Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD8848 · 5 trials · 4 indications
Mean of Reflective Total Nasal Symptom Score (absolute values) for symptoms over the last 10 minutes after allergen challenge, collected during clinic visits. The Mean is calculated over the Allergen challenge period, which is a seven day period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome. Allergen challenge period starts 24 hrs post last dose (visit 15). Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15).
Mean of morning measurements of Reflective Total Nasal Symptom Score (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome. Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15).
Mean of evening measurements of Reflective Total Nasal Symptom Score (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome. Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15).
Mean of Peak Nasal Inspiratory Flow (absolute values) recorded immediately after TNSS scoring (recall period 10 min), during Allergen challenge period. The Mean is calculated over the Allergen challenge period, which is a seven day period. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded. Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15).
Mean of morning measurements of Peak Nasal Inspiratory Flow (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded. Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15).
Mean of evening measurements of Peak Nasal Inspiratory Flow (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded. Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15).
Forced Expiratory Volume in 1 second (FEV1), Late Asthmatic Response (LAR), is derived as the ratio of FEV1 Area Under Curve 4-10 hour post allergen challenge (AUC 4-10h) (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.
FEV1, Late Asthmatic Response (LAR), is derived as the ratio of FEV1 AUC 4-10h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.
FEV1, Late Asthmatic Response (LAR), is derived as the ratio of FEV1 AUC 4-10h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.
| Arm | Type | Description |
|---|---|---|
| 1. AZD8848 | EXPERIMENTAL | 20 μg AZD8848 three times weekly |
| 2. Placebo | PLACEBO_COMPARATOR | Placebo three times weekly |
| 3. AZD8848 and placebo | EXPERIMENTAL | 60 μg AZD8848 once weekly and placebo twice weekly |
| 1 | EXPERIMENTAL | AZD8848 (30 μg PILOT part and 60 μg MAIN part) |
| 2 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| AZD8848 | DRUG | Nasal spray solution, intranasal, three times weekly for one month |
| Placebo | DRUG | Nasal spray solution, intranasal, three times weekly for one month |
| AZD8848 and placebo | DRUG | Nasal spray solution, intranasal, three times weekly for one month |
Inclusion Criteria: * Seasonal allergic rhinitis patients out of pollen season * Have a history and presence of birch and/or timothy grass pollen induced seasonal allergic rhinitis for at least the previous 2 years (verified by a positive skin prick test) * Patients with need of treatment for their...
AZD8848 was investigated for allergic asthma, allergic rhinitis, and butyrylcholinesterase deficiency. It is an investigational small molecule developed by AstraZeneca and studied in Phase 1 and Phase 2 clinical trials. The completed studies evaluated its safety, tolerability, and effects in patients with these conditions.
AZD8848 targets TLR7, a toll-like receptor involved in immune response. It acts as a TLR7 agonist, meaning it activates this receptor. This mechanism was explored for potential anti-inflammatory or immune-modulating effects in allergic diseases such as asthma and rhinitis.
AZD8848 is developed by AstraZeneca PLC, a pharmaceutical company traded on the Nasdaq under the ticker AZN. AstraZeneca sponsored the clinical trials investigating the drug in allergic asthma, allergic rhinitis, and butyrylcholinesterase deficiency.
AZD8848 has completed Phase 2 clinical development. It was studied in Phase 1 and Phase 2 trials, all of which are now completed. There are no active trials currently listed for this drug.
AZD8848 has been studied in four completed clinical trials: NCT01205867 in butyrylcholinesterase deficiency, NCT01185080 and NCT00770003 in allergic rhinitis, and NCT00999466 in allergic asthma. These trials enrolled a total of 278 participants across Denmark, Sweden, and the United Kingdom.