Allergic RhinitisPhase 1/2AN003NCT01728519
Phase I/IIa Clinical Evaluation of AllerT vs Placebo in Subjects Allergic to Birch Pollen
A Phase 1/2 study testing AllerT SC and AllerT ID in people with Allergic Rhinitis and Allergy, run by Anergis at 1 site in Switzerland.
Trial summary
Birch pollen allergic patients are currently treated by subcutaneous injections of pollen extracts either by standard allergen specific immunotherapy (SIT) or ultra-rush immunotherapy. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Allergic Rhinitis, Allergy
- What is being tested?
- AllerT SC and AllerT ID
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2008to Jul 2012
- Phase
- Phase 1/2
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Allergic rhinitis symptoms during the pollen season preceding the study, confirmed by SPT (prick tests) and/or a positive specific IgE CAP test for birch pollen (class I minimum)
- Positive SPT to Bet v 1 (prick tests), negative SPT to AllerT
Who cannot join
- received immunotherapy against any allergen within 3 years before the start of the study.
- symptomatic to perennial allergens or active seasonal allergy during the trial.
- non controlled asthma (peak flow lower than 30% of predicted value).
- history of any severe medical condition able to influence the course of the study
- Any confirmed or suspected immunodeficiency condition, including human immunodeficiency virus (HIV) infection and asplenia.
- Subjects under immunosuppressive medication.
- Pregnant or lactating women or women willing or intending to become pregnant during the study.
- Any other significant finding which, in the opinion of the investigator, would increase the risk of having an adverse outcome from participating in this protocol or of dropping out of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I/IIa Study to Assess the Safety, Immunogenicity and Efficacy of AllerT, a Combination of Peptides Derived From Bet v 1, Administered Via the Subcutaneous or Intradermal Route to Volunteers Allergic to Birch Pollen
Birch pollen allergic patients are currently treated by subcutaneous injections of pollen extracts either by standard allergen specific immunotherapy (SIT) or ultra-rush immunotherapy. Such treatment is prone to side effects and has to be performed in a hospital environment due to the risk of potential anaphylactic reactions. The aim of this study is to test the new product AllerT expected to show widely reduced side effects. AllerT will be injected via two different routes, subcutaneous versus intradermal. The primary endpoint of the study is the local and systemic safety of repeated injections of the product. Since AllerT should provide patients with a pre-seasonal treatment to decrease seasonal allergic symptoms, we will also evaluate the potential efficacy of the approach using a nasal provocation test (NPT) with birch pollen
Read the detailed description
In addition to the initial protocol, post hoc evaluations were conducted, after new ethics committee reviews, to assess quality of life during the birch pollen season following the trial (April 2009) and to obtain blood samples for evaluation of immunology markers IgG4 and IgE after the season 2010 (July 2010) and after the season 2012 (July 2012),
- Conditions
- Allergic Rhinitis, Allergy
- Being tested
- AllerT SC, AllerT ID, Placebo SC, Placebo ID
- Keywords
- Allergy, Birch Pollen, Immunotherapy
- Medical subject headings
- Rhinitis, Allergic, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllerT SCDrug
Also called AllerT subcutaneous injections
AllerT subcutaneous injections on days 1, 7, 14, 21 and 56 - cumulative dose 440 microgram)
AllerT IDDrug
Also called Aller T intra-dermal injections
AllerT intra-dermal injections on days 1, 7, 14, 21 and 56 - cumulative dose 440 microgram)
Placebo SCDrug
Also called Placebo subcutaneous injections
Placebo subcutaneous injections on days 1, 7, 14, 21 and 56
Placebo IDDrug
Also called Placebo intra-dermal
Placebo intra-dermal injections on days 1, 7, 14, 21 and 56
| Study group | Role | What they receive |
|---|---|---|
| AllerT SC | Experimental | AllerT subcutaneous injections Receives: Drug: AllerT SC |
| Placebo SC | Placebo comparator | placebo subcutaneous injections Receives: Drug: Placebo SC |
| AllerT ID | Experimental | AllerT intra-dermal injections Receives: Drug: AllerT ID |
| Placebo ID | Placebo comparator | placebo intra-dermal injections Receives: Drug: Placebo ID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
collection of local or systemic allergic reactions and any other adverse events through patient diaries and investigators' interviews during the 8-week treatment period and 4 week post-treatment follow-up (Day 84)
Measured: 84 days
Secondary outcomes (2)
change from baseline in blood levels of specific IgG4 and IgE
blood samples were taken at baseline and at weeks 1, 2, 4 and 8 of the treatment period, 4 weeks later and then in July 2010 and in July 2012
Measured: after 7, 14, 21, 56 and 84 days and after 16 to 18 months and 40 to 42 months
change from baseline in nasal provocation tests
nasal provocation tests with birch pollen extract are assessed before treatment and at visit on day 84 of the trial, 4 weeks after completion of treatment
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startAug 2008
- Primary completionMar 2009
- Study completionJul 2012
Why it stopped: Recruitment was stopped before start of the pollen season
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anergis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francois Spertini, MD, Principal investigator, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01728519
- Sponsor's protocol ID
- AN003
- Acronym
- AN003
- Status last verified
- Nov 2012
- First submitted
- 9 Nov 2012
- Last updated
- 20 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/IIa Study to Assess the Safety, Immunogenicity and Efficacy of AllerT, a Combination of Peptides Derived From Bet v 1, Administered Via the Subcutaneous or Intradermal Route to Volunteers Allergic to Birch Pollen
- ClinicalTrials.gov ID
- NCT01728519
- Acronym / sponsor ID
- AN003 / AN003
- Conditions
- Allergic Rhinitis, Allergy
- Keywords
- Allergy, Birch Pollen, Immunotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment was stopped before start of the pollen season
- Enrolment
- 29 participants (actual)
- Lead sponsor
- AnergisIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 20 Nov 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.
