12 to 24 weeks of AZD4831 versus placebo for treatment of moderate to severe chronic obstructive pulmonary disease

A Phase IIa Randomised, Double-Blind, Placebo Controlled, Parallel Arm, Multi-Centre Study to Evaluate the Efficacy and Safety of AZD4831, for 12-24 Weeks, in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) - CRESCENDO

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-002441-18-ES

Enrollment

288

Registered

2022-09-30

Start date

2022-12-22

Completion date

Unknown

Last updated

2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 21.1 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Name: AZD4831 film-coated tablet 5 mg Product Code: AZD4831 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Not available CAS Number: 1933460-19-5 Current Sponsor code: AZD4831 Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Confirmed primary diagnosis of moderate to severe COPD as per FEV1/FVC =65 years) yes F.1.3.1 Number of subjects for this age range 144

Exclusion criteria

Exclusion criteria: 1. Positive diagnostic lateral flow test for SARS-CoV-2 at SV1 or SV3. Participants will be eligible for rescreening = 2 weeks after a positive SARS-CoV-2 lateral flow test once COVID-19 symptoms have resolved, at the investigator’s discretion 2. Current diagnosis of asthma or past diagnosis of asthma which persisted beyond the age of 25 years 3. Active malignancy requiring treatment (with the exception of basal cell or squamous cell carcinomas of the skin and stable prostate cancer) 4. Evidence of untreated active TB: Participants currently receiving treatment for active TB may be considered after completion of an appropriate course of therapy. 5. Change in smoking status in 12 weeks prior to enrolment or intention to change smoking status between enrolment and end of follow-up. 6. Current diagnosis of hyperthyroidism, uncontrolled hypothyroidism (including but not limited to TSH = 10 mIU/mL), or any clinically significant thyroid disease. 7. Participant who is going to start or finish intensive COPD rehabilitation program at anytime during study period. Participants can be recruited immediately following the completion of their COPD rehabilitation program.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effect of AZD4831 as compared to placebo on the time to first COPDCompEx event.;Secondary Objective: - To assess the PK of AZD4831 in participants with moderate to severe COPD. - To evaluate the effect of AZD4831 as compared to placebo on the time to first moderate or severe COPD exacerbation. - To assess the effects of AZD4831 as compared to placebo on post-BD FEV1 in participants with moderate to severe COPD. - To assess the effect of AZD4831 compared with placebo on respiratory symptoms in participants with moderate to severe COPD. - To assess the effect of AZD4831 compared with placebo on disease impact participants with moderate to severe COPD.;Primary end point(s): Time to first COPDCompEx event. COPDCompEx events include changes in COPD symptoms, lung function testing, COPD exacerbations, study dropout due to lack of efficacy, and use of reliever medication.;Timepoint(s) of evaluation of this end point: Not applicable as this is an event driven endpoint.	—

Measure

Time frame

Main Objective: To evaluate the effect of AZD4831 as compared to placebo on the time to first COPDCompEx event.;Secondary Objective: - To assess the PK of AZD4831 in participants with moderate to severe COPD. - To evaluate the effect of AZD4831 as compared to placebo on the time to first moderate or severe COPD exacerbation. - To assess the effects of AZD4831 as compared to placebo on post-BD FEV1 in participants with moderate to severe COPD. - To assess the effect of AZD4831 compared with placebo on respiratory symptoms in participants with moderate to severe COPD. - To assess the effect of AZD4831 compared with placebo on disease impact participants with moderate to severe COPD.;Primary end point(s): Time to first COPDCompEx event. COPDCompEx events include changes in COPD symptoms, lung function testing, COPD exacerbations, study dropout due to lack of efficacy, and use of reliever medication.;Timepoint(s) of evaluation of this end point: Not applicable as this is an event driven endpoint.

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Secondary

Measure	Time frame
Secondary end point(s): - Plasma AZD4831 concentration-time profiles during the intervention and follow-up periods, and PK numbers. - Time to first COPD exacerbation event. - Change from baseline in post-BD FEV1 after 12 weeks. - Change from baseline in E-RS:COPD, BCSS score, and cough VAS at Week 12 and Week 24. - Change from baseline in Total CAT measured in clinic at Week 12. - Safety and tolerability evaluations using AEs, SAEs, AESIs (skin reactions, including maculopapular rash, and infections, including pneumonia), vital sign measures, clinical laboratory assessments (clinical chemistry, haematology, and urinalysis), and ECG. - Sputum parameters including colour, differential cell counts, and markers of neutrophil activation and inflammation; MPO- and neutrophil- related circulating biomarkers; Putative biomarkers of lung tissue destruction and COPD disease progression; Systemic biomarkers of cardiovascular comorbidities including fibrinogen, hsCRP, IL-6, and NT-proBNP. - Average change from baseline to Week 12 in MPO activity normalised to MPO concentration in sputum.;Timepoint(s) of evaluation of this end point: - To assess the PK of AZD4831 in participants with moderate to severe COPD (timepoint not applicable) - To evaluate the effect of AZD4831 as compared to placebo on the time to first moderate or severe COPD exacerbation (timepoint not applicable) - To assess the effects of AZD4831 as compared to placebo on post-BD FEV1 in participants with moderate to severe COPD (week 12) - To assess the effect of AZD4831 compared with placebo on respiratory symptoms in participants with moderate to severe COPD (week 12) - To assess the effect of AZD4831 compared with placebo on disease impact participants with moderate to severe COPD (week 12)	—

Measure

Time frame

Secondary end point(s): - Plasma AZD4831 concentration-time profiles during the intervention and follow-up periods, and PK numbers. - Time to first COPD exacerbation event. - Change from baseline in post-BD FEV1 after 12 weeks. - Change from baseline in E-RS:COPD, BCSS score, and cough VAS at Week 12 and Week 24. - Change from baseline in Total CAT measured in clinic at Week 12. - Safety and tolerability evaluations using AEs, SAEs, AESIs (skin reactions, including maculopapular rash, and infections, including pneumonia), vital sign measures, clinical laboratory assessments (clinical chemistry, haematology, and urinalysis), and ECG. - Sputum parameters including colour, differential cell counts, and markers of neutrophil activation and inflammation; MPO- and neutrophil- related circulating biomarkers; Putative biomarkers of lung tissue destruction and COPD disease progression; Systemic biomarkers of cardiovascular comorbidities including fibrinogen, hsCRP, IL-6, and NT-proBNP. - Average change from baseline to Week 12 in MPO activity normalised to MPO concentration in sputum.;Timepoint(s) of evaluation of this end point: - To assess the PK of AZD4831 in participants with moderate to severe COPD (timepoint not applicable) - To evaluate the effect of AZD4831 as compared to placebo on the time to first moderate or severe COPD exacerbation (timepoint not applicable) - To assess the effects of AZD4831 as compared to placebo on post-BD FEV1 in participants with moderate to severe COPD (week 12) - To assess the effect of AZD4831 compared with placebo on respiratory symptoms in participants with moderate to severe COPD (week 12) - To assess the effect of AZD4831 compared with placebo on disease impact participants with moderate to severe COPD (week 12)

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Countries

Bulgaria, Canada, Denmark, Germany, Italy, Netherlands, Poland, South Africa, Spain, Turkey, United Kingdom, United States

Contacts

Public ContactUnidad de Investigación Clínica

AstraZeneca Farmacéutica Spain, S.A.

informacionEECC-Spain@astrazeneca.com0034900200444

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026