Trial record 1 of 1 for:
D6582C00001
An Efficacy and Safety Study of Mitiperstat (AZD4831) (MPO Inhibitor) vs Placebo in the Treatment of Moderate to Severe COPD. (CRESCENDO)
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| ClinicalTrials.gov Identifier: NCT05492877 |
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Recruitment Status :
Recruiting
First Posted : August 9, 2022
Last Update Posted : February 28, 2024
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Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
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Brief Summary:
This is a research study to evaluate the efficacy and safety of the investigational drug Mitiperstat (AZD4831) in adult patients with chronic obstructive pulmonary disease.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Obstructive Pulmonary Disease (COPD) | Drug: Mitiperstat (AZD4831) Other: Placebo | Phase 2 |
Study D6582C00001 is a phase IIa randomised, double blind, placebo controlled, parallel arm study to evaluate the efficacy and safety of Mitiperstat (AZD4831) in adult participants with moderate to severe chronic obstructive pulmonary disease.
Approximately 100 sites globally will participate in this study. Approximately 406 participants will be randomised to two treatment groups; Mitiperstat (AZD4831) vs placebo in a 1:1 ratio.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 406 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Participants will be randomised to receive either Mitiperstat (AZD4831) or placebo. |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase IIa Randomised, Double Blind, Placebo Controlled, Parallel Arm, Multi-Centre Study to Evaluate the Efficacy and Safety of Mitiperstat (AZD4831), for 12-24 Weeks, in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) |
| Actual Study Start Date : | November 14, 2022 |
| Estimated Primary Completion Date : | November 15, 2024 |
| Estimated Study Completion Date : | November 15, 2024 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo
Approximately 203 participants will be randomised to receive placebo.
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Other: Placebo
Oral dosage, once daily. |
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Experimental: Mitiperstat (AZD4831)
Approximately 203 participants will be randomised to receive mitiperstat (AZD4831).
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Drug: Mitiperstat (AZD4831)
Oral dosage, once daily. |
Primary Outcome Measures :
- To evaluate the effect of mitiperstat (AZD4831) as compared to placebo on the time to first COPD Composite Exacerbation (CompEx) event in patients with moderate to severe COPD. [ Time Frame: From baseline to up to 24 weeks ]All patients randomised to either active or placebo arm.
Secondary Outcome Measures :
- To assess the pharmacokinetics (PK) of mitiperstat (AZD4831) in patients with moderate to severe COPD. [ Time Frame: Baseline and week 12 (or at early discontinuation visit due to rash) ]Measurement of Maximum Plasma Concentration (Cmax) at pre-randomisation (baseline visit) and week 12 (or at early discontinuation visit due to rash).
- To assess the PK of mitiperstat (AZD4831) in patients with moderate to severe COPD [ Time Frame: Baseline and week 12 (or at early discontinuation visit due to rash) ]Measurement of Time to Reach Maximum Plasma Concentration (Tmax) at pre-randomisation (baseline visit) and week 12 (or at early discontinuation visit due to rash).
- To evaluate the effect of mitiperstat (AZD4831) as compared to placebo on the time to first moderate or severe exacerbation. [ Time Frame: From baseline to up to week 24 ]All patients randomised to either active or placebo arms.
- To assess the effects of mitiperstat (AZD4831) as compared to placebo on post-bronchodilator (BD) forced expiratory volume in the first second (FEV1) in patients with moderate to severe COPD. [ Time Frame: From baseline to week 12 ]All patients randomised to either active or placebo arms. Change in post-BD FEV1.
- To assess the effect of mitiperstat (AZD4831) compared to placebo on respiratory symptoms in patients with moderate to severe COPD. [ Time Frame: From baseline to week 12 and week 24 ]All patients randomised to either active or placebo arms. Change from baseline in EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) which is a 14-item ePRO instrument developed to assess the frequency, severity and duration of COPD exacerbations.
- To assess the effect of mitiperstat (AZD4831) compared to placebo on respiratory symptoms in patients with moderate to severe COPD. [ Time Frame: From baseline to week 12 and week 24 ]All patients randomised to either active or placebo arms. Change from baseline in Breathlessness, Cough and Sputum Score (BCSS) with the 5-point Likert scale ranging from 0 (no symptoms) to 4 (severe symptoms).
- To assess the effect of mitiperstat (AZD4831) compared to placebo on respiratory symptoms in patients with moderate to severe COPD. [ Time Frame: From baseline to week 12 and week 24 ]All patients randomised to either active or placebo arms. Change from baseline in cough Visual Analogue Scale (cough VAS) with the 100-point linear scale ranging from 0 (no cough) to 100 (worst cough).
- To assess the effect of mitiperstat (AZD4831) compared to placebo in disease impact in patients with moderate to severe COPD. [ Time Frame: From baseline to Week 12 ]All patients randomised to either active or placebo arms. Change from baseline in total COPD Assessment Test (CAT) with the 5-point Likert scale ranging from 0 (no symptoms/no impact) to 5 (severe symptoms/impact).
Information from the National Library of Medicine
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| Ages Eligible for Study: | 40 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Provision of informed consent.
- Participants must be deemed as high risk of exacerbations as defined by: >= 1 moderate or severe exacerbation in the previous 24 months; or frequent productive cough; or post-bronchodilator (BD) forced expiratory volume in the first second (FEV1) < 50% predicted.
- Participants must be 40-80 years of age inclusive, at the time of signing informed consent form (ICF).
- Participants who have a confirmed primary diagnosis of moderate to severe COPD.
- Participants who are current or ex-smokers with a tobacco history of ≥ 10 pack-years.
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Participants who have a documented stable regimen of triple therapy or dual therapy for
≥ 3 months prior to enrolment.
- Body mass index within the range 18 to 40 kg/m2 (inclusive).
Exclusion Criteria:
- As judged by the investigator, any evidence of any active medical or psychiatric condition or other reason (at SV1 [screening] and SV3 [pre-dose]) which in the investigator's opinion makes it undesirable for the participant to participate in the study.
- Current diagnosis of asthma or past diagnosis of asthma which persisted beyond the age of 25 years.
- Clinically important pulmonary disease other than COPD.
- Any other clinically relevant abnormal findings on physical examination, laboratory testing including haematology, coagulation, serum chemistry, or urinalysis; or chest CT scan at screening or randomisation, which in the opinion of the investigator or medical monitor may compromise the safety of the participant in the study or interfere with evaluation of the study intervention or reduce the participant's ability to participate in the study.
- History of a clinically significant infection (viral, bacterial, or fungal; defined as requiring systemic antibiotics, antiviral, or antifungal medication for > 7 days) within 4 weeks prior to SV3 (Day 1) (including unexplained diarrhoea) or clinical suspicion of infection at time of dosing.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05492877
Contacts
| Contact: AstraZeneca Clinical Study Information Center | 1-877-240-9479 | information.center@astrazeneca.com |
Locations
Show 115 study locations
Sponsors and Collaborators
AstraZeneca
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT05492877 |
| Other Study ID Numbers: |
D6582C00001 2022-002441-18 ( EudraCT Number ) |
| First Posted: | August 9, 2022 Key Record Dates |
| Last Update Posted: | February 28, 2024 |
| Last Verified: | February 2024 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by AstraZeneca:
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Mitiperstat AZD4831 Myeloperoxidase MPO |
Myeloperoxidase inhibitor COPD Chronic Obstructive Pulmonary Disease Lung function |
Additional relevant MeSH terms:
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Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases |
Chronic Disease Disease Attributes Pathologic Processes |