Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Depiquick Birch · 1 trial · 1 indication
The SMS represents the sum of the mean daily symptom severity score plus the mean daily rescue medication score. The symptom severity score is defined as the mean of the daily symptom severity scores during the pollen season. The rescue medication score is defined as the mean of the daily rescue medication scores during the pollen season. A lower score indicates an improvement in the allergic condition. Minimum score of the SMS is "0", maximum score is dependent on intake of rescue medication.
| Arm | Type | Description |
|---|---|---|
| Depiquick® Birch | EXPERIMENTAL | At the screening visit (Visit 1), patients will be instructed how to complete the eDiary. Eligible patients will return for visit 2 as soon as they experience significant allergic symptoms. Significant allergic symptoms are defined by a symptom score ≥ 2. If the patients' eligibility has been confirmed according to inclusion/exclusion criteria checklist, randomization to one of the 2 treatment arms will be conducted. Patients will receive two consecutive subcutaneous injections of study medication (0,2 and 0,3 ml) with a time lag of ≥ 30 minutes. Patients return to the study site in weekly intervals for visit 3, visit 4, visit 5, visit 6, and visit 7 to receive study medication injections (0,5 ml each). If treatment is completed before the end of the tree pollen season, patients will be followed-up by telephone calls every 4 weeks until the end of the tree pollen season. The study completion visit will take place 4 weeks after the end of the tree pollen season. |
| Placebo | PLACEBO_COMPARATOR | At the screening visit (Visit 1), patients will be instructed how to complete the eDiary. Eligible patients will return for visit 2 as soon as they experience significant allergic symptoms. Significant allergic symptoms are defined by a symptom score ≥ 2. If the patients' eligibility has been confirmed according to inclusion/exclusion criteria checklist, randomization to one of the 2 treatment arms will be conducted. Patients will receive two consecutive subcutaneous injections of study medication (0,2 and 0,3 ml) with a time lag of ≥ 30 minutes. Patients return to the study site in weekly intervals for visit 3, visit 4, visit 5, visit 6, and visit 7 to receive study medication injections (0,5 ml each). If treatment is completed before the end of the tree pollen season, patients will be followed-up by telephone calls every 4 weeks until the end of the tree pollen season. The study completion visit will take place 4 weeks after the end of the tree pollen season. |
| Name | Type | Description |
|---|---|---|
| Depiquick Birch (DPG103) | DRUG | - |
| Placebo | DRUG | - |
Inclusion criteria: 1. Patients must experience significant allergic symptoms on visit 2 2. Medical history of allergic rhinitis and/or rhinoconjunctivitis with clinically relevant sensitization to tree allergens 3. Specific IgE against birch allergens (CAP RAST ≥ 2) Exclusion criteria: 1. Histor...
Depiquick Birch is an investigational small molecule being developed for the treatment of allergic rhinoconjunctivitis. It is administered as an intraseasonal specific immunotherapy. The drug is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
Depiquick Birch 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 trials to evaluate the efficacy and safety of this investigational therapy for allergic rhinoconjunctivitis.
Depiquick Birch is in Phase 3 clinical development. A Phase 3 trial has been completed, which evaluated the efficacy and safety of intraseasonal specific immunotherapy with Depiquick Birch in patients with allergic rhinoconjunctivitis. The drug remains investigational and is not yet approved.
Depiquick Birch has one completed Phase 3 clinical trial registered as NCT01902992. This randomized, double-blind, placebo-controlled study enrolled 202 participants aged 12 years and older with allergic rhinoconjunctivitis in Germany. The trial evaluated the efficacy and safety of intraseasonal specific immunotherapy with Depiquick Birch.
Depiquick Birch is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for allergic rhinoconjunctivitis. A Phase 3 trial has been completed, but the drug has not yet received regulatory approval from the FDA or other health authorities.