Birch pollen allergic patients are currently treated by subcutaneous injections of pollen extracts either by standard allergen specific immunotherapy (SIT) or ultra-rush immunotherapy. Such treatment is prone to side effects and has to be performed in a hospital environment due to the risk of potential anaphylactic reactions. The aim of this study is to test the new product AllerT expected to show widely reduced side effects. AllerT will be injected via two different routes, subcutaneous versus intradermal. The primary endpoint of the study is the local and systemic safety of repeated injections of the product. Since AllerT should provide patients with a pre-seasonal treatment to decrease seasonal allergic symptoms, we will also evaluate the potential efficacy of the approach using a nasal provocation test (NPT) with birch pollen
Detailed description
In addition to the initial protocol, post hoc evaluations were conducted, after new ethics committee reviews, to assess quality of life during the birch pollen season following the trial (April 2009) and to obtain blood samples for evaluation of immunology markers IgG4 and IgE after the season 2010 (July 2010) and after the season 2012 (July 2012),
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AllerT SC | Experimental | Drug: AllerT SCAllerT subcutaneous injections |
| Placebo SC | Placebo comparator | Drug: Placebo SCplacebo subcutaneous injections |
| AllerT ID | Experimental | Drug: AllerT IDAllerT intra-dermal injections |
| Placebo ID | Placebo comparator | Drug: Placebo IDplacebo intra-dermal injections |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Allergic rhinitis symptoms during the pollen season preceding the study, confirmed by SPT (prick tests) and/or a positive specific IgE CAP test for birch pollen (class I minimum)
- Positive SPT to Bet v 1 (prick tests), negative SPT to AllerT
Key exclusion criteria (8 listed)
- received immunotherapy against any allergen within 3 years before the start of the study.
- symptomatic to perennial allergens or active seasonal allergy during the trial.
- non controlled asthma (peak flow lower than 30% of predicted value).
- history of any severe medical condition able to influence the course of the study
- Any confirmed or suspected immunodeficiency condition, including human immunodeficiency virus (HIV) infection and asplenia.
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 |
|---|---|---|
| AllerT SCAlso: AllerT subcutaneous injectionsAllerT subcutaneous injections on days 1, 7, 14, 21 and 56 - cumulative dose 440 microgram) | Drug | AllerT SC |
| AllerT IDAlso: Aller T intra-dermal injectionsAllerT intra-dermal injections on days 1, 7, 14, 21 and 56 - cumulative dose 440 microgram) | Drug | AllerT ID |
| Placebo SCAlso: Placebo subcutaneous injectionsPlacebo subcutaneous injections on days 1, 7, 14, 21 and 56 | Drug | Placebo SC |
| Placebo IDAlso: Placebo intra-dermalPlacebo intra-dermal injections on days 1, 7, 14, 21 and 56 | Drug | Placebo ID |
Primary outcome
Number of participants with adverse events
Time frame: 84 days
collection of local or systemic allergic reactions and any other adverse events through patient diaries and investigators' interviews during the 8-week treatment period and 4 week post-treatment follow-up (Day 84)
2 secondary outcomes
change from baseline in blood levels of specific IgG4 and IgE
Time frame: after 7, 14, 21, 56 and 84 days and after 16 to 18 months and 40 to 42 months
change from baseline in nasal provocation tests
Time frame: 84 days
Results and safety
The study was stopped early (reason given: Recruitment was stopped before start of the pollen season). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2012.
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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.
Francois Spertini, MD principal investigator
University of Lausanne Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AllerT SC and AllerT ID in people with Allergic Rhinitis and Allergy, run by Anergis at 1 site in Switzerland.
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 2 inclusion and 8 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: stopped early, as of the sponsor's last update on 20 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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 combined 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.
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 was stopped early (reason given: Recruitment was stopped before start of the pollen season). Results are not available in the source record.
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 of participants with adverse events (time frame: 84 days). 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 Nov 2012.