Allergic RhinitisPhase 2NCT01720251
Efficacy Study of a Preseasonal Treatment With AllerT in Subjects With Birch Pollen Allergy
A Phase 2 study testing AllerT low dose and AllerT full dose in people with Allergic Rhinitis and Rhinoconjunctivitis, run by Anergis at 24 sites in 7 countries.
Trial summary
The main objective of the trial is to demonstrate the efficacy of a two months pre-seasonal treatment with AllerT 100 µg maintenance dose in reducing symptoms of allergic rhinoconjunctivitis during the following birch pollen season Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Allergic Rhinitis, Rhinoconjunctivitis
- What is being tested?
- AllerT low dose and AllerT full dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 24 sitesin 7 countries
- Study dates
- Oct 2012to Sep 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- moderate to severe allergic rhinoconjunctivitis to birch pollen:
- Score of symptoms of the Rhinoconjunctivitis Symptom Score (RSS) ≥ 12 during the two preceding birch pollen seasons
- Previous use of anti-allergy medications during the two preceding birch pollen seasons
- Positive SPT to birch pollen extract
- Positive specific IgE CAP test for Bet v 1
Who cannot join
- uncontrolled asthma, FEV1 < 80% of predicted
- previous SIT (specific immunotherapy) to birch pollen or any other SIT within 5 years
- clinical symptoms due to allergens other than birch pollen during the whole trial period
- history of anaphylaxis
- positive skin prick test to AllerT
- any other treatment or conditions which may increase the risk of the study for the subject or affect the efficacy assessments during the birch pollen season
Trial locations and contacts
24 sites in 7 countries.
24 sites in 7 countries
Poland8 sites
SPZOZ Uniwersytecki Szpital Kliniczny - Allergology
Lodz, 90153
Alergologii Centrum
Lodz, 90553
Alergotest
Lublin, 20095
Alergo-Med
Tarnów, 33100
Centrum Alergologii IRMED
Warsaw, 01157
Silesian Piasts University of Medicine in Wrocław
Wroclaw, 50-368
Aler-med
Wroclaw, 54203
NZOZ Przychodnia Lekarska Hipokrates
Zabrze, 41800
Lithuania4 sites
Kaunas Clinics University Hospital
Kaunas, 50009
Allergy Clinic JSC Perspektyvos
Vilnius, 08431
Vilnius University Hospital
Vilnius, 08661
Antakalnio affiliation of the Vilnius City Allergy Center
Vilnius, 10200
Denmark3 sites
Lungemedicinsk Forskningsafdeling
Aarhus, 8000
Allergiklinikken
Hellerup, Copenhagen, 2900
Klinisk Institute
Odense, 5000
Latvia3 sites
Viktorija Vevere private practice of Allergology
Rēzekne, 4601
Paul Stradins Clinical University Hospital - Pulmonology Allergology
Riga, 1002
Center of examination and treatment of allergic diseases
Riga, 1003
Sweden3 sites
University hospital Skane
Lund, 22185
Orebro University Hospital
Örebro, 70185
Lungavdelningen, Vastmanlands
Västerås, 72189
France2 sites
CHU de Reims
Reims, 51092
Hopitaux Universitaires de Strasbourg
Strasbourg, 67000
Switzerland1 site
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1005
About this study
Official title: Phase IIb Study to Assess the Efficacy, Safety and Tolerability of Two Dosing Regimens of AllerT in Comparison to Placebo in Adult Subjects Allergic to Birch Pollen
The main objective of the trial is to demonstrate the efficacy of a two months pre-seasonal treatment with AllerT 100 µg maintenance dose in reducing symptoms of allergic rhinoconjunctivitis during the following birch pollen season
- Conditions
- Allergic Rhinitis, Rhinoconjunctivitis
- Being tested
- placebo, AllerT low dose, AllerT full dose
- Keywords
- allergic rhinitis, birch pollen, immunotherapy
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
SC injections of placebo on days 1, 7, 14, 28 and 56
AllerT low doseDrug
Also called AllerT 25-50 micrograms
SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56
AllerT full doseDrug
Also called AllerT 50-100 micrograms
SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | SC injections of placebo Receives: Drug: placebo |
| AllerT low dose | Experimental | SC injections of AllerT 25 or 50 micrograms Receives: Drug: AllerT low dose |
| AllerT full dose | Experimental | SC injections of AllerT 50-100 micrograms Receives: Drug: AllerT full dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined Rhinoconjunctivitis Symptom and Medication Score
The efficacy analysis will be performed on the symptom and medication data collected from the first day of the birch pollen season as defined by pollen counts in the air in each site region (from March to May 2013 depending on site region), to 42 days later or to the end of the pollen season, whichever comes first.
