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Also known as Depiquick Birch (DPG103)
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 being developed for allergic rhinoconjunctivitis, an allergic condition affecting the nose and eyes. It is a small molecule therapy administered as intraseasonal specific immunotherapy. Novartis AG is developing the asset, which has reached Phase 3 clinical development.
Depiquick Birch is being developed by Novartis AG, which trades under the ticker NVS. The company is responsible for the clinical program evaluating the therapy in allergic rhinoconjunctivitis.
Depiquick Birch is in Phase 3 clinical development. One Phase 3 trial has been completed, and no trials are currently active. The drug is investigational and has not been approved by the FDA.
Depiquick Birch has been evaluated in one completed Phase 3 trial, NCT01902992, titled Efficacy and Safety of Intraseasonal Specific Immunotherapy With Depiquick Birch. The trial enrolled 202 participants in Germany, was randomized, double-blind, and placebo-controlled, and included participants aged 12 years and older.
Yes, Depiquick Birch is also known as DPG103. Both names refer to the same investigational small molecule developed by Novartis AG for allergic rhinoconjunctivitis.