Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00396409 | Efficacy/ Safety of Omalizumab in Patients With Seasonal Allergic Asthma and Seasonal Allergic Rhinoconjunctivitis | PHASE3 | COMPLETED | 128 | — | — | Feb 1, 2006 | Aug 1, 2008 | Mar 30, 2017 | 1 | Germany |
The daily symptom load (low=0, high=unbounded) represents the daily combined asthma and rhinoconjunctivitis symptom severity scores plus the daily asthma rescue medication score based on patient diary entries. A higher score indicates a worse patient asthma condition. Symptoms (e.g. - difficulty breathing, cough, tightness of chest, sneezing, itchy nose, red eyes, etc.) were evaluated daily by the patient using a 4-point scale (0=no symptom, 1=mild, 2=moderate, 3=severe). Point values were assigned by specific rescue medication usage. The daily scores were averaged over pollen days by site.
| Arm | Type | Description |
|---|---|---|
| Depigold+Omalizumab | EXPERIMENTAL | Xolair® (Omalizumab, double-blind core study period only), Depigoid® (grass/rye pollen 50/50) |
| Depigoid+Placebo | EXPERIMENTAL | Depigoid® (grass/rye pollen 50/50) + Placebo |
| Name | Type | Description |
|---|---|---|
| Depigoid | DRUG | Administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL) |
| Omalizumab | DRUG | anti-IgE (Omalizumab) given during the 2006 core study |
| Placebo | DRUG | Placebo given during the 2006 core study |
Inclusion Criteria: * Males or females of any race who are 12-45 years of age with a body weight ≥ 20 kg and ≤ 150 kg and with a total serum IgE level ≥ 30 to ≤ 700 IU/ml (suitable weight for dosing) * Patients with the diagnosis of not adequately controlled seasonal grass pollen (and/or rye pollen...