Recent Updates
Recently added Catalysts

AZD9056

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |AstraZeneca PLC|Last Updated: Feb 4, 2013

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment397

FDA Designations

No designations recorded

Clinical trial landscape

AZD9056 · 2 trials · 1 indication

Phase 2 1Phase 1 1
NCT00520572A 6-month Randomised, Double-blind, Open Arm Comparator, Phase IIb, With AZD9056, in Patients With Rheumatoid Arthritis (RA)Rheumatoid Arthritis
COMPLETED385 Analytics
PHASE2COMPLETED
A 6-month Randomised, Double-blind, Open Arm Comparator, Phase IIb, With AZD9056, in Patients With Rheumatoid Arthritis (RA)
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

American College of Rheumatology 20 Response (ACR20) at 6 Months
6 months

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

The effect of a single dose of AZD9056 (800mg) on retinal function will be assessed by Electroretinography
Electroretinography measurements will be performed at baseline, 6 hours post dosing at both treatment and crossover placebo treatment visits, and at post study medical follow up visits.

Secondary Endpoints

American College of Rheumatology 50 Response (ACR50) at 6 Months
6 months
American College of Rheumatology 70 Response (ACR70) at 6 Months
6 months
Disease Activity Score (Based on 28 Joint Count) (DAS28) at 6 Months.
Baseline to 6 months
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATOREtanercept 50mg, subcutaneous, once weekly
2EXPERIMENTAL50mg oral, once daily
3EXPERIMENTAL100 mg oral, once daily
4EXPERIMENTAL200 mg oral, once daily
5EXPERIMENTAL400mg once, daily
6PLACEBO_COMPARATORoral, once daily

Interventions

NameTypeDescription
AZD9056DRUG -
EtanerceptDRUG -
PlaceboDRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites51

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...

Countries:United StatesArgentinaAustraliaBelgiumCanadaCzechiaFranceMexicoPolandRomaniaRussiaSlovakiaUnited Kingdom
Unlock Eligibility Criteria

Frequently asked questions about AZD9056

What is AZD9056 used for?

AZD9056 is an investigational small molecule being studied for the treatment of rheumatoid arthritis. It has been evaluated in clinical trials involving patients with rheumatoid arthritis and in healthy volunteers for safety and drug interaction studies. The drug is not approved and remains in clinical development.

Who makes AZD9056?

AZD9056 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca has sponsored clinical trials of AZD9056 in rheumatoid arthritis and healthy volunteers.

What phase is AZD9056 in?

AZD9056 has completed a Phase 2b clinical trial in patients with rheumatoid arthritis. It has also completed Phase 1 studies in healthy volunteers. The drug is investigational and has not received regulatory approval.

What clinical trials is AZD9056 in?

AZD9056 has been studied in two completed trials. NCT00520572 was a Phase 2b randomized, double-blind, placebo-controlled study in 385 patients with rheumatoid arthritis. NCT00700986 was a Phase 1 crossover study in 12 healthy male volunteers to investigate retinal function. NCT00736606 was a Phase 1 drug interaction study with simvastatin in healthy volunteers.

Is AZD9056 the same as any other drug?

AZD9056 is the sole name used for this investigational drug in clinical trial records. No alternative names have been associated with it in the available trial information.