Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Depigoid · 1 trial · 1 indication
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...
Depigoid is an investigational small molecule being developed for the treatment of allergic asthma. It is intended for patients with this respiratory condition, though it remains in clinical development and is not yet approved.
Depigoid is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical research to evaluate the drug's safety and efficacy.
Depigoid is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to assess its safety and effectiveness for treating allergic asthma.
Depigoid has one completed Phase 3 clinical trial registered as NCT00396409. This study evaluated the efficacy and safety of the drug in patients with seasonal allergic asthma and seasonal allergic rhinoconjunctivitis. The trial enrolled 128 participants in Germany and was randomized, double-blind, and controlled.
Depigoid is not FDA approved. It is an investigational drug currently in Phase 3 clinical development. The completed trial NCT00396409 has finished, but the drug has not yet received regulatory approval for the treatment of allergic asthma.