Allergic RhinoconjunctivitisPhase 2/3NCT01454531
An Open Trial to Assess the Tolerability of AVANZ Phleum Pratense Immunotherapy
A Phase 2/3 study testing AVANZ Phleum pratense in people with Allergic Rhinoconjunctivitis, run by ALK-Abelló A/S at 20 sites in Spain.
Trial summary
The purpose of this study is to assess the tolerability of AVANZ. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinoconjunctivitis
- What is being tested?
- AVANZ Phleum pratense
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 20 sitesSpain
- Study dates
- Jun 2011to Apr 2012
- Phase
- Phase 2/3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of grass pollen rhinoconjunctivitis
- Positive SPT to Phleum pratense
- Positive specific IgE against Phleum pratense
Who cannot join
- Uncontrolled severe asthma
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Spain20 sites
Hospital Nuestra Señora de Sonsoles
Ávila, 05071
Hospital Universitario Infanta Cristina
Badajoz, 06007
Hospital de Basurto
Bilbao, Bilbao, 48013
Complejo Hospitalario de Burgos
Burgos, 09001
Hospital Nuestra Señora de La Montaña
Cáceres, 10004
H. Campo Arañuelo
Cáceres, 10300
Fundación Jiménez Diaz
Madrid, Madrid, 28025
Hospital Infanta Elena
Madrid, Madrid, 28342
Hospital Universitario de La Princesa
Madrid, 28006
Hospital Gregorio Marañón
Madrid, 28007
Hospital Infanta Leonor
Madrid, 28031
Hospital Univesitario Fundación Hospital de Alcorcón
Madrid, 28922
Hospital Carlos Haya
Málaga, 29009
Hospital Rio Carrion
Palencia, 34005
Hospital Santa Bárbara
Puertollano, 13500
Hospital Universitario de Salamanca
Salamanca, 37007
Hospital Univeritario Marques de Valdeilla
Santander, 39008
Hospital Universitari Politecnic La Fe
Valencia, Valencia, 46026
Hospital Santiago Apostol
Vitoria-Gasteiz, 01004
Hospital Virgen de La Concha
Zamora, 49022
About this study
The purpose of this study is to assess the tolerability of AVANZ.
Read the detailed description
To assess the tolerability of the up-dosing phase of AVANZ Phleum pratense. The frequency of patients with adverse reactions will be the study primary endpoint.
- Conditions
- Allergic Rhinoconjunctivitis
- Being tested
- AVANZ Phleum pratense
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVANZ Phleum pratenseDrug
AVANZ Phleum pratense up-dosing phase (300, 600, 3000, 6000 and 15,000 SQ+) + one 15,000 SQ+ maintenance injection
| Study group | Role | What they receive |
|---|---|---|
| AVANZ Phleum pratense | Experimental | AVANZ Phleum pratense up-dosing phase (300, 600, 3000, 6000 and 15,000 SQ+) + one 15,000 SQ+ maintenance injection Receives: Drug: AVANZ Phleum pratense |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Subjects With Adverse Drug Reactions
Frequency of patients with adverse reactions, local or systemic
Measured: 6 weeks
Secondary outcomes (5)
Frequency of Subjects With Systemic Reactions
Frequency of patients with systemic reactions, based on EAACI classification: Grade I (mild systemic reaction) to IV (anaphylactic shock)
Measured: 6 weeks
Frequency of Subjects With Local Adverse Reaction
Frequency of patients with local adverse reactions
Measured: 6 weeks
Change in Phleum Pratense Specific IgE-blocking Factor
IgE-blocking factor measures the amount of IgE bound to the allergen in the presence of allergen-competing factors present in the serum of a subject treated with allergen immunotherapy. The test is based in a double IgE measurement, an ordinary assay and an assay in the presence of competing components and takes the form of:
IgE blocking factor = 1 - (Competitive IgE/Ordinary IgE). Theoretical limits are from 0 (no IgE blocked) to 1 (all IgE blocked) and, being a ratio, is a dimensionless measure
Measured: baseline (visit 1) and at 6 weeks (visit 6)
Change in Phleum Pratense Specific IgG4
Measured: baseline (visit 1) and at 6 weeks (visit 6)
Change in Immediate Cutaneous Response to Phleum Pratense
