Efficacy Study of a Preseasonal Treatment With AllerT in Subjects With Birch Pollen Allergy
This study is ongoing, but not recruiting participants.
Sponsor:
Anergis
Information provided by (Responsible Party):
Anergis
ClinicalTrials.gov Identifier:
NCT01720251
First received: October 29, 2012
Last updated: February 7, 2013
Last verified: February 2013
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Allergic Rhinitis Rhinoconjunctivitis |
Drug: placebo Drug: AllerT low dose Drug: AllerT full dose |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Anergis:
Primary Outcome Measures:
- Combined Rhinoconjunctivitis Symptom and Medication Score [ Time Frame: up to 6 weeks during the birch pollen season 2013 ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- quality of life [ Time Frame: up to 6 weeks during the birch pollen season 2013 ] [ Designated as safety issue: No ]mini-RQLQ questionnaires
- Safety and tolerability [ Time Frame: from start of treatment to 28 days after completion of treatment, i.e. for approximately 12 weeks ] [ Designated as safety issue: No ]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
Other Outcome Measures:
- immunological markers: specific IgE and IgG4 [ Time Frame: before treatment, 4 weeks after the last injection and 2 weeks before, at the peak time and within 2 weeks after the end of the expected birch pollen season 2013 ] [ Designated as safety issue: No ]blood samples will be drawn at the above time points to measure immunological markers: specific IgE and IgG4
| Estimated Enrollment: | 306 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: placebo
SC injections of placebo
|
Drug: placebo
SC injections of placebo on days 1, 7, 14, 28 and 56
Other Name: placebo
|
|
Experimental: AllerT low dose
SC injections of AllerT 25 or 50 micrograms
|
Drug: AllerT low dose
SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56
Other Name: AllerT 25-50 micrograms
|
|
Experimental: AllerT full dose
SC injections of AllerT 50-100 micrograms
|
Drug: AllerT full dose
SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56
Other Name: AllerT 50-100 micrograms
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01720251
Locations
| Denmark | |
| Allergiklinikken | |
| Hellerup, Copenhagen, Denmark, 2900 | |
| Lungemedicinsk Forskningsafdeling | |
| Arhus, Denmark, 8000 | |
| Klinisk Institute | |
| Odense, Denmark, 5000 | |
| France | |
| CHU de Reims | |
| Reims, France, 51092 | |
| Hopitaux Universitaires de Strasbourg | |
| Strasbourg, France, 67000 | |
| Latvia | |
| Viktorija Vevere private practice of Allergology | |
| Rezekne, Latvia, 4601 | |
| Paul Stradins Clinical University Hospital - Pulmonology Allergology | |
| Riga, Latvia, 1002 | |
| Center of examination and treatment of allergic diseases | |
| Riga, Latvia, 1003 | |
| Lithuania | |
| Kaunas Clinics University Hospital | |
| Kaunas, Lithuania, 50009 | |
| Vilnius University Hospital | |
| Vilnius, Lithuania, 08661 | |
| Allergy Clinic JSC Perspektyvos | |
| Vilnius, Lithuania, 08431 | |
| Antakalnio affiliation of the Vilnius City Allergy Center | |
| Vilnius, Lithuania, 10200 | |
| Poland | |
| Alergologii Centrum | |
| Lodz, Poland, 90553 | |
| SPZOZ Uniwersytecki Szpital Kliniczny - Allergology | |
| Lodz, Poland, 90153 | |
| Alergotest | |
| Lublin, Poland, 20095 | |
| Alergo-Med | |
| Tarnow, Poland, 33100 | |
| Centrum Alergologii IRMED | |
| Warszawa, Poland, 01157 | |
| Silesian Piasts University of Medicine in Wrocław | |
| Wroclaw, Poland, 50-368 | |
| Aler-med | |
| Wroclaw, Poland, 54203 | |
| NZOZ Przychodnia Lekarska Hipokrates | |
| Zabrze, Poland, 41800 | |
| Sweden | |
| University hospital Skane | |
| Lund, Sweden, 22185 | |
| Orebro University Hospital | |
| Orebro, Sweden, 70185 | |
| Lungavdelningen, Vastmanlands | |
| Vasteras, Sweden, 72189 | |
| Switzerland | |
| Centre Hospitalier Universitaire Vaudois | |
| Lausanne, VD, Switzerland, 1005 | |
Sponsors and Collaborators
Anergis
Investigators
| Principal Investigator: | Francois Spertini, MD | Centre hospitalier universitaire vaudois, Lausanne, Switzerland |
More Information
No publications provided
| Responsible Party: | Anergis |
| ClinicalTrials.gov Identifier: | NCT01720251 History of Changes |
| Other Study ID Numbers: | AN004T, 2011-002259-32 |
| Study First Received: | October 29, 2012 |
| Last Updated: | February 7, 2013 |
| Health Authority: | Denmark: Danish Health and Medicines Authority France: Agence Nationale de Sécurité du Médicament et des produits de santé Lithuania: State Medicine Control Agency - Ministry of Health Latvia: State Agency of Medicines Poland: Ministry of Health Sweden: Medical Products Agency Switzerland: Swissmedic |
Keywords provided by Anergis:
|
allergic rhinitis birch pollen immunotherapy |
Additional relevant MeSH terms:
|
Rhinitis Conjunctivitis Nose Diseases Respiratory Tract Diseases |
Respiratory Tract Infections Otorhinolaryngologic Diseases Conjunctival Diseases Eye Diseases |
ClinicalTrials.gov processed this record on June 18, 2013