What side effects are associated with this type of intervention?

Common treatments for COPD, particularly those involving monoclonal antibodies like Itepekimab (anti-IL-33), anti-IL-5, and anti-IL-4/13 agents, are generally associated with an increased risk of adverse events. These can include injection site reactions, increased risk of infections, headache, and gastrointestinal symptoms. Some treatments may also lead to elevated blood eosinophil levels and potential hypersensitivity reactions. While these treatments can reduce exacerbation rates and improve certain clinical outcomes, the side effects are an important consideration for patients and healthcare providers.

What prior FDA approvals exist?

The FDA has approved several treatments for COPD, including long-acting muscarinic antagonists (LAMAs) like tiotropium and umeclidinium, often used in combination with long-acting beta agonists (LABAs) such as vilanterol. These combinations have shown improvements in lung function, quality of life, and reduction in exacerbation frequency. While Itepekimab, an anti-IL-33 monoclonal antibody, is still under investigation, other biologics like mepolizumab, which targets IL-5, have been approved for severe eosinophilic asthma, a condition related to COPD. These treatments represent a growing class of targeted therapies aimed at reducing inflammation and improving respiratory outcomes in COPD patients.

What other types of research exist?

Promising novel alternatives to Itepekimab for COPD patients include Dupilumab (anti-IL-4 subunit alpha) and Tezepelumab (anti-TSLP). Both have shown efficacy in reducing inflammation and improving lung function in related respiratory conditions such as asthma, which suggests potential benefits for COPD management.

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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

Documented or self-reported history of exacerbation having had ≥1 moderate or severe exacerbation within the 5 years prior to Screening (Visit 1) with at least 1 exacerbation treated with systemic corticosteroids

Participants who have received appropriate vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) administered a minimum of 1 week prior to Screening (Visit 1)

Must not have

Participants who require more than 2 L/min of long-term treatment with oxygen at rest

Moderate or severe exacerbation of COPD (AECOPD) within 8 weeks prior to Screening (Visit 1) or during the screening period

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to eos (week 32)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests Itepekimab, a drug that blocks a protein to reduce lung inflammation, in smokers with COPD aged 40 to 70. The goal is to see if it helps improve their breathing and symptoms. Itepekimab has shown promise in reducing flare-ups and improving lung function in former smokers with COPD, with ongoing studies to confirm its effectiveness and safety.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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I've had a severe asthma attack treated with steroids in the last 5 years.

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I have been vaccinated against COVID-19 at least a week before my screening.

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

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I have symptoms like coughing and mucus that suggest I have chronic bronchitis.

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I am between 40 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need more than 2 liters per minute of oxygen for daily use.

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I have had a serious COPD flare-up in the last 8 weeks.

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I have no surgeries or major procedures planned during the study.

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My heart condition is not stable.

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I have HIV or tested positive for HIV.

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I have had surgery or a procedure on my lung before.

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I am currently on medication for a serious infection.

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I suspect or have been confirmed to have COVID-19, or I've been in contact with someone who has it.

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I have an active autoimmune disease or am on immunosuppressive therapy for it.

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I need a BiPAP machine due to high carbon dioxide levels in my blood.

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I have or am at high risk for tuberculosis.

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I need medication to prevent heart infection due to my condition.

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I have been diagnosed with asthma following GINA guidelines, or it resolved before I turned 18.

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I have irregular heartbeats, including occasional atrial fibrillation.

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I have previously used Itepekimab.

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My high blood pressure is not under control.

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I have been diagnosed with heart issues related to lung blood pressure.

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I have a lung condition that is not COPD.

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I have severe heart failure or a serious heart condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to eos (week 32)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to eos (week 32)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to eos (week 32) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change from baseline in itepekimab pharmacodynamic NES derived from former smokers in bronchial brushings in current smokers with COPD

Change from baseline in itepekimab pharmacodynamic NES derived from former smokers in nasal brushings in current smokers with COPD

Change from baseline in itepekimab pharmacodynamic normalized enrichment score (NES) derived from former smokers in endobronchial biopsies in current smokers with COPD

Secondary study objectives

Change from baseline in IL-33 treated eosinophil-associated NES in endobronchial biopsies

Change from baseline in IL-33 treated mast cell-associated NES in endobronchial biopsies

Change from baseline in blood eosinophil count

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: ItepekimabExperimental Treatment1 Intervention

This arm includes participants from 2 populations: Part A-former smokers and Part B-current smokers. Subcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for 12 weeks

0 / 24Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Chronic Obstructive Pulmonary Disease (COPD) include bronchodilators, inhaled corticosteroids, and combination therapies. Bronchodilators, such as long-acting beta agonists (LABAs) and long-acting muscarinic antagonists (LAMAs), work by relaxing the muscles around the airways, making it easier to breathe. Inhaled corticosteroids reduce inflammation in the airways, decreasing the frequency and severity of exacerbations. Combination therapies, which often include both bronchodilators and corticosteroids, provide a synergistic effect to improve lung function and reduce symptoms. Emerging treatments like Itepekimab, an anti-IL-33 monoclonal antibody, target specific inflammatory pathways, offering potential for more personalized and effective management of COPD. These treatments are crucial for COPD patients as they help manage symptoms, improve quality of life, and reduce the risk of severe exacerbations.

Advances in the management of chronic obstructive pulmonary disease.