ToleroMune Ragweed Exposure Chamber Study
Parole chiave
Astratto
Descrizione
This study is designed as a randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability of ToleroMune Ragweed in ragweed allergic subjects with allergic rhinoconjunctivitis,subjects may also have controlled asthma. The efficacy of ToleroMune Ragweed will be explored in subjects using an(Environmental Exposure Chamber)EEC.
The study will consist of 3 study periods. In Period 1, Screening will be performed up to a maximum of 12 weeks before randomisation and may consist of one or two visits to the clinic, at the Investigator's discretion. Baseline Challenge will consist of 4 visits to the EEC at least 3 days before randomisation.
In Period 2, subjects in each cohort complying with the inclusion/exclusion criteria will be randomised to one of five groups and will receive treatment every 2 weeks (±2 days) for 14 weeks.
In Period 3, Post Treatment Challenge will consist of 4 visits to the EEC 18-22 weeks after the first administration in the treatment period and assessments will be performed identical to those at the baseline challenge. Follow-up will be conducted 3-10 days after PTC.
Date
| Ultimo verificato: | 09/30/2011 |
| Primo inviato: | 09/05/2010 |
| Iscrizione stimata inviata: | 09/08/2010 |
| Primo pubblicato: | 09/09/2010 |
| Ultimo aggiornamento inviato: | 10/05/2011 |
| Ultimo aggiornamento pubblicato: | 10/06/2011 |
| Data di inizio effettiva dello studio: | 08/31/2010 |
| Data di completamento primaria stimata: | 07/31/2011 |
| Data stimata di completamento dello studio: | 07/31/2011 |
Condizione o malattia
Intervento / trattamento
Biological: ToleroMune Ragweed
Biological: Placebo
Fase
Gruppi di braccia
| Braccio | Intervento / trattamento |
|---|---|
| Placebo Comparator: Placebo | Biological: Placebo Intradermal injection, 1x8 administrations 2 weeks apart |
| Experimental: ToleroMune Ragweed Regimen 1 | |
| Experimental: ToleroMune Ragweed Regimen 2 | |
| Experimental: ToleroMune Ragweed Regimen 3 | |
| Experimental: ToleroMune Ragweed Regimen 4 |
Criteri di idoneità
| Età idonea per lo studio | 18 Years Per 18 Years |
| Sessi idonei allo studio | All |
| Accetta volontari sani | sì |
| Criteri | Inclusion criteria - Male or female, aged 18-65 years. - Minimum 2-year documented history of rhinoconjunctivitis on exposure to ragweed. [Subjects may also have controlled asthma - Positive skin prick test to ragweed allergen. - Minimum qualifying rhinoconjunctivitis symptom scores Exclusion criteria - History of asthma. - A history of anaphylaxis to ragweed allergen. - Subjects with an FEV1 <70% of predicted. - Subjects who cannot tolerate baseline challenge in the EEC. - Subjects for whom administration of epinephrine is contra-indicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension). - A history of severe drug allergy, severe angioedema or anaphylactic reaction to food. - A history of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment). |
Risultato
Misure di esito primarie
1. Total Rhinoconjunctivitis Symptom Score [Upto 22 weeks]
Misure di esito secondarie
1. Symptom scores for ocular and nasal symptoms [Upto 22 weeks]
2. Acoustic Rhinometry [Upto 22 weeks]
3. Skin prick testing [Baseline and final follow up]
4. Ragweed specific IgE [At baseline and at follow up]
5. Ragweed specific IgA [At baseline and follow up]
6. Ragweed specific IgG4 [At baseline and at follow up]
7. Adverse Events [Upto 23 weeks]
