What side effects are associated with this type of intervention?

Common treatments for COPD, particularly those involving monoclonal antibodies like itepekimab, include anti-interleukin-5 (IL-5) and anti-interleukin-13/-4 agents. These treatments are generally associated with an increased incidence of adverse events compared to placebo. Specific side effects can include increased risk of infections, injection site reactions, and potential immunogenicity. For example, mepolizumab, an anti-IL-5 agent, has a safety profile similar to placebo but can lead to a lower rate of moderate or severe exacerbations in patients with higher blood eosinophil counts. Overall, while these treatments can be effective in reducing exacerbations and improving health status, they come with a risk of adverse events that should be monitored.

What prior FDA approvals exist?

The FDA has approved several treatments for Chronic Obstructive Pulmonary Disease (COPD), including long-acting bronchodilators such as umeclidinium (a LAMA) and vilanterol (a LABA), often used in combination to improve lung function and reduce exacerbations. Additionally, biologics like mepolizumab, an anti-IL-5 monoclonal antibody, have been studied for their efficacy in COPD patients with elevated eosinophil levels. While Itepekimab, an anti-IL-33 monoclonal antibody, is still under investigation, these existing treatments highlight the ongoing efforts to manage COPD through targeted therapies.

What other types of research exist?

Promising novel alternatives to Itepekimab for COPD patients include Dupilumab (anti-IL-4/IL-13 monoclonal antibody) and Tezepelumab (anti-TSLP monoclonal antibody). Both have shown efficacy in managing Type 2 inflammatory diseases and severe asthma, which shares some inflammatory pathways with COPD.

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Itepekimab for COPD (AERIFY-4 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

- Patients with COPD who completed the treatment period in a previous itepekimab COPD Phase 3 clinical study (ie, EFC16750 or EFC16819) and for which an end-of-treatment (EOT) visit occurred no later than 3 days before the enrolment visit of this study.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline of the parent studies (efc16750,efc16819) up to week 52

Awards & highlights

Pivotal Trial

Summary

This trial involves giving COPD patients injections under the skin at regular intervals. The goal is to see if the treatment is safe and effective over a longer period. The treatment works by reducing inflammation in the lungs, which helps improve breathing.

Who is the study for?

This trial is for patients with COPD who finished a previous Phase 3 itepekimab study and had their end-of-treatment visit within 3 days before enrolling in this study. It's not specified who can't join, but typically those with certain health issues or conflicting treatments are excluded.

What is being tested?

The trial tests the long-term safety of Itepekimab given every two or four weeks to people with COPD. Participants will either continue receiving Itepekimab or a placebo without knowing which one they're getting, to compare outcomes over up to 72 weeks.

What are the potential side effects?

While specific side effects aren't listed here, common ones for new respiratory drugs may include irritation at the injection site, headache, coughing, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline of the parent studies (efc16750,efc16819) up to week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline of the parent studies (efc16750,efc16819) up to week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline of the parent studies (efc16750,efc16819) up to week 52 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of treatment-emergent AEs, AESIs, SAEs, and AEs leading to permanent treatment discontinuation

Secondary study objectives

Change from Week 0 for CASA-Q

Change from baseline of the parent studies (EFC16750, EFC16819): EQ-5D-5L single index score

Change from baseline of the parent studies (EFC16750, EFC16819): EQ-VAS

+2 more

Awards & Highlights

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

0 / 1Eligibility 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 antibiotics. 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. Antibiotics are used to treat bacterial infections that can worsen COPD symptoms. Itepekimab, an anti-IL-33 monoclonal antibody, targets the inflammatory pathway by inhibiting IL-33, a cytokine involved in chronic airway inflammation. This is significant for COPD patients as it offers a novel approach to reducing inflammation and potentially improving long-term outcomes.

Interleukin-33 promotes inflammatory cytokine production in chronic airway inflammation.Advances in the management of chronic obstructive pulmonary disease.