 years prior to the study against either the allergen being tested or an allergen which is cross-reactive, or who are currently receiving immunotherapy for any other allergen.
- Patients with severe asthma or FEV1< 70% or with asthma which requires treatment with inhaled or systemic corticoids at the time of the study or in the 8 weeks immediately prior to the onset of treatment.
- Patients with immunological, cardiac, renal or hepatic diseases or with any other illness which the investigators deem may interfere with the study.
- Patients with a prior history of anaphylaxis.
Show all 14Show fewer
- Patients with chronic urticaria.
- Patients with moderate-severe atopic dermatitis.
- Patients with clinically relevant malformations of the upper respiratory tract.
- Patients who have participated in another clinical trial within 3 months prior to this study.
- Patients being treated with tricyclic antidepressants, psychotropic drugs, beta-blockers, or angiotensin-converting enzyme inhibitors (ACEIs).
- Women who are pregnant or breast-feeding or are of child-bearing age and who do not agree to use adequate contraception if they are sexually active and who have not demonstrated that they have been surgically sterilized or have other means of not bearing children.
- Patients who cannot attend study visits.
- Patients who are uncooperative or refuse to participate in the study.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Spain12 sites
Hospital Germans Triasl i Pujol
Badalona, Barcelona, 08916
Hospital Universitari de Bellvitge
Barcelona, 08907
Hospital Donostia
Donostia / San Sebastian, Guipuzcoa, 20014
Hospital Virgen de la Arrixaca
El Palmar, Murcia, 30120
Hospital Blanca Paloma
Huelva, 21005
Hospital de Manises
Manises, Valencia, 46940
Hospital Vega Baja
Orihuela, Alicante, 03314
Hospital Marqués de Valdecilla
Santander, 39008
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, La Coruña, 15706
Hospital Universitari i Politècnic La Fe
Valencia, 46026
Hospital Xeral de Vigo
Vigo, Pontevedra, 36024
Hospital Luis Alcañiz
Xátiva, Valencia, 46800
About this study
Official title: Phase II, Multicenter, Randomized, Double-blind Study, With Subcutaneous Immunotherapy, in Parallel Groups and Placebo-controlled, in Patients With Rhinoconjunctivitis ± Asthma Sensitized to Dermatophagoides Pteronyssinus.
As part of the registration plan of our products and after performing a Phase I study the present trial has been designed to compare the efficacy of 5 different doses of subcutaneous immunotherapy in depot presentation.
- Conditions
- Allergic Rhinoconjunctivitis
- Being tested
- Allergovac depot
- Keywords
- Allergy, Allergic rhinoconjunctivitis, Immunotherapy, D. pteronyssinus, house dust allergy
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allergovac depotBiological
Depot sterile suspension fpor subcutaneous injection
Increasing concentrations to reach the following maintenance doses:
Group 1: 0.25 SPT
Allergovac depotBiological
Depot sterile suspension for subcutaneous injection.
Increasing concentrations to reach the following maintenance doses:
Group 2: 0.5 SPT
Allergovac depotBiological
Depot sterile suspension for subcutaneous injection.
Increasing concentrations to reach the following maintenance doses:
Group 3: 1 SPT
Allergovac depotBiological
depot sterile suspension for subcutaneous injection
Increasing concentrations to reach the following maintenance doses:
Group 4: 2 SPT
Allergovac depotBiological
Depot sterile suspension for subcutaneous injection.
Increasing concentrations to reach the following maintenance doses:
Group 5: 4 SPT
Allergovac depotBiological
Sterile suspension for subcutaneous injection.
Same number of administration as the active groups
| Study group | Role | What they receive |
|---|---|---|
| Allergovac depot. Group 1 | Experimental | Increasing dosages till the maintenance dose of 0.0625 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals. Receives: Biological: Allergovac depot |
| Allergovac depot. Group 2 | Experimental | Increasing dosages till the maintenance dose of 0.125 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals. Receives: Biological: Allergovac depot |
| Allergovac depot. Group 3 | Experimental | Increasing dosages till the maintenance dose of 0.25 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals. Receives: Biological: Allergovac depot |
| Allergovac depot. Group 4 | Experimental | Increasing dosages till the maintenance dose of 0.5 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals. Receives: Biological: Allergovac depot |
| Allergovac depot. Group 5 | Experimental | Increasing dosages till the maintenance dose of 0.75 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals. Receives: Biological: Allergovac depot |
| Allergovac depot placebo. Group 6 | Placebo comparator | The same scheme of treatment as the active groups Receives: Biological: Allergovac depot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in nasal provocation test
Variation of the concentration of DPT extract needed to produce a positive nasal provocation test from baseline (V0) to final visit (FV). The changes will be compared among groups (including the placebo group).
Measured: from baseline (V0) to final visit (VF 18 weeks after randmization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2013
- Study completionMay 2013
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roxall Medicina España S.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fernando Rodríguez, MD, Principal investigator, Hospital Universitario Marqués de ValdecillaRamón Lleonart, MD, Principal investigator, Hospital Universitario Marqués de ValdecillaAlbert Roger, MD, Principal investigator, Germans Trias i Pujol HospitalDolores Hernández, MD, Principal investigator, Hospital Universitario La FeCarmen Vidal, MD, Principal investigator, Complejo Hospitalario Universitario de SantiagoJuan A Pagán, MD, Principal investigator, Hospital Virgen de la ArrixacaCarmen Marcos, MD, Principal investigator, Hospital Xeral de VigoJose A Navarro, MD, Principal investigator, Hospital Donostia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01564017
- Sponsor's protocol ID
- BIA--DPT-P2-001
- Other IDs
- 2011-004583-30
- Status last verified
- Apr 2017
- First submitted
- 23 Mar 2012
- 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
- Phase II, Multicenter, Randomized, Double-blind Study, With Subcutaneous Immunotherapy, in Parallel Groups and Placebo-controlled, in Patients With Rhinoconjunctivitis ± Asthma Sensitized to Dermatophagoides Pteronyssinus.
