Itepekimab for COPD

(AERIFY-4 Trial)

Not currently recruiting at 320 trial locations

Overseen By Trial Transparency email recommended (Toll free for US & Canada)

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Sanofi

Disqualifiers: Malignancy, Opportunistic infections, Anaphylactic reactions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called itepekimab for individuals with COPD, a lung condition that makes breathing difficult. The goal is to assess the safety and effectiveness of itepekimab when administered every two or four weeks. Participants must have completed a previous itepekimab COPD study. Those with COPD who participated in one of these earlier studies might be suitable candidates for this research. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that itepekimab is generally safe for people with COPD, a lung disease that makes breathing difficult. Earlier studies indicated that participants experienced side effects similar to those of other treatments, with most being mild to moderate. This suggests itepekimab is likely safe for most people. However, treatments can affect individuals differently. It's important to discuss any concerns with a doctor before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments for COPD?

Unlike the standard treatments for COPD, like bronchodilators or inhaled corticosteroids, Itepekimab targets a different part of the immune response. It works by blocking IL-33, a protein that can trigger inflammation in the lungs, which is a key issue in COPD. Researchers are excited because this approach could offer improved control of inflammation, potentially leading to better lung function and fewer exacerbations. Additionally, Itepekimab is administered subcutaneously every two to four weeks, which might be more convenient for some patients compared to daily inhalers.

What evidence suggests that itepekimab might be an effective treatment for COPD?

Research has shown that itepekimab may help treat COPD (chronic obstructive pulmonary disease). One important study found that itepekimab reduced the number of moderate-to-severe COPD flare-ups compared to a placebo, resulting in fewer sudden worsening of symptoms for patients. This trial will test two different dosing schedules of itepekimab: one group will receive it every 2 weeks, and another every 4 weeks. Itepekimab targets IL-33, a protein that causes inflammation, and has also been effective in treating asthma, suggesting it might help manage COPD as well. However, results have varied across different studies, so while some findings are promising, more research is needed to confirm its overall effectiveness. ^{1 2 3 4 6}

Who Is on the Research Team?

Clinical Sciences & Operations

Principal Investigator

Sanofi

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You participated in a previous itepekimab COPD Phase 3 clinical study and completed the treatment period, with an end-of-treatment visit no later than 3 days before this study's enrolment visit.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive itepekimab subcutaneously every 2 or 4 weeks for up to 52 weeks

52 weeks

7 visits (in-person), 5 contacts (phone)

Follow-up

Participants are monitored for safety and effectiveness after treatment

20 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Itepekimab

Trial Overview 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.

How Is the Trial Designed?

Group I: Itepekimab Q4W Experimental Treatment 2 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 Q2W Experimental Treatment 1 Intervention

Subcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for up to 52 weeks

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Regeneron Pharmaceuticals

Industry Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Published Research Related to This Trial

Mepolizumab has been shown to significantly reduce the rate of exacerbations in patients with severe COPD who frequently experience flare-ups and have elevated blood eosinophil levels.

This treatment represents a step forward in precision medicine for COPD, allowing for more targeted therapies based on individual patient characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Precision medicine in COPD: review of mepolizumab for eosinophilic COPD. Long, G., Wall, J.[2020]

Tezepelumab, a monoclonal antibody targeting thymic stromal lymphopoietin, significantly reduced asthma exacerbations by up to 71% in adults with severe, uncontrolled asthma, as shown in the previous PATHWAY phase 2b study.

The ongoing NAVIGATOR phase 3 study, involving 1061 participants, aims to evaluate tezepelumab's efficacy in reducing exacerbations and improving lung function and quality of life across various asthma phenotypes, including those with low eosinophil counts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NAVIGATOR: a phase 3 multicentre, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of tezepelumab in adults and adolescents with severe, uncontrolled asthma. Menzies-Gow, A., Colice, G., Griffiths, JM., et al.[2021]

In a phase 2a trial involving 343 patients with moderate-to-severe COPD, itepekimab did not significantly reduce the overall rate of acute exacerbations compared to placebo, but showed promising results in former smokers, with a 42% reduction in exacerbation rates and improved lung function.

