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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, 44 to 72 weeks for potential additional randomized former smoker participants)
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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 eos (week 72 for initial randomized participants, 44 to 72 weeks for potential additional randomized former smoker participants)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to eos (week 72 for initial randomized participants, 44 to 72 weeks for potential additional randomized former smoker participants)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Annualized rate of moderate or severe acute exacerbation of COPD (AECOPD) in former smokers
Secondary outcome measures
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
+18 moreTrial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: Itepekimab Q4W in former smokersExperimental Treatment1 Intervention
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
Find a Location
Who is running the clinical trial?
Regeneron PharmaceuticalsIndustry Sponsor
625 Previous Clinical Trials
380,588 Total Patients Enrolled
SanofiLead Sponsor
2,166 Previous Clinical Trials
3,515,053 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
863 Previous Clinical Trials
2,018,981 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a current smoker and not planning to quit soon.I have had severe breathing issues that needed steroids or antibiotics.I have had severe lung flare-ups needing more than a day's hospital stay.I've been on a stable asthma treatment for at least 3 months.I have asthma or had it before I turned 18.I have not vaped any products in the last 6 months.I do not have active or latent TB, nor have I been in close contact with TB patients recently.I have been diagnosed with COPD for at least a year.I have had a chronic cough for at least 3 months in the past year, and it's not due to other known causes.I have or might have COVID-19, or I've been in close contact with someone who has it.I have smoked at least 10 pack-years and if I quit, it was more than 6 months ago.I have an active autoimmune disease or am on immunosuppressive therapy for one.I have irregular heartbeats, including occasional atrial fibrillation.I have had a chronic cough for at least 3 months in the past year, and it's not due to other common causes.I've had at least 2 moderate or 1 severe breathing flare-up in the last year, treated with steroids.I am between 40 and 85 years old.I need a BiPAP machine due to high carbon dioxide levels in my blood.I have moderate-to-severe chronic obstructive pulmonary disease.I am not able to have children or I agree to use birth control during and after the study.I am between 40 and 85 years old.I have previously used itepekimab.I have been diagnosed with COPD for at least a year.I have moderate-to-severe chronic obstructive pulmonary disease.I have been diagnosed with heart issues related to lung blood pressure.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo in current smokers
- Group 2: Itepekimab Q2W in current smokers
- Group 3: Itepekimab Q2W in former smokers
- Group 4: Itepekimab Q4W in former smokers
- Group 5: Placebo in former smokers
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there other examples of scientific research using Itepekimab SAR440340?
"The first clinical trial for Itepekimab SAR440340 was in 2020. Since then, there have been a total of 18279 completed studies. Right now, there are 2 active trials taking place; many of these are located in Lampasas, Texas."
Answered by AI
Can regular people join this trial at this time?
"The clinical trial is still recruiting patients, as shown by the information available on clinicaltrials.gov. The first posting was on February 12th, 2021 and the most recent update was on October 26th, 2022. This study seeks to enroll 1170 individuals at 100 different sites."
Answered by AI
Does this research project restrict eligibility to people under 50 years old?
"The age requirements for this clinical trial are between 40 and 85 years old."
Answered by AI
What is the US government's opinion of Itepekimab SAR440340?
"Itepekimab SAR440340 has some efficacy data supporting it and multiple rounds of safety data, so it was given a score of 3 for safety."
Answered by AI
For which patient demographics is this study looking for participants?
"This trial is admitting 1170 patients with airflow obstruction and chronic aged 40 and 85. Most notable, patients must meet the following criteria: A physician diagnosis of COPD for at least 1 year (based on Global Initiative for Chronic Obstructive Lung Disease [GOLD] definition., Moderate exacerbations will be recorded by the Investigator and are defined as acute worsening of respiratory symptoms that requires either systemic corticosteroids (IM, IV, or oral) and/or antibiotics., Severe exacerbations will be recorded by the Investigator and are defined as AECOPD that require hospitalization or observation for >24 hours in emergency department"
Answered by AI
Who else is applying?
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What state do they live in?
Florida
Tennessee
Other
Arizona
What site did they apply to?
Noble Clinical Research
Renstar Medical Research
Probe Clinical Research Corporation-Site Number:8400188
Other
How many prior treatments have patients received?
2
3+
Why did patients apply to this trial?
looking for help with my copd. Current treatments seem diminished effect. Why not? COPD is a killer so anything may help.
PatientReceived 2+ prior treatments
i HAVE TRIED OTHER TREATMENTS AND THEY HAVE NOT HELPED.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How much does it pay?
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Phone Call
Average response time
- < 2 Days
Most responsive sites:
- Noble Clinical Research: < 24 hours
- Renstar Medical Research: < 48 hours
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