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Monoclonal Antibodies

Itepekimab for COPD (AERIFY-2 Trial)

Verified Trial

Phase 3

Waitlist Available

Research Sponsored by Sanofi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant must be 40 to 85 years of age inclusive.

Physician diagnosis of COPD for at least 1 year (based on Global Initiative for Chronic Obstructive Lung Disease [GOLD] definition).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to eot (week 52 for initial randomized participants, 24 to 52 weeks for potential additional randomized former smoker participants)

Awards & highlights

Pivotal Trial

Summary

This trial will compare itepekimab to placebo in smokers with COPD to see if it reduces exacerbations and improves pulmonary function.

Who is the study for?

This trial is for adults aged 40-85 with moderate-to-severe COPD who are either current or former smokers. They must have had at least one severe exacerbation requiring hospitalization or two moderate ones treated with steroids in the past year, and be on a stable dose of standard COPD therapy.

What is being tested?

The study tests Itepekimab's effectiveness compared to a placebo in reducing the rate of severe COPD flare-ups, improving lung function, and enhancing quality of life among both current and former smokers with COPD.

What are the potential side effects?

While specific side effects aren't listed here, participants will be monitored for any adverse reactions to Itepekimab which could include typical drug-related responses such as allergic reactions, injection site discomfort, or other immune-related symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 40 and 85 years old.

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I have been diagnosed with COPD for at least a year.

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I have smoked at least 10 pack-years and if I quit, it was more than 6 months ago.

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I have moderate-to-severe chronic obstructive pulmonary disease.

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I have had a chronic cough for at least 3 months in the past year, and it's not due to other common causes.

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I've had at least 2 moderate or 1 severe breathing flare-up in the last year, treated with steroids.

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I've been on a stable asthma treatment for at least 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to eot (week 52 for initial randomized participants, 24 to 52 weeks for potential additional randomized former smoker participants)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to eot (week 52 for initial randomized participants, 24 to 52 weeks for potential additional randomized former smoker participants)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to eot (week 52 for initial randomized participants, 24 to 52 weeks for potential additional randomized former smoker participants) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Annualized rate of moderate or severe acute exacerbation of COPD (AECOPD) in former smokers

Secondary study objectives

Annualized rate of corticosteroid-treated AECOPD in former smokers

Annualized rate of moderate or severe AECOPD in current smokers

Annualized rate of severe AECOPD in former smokers

+9 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Itepekimab Q4W in former smokersExperimental Treatment2 Interventions

SC administration of Itepekimab every 4 weeks (Q4W) for up to 52 weeks, with alternating SC administration of matching placebo at the 2-week interval between active IMP

Group II: Itepekimab Q2W in former smokersExperimental Treatment1 Intervention

Subcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for up to 52 weeks

Group III: Itepekimab Q2W in current smokersExperimental Treatment1 Intervention

SC administration of Itepekimab every 2 weeks (Q2W) for 52 weeks

Group IV: Placebo in current smokersPlacebo Group1 Intervention

SC administration of matching placebo Q2W for 52 weeks

Group V: Placebo in former smokersPlacebo Group1 Intervention

SC administration of matching placebo Q2W for up to 52 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug