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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003881-15 | EudraCT Number |
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Study aiming to evaluate the efficacy of a 2-month pre-seasonal treatment with an AllerT 50 µg or 100 µg maintenance dose administered in previous study AN004T in reducing symptoms of allergic rhinoconjunctivitis during the 2nd following birch pollen season.
Multicenter, international, parallel-group follow-up study of subjects randomized and treated in Study AN004T (AllerT 100 µg, AllerT 50 µg, placebo) and followed over the 2nd, and if appropriate, the 3rd and 4th birch pollen seasons in this study (still double-blind during the 1st year, open-label in the 2nd and 3rd years).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AllerT 100 μg | patients having received AllerT at a first dose of 50 μg and 4 maintenance doses of 100 μg in study AN004T | ||
| AllerT 50 μg | patients having received AllerT at a first dose of 25 μg and 4 maintenance doses of 50 μg in study AN004T | ||
| Placebo | Patients having received Placebo (i.e., adjuvant alone) delivered in the same manner as AllerT in study AN004T |
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| Measure | Description | Time Frame |
|---|---|---|
| Average of the Combined Rhinoconjunctivitis Symptom and Medication Score (RSMS) Obtained Daily During the Birch Pollen Season | 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 The Rhinoconjunctivitis Symptom Score (RSS) comprises 6 different symptoms from the nose and eyes. The sum of the 6 symptom scores divided by 6 will be used as the RSS (scale of 0 to 3). The daily Rhinoconjunctivitis Medication Score (RMS) will be determined by assigning daily scores as follows: 0 = no medication
| from the first of 3 consecutive days with a regional pollen count > 10 grains/m3 to the earliest between the 42nd day after the start of the season and the last day in the last occurrence of 3 consecutive days with a regional pollen count ≥ 10 grains/m3 |
| Measure | Description | Time Frame |
|---|---|---|
| Average of the Total Score of the Validated Mini Rhinoconjunctivitis Quality-of-life Questionnaire© (Mini RQLQ) Obtained Weekly During the Birch Pollen Season | The Mini-RQLQ will be used. This evaluation tool includes 14 questions assessing 5 domains (activity limitation, practical problems, nose symptoms, eye symptoms, and non-nose/eye symptoms). For each question the answer is quoted from 0: "no troubled" to 6: "extremely troubled"; then the average of the score for the 14 questions is calculated resulting in a scale from 0 to 6, 0 being the best case and 6 the worst case |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with moderate to severe allergic rhiniconjunctivitis to birch pollen
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| Name | Affiliation | Role |
|---|---|---|
| Framçois SPERTINI, MD | University of Lausanne Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allergiklinikken | Hellerup | Copenhagen | 2900 | Denmark | ||
| Lungemedicinsk Forskningsafdeling |
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| ID | Title | Description |
|---|---|---|
| FG000 | AllerT 100 μg | patients having received AllerT at a first dose of 50 μg and 4 maintenance doses of 100 μg in study AN004T |
| FG001 | AllerT 50 μg | patients having received AllerT at a first dose of 25 μg and 4 maintenance doses of 50 μg in study AN004T |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| between the 42nd day after the start of the season and the last day in the last occurrence of 3 consecutive days with a regional pollen count ≥ 10 grains/m3 |
| Aarhus |
| 8000 |
| Denmark |
| Klinisk Institute | Odense | 5000 | Denmark |
| Hopitaux Universitaires de Strasbourg | Strasbourg | 67000 | France |
| Viktorija Vevere private practice of Allergology | Rēzekne | 4601 | 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 | Placebo | Patients having received Placebo (i.e., adjuvant alone) delivered in the same manner as AllerT in study AN004T |
| COMPLETED |
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| NOT COMPLETED |
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Safety set : subjects having received at least one injection of AllerT or placebo in AN004T and successfully screened in AN005T
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| ID | Title | Description |
|---|---|---|
| BG000 | AllerT 100 μg | patients having received AllerT at a first dose of 50 μg and 4 maintenance doses of 100 μg in study AN004T |
| BG001 | AllerT 50 μg | patients having received AllerT at a first dose of 25 μg and 4 maintenance doses of 50 μg in study AN004T |
| BG002 | Placebo | Patients having received Placebo (i.e., adjuvant alone) delivered in the same manner as AllerT in study AN004T |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Average of the Combined Rhinoconjunctivitis Symptom and Medication Score (RSMS) Obtained Daily During the Birch Pollen Season | 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 The Rhinoconjunctivitis Symptom Score (RSS) comprises 6 different symptoms from the nose and eyes. The sum of the 6 symptom scores divided by 6 will be used as the RSS (scale of 0 to 3). The daily Rhinoconjunctivitis Medication Score (RMS) will be determined by assigning daily scores as follows: 0 = no medication
| Modified-ITT analysis set : participants having received at least 4 injections of AllerT or placebo in AN004T | Posted | Mean | Standard Deviation | units on a scale | from the first of 3 consecutive days with a regional pollen count > 10 grains/m3 to the earliest between the 42nd day after the start of the season and the last day in the last occurrence of 3 consecutive days with a regional pollen count ≥ 10 grains/m3 |
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| Secondary | Average of the Total Score of the Validated Mini Rhinoconjunctivitis Quality-of-life Questionnaire© (Mini RQLQ) Obtained Weekly During the Birch Pollen Season | The Mini-RQLQ will be used. This evaluation tool includes 14 questions assessing 5 domains (activity limitation, practical problems, nose symptoms, eye symptoms, and non-nose/eye symptoms). For each question the answer is quoted from 0: "no troubled" to 6: "extremely troubled"; then the average of the score for the 14 questions is calculated resulting in a scale from 0 to 6, 0 being the best case and 6 the worst case | Modified-ITT analysis set : patients having received at least 4 injections of AllerT or placebo in AN004T | Posted | Mean | Standard Deviation | units on a scale | between the 42nd day after the start of the season and the last day in the last occurrence of 3 consecutive days with a regional pollen count ≥ 10 grains/m3 |
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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 | AllerT 100 μg | patients having received AllerT at a first dose of 50 μg and 4 maintenance doses of 100 μg in study AN004T | 0 | 62 | 2 | 62 | ||
| EG001 | AllerT 50 μg | patients having received AllerT at a first dose of 25 μg and 4 maintenance doses of 50 μg in study AN004T | 2 | 66 | 1 | 66 | ||
| EG002 | Placebo | Patients having received Placebo (i.e., adjuvant alone) delivered in the same manner as AllerT in study AN004T | 0 | 68 | 4 | 68 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angioedema | Skin and subcutaneous tissue disorders | Angioedema | Non-systematic Assessment | Non drug-related |
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| Rash generalised | Skin and subcutaneous tissue disorders | Rash generalised | Non-systematic Assessment | Non drug-related |
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| Threatened labor | Pregnancy, puerperium and perinatal conditions | Threatened labor | Non-systematic Assessment | Non drug-related |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | Nasopharyngitis | Systematic Assessment | Non drug-related |
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The PI coordinator of the study owns shares in Anergis SA
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| G. DELLA CORTE Clinical Development Director | ANERGIS SA | +41 21 651 92 30 | gilles.dellacorte@anergis.ch |
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