Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Experimental: Tralokinumab · 1 trial · 1 indication
Asthma exacerbation was defined as a worsening of asthma that led to any of the following: * Use of systemic corticosteroids for at least 3 days; a single depo-injectable dose of corticosteroids was considered equivalent to a 3-day course of systemic corticosteroids. * An emergency room (ER) or urgent care (UC) visit (defined as evaluation and treatment for \<24 hours in an ER or UC centre) due to asthma that required systemic corticosteroids (see above). * An inpatient hospitalisation (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥24 hours) due to asthma. AAER = number of exacerbations\*365.25 / (follow-up date - date of randomisation + 1) (where maximum follow-up time for a patient was approximately 52 weeks). AAER in the tralokinumab group was compared to that seen in the placebo group up to Week 52 using a negative binomial model; rate ratios and rate reductions are both presented for comparative statistical analyses.
| Arm | Type | Description |
|---|---|---|
| Tralokinumab | EXPERIMENTAL | Tralokinumab subcutaneous injection |
| Placebo | PLACEBO_COMPARATOR | Placebo subcutaneous injection |
| Name | Type | Description |
|---|---|---|
| Experimental: Tralokinumab | BIOLOGICAL | Tralokinumab subcutaneous injection |
| Placebo | OTHER | Placebo subcutaneous injection |
Inclusion Criteria: 1. Age 12 -75 2. Documented physician-diagnosed asthma. 3. Documented treatment with ICS at a total daily dose corresponding to ≥500μg fluticasone propionate dry powder formulation equivalents) and a LABA 4. Morning pre-BD FEV1 value of ≥40 and \<80% value (\<90% for patients 12...
Tralokinumab is an investigational monoclonal antibody being studied for the treatment of uncontrolled asthma in adults and adolescents. It is administered to patients whose asthma is not well controlled despite standard therapy. The drug is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
Tralokinumab is a monoclonal antibody that targets the cytokine interleukin-13 (IL-13). By binding to IL-13, it is designed to block its activity, which is believed to play a role in the inflammation associated with asthma. This mechanism is being evaluated in clinical trials for uncontrolled asthma.
Tralokinumab is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol AZN. AstraZeneca is conducting clinical trials to evaluate the safety and efficacy of tralokinumab in patients with uncontrolled asthma.
Tralokinumab is in Phase 3 clinical development for uncontrolled asthma. It is an investigational drug, meaning it has not yet been approved by regulatory agencies such as the FDA. The Phase 3 trial has been completed, and the results are being analyzed to determine the drug's potential for regulatory submission.
Tralokinumab has been studied in a Phase 3 clinical trial identified as NCT02194699. This randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of tralokinumab in adults and adolescents with uncontrolled asthma. The trial enrolled 856 participants across multiple countries and has been completed.
Tralokinumab is an investigational biologic that is not the same as any currently approved asthma medication. It is a monoclonal antibody targeting IL-13, a different mechanism from approved biologics such as those targeting IgE or IL-5. Tralokinumab is still in clinical development and has not received regulatory approval.