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Monoclonal Antibodies

Itepekimab for COPD (AERIFY-3 Trial)

Phase 2
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 70 years of age inclusive
Participants treated with SoC controller therapy for ≥3 months before Screening (Visit 1) and at a stable dose and regimen of controller therapy for at least 1 month before the screening visit AND during the screening period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to end of study (week 32)
Awards & highlights
No Placebo-Only Group

AERIFY-3 Trial Summary

This trialtests how a new drug, Itepekimab, affects airway inflammation in smokers with COPD. Participants will stay on their current COPD treatments while being monitored over 36 weeks.

Who is the study for?
This trial is for former and current smokers aged 40-70 with COPD, diagnosed per GOLD standards. They must have a BMI ≥18 kg/m2, be vaccinated against SARS-CoV-2, not pregnant or breastfeeding (if female), and agree to contraception if of childbearing potential. Participants should have used standard COPD treatments for at least 3 months and had an exacerbation treated with steroids in the past 5 years.Check my eligibility
What is being tested?
The study tests Itepekimab's effect on airway inflammation in COPD patients over a total of approximately 36 weeks: a four-week screening period, twelve-week treatment period, followed by twenty weeks of follow-up while maintaining their usual COPD medications.See study design
What are the potential side effects?
While specific side effects are not listed here, as an anti-IL-33 monoclonal antibody like Itepekimab can cause immune-related reactions such as infusion responses or allergic reactions; it may also affect how the body responds to infections.

AERIFY-3 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 70 years old.
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I have been on a stable dose of my standard asthma treatment for at least 4 months.
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I have been diagnosed with COPD for at least a year.
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I have been vaccinated against COVID-19 at least a week before my screening.
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I am not pregnant or breastfeeding and either cannot become pregnant or agree to use birth control.
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I quit smoking more than 6 months ago and don't plan to start again.
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I have symptoms like coughing and mucus that suggest I have chronic bronchitis.
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I've had a severe asthma attack treated with steroids in the last 5 years.

AERIFY-3 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to end of study (week 32)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to end of study (week 32) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A: Log2 relative change from baseline in gene expression in endobronchial biopsies
Part B: Change from baseline in Itepekimab treatment normalized enrichment score (NES) developed in Part A in endobronchial biopsies
Secondary outcome measures
Part A: Change from baseline in IL-33 treated eosinophil and mast cell-derived NES in endobronchial biopsies
Part A: Change from baseline in blood eosinophil count
Part A: Change from baseline in bronchial allergen challenge-derived NES in endobronchial biopsies
+15 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

AERIFY-3 Trial Design

1Treatment groups
Experimental Treatment
Group I: ItepekimabExperimental Treatment1 Intervention
This arm includes participants from 3 populations: Part A-former smokers, Part B-former smokers and Part B-current smokers. Subcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for 12 weeks

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,154 Previous Clinical Trials
3,508,533 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
607 Previous Clinical Trials
378,287 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
856 Previous Clinical Trials
2,020,189 Total Patients Enrolled

Media Library

Itepekimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05326412 — Phase 2
Chronic Obstructive Pulmonary Disease Research Study Groups: Itepekimab
Chronic Obstructive Pulmonary Disease Clinical Trial 2023: Itepekimab Highlights & Side Effects. Trial Name: NCT05326412 — Phase 2
Itepekimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05326412 — Phase 2

Frequently Asked Questions

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

Does this research include participants over the age of 40?

"According to the outlined parameters of this trial, individuals aged 40 and above but below 70 are eligible for enrollment."

Answered by AI

Are there any vacancies remaining for participants in this clinical trial?

"Indeed, the information on clinicaltrials.gov states that recruitment for this trial is in progress. It was posted initially on May 19th 2022 and most recently updated January 17th 2023. The study requires 60 patients to be enrolled from two sites."

Answered by AI

What impact has Itepekimab been found to have on patients' well-being?

"Our risk assessment of itepekimab's safety is moderate, rating a 2 out of 3. This drug has passed through stage two clinical trials, demonstrating some proof-of-concept regarding its security; however, there is no definitive evidence on the efficacy yet."

Answered by AI

Who would be an ideal candidate for this medical experiment?

"This medical trial is seeking 60 participants from the age range of 40-70 with a confirmed diagnosis of chronic obstructive pulmonary disease (COPD). To be eligible for enrolment, volunteers must have smoked for at least 10 pack-years and their COPD symptoms should have been present in the year preceding screening. Additionally, they must not currently be smoking or planning to start any smoking cessation interventions before or during the screening period. Furthermore, those partaking must meet other criteria such as having experienced moderate exacerbations requiring systemic corticosteroids/antibiotics and receiving stable doses of controller therapy among others. Finally, it is obligatory that"

Answered by AI

What goals are you attempting to accomplish with this research?

"This trial, which will be tracked from the outset to Week 12, has one primary goal: a logarithmic shift in gene expression as observed through endobronchial biopsies. Secondary objectives include an alteration of interleukin-33 affected eosinophil and mast cell derived NESs when tested on former smokers with COPD; likewise, changes must also be monitored in preclinical mouse models-derived neutrophilic extracellular traps (NESs) amongst this cohort."

Answered by AI

How many individuals are taking part in the clinical trial?

"Affirmative, the clinical trial is presently open for enrollment. As per the info posted on clinicaltrials.gov, this study was first available on May 19th 2022 and last edited on January 17th 2023. The researchers need 60 participants from two locations."

Answered by AI
~17 spots leftby Nov 2024