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AZD2423

Phase 2

Chronic Obstructive Pulmonary Disease | Small molecule | Respiratory |AstraZeneca PLC|Trials Updated: Apr 10, 2015

AZD2423 development status

Highest phase Phase 2
Registered trials 8 across 1 sponsor since Jul 2009

AZD2423 target and mechanism

Molecular targetCCR2
Target classAntagonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials4
Total Enrollment401

FDA Designations

No designations recorded

AZD2423 clinical trials

AZD2423 · 4 trials · 4 indications

Phase 2 4
NCT01153321Investigation of the Effect of Oral Treatment With 100 mg AZD2423 in Subjects With Mild Chronic Obstructive Pulmonary Disease (COPD)Chronic Obstructive Pulmonary Disease
COMPLETED71 Analytics
NCT01200524A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Posttraumatic Neuralgia..Nerve Pain
COMPLETED133 Analytics
NCT01215279AZD2423 Safety and Tolerability Study in Patients With Moderate and Severe Chronic Obstructive Pulmonary Disease(COPD)Chronic Obstructive Pulmonary Disease
COMPLETED63 Analytics
NCT01201317A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Painful Diabetic PolyneuropathyNeuropathic Pain
COMPLETED134 Analytics
PHASE2COMPLETED
Investigation of the Effect of Oral Treatment With 100 mg AZD2423 in Subjects With Mild Chronic Obstructive Pulmonary Disease (COPD)
Chronic Obstructive Pulmonary DiseaseUnlock trial analytics
PHASE2COMPLETED
A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Posttraumatic Neuralgia..
Nerve PainUnlock trial analytics
PHASE2COMPLETED
AZD2423 Safety and Tolerability Study in Patients With Moderate and Severe Chronic Obstructive Pulmonary Disease(COPD)
Chronic Obstructive Pulmonary DiseaseUnlock trial analytics
PHASE2COMPLETED
A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Painful Diabetic Polyneuropathy
Neuropathic PainUnlock trial analytics

Study Endpoints

Primary Endpoints

Absolute Monocyte Count in BAL Post-LPS Challenge
Day 11

Monocyte count in BAL post-LPS challenge (Day 11)

Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score.
Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28

Last Observation Carried Forward (LOCF). Twice daily, the participants rated their Average Pain intensity during the past 12 hours on an Numerical Rating Scale (NRS) scale 0-10. 0= No pain, 10= Worst pain imaginable.

Number of Participants With Clinically Significant Changes in Laboratory Variables Other Than Monocytes
Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)

Number of all participants with clinically significant changes in laboratory variables, except monocyte, assessed at all the listed time points

Number of Participants With Clinically Significant Changes in Vital Signs
Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)

Number of participants with clinically significant changes in vital signs assessed at all the listed time points

Number of Participants With Clinically Significant Changes in ECG Variables
Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)

Number of participants with clinically significant changes in ECG variables assessed at all the listed time points

Number of Participants With Clinically Significant Changes in Physical Examination
Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)

Number of participants with clinically significant changes in physical examination assessed at all the listed time points

Monocytes at Baseline
Day 1

Monocyte count in peripheral blood at baseline (Pre-dose, Day 1)

Monocytes at End of Treatment
week 4

Monocyte count in peripheral blood at end of treatment (4 weeks)

Monocytes at Follow-up
week 5 (follow-up)

Monocyte count in peripheral blood at follow-up (Week 5; 1 week after end of treatment)

Secondary Endpoints

Total Neutrophils in Biopsy Sample (Post-LPS Challenge)
Day 11
Total Macrophages in Biopsy Sample (Post-LPS Challenge)
Day 11
CD45+ in Biopsy Sample (Post-LPS Challenge)
Day 11
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
1EXPERIMENTALOral treatment
2PLACEBO_COMPARATOROral treatment
AZD2423, 20mgEXPERIMENTAL -
AZD2423, 150 mgEXPERIMENTAL -
PlaceboPLACEBO_COMPARATORTablet to match the 20 mg and 50 mg AZD2423 active tablet
AZD2423EXPERIMENTALAZD2423 Oral Treatment for 28 days
AZD2423, 20 mgEXPERIMENTALTablets, 20 mg once daily in the morning.

Interventions

NameTypeDescription
AZD2423DRUG100mg Oral dose od
AZD2423 PlaceboDRUGOral dose od
PlaceboDRUGPlacebo
Placebo to AZD2423DRUGOral treatment once daily for 28 days
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Only women of non-child bearing potential are included in the study i.e. women who are permanently or surgically sterilised or post menopausal. * ≥ 40 years of age at Visit 1 * Clinical diagnosis of COPD (GOLD stage 1) * FEV1 ≥ 80% of the predicted normal post-bronchodilator a...

Countries:GermanyBulgariaDenmarkFrancePolandRussiaSwedenUnited KingdomSlovakiaUnited StatesCanada
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Frequently asked questions about AZD2423

What is AZD2423?

AZD2423 is an investigational small molecule developed by AstraZeneca PLC. It has been studied in Phase 2 clinical trials for chronic obstructive pulmonary disease (COPD) and for nerve pain, including neuropathic pain. It is a CCR2 antagonist and is not an approved medicine.

What is AZD2423 used for?

AZD2423 has been studied in clinical trials for chronic obstructive pulmonary disease (COPD) and for nerve pain, including neuropathic pain such as painful diabetic polyneuropathy and posttraumatic neuralgia. It is investigational and has not been approved for any use.

What does AZD2423 target?

AZD2423 targets CCR2, a chemokine receptor. It acts as a CCR2 antagonist, meaning it blocks this receptor rather than activating it. This target class is the basis for its study in inflammatory airway disease such as COPD and in neuropathic pain conditions.

Who makes AZD2423?

AZD2423 is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca sponsored the Phase 2 studies of the compound in COPD and in nerve pain, including neuropathic pain.

What phase is AZD2423 in?

AZD2423 is in Phase 2 development. It is investigational and has not been approved by the FDA or any other regulator. All of its recorded Phase 2 trials are completed, and no trials are currently active.

What clinical trials is AZD2423 in?

Four completed Phase 2 trials are recorded for AZD2423: NCT01215279 and NCT01153321 in COPD, NCT01201317 in painful diabetic polyneuropathy, and NCT01200524 in posttraumatic neuralgia. All were randomized, double-blind, and placebo-controlled, with enrollment ranging from 63 to 134 participants.

Is AZD2423 the same as Part 2 - AZD2423 or Part 3 - AZD2423?

Yes. AZD2423 is also referred to as Part 2 - AZD2423, Part 2- AZD2423, Part 3 - AZD2423, and Part 3- AZD2423. These are alternate labels for the same AstraZeneca CCR2 antagonist compound, so searches using any of these names refer to AZD2423.