- ClinicalTrials.gov ID
- NCT01564017
- Acronym / sponsor ID
- BIA--DPT-P2-001
- Conditions
- Allergic Rhinoconjunctivitis
- Keywords
- Allergy, Allergic rhinoconjunctivitis, Immunotherapy, D. pteronyssinus, house dust allergy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Roxall Medicina España S.AIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 27 Mar 2012 (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.
As part of the registration plan of our products and after performing a Phase I study the present trial has been designed to compare the efficacy of 5 different doses of subcutaneous immunotherapy in depot presentation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Allergovac depot. Group 1 | Experimental | Biological: Allergovac depotIncreasing dosages till the maintenance dose of 0.0625 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals. |
| Allergovac depot. Group 2 | Experimental | Biological: Allergovac depotIncreasing dosages till the maintenance dose of 0.125 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals. |
| Allergovac depot. Group 3 | Experimental | Biological: Allergovac depotIncreasing dosages till the maintenance dose of 0.25 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals. |
| Allergovac depot. Group 4 | Experimental | Biological: Allergovac depotIncreasing dosages till the maintenance dose of 0.5 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals. |
| Allergovac depot. Group 5 | Experimental | Biological: Allergovac depotIncreasing dosages till the maintenance dose of 0.75 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals. |
| Allergovac depot placebo. Group 6 | Placebo comparator | Biological: Allergovac depotThe same scheme of treatment as the active groups |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Patients must sign the Informed Consent Form.
- Patients must be between 18 and 60 years of age.
- Patients with perennial allergic rhinoconjunctivitis produced by Dermatophagoides pteronyssinus during at least 2 years prior to participating in the study. Although the pathology being studied is allergic rhinoconjunctivitis, patients who have concomitant mild or moderate asthma may be included.
- Patients who have had a skin prick test result greater or equal to 3 mm in diameter against Dermatophagoides pteronyssinus.
- Patients who have specific Immunoglobulin E (IgE) greater or equal to class 2 (CAP/PHADIA) to Dermatophagoides pteronyssinus.
Key exclusion criteria (14 listed)
- Patients with stable and continued use of medication to treat their allergic condition during the 2 weeks prior to their inclusion in the study.
- Patients sensitized and with specific IgE levels greater or equal to class 2 to other perennial or seasonal allergens clinically relevant including other mites unless they are cross reactive with Dermatophagoides pteronyssinus.
- Patients who have received immunotherapy in the 5 years prior to the study against either the allergen being tested or an allergen which is cross-reactive, or who are currently receiving immunotherapy for any other allergen.
- Patients with severe asthma or FEV1< 70% or with asthma which requires treatment with inhaled or systemic corticoids at the time of the study or in the 8 weeks immediately prior to the onset of treatment.
- Patients with immunological, cardiac, renal or hepatic diseases or with any other illness which the investigators deem may interfere with 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 |
|---|---|---|
| Allergovac depotDepot sterile suspension fpor subcutaneous injection Increasing concentrations to reach the following maintenance doses: Group 1: 0.25 SPT | Biological | Allergovac depot. Group 1 |
| Allergovac depotDepot sterile suspension for subcutaneous injection. Increasing concentrations to reach the following maintenance doses: Group 2: 0.5 SPT | Biological | Allergovac depot. Group 2 |
| Allergovac depotDepot sterile suspension for subcutaneous injection. Increasing concentrations to reach the following maintenance doses: Group 3: 1 SPT | Biological | Allergovac depot. Group 3 |
| Allergovac depotdepot sterile suspension for subcutaneous injection Increasing concentrations to reach the following maintenance doses: Group 4: 2 SPT | Biological | Allergovac depot. Group 4 |
| Allergovac depotDepot sterile suspension for subcutaneous injection. Increasing concentrations to reach the following maintenance doses: Group 5: 4 SPT | Biological | Allergovac depot. Group 5 |
| Allergovac depotSterile suspension for subcutaneous injection. Same number of administration as the active groups | Biological | Allergovac depot placebo. Group 6 |
Primary outcome
Changes in nasal provocation test
Time frame: from baseline (V0) to final visit (VF 18 weeks after randmization)
Variation of the concentration of DPT extract needed to produce a positive nasal provocation test from baseline (V0) to final visit (FV). The changes will be compared among groups (including the placebo group).
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.
Related trials for Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
Allergic Rhinoconjunctivitis
Recruiting
Creating A Risk Assessment Tool for Thunderstorm Asthma: the CARISTA Study
Allergic Asthma, Thunderstorm Asthma
RecruitingPhase 3
Efficacy and Safety of SLIT in Patients With Rhinitis/RC With/Without Mild-moderate Asthma, Due to Dpt and/or Df
Rhinitis, Rhinoconjunctivitis
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.
Fernando Rodríguez, MD principal investigator
Hospital Universitario Marqués de Valdecilla
Ramón Lleonart, MD principal investigator
Hospital Universitario Marqués de Valdecilla
Albert Roger, MD principal investigator
Germans Trias i Pujol Hospital
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Allergovac depot in people with Allergic Rhinoconjunctivitis, run by Roxall Medicina España S.A at 12 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 11 inclusion and 14 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 12 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Changes in nasal provocation test (time frame: from baseline (V0) to final visit (VF 18 weeks after randmization)). 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.