Mitiperstat for COPD

(CRESCENDO Trial)

No longer recruiting at 108 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AstraZeneca

Must be taking: Triple therapy, Dual therapy

Disqualifiers: Asthma, Other pulmonary disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 12

Duration: 12-24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a new drug, Mitiperstat, for individuals with chronic obstructive pulmonary disease (COPD), a condition that makes breathing difficult. Researchers aim to determine if Mitiperstat can reduce symptoms and ensure its safety. Participants will receive either the actual drug or a placebo (a pill with no active medicine) to compare results. The trial seeks individuals with moderate to severe COPD, frequent flare-ups, or a long history of smoking who are already on a stable treatment plan. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should have a stable regimen of triple or dual therapy for at least 3 months before joining, which suggests you may need to continue your current COPD treatment.

Is there any evidence suggesting that Mitiperstat (AZD4831) is likely to be safe for humans?

Research shows that Mitiperstat (AZD4831) is under testing for safety in treating chronic obstructive pulmonary disease (COPD). Previous studies indicate that Mitiperstat is generally well-tolerated. Most side effects, such as headaches and nausea, were mild to moderate and usually manageable. Serious side effects were rare. As the drug remains under study, further information will enhance understanding of its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for COPD?

Unlike the standard treatments for COPD, which typically involve bronchodilators and corticosteroids, Mitiperstat (AZD4831) works by targeting a different pathway. Researchers are excited about this treatment because it inhibits the enzyme myeloperoxidase, which is thought to reduce inflammation and oxidative stress in the lungs. This novel mechanism could potentially offer improved symptom control and better lung function for patients with COPD, setting it apart from existing options.

What evidence suggests that Mitiperstat might be an effective treatment for COPD?

Research shows that Mitiperstat (AZD4831), which participants in this trial may receive, targets a type of inflammation that significantly affects chronic obstructive pulmonary disease (COPD). This inflammation can lead to more frequent flare-ups and worsen the condition. Early findings suggest that Mitiperstat can reduce this inflammation, potentially decreasing flare-ups and improving symptoms in people with COPD. Previous studies have shown promise in improving breathing symptoms, which is crucial for those with moderate to severe COPD. These initial results offer hope that Mitiperstat could effectively manage COPD symptoms. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

Adults aged 40-80 with moderate to severe COPD, who are current or ex-smokers with a significant smoking history. They must have had at least one exacerbation in the past two years or show other signs of high risk for exacerbations and be on a stable regimen of COPD therapy.

Inclusion Criteria

Provision of informed consent

I am between 40 and 80 years old.

I have been diagnosed with moderate to severe COPD.

Exclusion Criteria

I don't have any health issues that could make the study unsafe for me or affect the results.

I have a significant lung condition that is not COPD.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Mitiperstat (AZD4831) or placebo for up to 24 weeks

12-24 weeks

Baseline visit, week 12 visit, and week 24 visit

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AZD4831

Trial Overview

The trial is testing Mitiperstat (AZD4831), an experimental drug, against a placebo to see if it's effective and safe for treating chronic obstructive pulmonary disease (COPD) in adults.

How Is the Trial Designed?

Group I: Mitiperstat (AZD4831) Experimental Treatment 1 Intervention

Approximately 203 participants will be randomised to receive mitiperstat (AZD4831).

Group II: Placebo Placebo Group 1 Intervention

Approximately 203 participants will be randomised to receive placebo.

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05492877

NCT05492877 | An Efficacy and Safety Study of Mitiperstat ...

This is a research study to evaluate the efficacy and safety of the investigational drug Mitiperstat (AZD4831) in adult patients with chronic obstructive ...

2.

astrazenecaclinicaltrials.com

astrazenecaclinicaltrials.com/study/D6582C00001

An Efficacy and Safety Study of Mitiperstat (AZD4831) ...

This is a research study to evaluate the efficacy and safety of the investigational drug Mitiperstat (AZD4831) in adult patients with chronic obstructive ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12477066/

Phase 2a, Randomized Trial of Mitiperstat Versus Placebo in ...

Neutrophilic inflammation, a key feature of chronic obstructive pulmonary disease (COPD), is associated with exacerbations and poor outcomes.

4.

s3.amazonaws.com

s3.amazonaws.com/ctr-med-7111/D6582C00001/9d47cf65-5b68-48b9-ad78-4cbf1f20dc73/3650306e-92c2-48cf-a972-4f9d9de26a38/D6582C00001_CSR_Synopsis-v2.pdf

A Phase IIa Randomised, Double Blind, Placebo ...

To assess the effect of mitiperstat compared with placebo on respiratory symptoms in patients with moderate to severe COPD. Population: all ...

5.

trial.medpath.com

trial.medpath.com/clinical-trial/76149e7170e98d16/euctr2022-002441-18-bg-mitiperstat-azd4831-copd-efficacy-safety

An Efficacy and Safety Study of Mitiperstat (AZD4831) (MPO ...

4. Clinically stable and free from an exacerbation of COPD for 1 month prior to SV1 (screening) and prior to Day 1. 5. Participants who are at least 70% ...