Allergic RhinoconjunctivitisPhase 2NCT01567306

Phase II Trial With Subcutaneous Immunotherapy in Patients Sensitized to Phleum Pratense

A Phase 2 study testing Allergovac Depot in people with Allergic Rhinoconjunctivitis, run by Roxall Medicina España S.A at 10 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Based on EMA (European Medicines Agency) new guidelines on the clinical development of products for immunotherapy for the treatment of allergic diseases the aim of this study is to establish a dose-response relationship for clinical efficacy of Phleum pratense pollen extract subcutaneous vaccine. 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
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 151 participants
Where: 10 sitesin 2 countries
Study dates: Oct 2011to Apr 2013
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 produced by Phleum pratense 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 equal or more than 3 mm in diameter against Phleum pratense.
Patients who have specific IgE equal or more than class 2 (CAP/PHADIA) to Phleum pratense.
Patients will preferably be monosensitized to Phleum pratense. Polysensitized patients may only be included in the study if their other sensitizations are produced by:

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Overlapping seasonal pollens which are cross-reactive with Phleum pratense.
Pollens whose seasons do not overlap with Phleum pratense and which are not expected to produce symptoms during the study period.
Other allergens which are not expected 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 allergy medication during the 2 weeks prior to their inclusion in the study.
Patients sensitized to allergens with overlapping seasons but which are not cross-reactive with Phleum pratense and with specific IgE levels equal or less than class 2 CAP/PHADIA.
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 any with any other illness which the investigators deem may interfere with the study.
Patients with a prior history of anaphylaxis.

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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

10 sites in 2 countries.

Country

City, postcode or hospital

10 sites in 2 countries

Portugal5 sites

Hospital da Universidade de Coimbra
Coimbra, 3000-075
Centro Hospitalar de S. João
Porto, 4200-319
Instituto CUF Porto
Senhora da Hora, 4460-188
Centro Hospitalar de Setúbal - Hospital de São Bernardo
Setúbal, 2910-446
Centro Hospitalar Gaia/Espinho
Vila Nova de Gaia, 4434-502

Other trials in Portugal

Spain5 sites

Hospital Universitario Gregorio Marañón
Madrid, 28007
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Puerta de Hierro
Madrid, 28222
Hospital Ntra. Sra. del Prado
Talavera de la Reina, Toledo, 45600

Other trials in Spain

About this study

Official title: Phase II, Multicenter, Randomized, Double Blind Study, With Subcutaneous Immunotherapy At Different Doses, in Parallel Groups and Placebo-Controlled, in Patients With Rhinoconjunctivitis ± Asthma Sensitized to Phleum Pratense

Read the detailed description

In adherence to EMA guidelines, the Phase I Clinical trial was carried out using Phleum pratense extract in depot presentation using 3 different dose escalation scheme. The objective was to compare tolerance and safety of the three dose escalation scheme as well as to determine the maximum dose tolerated by the population.

Once the range of tolerated doses was established, and following the strict norms of the EMA, a Phase II dose response clinical trial was designed wherein the efficacy of subcutaneous immunotherapy in depot presentation could be compared in 5 different doses. One of these doses will be the MTD established by the population in the first study, another will be lower than this dose, and three will be greater than it. The dose escalation scheme to be tested was chosen based on the results of the aforementioned clinical trial. As dictated by EMA norms, a control placebo will be used.

Conditions: Allergic Rhinoconjunctivitis
Being tested: Allergovac Depot, Placebo
Keywords: Allergy, Allergic rhinoconjunctivitis, Subcutaneous Immunotherapy, Phleum pratense pollen extract
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
Also called Allergovac
Increasing dosages till the maintenance dose of 0.25 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
Allergovac DepotBiological
Also called Allergovac
Increasing dosages till the maintenance dose of 0.5 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
Allergovac DepotBiological
Also called Allergovac
Increasing dosages till the maintenance dose of 1SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
Allergovac DepotBiological
Also called Allergovac
Increasing dosages till the maintenance dose of 2 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
Allergovac DepotBiological
Also called Allergovac
Increasing dosages till the maintenance dose of 4SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
PlaceboBiological
Also called Allergovac
Increasing volumes of placebo. Afterwards, 3 maintenance doses are given at 4-weekly intervals.

