Allergic RhinitisPhase 2ATIBARNCT02943720
ATIBAR - Efficacy and Safety of Two Doses of AllerT in Patients Allergic to Birch Pollen
A Phase 2 study testing AllerT in people with Allergic Rhinitis, run by Anergis at 36 sites in 8 countries.
Trial summary
A multicentre, Double-blind, Placebo-Controlled, Randomized Trial to Assess the Efficacy and Tolerability of Two Dosing Regimens of AllerT, a Combination of Contiguous Overlapping Peptides Derived from Bet v 1, in Adults with Birch Pollen Allergic Rhinitis/Rhinoconjunctivitis Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- AllerT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 421 participants
- Where
- 36 sitesin 8 countries
- Study dates
- Sep 2016to Oct 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subjects 18 to 65 yrs old, male or female
- moderate to severe allergic Rhinitis/Rhinoconjunctivitis to birch pollen during the two preceding birch pollen seasons
- positive Skin Prick Test (SPT) to birch pollen extract
- positive specific IgE CAP to Bet v1.
Who cannot join
- persistent non-controlled asthma (Forced Expiratory Volume, FEV1 < 85% of predicted),
- previous specific immunotherapy (SIT) to tree pollens,
- previous SIT to any allergen within 5 years,
- previous history of severe anaphylactic reaction,
- perennial allergic Rhinitis/Rhinoconjunctivitis,
- other disorder possibly influencing the trial outcomes,
Show all 9Show fewer
- pregnancy,
- any severely debilitating disease,
- primary or secondary immunodeficiency or treatment with immunosuppressor drugs within one month prior to randomization (oral steroids, other immunosuppressors).
Trial locations and contacts
36 sites in 8 countries.
36 sites in 8 countries
Germany7 sites
HNO Heilkunde u. Allergologie praxis
Berlin, 13057
HNO Praxis Dr Yarin
Dresden, 01139
HNO Praxis Dr Thieme
Duisburg, 47051
HNO Praxis Dr Horn
Heidelberg, 69120
Dres Heimlich HNO praxis
Heidelberg, 69126
Medamed
Leipzig, 04109
Zentrum fur Rhinologie une Allergologie
Wiesbaden, 65183
Poland7 sites
Clinica Vitae
Gdansk, 80405
Grazyna Pulka Specjalistyczny Osradek All-Med
Krakow, 31024
Malopolskie Centrum Alergologii
Krakow, 31624
EMED Centrum Uslug Medycznych
Rzeszów, 35205
Clinmedica Research OMC
Skierniewice, 96100
All-Med Specjalistyczna Opieka Medyczna
Wroclaw, 53201
NZOZ-ALER-med Specjalistyczna Opieka Medycna
Wroclaw, 54203
Slovakia7 sites
ALIAN s.r.o. Ambulancia alergologie
Bardejov, 08501
Imunologia a alergologia
Komárno, 94501
ALERSA s.r.o. Imunoalergologicka ambulancia
Košice, 04022
STALERG s.r.o. Imunoalergologicka ambulancia
Košice, 04022
DANIMED s.r.o. Ambulancia klinickejimunologie a alergologie
Levice, 93401
EMED s.r.o. Alergoimunologické centrum
Prešov, 08001
Imunoalergologicka ambulancia
Šurany, 94201
Denmark5 sites
Lungemedicinsk Forskningsafdeling,
Aarhus, 8000
Herlev-Gentofte Hospital, Hud - og Allergiafdelingen,
Hellerup, 2900
Kolding Hospital
Kolding, 6000
Næstved Sygehus, Lungemedicinsk avd
Næstved, 4700
Odense Universitetshospital
Odense, 5000
Lithuania4 sites
Hospital of Lithuanian University
Kaunas, 50009
CD8 Klinika
Kaunas, 50154
Vilnius University Hospital
Vilnius, 08661
Vilnius City Clinical hospital
Vilnius, 10200
Norway3 sites
Harestua Medisinske Senter
Harestua, 2743
KAL Kliniken
Oslo, 0855
Ski Ore-Nese-Hals
Ski, 1400
Finland2 sites
Oulun Yliopistollinen sairaala Korva-, nenä- ja kurkkutautien poliklinikka.