Wheal size provoked after prick test with 4, 20 and 100 µg/ml Phl p 5 allergen extracts analysed by Parallel Line Assay. Cutaneous Tolerance Index (CTI) is the factor it is necessary to multiply the extract concentration by after SCIT (V6) to obtain the same response in terms of wheal area as at baseline (V1). CTI, being an index, is a dimensionless measure. A CTI of 1 indicates no change in skin sensitivity while if higher than 1 a decrease in skin sensitivity (it would be needed a more concentrated allergen extract at V6 to elicit the same skin response as at V1
Measured: baseline (visit 1) and at 6 weeks (visit 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startJun 2011
- Primary completionMar 2012
- Study completionApr 2012
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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALK-Abelló A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- JOAQUIN SASTRE, MD, PhD, Principal investigator, FUNDACIÓN JIMÉNEZ DIAZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01454531
- Sponsor's protocol ID
- AV-G-01
- Status last verified
- Feb 2015
- First submitted
- 13 Oct 2011
- Last updated
- 6 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Trial to Assess the Tolerability of AVANZ Phleum Pratense Immunotherapy
- ClinicalTrials.gov ID
- NCT01454531
- Acronym / sponsor ID
- AV-G-01
- Conditions
- Allergic Rhinoconjunctivitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- ALK-Abelló A/SIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 19 Oct 2011 (estimated)
- Results
- Posted 6 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the tolerability of AVANZ.
Detailed description
To assess the tolerability of the up-dosing phase of AVANZ Phleum pratense. The frequency of patients with adverse reactions will be the study primary endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AVANZ Phleum pratense | Experimental | Drug: AVANZ Phleum pratenseAVANZ Phleum pratense up-dosing phase (300, 600, 3000, 6000 and 15,000 SQ+) + one 15,000 SQ+ maintenance injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of grass pollen rhinoconjunctivitis
- Positive SPT to Phleum pratense
- Positive specific IgE against Phleum pratense
Key exclusion criteria (1 listed)
- Uncontrolled severe asthma
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 |
|---|---|---|
| AVANZ Phleum pratenseAVANZ Phleum pratense up-dosing phase (300, 600, 3000, 6000 and 15,000 SQ+) + one 15,000 SQ+ maintenance injection | Drug | AVANZ Phleum pratense |
Primary outcome
Frequency of Subjects With Adverse Drug Reactions
Time frame: 6 weeks
Frequency of patients with adverse reactions, local or systemic
5 secondary outcomes
Frequency of Subjects With Systemic Reactions
Time frame: 6 weeks
Frequency of Subjects With Local Adverse Reaction
Time frame: 6 weeks
Change in Phleum Pratense Specific IgE-blocking Factor
Time frame: baseline (visit 1) and at 6 weeks (visit 6)
Change in Phleum Pratense Specific IgG4
Time frame: baseline (visit 1) and at 6 weeks (visit 6)
Change in Immediate Cutaneous Response to Phleum Pratense
Time frame: baseline (visit 1) and at 6 weeks (visit 6)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
- 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.
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.
JOAQUIN SASTRE, MD, PhD principal investigator
FUNDACIÓN JIMÉNEZ DIAZ
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing AVANZ Phleum pratense in people with Allergic Rhinoconjunctivitis, run by ALK-Abelló A/S at 20 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 3 inclusion and 1 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 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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 combined 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.
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?
Yes. Results are posted in the registry (first posted 6 Mar 2015). 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?
Frequency of Subjects With Adverse Drug Reactions (time frame: 6 weeks). 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 6 Mar 2015.