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AZD5672

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |AstraZeneca PLC|Trials Updated: Oct 3, 2011

AZD5672 development status

Highest phase Phase 2
Registered trials 8 across 1 sponsor since Jul 2008

AZD5672 target and mechanism

Molecular targetCCR5
Target classAntagonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials5
Total Enrollment505

FDA Designations

No designations recorded

AZD5672 clinical trials

AZD5672 · 5 trials · 2 indications

Phase 2 1Phase 1 4
NCT00713544A Proof of Concept and Dose Ranging Study in Patients With Rheumatoid ArthritisRheumatoid Arthritis
COMPLETED373 Analytics
PHASE2COMPLETED
A Proof of Concept and Dose Ranging Study in Patients With Rheumatoid Arthritis
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

American College of Rheumatology 20 Response (ACR20)
12 weeks

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 12 Weeks' treatment.

Evaluate time-matched QTcF intervals of single dose AZD5672 600mg compared to placebo.
Up to 24 hours postdose
Relative bioavailability of AZD5672 using PK variables AUC ss and C max ss
Frequent sampling occasions during study periods, with intensive sampling occurring on days 7,14,21 and 28
PK variables
Frequent sampling occasions during study period
total radioactivity in plasma, whole blood, faeces and urine.
Pre-dose, post dose, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2, 3, 4, 6, 9, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240h
Additional metabolite identification
0.5h, 3h, 6h, 12h, 24h

Secondary Endpoints

American College of Rheumatology 50 Response (ACR50)
12 weeks
American College of Rheumatology 70 Response (ACR70)
12 weeks
Disease Activity Score (Based on 28 Joint Count) (DAS28)
Baseline to 12 Weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATOR -
2EXPERIMENTAL20mg
3EXPERIMENTAL50mg
4EXPERIMENTAL100mg
5EXPERIMENTAL150mg
6PLACEBO_COMPARATOR -
AEXPERIMENTAL600mg AZD5672 + Moxifloxacin placebo
BEXPERIMENTAL100mg AZD5672 + Moxifloxacin placebo
CACTIVE_COMPARATORAZD5672 placebo + Moxifloxacin 400mg
DPLACEBO_COMPARATORAZD5672 placebo + Moxifloxacin placebo

Interventions

NameTypeDescription
AZD5672DRUG20 mg oral, once daily
EtanerceptDRUG50 mg, subcutaneous injection, weekly
PlaceboDRUGplacebo, oral, once daily
MoxifloxacinDRUG1 x 400mg capsule, oral, single dose
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites49

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 of positive rheumatoid f...

Countries:BulgariaColombiaCzechiaHungaryItalyLatviaMaltaPolandRomaniaRussiaSerbiaSlovakiaSouth AfricaUkraineUnited KingdomGermany
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Frequently asked questions about AZD5672

What is AZD5672?

AZD5672 is an investigational small molecule developed by AstraZeneca PLC (ticker AZN). It has been studied in Phase 1 and Phase 2 clinical trials for rheumatoid arthritis and renal impairment. It is a CCR5 antagonist. The drug is not approved and remains in clinical development.

What is AZD5672 used for in rheumatoid arthritis?

AZD5672 has been studied as a potential treatment for rheumatoid arthritis. A Phase 2 proof of concept and dose ranging study (NCT00713544) enrolled 373 patients with rheumatoid arthritis across multiple countries. Phase 1 trials also included rheumatoid arthritis as a condition. The drug is investigational and not approved for any use.

What does AZD5672 target?

AZD5672 targets CCR5, a chemokine receptor. It acts as a CCR5 antagonist. By blocking CCR5, the drug may interfere with inflammatory signaling pathways relevant to rheumatoid arthritis. This mechanism is under investigation in clinical trials.

Who is developing AZD5672?

AZD5672 is being developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca sponsored the clinical trials for this drug, including Phase 1 and Phase 2 studies in rheumatoid arthritis and renal impairment.

What phase is AZD5672 in?

AZD5672 has completed Phase 1 and Phase 2 clinical trials. The most advanced trial was a Phase 2 proof of concept and dose ranging study in rheumatoid arthritis (NCT00713544). The drug is investigational and has not been approved by the FDA or any regulatory agency.

What clinical trials is AZD5672 in?

AZD5672 has been evaluated in four completed clinical trials. These include NCT00887770, a Phase 1 cardiac conduction study; NCT00871767, a Phase 1 bioavailability study; NCT00715702, a Phase 1 safety study in renally impaired subjects; and NCT00713544, a Phase 2 proof of concept and dose ranging study in rheumatoid arthritis.