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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002259-32 | EudraCT Number |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | SC injections of placebo |
|
| AllerT low dose | Experimental | SC injections of AllerT 25 or 50 micrograms |
|
| AllerT full dose | Experimental | SC injections of AllerT 50-100 micrograms |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | SC injections of placebo on days 1, 7, 14, 28 and 56 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 6 weeks during the birch pollen season 2013 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | mini-RQLQ questionnaires | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Immunological Markers: Specific IgE and IgG4 | blood samples will be drawn at the above time points to measure immunological markers: specific IgE and IgG4 | 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 |
Inclusion Criteria:
moderate to severe allergic rhinoconjunctivitis to birch pollen:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francois Spertini, MD | Centre Hospitalier Universitaire Vaudois | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allergiklinikken | Hellerup | Copenhagen | 2900 | Denmark | ||
| Lungemedicinsk Forskningsafdeling |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | SC injections of placebo placebo: SC injections of placebo on days 1, 7, 14, 28 and 56 |
| FG001 | AllerT Low Dose | SC injections of AllerT 25 or 50 micrograms AllerT low dose: SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| AllerT low dose |
| Drug |
SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56 |
|
|
| AllerT full dose | Drug | SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56 |
|
|
| from start of treatment to 28 days after completion of treatment, i.e. for approximately 12 weeks |
| Aarhus |
| 8000 |
| Denmark |
| Klinisk Institute | Odense | 5000 | Denmark |
| CHU de Reims | Reims | 51092 | France |
| Hopitaux Universitaires de Strasbourg | Strasbourg | 67000 | France |
| Viktorija Vevere private practice of Allergology | Rēzekne | 4601 | Latvia |
| Paul Stradins Clinical University Hospital - Pulmonology Allergology | Riga | 1002 | Latvia |
| Center of examination and treatment of allergic diseases | Riga | 1003 | Latvia |
| Kaunas Clinics University Hospital | Kaunas | 50009 | Lithuania |
| Allergy Clinic JSC Perspektyvos | Vilnius | 08431 | Lithuania |
| Vilnius University Hospital | Vilnius | 08661 | Lithuania |
| Antakalnio affiliation of the Vilnius City Allergy Center | Vilnius | 10200 | Lithuania |
| SPZOZ Uniwersytecki Szpital Kliniczny - Allergology | Lodz | 90153 | Poland |
| Alergologii Centrum | Lodz | 90553 | Poland |
| Alergotest | Lublin | 20095 | Poland |
| Alergo-Med | Tarnów | 33100 | Poland |
| Centrum Alergologii IRMED | Warsaw | 01157 | Poland |
| Silesian Piasts University of Medicine in Wrocław | Wroclaw | 50-368 | Poland |
| Aler-med | Wroclaw | 54203 | Poland |
| NZOZ Przychodnia Lekarska Hipokrates | Zabrze | 41800 | Poland |
| University hospital Skane | Lund | 22185 | Sweden |
| Orebro University Hospital | Örebro | 70185 | Sweden |
| Lungavdelningen, Vastmanlands | Västerås | 72189 | Sweden |
| Centre Hospitalier Universitaire Vaudois | Lausanne | Canton of Vaud | 1005 | Switzerland |
| FG002 | AllerT Full Dose | SC injections of AllerT 50-100 micrograms AllerT full dose: SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56 |
| COMPLETED |
|
| NOT COMPLETED |
|
In AllerT low dose group, one patient has been randomized but not treated explaining the difference beween baseline participants number and participant flow
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | SC injections of placebo placebo: SC injections of placebo on days 1, 7, 14, 28 and 56 |
| BG001 | AllerT Low Dose | SC injections of AllerT 25 or 50 micrograms AllerT low dose: SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56 |
| BG002 | AllerT Full Dose | SC injections of AllerT 50-100 micrograms AllerT full dose: SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | score (maximum=3) | up to 6 weeks during the birch pollen season 2013 |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Quality of Life | mini-RQLQ questionnaires | Not Posted | up to 6 weeks during the birch pollen season 2013 | ||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Not Posted | from start of treatment to 28 days after completion of treatment, i.e. for approximately 12 weeks | ||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Immunological Markers: Specific IgE and IgG4 | blood samples will be drawn at the above time points to measure immunological markers: specific IgE and IgG4 | Not Posted | 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 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | All patients having received at least one injection of Placebo (Safety Set) | 0 | 79 | 59 | 79 | ||
| EG001 | Allert 50 µg | All patients having received at least one injection of Allert 50 µg (Safety Set) | 1 | 78 | 70 | 78 | ||
| EG002 | AllerT 100 µg | All patients having received at least one injection of Allert 100 µg (Safety Set) | 2 | 82 | 70 | 82 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| conjunctivitis | Eye disorders | conjunctivitis | Non-systematic Assessment |
| |
| Hypersensitivity | General disorders | Hypersensitivity | Non-systematic Assessment |
| |
| Oropharyngeal discomfort | Gastrointestinal disorders | Oropharyngeal discom | Non-systematic Assessment |
| |
| Skull fracture | Musculoskeletal and connective tissue disorders | Skull fracture | Non-systematic Assessment | considered as non drug-related |
|
| Tongue oedema | Gastrointestinal disorders | Tongue oedema | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | Urticaria | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | Skin and subcutaneous tissue disorders | Injection site pain | Systematic Assessment |
| |
| Injection site reaction | Skin and subcutaneous tissue disorders | Injection site react | Systematic Assessment |
| |
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | Nasopharyngitis | Systematic Assessment |
| |
| Injection site erythema | Skin and subcutaneous tissue disorders | Injection site eryth | Systematic Assessment |
| |
| Rhinitis | Respiratory, thoracic and mediastinal disorders | Rhinitis | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Dyspnea | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | Cough | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | Pruritus | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | Conjunctivitis | Systematic Assessment |
| |
| Injection site oedema | Skin and subcutaneous tissue disorders | Injection site oedem | Systematic Assessment |
|
The PI of the trial owns options in the sponsor company and is member of the Board of Anergis SA
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Gilles DELLA CORTE Clinical Development Director | ANERGIS SA | +41 21 651 92 30 | gilles.dellacorte@anergis.ch |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| Male |
|