Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD1419 · 1 trial · 1 indication
LOAC was defined as any of the following: * Increase of asthma control questionnaire-5 (ACQ-5) to ≥ 1.5. * ≥ 30% reduction in morning peak expiratory flow (PEF) from baseline on 2 consecutive days. * ≥ 6 additional reliever inhalations of short-acting β agonist (SABA) in a 24-hour period relative to baseline on 2 consecutive days. * Exacerbation requiring systemic corticosteroids as decided by Investigator. Time to LOAC was calculated as start date of first LOAC - date of randomization + 1. Start date of LOAC was latest date that 1 of the 4 criteria were satisfied immediately prior to the exacerbation start date, provided no more than 7 days between LOAC and exacerbation start date. Time to LOAC was displayed using a Kaplan-Meier plot and the outcome measure is presented as number of participants with events. Cox regression analysis was used to compare treatments.
| Arm | Type | Description |
|---|---|---|
| AZD1419 | EXPERIMENTAL | Dose adaption of AZD1419, 4 mg or 8 mg or 1 mg based on occurence of AE's |
| Placebo | PLACEBO_COMPARATOR | Matching placebo |
| Name | Type | Description |
|---|---|---|
| AZD1419 | DRUG | Inhaled AZD1419 administered at the clinic as once weekly inhalations with the I-neb® device. Start dose is 4 mg and dose adaptation is applied (downtitration to 1mg or uptitration to 8 mg or remain on 4 mg) based on appearance of flu like adverse events |
| Placebo | DRUG | Inhaled Placebo administered at the clinic as once weekly inhalations with the I-neb® device. Start dose is Placebo 4 mg and dose adaptation is applied (downtitration to 1mg or uptitration to 8 mg or remain on 4 mg) based on appearance of flu like adverse events |
Inclusion Criteria: * Male and female patients 18 years and above * Physician-diagnosed asthma requiring treatment with ICS and a long-acting beta agonist (LABA). Patients must have taken ICS plus LABA controller medication for at least 3 months prior to screening * Pre-bronchodilator forced expira...
AZD1419 is an investigational small molecule being developed for the treatment of asthma. It is currently in Phase 2 clinical development, with a completed Phase 2a study in patients with asthma.
AZD1419 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN.
AZD1419 is in Phase 2 clinical development. A Phase 2a study has been completed, and the drug is not yet approved by regulatory authorities.
AZD1419 has been studied in one completed Phase 2a clinical trial with the identifier NCT02898662. This trial enrolled 81 participants with asthma and was conducted in Denmark, Hungary, Poland, and Sweden.
No, AZD1419 is not FDA approved. It is an investigational drug that has completed a Phase 2a clinical trial and is still in clinical development.