Oulu, 90220
TYKS T-sairaala Allergiayksikkö TA2
Turku, 20520
About this study
Official title: A Multicentre, Double-blind, Placebo-Controlled, Randomized Trial to Assess the Efficacy and Tolerability of Two Dosing Regimens of AllerT in Adults With Birch Pollen Allergic Rhinitis
A multicentre, Double-blind, Placebo-Controlled, Randomized Trial to Assess the Efficacy and Tolerability of Two Dosing Regimens of AllerT, a Combination of Contiguous Overlapping Peptides Derived from Bet v 1, in Adults with Birch Pollen Allergic Rhinitis/Rhinoconjunctivitis
- Conditions
- Allergic Rhinitis
- Being tested
- AllerT, placebo
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllerTDrug
Bet v 1 contiguous overlapping peptides mixed with aluminium hydroxide solution
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | 5 SC injections in 2 months Receives: Drug: placebo |
| AllerT 50 ug | Experimental | 5 SC injections in 2 months Receives: Drug: AllerT |
| AllerT 10 ug | Experimental | 5 SC injections in 2 months Receives: Drug: AllerT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined Symptom and Medication Score (CSMS)
the CSMS will be assessed daily throughout the first birch pollen season following the end of the preseasonal 2-month treatment. The difference in average daily CSMS per treatment group will be compared taking into account all days of the birch pollen season at each study center. All patients will receive treatment during the preceding winter or spring and will thus have the primary outcome assessment performed between 2 and 6 months after the end of treatment.
Measured: 2 to 6 months after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionJul 2017
- Study completionOct 2017
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 421 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anergis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Durham, MD, Study chair, NHLI, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02943720
- Sponsor's protocol ID
- AN006T
- Acronym
- ATIBAR
- Status last verified
- Jan 2018
- First submitted
- 21 Oct 2016
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Double-blind, Placebo-Controlled, Randomized Trial to Assess the Efficacy and Tolerability of Two Dosing Regimens of AllerT in Adults With Birch Pollen Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT02943720
- Acronym / sponsor ID
- ATIBAR / AN006T
- Conditions
- Allergic Rhinitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 421 participants (actual)
- Lead sponsor
- AnergisIndustry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 25 Oct 2016 (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.
A multicentre, Double-blind, Placebo-Controlled, Randomized Trial to Assess the Efficacy and Tolerability of Two Dosing Regimens of AllerT, a Combination of Contiguous Overlapping Peptides Derived from Bet v 1, in Adults with Birch Pollen Allergic Rhinitis/Rhinoconjunctivitis
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: placebo5 SC injections in 2 months |
| AllerT 50 ug | Experimental | Drug: AllerT5 SC injections in 2 months |
| AllerT 10 ug | Experimental | Drug: AllerT5 SC injections in 2 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult subjects 18 to 65 yrs old, male or female
- moderate to severe allergic Rhinitis/Rhinoconjunctivitis to birch pollen during the two preceding birch pollen seasons
- positive Skin Prick Test (SPT) to birch pollen extract
- positive specific IgE CAP to Bet v1.
Key exclusion criteria (9 listed)
- persistent non-controlled asthma (Forced Expiratory Volume, FEV1 < 85% of predicted),
- previous specific immunotherapy (SIT) to tree pollens,
- previous SIT to any allergen within 5 years,
- previous history of severe anaphylactic reaction,
- perennial allergic Rhinitis/Rhinoconjunctivitis,
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 |
|---|---|---|
| AllerTBet v 1 contiguous overlapping peptides mixed with aluminium hydroxide solution | Drug | AllerT 10 ug, AllerT 50 ug |
| placeboplacebo | Drug | placebo |
Primary outcome
Combined Symptom and Medication Score (CSMS)
Time frame: 2 to 6 months after the end of treatment
the CSMS will be assessed daily throughout the first birch pollen season following the end of the preseasonal 2-month treatment. The difference in average daily CSMS per treatment group will be compared taking into account all days of the birch pollen season at each study center. All patients will receive treatment during the preceding winter or spring and will thus have the primary outcome assessment performed between 2 and 6 months after the end of treatment.
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 10 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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.
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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.
Stephen Durham, MD study chair
NHLI, Imperial College London
36 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AllerT in people with Allergic Rhinitis, run by Anergis at 36 sites in 8 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 4 inclusion and 9 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 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in Germany, Poland, Slovakia, Denmark, Lithuania and 3 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?
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?
Combined Symptom and Medication Score (CSMS) (time frame: 2 to 6 months after the end of treatment). 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 10 Jan 2018.