Study groups in NCT01567306
Study group	Role	What they receive
Allergovac Depot Group 1 Active	Experimental	Not described Receives: Biological: Allergovac Depot
Allergovac Depot Group 2 Active	Experimental	Not described Receives: Biological: Allergovac Depot
Allergovac Depot Group 3 Active	Experimental	Not described Receives: Biological: Allergovac Depot
Allergovac Depot Group 4 Active	Experimental	Not described Receives: Biological: Allergovac Depot
Allergovac Depot Group 5 Active	Experimental	Not described Receives: Biological: Allergovac Depot
Placebo - Group 6	Placebo comparator	Not described Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Variation of the Concentration of Phleum Pratense Extract Needed to Produce a Positive Nasal Provocation Test From Baseline (V0) to Final Visit (FV).
Variation of the concentration of Phleum pratense 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: Baseline (V0) and Final Visit (FV). The Final Visit will be conducted within 7 plus minus 2 days after the last dose is administered. The study will be carried out outside the pollination season of Phleum pratense.

Secondary outcomes (1)

All Adverse Reactions and or Events Will be Recorded Both by the Patient and the Health Care Personnel Responsible for the Administration of the Subcutaneous Immunotherapy.
All adverse reactions and/or events were recorded both by the patient and the health care personnel responsible for the administration of the subcutaneous immunotherapy. The incidence and intensity of adverse events was compared among the treatment groups.
Measured: From baseline (V0) to final visit (VF). The Final Visit will be conducted within 7 plus minus 2 days after the last dose is administered. All AE should be monitored until they are satisfactorily resolved or stabilized after the final visit of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2011Apr 2013

First posted30 Mar 2012 (estimated)
Study startOct 2011
Primary completionApr 2013
Study completionApr 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 151 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01567306
Sponsor's protocol ID: BIA-PHL-P2-001
Other IDs: 2011-000814-21
Status last verified: Jan 2019
First submitted: 23 Mar 2012
Last updated: 29 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Allergic Rhinoconjunctivitis trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2019. 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 At Different Doses, in Parallel Groups and Placebo-Controlled, in Patients With Rhinoconjunctivitis ± Asthma Sensitized to Phleum Pratense
ClinicalTrials.gov ID: NCT01567306
Acronym / sponsor ID: BIA-PHL-P2-001
Conditions: Allergic Rhinoconjunctivitis
Keywords: Allergy, Allergic rhinoconjunctivitis, Subcutaneous Immunotherapy, Phleum pratense pollen extract
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 151 participants (actual)
Lead sponsor: Roxall Medicina España S.AIndustry (pharma, biotech, devices)
Study start: Oct 2011
Primary completion: Apr 2013 (actual)
Study completion: Apr 2013 (actual)
First posted: 30 Mar 2012 (estimated)
Results: Posted 29 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Allergovac Depot Group 1 Active	Experimental	Biological: Allergovac Depot
Allergovac Depot Group 2 Active	Experimental	Biological: Allergovac Depot
Allergovac Depot Group 3 Active	Experimental	Biological: Allergovac Depot
Allergovac Depot Group 4 Active	Experimental	Biological: Allergovac Depot
Allergovac Depot Group 5 Active	Experimental	Biological: Allergovac Depot
Placebo - Group 6	Placebo comparator	Biological: Placebo

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 seasonal allergic rhinoconjunctivitis produced by Phleum pratense 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 equal or more than 3 mm in diameter against Phleum pratense.
Patients who have specific IgE equal or more than class 2 (CAP/PHADIA) to Phleum pratense.

Key exclusion criteria (14 listed)

Patients with stable and continued use of allergy medication during the 2 weeks prior to their inclusion in the study.
Patients sensitized to allergens with overlapping seasons but which are not cross-reactive with Phleum pratense and with specific IgE levels equal or less than class 2 CAP/PHADIA.
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 any 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 DepotAlso: AllergovacIncreasing dosages till the maintenance dose of 0.25 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.	Biological	Allergovac Depot Group 1 Active
Allergovac DepotAlso: AllergovacIncreasing dosages till the maintenance dose of 0.5 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.	Biological	Allergovac Depot Group 2 Active
Allergovac DepotAlso: AllergovacIncreasing dosages till the maintenance dose of 1SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.	Biological	Allergovac Depot Group 3 Active
Allergovac DepotAlso: AllergovacIncreasing dosages till the maintenance dose of 2 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.	Biological	Allergovac Depot Group 4 Active
Allergovac DepotAlso: AllergovacIncreasing dosages till the maintenance dose of 4SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.	Biological	Allergovac Depot Group 5 Active
PlaceboAlso: AllergovacIncreasing volumes of placebo. Afterwards, 3 maintenance doses are given at 4-weekly intervals.	Biological	Placebo - Group 6

Primary outcome

Variation of the Concentration of Phleum Pratense Extract Needed to Produce a Positive Nasal Provocation Test From Baseline (V0) to Final Visit (FV).
Time frame: Baseline (V0) and Final Visit (FV). The Final Visit will be conducted within 7 plus minus 2 days after the last dose is administered. The study will be carried out outside the pollination season of Phleum pratense.
Variation of the concentration of Phleum pratense 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).

