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AZD5423

Phase 2

Asthma | Small molecule | Respiratory |AstraZeneca PLC|Trials Updated: Apr 2, 2015

AZD5423 development status

Highest phase Phase 2
Registered trials 7 across 1 sponsor since Aug 2009

AZD5423 target and mechanism

Molecular targetNR3C1
Target classModulator
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials3
Total Enrollment392

FDA Designations

No designations recorded

AZD5423 clinical trials

AZD5423 · 3 trials · 3 indications

Phase 2 2Phase 1 1
NCT01555099Multi-centre Study to Assess the Efficacy and Safety of AZD5423 in COPD Patients on a Background Therapy of FormoterolChronic Obstructive Pulmonary Disease (COPD)
COMPLETED353 Analytics
NCT01225549The Study Will Evaluate the Efficacy of AZD5423 in Patients With Mild Asthma Challenged With an Inhaled AllergenAsthma
COMPLETED27 Analytics
PHASE2COMPLETED
Multi-centre Study to Assess the Efficacy and Safety of AZD5423 in COPD Patients on a Background Therapy of Formoterol
Chronic Obstructive Pulmonary Disease (COPD)Unlock trial analytics
PHASE2COMPLETED
The Study Will Evaluate the Efficacy of AZD5423 in Patients With Mild Asthma Challenged With an Inhaled Allergen
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Absolute change from baseline to mean of weeks 8 to 12 in pre-dose forced expiratory volume in 1 sec (FEV1)
Baseline (week 0), and at week 8, 10, and 12
Late Allergic Response (LAR) by Assessment of Minimum Percentage of FEV1 3-7 Hours Post Allergen Challenge Compared to Pre Allergen Challenge FEV1
From Randomization to end of treatment

LAR was assessed on Day 6 as minimum percentage of FEV1 over 3 to 7 hours based on the analysis of the minimum percentage of FEV1 remaining over 3 to 7 hours post allergen challenge (post AC) compared to pre allergen challenge (pre AC) FEV1

Pharmacokinetics of AZD5423 measured by: Absolute bioavailability (F)
Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period
Pharmacokinetics of AZD5423 measured by: Pulmonary bioavailability (Fpulmonary)
Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period
Pharmacokinetics of AZD5423 measured by: Oral bioavailability after inhaled treatments (Foral)
Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period
Pharmacokinetics of AZD5423 measured by: Area under the plasma concentration-time curve from time zero to infinity (AUC).
Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period

Secondary Endpoints

Percent change from baseline in twenty-four hour plasma cortisol
Baseline (week 0), and at week 4 and 12
Time to first exacerbation (hospitalisation, oral/parenteral corticosteroid, oral/parenteral antibiotics)
Baseline(week 0) and week 2, 4, 8, 10, 12 and daily by eDairy
The percent change from baseline in pre-dose hsCRP at week 4 and 12
Baseline(week 0), and at week 4 and 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AZD5423EXPERIMENTALNew study drug
BudesonideACTIVE_COMPARATORComparator to which the new study drug will be compared
PlaceboPLACEBO_COMPARATORNo drug to which both other arms will be compared
1EXPERIMENTALAZD5423 75ug
2EXPERIMENTALAZD5423 300ug
3ACTIVE_COMPARATORBudesonide 200 microgram
4PLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
AZD5423DRUGoral inhaled
BudesonideDRUGoral inhaled
PlaceboDRUGoral inhaled
Budesonide 200 microgramDRUGDry powder for inhalation twice daily 7 days
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites44

Inclusion Criteria: * Provision of signed and dated informed consent prior to conducting any study specific procedures * Men or women aged ≥ 40 years * Men or post-menopausal or surgically sterile women. Women will be considered post-menopausal if they have been amenorrheic for at least 12 months, ...

Countries:BulgariaFranceHungaryItalyPolandRussiaSlovakiaUkraineCanadaUnited Kingdom
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Frequently asked questions about AZD5423

What is AZD5423?

AZD5423 is an investigational small molecule drug developed by AstraZeneca PLC for respiratory conditions, specifically asthma and chronic obstructive pulmonary disease (COPD). It is a modulator of NR3C1, also known as the glucocorticoid receptor. AZD5423 has completed Phase 2 clinical trials and has not been approved for any indication.

What is AZD5423 used for in asthma and COPD?

AZD5423 was studied for the treatment of asthma and chronic obstructive pulmonary disease (COPD). In COPD, it was evaluated in patients receiving background therapy with formoterol. In asthma, it was tested in patients with mild asthma challenged with an inhaled allergen. The drug remains investigational and is not approved for these or any other uses.

What does AZD5423 target?

AZD5423 targets NR3C1, the glucocorticoid receptor. It is classified as a modulator of this receptor. By interacting with NR3C1, AZD5423 is designed to modulate glucocorticoid receptor activity, which is relevant to inflammatory respiratory conditions such as asthma and COPD. The drug is a small molecule administered via inhalation in clinical studies.

Who is developing AZD5423?

AstraZeneca PLC, which trades under the ticker AZN, is the developer of AZD5423. The company sponsored the clinical trials evaluating the drug in asthma and COPD. AstraZeneca is a global biopharmaceutical company headquartered in the United Kingdom.

What phase is AZD5423 in?

AZD5423 has completed Phase 2 clinical development. Two Phase 2 trials and one Phase 1 trial have been completed, with no active trials ongoing. The drug is investigational and has not received FDA approval. It was studied in a total of 353 participants across the Phase 2 COPD trial and smaller asthma studies.

What clinical trials is AZD5423 in?

AZD5423 has been evaluated in completed trials including NCT01555099, a Phase 2 study in COPD patients on formoterol background therapy with 353 participants across multiple European countries. NCT01225549 was a Phase 2 allergen challenge study in mild asthma with 27 patients in Canada. NCT01310322 was a Phase 1 pharmacokinetic study in healthy subjects and mild asthmatics in the United Kingdom.