Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD9056 · 2 trials · 1 indication
The number of participants with greater to or equal to 20% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient's assessment of pain, disease activity and physical function; physician's assessment of disease activity; and CRP) after 6 months' treatment
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | Etanercept 50mg, subcutaneous, once weekly |
| 2 | EXPERIMENTAL | 50mg oral, once daily |
| 3 | EXPERIMENTAL | 100 mg oral, once daily |
| 4 | EXPERIMENTAL | 200 mg oral, once daily |
| 5 | EXPERIMENTAL | 400mg once, daily |
| 6 | PLACEBO_COMPARATOR | oral, once daily |
| Name | Type | Description |
|---|---|---|
| AZD9056 | DRUG | - |
| Etanercept | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * Diagnosis of RA with active disease defined as: ≥4 swollen joints and ≥6 tender/painful joints, and either have (blood tests) elevated erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). At least one of the following: documented history and current presence of po...
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AZD9056 was developed for the treatment of rheumatoid arthritis, an inflammatory joint disease. It was studied in a Phase 2b trial in patients with rheumatoid arthritis and in a Phase 1 retinal function study in healthy male volunteers. AZD9056 is an investigational small molecule and is not an approved therapy.
AZD9056 targets P2RX7, a purinergic receptor, and acts as an antagonist. By blocking this receptor, AZD9056 was designed to interfere with inflammatory signaling relevant to rheumatoid arthritis. P2RX7 antagonism was the mechanism explored in its clinical development program.
AZD9056 is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca sponsored the clinical trials evaluating AZD9056 in rheumatoid arthritis and in a Phase 1 retinal function study.
AZD9056 reached Phase 2 development. Its Phase 2b trial in rheumatoid arthritis and a Phase 1 retinal function study are both completed, and no trials are currently active. AZD9056 is an investigational agent and has not been approved for any indication.
AZD9056 was evaluated in two completed trials. NCT00520572 was a 6-month randomized, double-blind, placebo-controlled Phase 2b study in 385 patients with rheumatoid arthritis across multiple countries. NCT00700986 was a Phase 1 crossover study of retinal function after a single dose in 12 healthy male volunteers in the United Kingdom.