1 secondary outcome

All Adverse Reactions and or Events Will be Recorded Both by the Patient and the Health Care Personnel Responsible for the Administration of the Subcutaneous Immunotherapy.
Time frame: From baseline (V0) to final visit (VF). The Final Visit will be conducted within 7 plus minus 2 days after the last dose is administered. All AE should be monitored until they are satisfactorily resolved or stabilized after the final visit of the study

Results and safety

Results posted to the registry on 29 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Allergovac Depot Group 1 Active	27	24
Allergovac Depot Group 2 Active	25	23
Allergovac Depot Group 3 Active	24	24
Allergovac Depot Group 4 Active	24	19
Allergovac Depot Group 5 Active	25	18
Placebo - Group 6	26	23

Primary outcome: Variation of the Concentration of Phleum Pratense Extract Needed to Produce a Positive Nasal Provocation Test From Baseline (V0) to Final Visit (FV).

Time frame: Baseline (V0) and Final Visit (FV). The Final Visit will be conducted within 7 plus minus 2 days after the last dose is administered. The study will be carried out outside the pollination season of Phleum pratense.. Mean (Standard Deviation). Unit: SPT

Measure	Allergovac Depot Group 1 Active n = 25	Allergovac Depot Group 2 Active n = 25	Allergovac Depot Group 3 Active n = 24	Allergovac Depot Group 4 Active n = 23	Allergovac Depot Group 5 Active n = 23	Placebo - Group 6 n = 23
Value	0.493 (2.060)	0.275 (2.884)	0.693 (2.142)	0.876 (2.414)	1.385 (2.170)	0.839 (2.328)

Population analysed: Intent-to-treat population (ITT): This population included all randomized patients who received at least one treatment dose and who presented baseline and post-baseline values for the primary efficacy variable.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: For each participant in the research, the treatment duration was established at 17 weeks, of which 5 weeks were needed for the induction phase and the other 12 weeks were for treatment at the maintenance dose. During this period adverse event data were collected.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Allergovac Depot Group 1 Active	1 of 27 (3.7%)	8 of 27 (29.6%)	0 of 27
Allergovac Depot Group 2 Active	2 of 25 (8%)	15 of 25 (60%)	0 of 25
Allergovac Depot Group 3 Active	2 of 24 (8.3%)	7 of 24 (29.2%)	0 of 24
Allergovac Depot Group 4 Active	3 of 24 (12.5%)	3 of 24 (12.5%)	0 of 24
Allergovac Depot Group 5 Active	8 of 25 (32%)	3 of 25 (12%)	0 of 25
Placebo - Group 6	1 of 26 (3.8%)	4 of 26 (15.4%)	0 of 26

Limitations and caveats (from the sponsor): The small simple size, the strong placebo effect and patients without a positive result with any of the tested vials at the final visit were assigned the vial 4 value for analysis purposes, meaning no real improvement could be observed in patients.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Allergic Rhinoconjunctivitis

RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
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RecruitingPhase 3
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.

Emilio Alvarez Cuesta, MD principal investigator

Hospital Universitario Ramon y Cajal

Santiago Quirce, MD principal investigator

Hospital Universitario La Paz

Matilde Rodríguez, MD principal investigator

Hospital Universitario Puerta de Hierro

10 sites in 2 countries: 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 10 sites in 2 countries.

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 29 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Portugal, 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?

Yes. Results are posted in the registry (first posted 29 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Variation of the Concentration of Phleum Pratense Extract Needed to Produce a Positive Nasal Provocation Test From Baseline (V0) to Final Visit (FV). (time frame: Baseline (V0) and Final Visit (FV). The Final Visit will be conducted within 7 plus minus 2 days after the last dose is administered. The study will be carried out outside the pollination season of Phleum pratense.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01567306.

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 29 Apr 2019.