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AZD1236

Phase 2

Chronic Obstructive Pulmonary Disease | Small molecule | Respiratory |AstraZeneca PLC|Trials Updated: Apr 16, 2015

AZD1236 development status

Highest phase Phase 2
Registered trials 4 across 1 sponsor since Sep 2008

AZD1236 target and mechanism

Molecular targetMMP12, MMP9
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment129

FDA Designations

No designations recorded

AZD1236 clinical trials

AZD1236 · 2 trials · 1 indication

Phase 2 2
NCT00758459Safety/Tolerability Study With AZD1236 in Chronic Obstructive Pulmonary Disease (COPD) PatientsChronic Obstructive Pulmonary Disease
COMPLETED74 Analytics
NCT00758706A Phase IIa Study Assessing the Effects of AZD1236 on Biomarkers in Chronic Obstructive Pulmonary Disease (COPD) PatientsChronic Obstructive Pulmonary Disease
COMPLETED55 Analytics
PHASE2COMPLETED
Safety/Tolerability Study With AZD1236 in Chronic Obstructive Pulmonary Disease (COPD) Patients
Chronic Obstructive Pulmonary DiseaseUnlock trial analytics
PHASE2COMPLETED
A Phase IIa Study Assessing the Effects of AZD1236 on Biomarkers in Chronic Obstructive Pulmonary Disease (COPD) Patients
Chronic Obstructive Pulmonary DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Adverse Events
all study visits

Number of patients who had an Adverse Event

Ratio of TNF Alpha at Week 6 to Baseline
Baseline and Week 6

Ratio reflects Sputum Tumor Necrosis Factor alpha (TNF alpha) at week 6 value divide by baseline value. Baseline is geometric mean of Visit 2 (last value during run-in) and Visit 3 (Randomization).

Ratio of Sputum Total Cells at Week 6 to Baseline
Baseline and Week 6

Ratio reflects Sputum Total Cells at week 6 value divide by baseline value. Baseline is geometric mean of Visit 2 (last value during run-in) and Visit 3 (Randomization).

Ratio of Total Urine Desmosine at Week 6 to Baseline
Baseline and Week 6

Ratio reflects Total Urine Desmosine at week 6 value divide by baseline value. Baseline is visit 3(Randomization) value.

Secondary Endpoints

Forced Expiratory Volume in 1 Second (FEV1)
Before treatment and after 1, 2, 4 and 6 weeks of treatment
Forced Vital Capacity (FVC)
Before treatment and after 1, 2, 4 and 6 weeks of treatment
Vital Capacity (VC)
Before treatment and after 1, 2, 4 and 6 weeks of treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -
AZD1236EXPERIMENTALoral tablet, 75 mg, twice daily during 6 weeks
PlaceboPLACEBO_COMPARATORDosing to match AZD1236

Interventions

NameTypeDescription
AZD1236DRUGoral tablet, 75 mg, twice daily during 6 weeks
PlaceboDRUGDosing to match AZD1236
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: * Diagnosis of COPD for 1 month * Men or postmenopausal women * Spirometry values indicating reduced lung function * Smoking history equivalent to using 20 cigarettes a day for 10 years Exclusion Criteria: * Any current respiratory tract disorders other than COPD * Requirement...

Countries:BulgariaFinlandGermanyHungarySlovakiaDenmarkNetherlandsNorway
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Frequently asked questions about AZD1236

What is AZD1236 used for?

AZD1236 is an investigational small molecule developed for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It was studied in patients aged 40 years and older with COPD, and it has not been approved for any indication. All clinical work to date has focused on the COPD patient population.

What does AZD1236 target?

AZD1236 targets the enzymes MMP12 and MMP9, two matrix metalloproteinases. It acts as an inhibitor of these targets. MMP12 and MMP9 are associated with airway inflammation and tissue remodeling in respiratory disease, which is the rationale for studying the compound in Chronic Obstructive Pulmonary Disease.

Who makes AZD1236?

AZD1236 is developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca sponsored both Phase 2 clinical trials of the compound in Chronic Obstructive Pulmonary Disease, one assessing biomarkers and one evaluating safety and tolerability.

What phase is AZD1236 in?

AZD1236 is in Phase 2 development. Two Phase 2 trials in Chronic Obstructive Pulmonary Disease have been completed, and no trials are currently active. The compound is investigational and has not been approved by the FDA or any other regulatory agency for marketing.

What clinical trials is AZD1236 in?

AZD1236 has been studied in two completed Phase 2 trials. NCT00758706 assessed the effects of AZD1236 on biomarkers in COPD patients across Denmark, Finland, the Netherlands, and Norway. NCT00758459 evaluated safety and tolerability in COPD patients across Bulgaria, Finland, Germany, Hungary, and Slovakia.

How many patients were enrolled in AZD1236 trials?

The two completed Phase 2 trials of AZD1236 enrolled a total of 129 patients with Chronic Obstructive Pulmonary Disease. NCT00758706 enrolled 55 patients and NCT00758459 enrolled 74 patients. Both studies were randomized, double-blind, and placebo-controlled, and both required participants to be at least 40 years old.