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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

AERIFY-1 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.Check my eligibility
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.See study design
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.

AERIFY-1 Trial 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.
Select...
I have been diagnosed with COPD for at least a year.
Select...
I smoked for 10 or more years but quit at least 6 months ago and don't plan to start again.
Select...
I have moderate-to-severe chronic obstructive pulmonary disease.
Select...
I have had a chronic cough for at least 3 months in the past year, and it's not due to other known causes.
Select...
I've had 2 or more moderate or 1 severe flare-up in the last year, treated with steroids.
Select...
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.
Select...
I am not pregnant or breastfeeding and either cannot become pregnant or will follow birth control guidelines.

AERIFY-1 Trial 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)
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Heart rate
Secondary outcome measures
Adrenal Cortex Hormones
Annualized rate of severe AECOPD
Change from baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) total score
+12 more

AERIFY-1 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

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,160 Previous Clinical Trials
3,513,502 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
613 Previous Clinical Trials
378,785 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,017,995 Total Patients Enrolled

Media Library

Itepekimab SAR440340 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04701983 — Phase 3
Chronic Obstructive Pulmonary Disease Research Study Groups: Itepekimab Q2W, Itepekimab Q4W, Placebo
Chronic Obstructive Pulmonary Disease Clinical Trial 2023: Itepekimab SAR440340 Highlights & Side Effects. Trial Name: NCT04701983 — Phase 3
Itepekimab SAR440340 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04701983 — Phase 3
Chronic Obstructive Pulmonary Disease Patient Testimony for trial: Trial Name: NCT04701983 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I possibly participate in this test if I qualify?

"This trial is looking for 930 patients that have obstructive lung disease and are between 40-85 years old. To meet the criteria for this study, participants must have moderate exacerbations, be diagnosed with COPD by a physician, have a smoking history of 10 pack years, not currently be smoking, and quit smoking 6 months prior to screening. Additionally, participants must have standard care controller therapy 3 months prior to screening at a stable dose for 1 month prior to screening. This includes inhaled corticosteroid (ICS) + long-acting beta-agonist (LABA), long-acting muscarinic antagonist (LAMA"

Answered by AI

Could people who are 50 or older still participate in this research project?

"This clinical trial only enrolls patients aged 40 to 85. If you are looking for a similar study but outside of this age range, there are 480 trials for patients over 65 and 36 for those under 18."

Answered by AI

Are there many hospitals doing this research in America?

"This trial has 80 different sites across the States, for example Clinrx Research-Site Number:8400021 in Carrollton, Clearlake Specialties-Site Number:8400025 in Webster, and Texas Tech University Health Sciences Center-Site Number: 8400189."

Answered by AI

Are enrolling any more patients in this clinical trial?

"From what is indicated on clinicaltrials.gov, this trial is still looking for patients to participate and has been since December 16th, 2020. The last update to the posting was on October 26th, 2022."

Answered by AI

Is Itepekimab SAR440340 dangerous to human beings?

"Itepekimab SAR440340 is estimated to be a safe medication because it has reached Phase 3 in clinical trials. This means that not only does the drug show some efficacy, but there is also multiple rounds of data supporting its safety."

Answered by AI

Could you please provide a list of all previous investigation involving Itepekimab SAR440340?

"Istekimab SAR440340 was first studied in 2020 at site number 8040004. There have been a total of 18279 completed studies as of now. Currently, there are two ongoing studies recruiting participants, with many of these taking place in Carrollton, Texas."

Answered by AI

Is this research project unique or have similar projects been undertaken in the past?

"There are 2 ongoing Itepekimab SAR440340 studies being conducted in 32 countries and 152 cities. The first study was completed in 2020 by Sanofi. That particular research project reached Phase 3 drug approval and involved 930 patients. To date, 18279 similar studies have been carried out since the year 2020."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Maine
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2
What site did they apply to?
University of Alabama at Birmingham-Site Number:8400012
GenHarp Clinical Solutions-Site Number:8400028
Noble Clinical Research-Site Number:8400182
Other

Why did patients apply to this trial?

I want to loose weight and feel better also see what is out there for my sleep apnea and COPD.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Average response time
  • < 2 Days
Most responsive sites:
  1. GenHarp Clinical Solutions-Site Number:8400028: < 48 hours
~249 spots leftby Jun 2025