Genetic analyses indicated that certain IL-33 pathway variants are associated with COPD risk, suggesting a potential mechanism for how itepekimab may work, particularly in patients with specific genetic backgrounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of itepekimab in patients with moderate-to-severe COPD: a genetic association study and randomised, double-blind, phase 2a trial. Rabe, KF., Celli, BR., Wechsler, ME., et al.[2022]

In a phase 2 trial involving 296 adults with moderate-to-severe asthma, itepekimab, a monoclonal antibody targeting interleukin-33, significantly reduced the incidence of asthma control loss compared to placebo, with 22% of patients experiencing loss of control versus 41% in the placebo group.

Itepekimab also improved lung function and quality of life, while showing a similar safety profile to other treatments, indicating its potential as an effective new therapy for asthma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Itepekimab in Patients with Moderate-to-Severe Asthma. Wechsler, ME., Ruddy, MK., Pavord, ID., et al.[2021]

In clinical trials, subcutaneous tezepelumab significantly reduced the annualized asthma exacerbation rate by up to 71% compared to placebo, demonstrating its efficacy in treating severe uncontrolled asthma.

Tezepelumab is effective across various asthma phenotypes, including nonallergic and noneosinophilic types, making it a versatile treatment option for patients with severe asthma regardless of their specific characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tezepelumab in the Treatment of Uncontrolled Severe Asthma. Feist, J., Lipari, M., Kale-Pradhan, P.[2023]

Itepekimab, a monoclonal antibody targeting interleukin-33, was found to be safe and well-tolerated in two phase I studies involving 63 participants, with no treatment-emergent anti-drug antibody responses detected.

The drug demonstrated effective pharmacokinetics with a long half-life and significant effects on reducing IL-33 levels and blood eosinophils, indicating its potential to reduce airway inflammation in asthma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and pharmacodynamics of itepekimab in healthy adults and patients with asthma: Phase I first-in-human and first-in-patient trials. Kosloski, MP., Kalliolias, GD., Xu, CR., et al.[2022]

The shift towards precision medicine in COPD emphasizes the need to integrate both biological and clinical information, using biomarkers to identify patient endotypes for more personalized treatment decisions.

Recent clinical trials suggest that monitoring the trajectory of FEV1 changes, rather than relying solely on a single FEV1 measurement, is crucial for assessing disease activity and guiding pharmacotherapy in COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Controversies in the Pharmacological Treatment of Chronic Obstructive Pulmonary Disease. Singh, D., Roche, N., Halpin, D., et al.[2022]

Citations

1. sanofi.com sanofi.com/en/media-room/press-releases/2025/2025-05-30-05-00-00-3090818

Press Release: Itepekimab met the primary endpoint in one ... Itepekimab met the primary endpoint in one of two COPD phase 3 studies. AERIFY-1 study met its primary endpoint of a statistically ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34302758/

Safety and efficacy of itepekimab in patients with moderate- ... Itepekimab, a monoclonal antibody targeting IL-33, demonstrated clinical activity in asthma, with potential in chronic obstructive pulmonary ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04701983

NCT04701983 | Study to Assess the Efficacy, Safety, and ... Primary Objective: Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former ...

4. congress.sanofimedical.com congress.sanofimedical.com/s3fs-public/2024-09/Reduction%20in%20Exacerbations%20With%20Itepekimab%20in%20Former%20Smokers%20With%20COPD%20by%20Prior%20Exacerbation%20%20Frequency.pdf?VersionId=nNk2gzs_dNhPclkw7Mxowm5yKrIAWkOK

COPD - Sanofi Congress aAmong patients with available data (2 COPD exacerbations: placebo n = 51, itepekimab n = 47; ≥3 COPD exacerbations: placebo n = 23, itepekimab ...

5. ajmc.com ajmc.com/view/itepekimab-shows-mixed-results-in-phase-3-copd-trials

Itepekimab Shows Mixed Results in Phase 3 COPD Trials Itepekimab, an investigational monoclonal antibody for chronic obstructive pulmonary disease (COPD), demonstrated mixed results in a pair of ...

6. investor.regeneron.com investor.regeneron.com/news-releases/news-release-details/latest-dupixentr-dupilumab-and-itepekimab-data-ers-highlight

Latest Dupixent® (dupilumab) and Itepekimab Data at ERS ... Additional COPD data to be presented at the meeting will evaluate the impact of Dupixent on daily symptom frequency and severity, exacerbations and lung ...