The scale range is from 0 to 3. Lower is the the RSMS value, better is the efficacy as this implies that lower is the symptoms and concomitant medication intake by the patient The RSMS includes 2 subscales : the Rhinoconjunctivitis Symptom Score (RSS) with a range of values from 0 to 3 and the Rhinoconjunctivitis Medication Score Score (RMS) with also a range of values from 0 to 3 The RSMS is the sum of the RSS and RMS divided by 2
Measured: up to 6 weeks during the birch pollen season 2013
Secondary outcomes (2)
Quality of Life
mini-RQLQ questionnaires
Measured: up to 6 weeks during the birch pollen season 2013
Safety and Tolerability
Adverse events will be collected throughout the trial period and will be reported as Treatment emergent adverse events occurring between start of treatment and 28 days after completion of treatment for each subject
Measured: from start of treatment to 28 days after completion of treatment, i.e. for approximately 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionSep 2013
- Study completionSep 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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anergis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francois Spertini, MD, Principal investigator, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01720251
- Sponsor's protocol ID
- AN004T
- Other IDs
- 2011-002259-32
- Status last verified
- Mar 2015
- First submitted
- 29 Oct 2012
- Last updated
- 13 Apr 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 13 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIb Study to Assess the Efficacy, Safety and Tolerability of Two Dosing Regimens of AllerT in Comparison to Placebo in Adult Subjects Allergic to Birch Pollen
- ClinicalTrials.gov ID
- NCT01720251
- Acronym / sponsor ID
- AN004T
- Conditions
- Allergic Rhinitis, Rhinoconjunctivitis
- Keywords
- allergic rhinitis, birch pollen, immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- AnergisIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 2 Nov 2012 (estimated)
- Results
- Posted 13 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of the trial is to demonstrate the efficacy of a two months pre-seasonal treatment with AllerT 100 µg maintenance dose in reducing symptoms of allergic rhinoconjunctivitis during the following birch pollen season
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placeboSC injections of placebo |
| AllerT low dose | Experimental | Drug: AllerT low doseSC injections of AllerT 25 or 50 micrograms |
| AllerT full dose | Experimental | Drug: AllerT full doseSC injections of AllerT 50-100 micrograms |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- moderate to severe allergic rhinoconjunctivitis to birch pollen:
Key exclusion criteria (6 listed)
- uncontrolled asthma, FEV1 < 80% of predicted
- previous SIT (specific immunotherapy) to birch pollen or any other SIT within 5 years
- clinical symptoms due to allergens other than birch pollen during the whole trial period
- history of anaphylaxis
- positive skin prick test to AllerT
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 |
|---|---|---|
| placeboSC injections of placebo on days 1, 7, 14, 28 and 56 | Drug | placebo |
| AllerT low doseAlso: AllerT 25-50 microgramsSC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56 | Drug | AllerT low dose |
| AllerT full doseAlso: AllerT 50-100 microgramsSC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56 | Drug | AllerT full dose |
Primary outcome
Combined Rhinoconjunctivitis Symptom and Medication Score
Time frame: up to 6 weeks during the birch pollen season 2013
The efficacy analysis will be performed on the symptom and medication data collected from the first day of the birch pollen season as defined by pollen counts in the air in each site region (from March to May 2013 depending on site region), to 42 days later or to the end of the pollen season, whichever comes first. The scale range is from 0 to 3. Lower is the the RSMS value, better is the efficacy as this implies that lower is the symptoms and concomitant medication intake by the patient The RSMS includes 2 subscales : the Rhinoconjunctivitis Symptom Score (RSS) with a range of values from 0 to 3 and the Rhinoconjunctivitis Medication Score Score (RMS) with also a range of values from 0 to 3 The RSMS is the sum of the RSS and RMS divided by 2
2 secondary outcomes
Quality of Life
Time frame: up to 6 weeks during the birch pollen season 2013
Safety and Tolerability
Time frame: from start of treatment to 28 days after completion of treatment, i.e. for approximately 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
Centre Hospitalier Universitaire Vaudois
24 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AllerT low dose and AllerT full dose in people with Allergic Rhinitis and Rhinoconjunctivitis, run by Anergis at 24 sites in 7 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 5 inclusion and 6 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 13 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Poland, Lithuania, Denmark, Latvia, Sweden and 2 more countries. 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 13 Apr 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?
Combined Rhinoconjunctivitis Symptom and Medication Score (time frame: up to 6 weeks during the birch pollen season 2013). 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 13 Apr 2015.