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Monoclonal Antibodies

Itepekimab for COPD (AERIFY-1 Trial)

Phase 3

Recruiting

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 eos (week 72 for initial randomized participants, week 44 to 72 for potential additional randomized participants)

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new medication, itepekimab, to see if it is effective in treating COPD in former smokers. The study will also look at the safety and tolerability of the medication.

Who is the study for?

This trial is for former smokers aged 40-85 with moderate-to-severe COPD who have had at least one exacerbation while on current therapy. They must not be currently smoking, have quit at least 6 months prior, and agree to contraception if applicable. Excluded are those with certain cardiac arrhythmias, active autoimmune diseases or treatments, a current asthma diagnosis, or previous use of itepekimab.

What is being tested?

The study tests the effectiveness of Itepekimab (SAR440340) against a placebo in reducing the rate of severe COPD flare-ups in participants. It also examines its impact on lung function, symptoms severity, quality of life and collects data on drug safety and how the body processes it.

What are the potential side effects?

While specific side effects for Itepekimab aren't listed here, similar drugs can cause immune reactions, injection site discomforts like pain or swelling, respiratory issues such as coughing or shortness of breath and general symptoms including fatigue and headaches.

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 smoked for 10 or more years but quit at least 6 months ago and don't plan to start again.

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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 known causes.

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

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I have had at least one worsening of my breathing problem while on my current medication.

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

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I am not pregnant or breastfeeding and either cannot become pregnant or will follow birth control guidelines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to eos (week 72 for initial randomized participants, week 44 to 72 for potential additional randomized participants)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to eos (week 72 for initial randomized participants, week 44 to 72 for potential additional randomized participants)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to eos (week 72 for initial randomized participants, week 44 to 72 for potential additional randomized 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

Heart rate

Secondary study objectives

Adrenal Cortex Hormones

Annualized rate of severe AECOPD

Change from baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) total score

+12 more

Awards & Highlights

Pivotal Trial

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

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Itepekimab Q4WExperimental 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 Q2WExperimental Treatment1 Intervention

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

Group III: PlaceboPlacebo 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

Placebo

1995

Completed Phase 3

~2670