Itepekimab for COPD (AERIFY-4 Trial)
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Sanofi
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
What safety data is available for Itepekimab in COPD treatment?The provided research articles do not contain specific safety data for Itepekimab in the treatment of COPD. They focus on immune checkpoint inhibitors and their adverse events in non-small cell lung cancer (NSCLC) patients. To find relevant safety data for Itepekimab, it would be necessary to look for studies or clinical trials specifically evaluating Itepekimab in COPD patients.3591112
Is the drug itepekimab a promising treatment for COPD?Itepekimab is a promising drug for COPD because it targets a protein called IL-33, which is linked to lung diseases like asthma and COPD. In studies, itepekimab has shown potential to help reduce inflammation in the airways, which can improve breathing for people with COPD.467810
What data supports the idea that Itepekimab for COPD is an effective drug?The available research shows that Itepekimab, a drug targeting a protein called IL-33, has shown potential in treating COPD. In a study, it was tested on patients with moderate-to-severe COPD who were already on other inhaled therapies. While the study primarily focused on safety and genetic links, it suggests that Itepekimab could be effective due to its success in reducing inflammation in asthma, a related lung condition. However, specific data on its effectiveness in COPD compared to other treatments like mepolizumab, which reduces flare-ups in severe cases, is not detailed in the available information.12678
Do I need to stop my current medications to join the trial?The protocol does not specify whether you need to stop your current medications. Please consult with the trial coordinators for more details.
Eligibility Criteria
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
- 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.
Treatment Details
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.
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
Find a clinic near you
Research locations nearbySelect from list below to view details:
Metroplex Pulmonary and Sleep Center Site Number : 8401015McKinney, TX
Investigational Site Number : 1240001Trois-Rivieres, Canada
Paul A Shapero, MD, PA Site Number : 8401016Bangor, ME
Beautiful Minds Clinical Research Center Site Number : 8401201Cutler Bay, FL
More Trial Locations
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Who is running the clinical trial?
SanofiLead Sponsor
Regeneron PharmaceuticalsIndustry Sponsor
References
Current Controversies in the Pharmacological Treatment of Chronic Obstructive Pulmonary Disease. [2022]Clinical phenotyping is currently used to guide pharmacological treatment decisions in chronic obstructive pulmonary disease (COPD), a personalized approach to care. Precision medicine integrates biological (endotype) and clinical (phenotype) information for a more individualized approach to pharmacotherapy, to maximize the benefit versus risk ratio. Biomarkers can be used to identify endotypes. To evolve toward precision medicine in COPD, the most appropriate biomarkers and clinical characteristics that reliably predict treatment responses need to be identified. FEV1 is a marker of COPD severity and has historically been used to guide pharmacotherapy choices. However, we now understand that the trajectory of FEV1 change, as an indicator of disease activity, is more important than a single FEV1 measurement. There is a need to develop biomarkers of disease activity to enable a more targeted and individualized approach to pharmacotherapy. Recent clinical trials testing commonly used COPD treatments have provided new information that is likely to influence pharmacological treatment decisions both at initial presentation and at follow up. In this Perspective, we consider the impact of recent clinical trials on current COPD treatment recommendations. We also focus on the movement toward precision medicine and propose how this field needs to evolve in terms of using clinical characteristics and biomarkers to identify the most appropriate patients for a given pharmacological treatment.
Precision medicine in COPD: review of mepolizumab for eosinophilic COPD. [2020]Mepolizumab can reduce exacerbation rates in those with frequently exacerbating, severe COPD and raised blood eosinophils; this represents a further advance in precision medicine for COPD and targeted therapies http://ow.ly/uklu30m4YcU.
Immune-related adverse events associated with programmed cell death protein-1 and programmed cell death ligand 1 inhibitors for non-small cell lung cancer: a PRISMA systematic review and meta-analysis. [2020]Programmed cell death protein-1 (PD-1) and programmed cell death ligand 1 (PD-L1) inhibitors have remarkable clinical efficacy in the treatment of non-small cell lung cancer (NSCLC); however, the breakdown of immune escape causes a variety of immune-related adverse events (irAEs). With the increasing use of PD-1/PD-L1 inhibitors alone or in combination with other therapies, awareness and management of irAEs have become more important. We aimed to assess the incidence and nature of irAEs associated with PD-1 and PD-L1 inhibitors for NSCLC.
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. [2021]Patients with severe, uncontrolled asthma have a significant unmet need for new treatments that have broader effects on airway inflammation, and that provide greater improvements in asthma outcomes than currently approved biologics and standard-of-care therapies. Tezepelumab is a human monoclonal antibody that blocks the activity of the epithelial cytokine thymic stromal lymphopoietin. In the PATHWAY phase 2b study (NCT02054130), tezepelumab significantly reduced exacerbations by up to 71% in adults with severe, uncontrolled asthma, irrespective of baseline disease phenotype. This article reports the design and objectives of the pivotal phase 3 NAVIGATOR study.
Pre-existing interstitial lung disease does not affect prognosis in non-small cell lung cancer patients with PD-L1 expression ≥50% on first-line pembrolizumab. [2021]The safety of pembrolizumab monotherapy in treatment-naïve non-small cell lung cancer (NSCLC) patients with high programed death-ligand 1 (PD-L1) expression and pre-existing interstitial lung disease (ILD) has not yet been determined. Here, we aimed to evaluate the prognosis, efficacy and safety associated with pembrolizumab in such settings.
Safety and efficacy of itepekimab in patients with moderate-to-severe COPD: a genetic association study and randomised, double-blind, phase 2a trial. [2022]Genetic data implicate IL-33 in asthma susceptibility. Itepekimab, a monoclonal antibody targeting IL-33, demonstrated clinical activity in asthma, with potential in chronic obstructive pulmonary disease (COPD). In this study we first aimed to test the hypothesis that genetic variants in the IL-33 pathway were also associated with COPD. On the basis of the strong association of IL-33 pathway genes with pulmonary diseases like asthma and COPD, we conducted this phase 2a trial to assess the safety and efficacy of itepekimab in patients with moderate-to-severe COPD on a stable regimen of triple-inhaled or double-inhaled background maintenance therapy.
Pharmacokinetics and pharmacodynamics of itepekimab in healthy adults and patients with asthma: Phase I first-in-human and first-in-patient trials. [2022]Itepekimab is a monoclonal antibody that targets interleukin (IL-33) and has been shown to reduce airway inflammation and associated tissue damage in preclinical studies. We assessed the safety, tolerability, pharmacokinetics (PKs), and pharmacodynamic profiles of single-ascending and multiple-ascending doses of itepekimab in two randomized, double-blind, placebo-controlled phase I studies. Healthy adults (N = 40) were randomized to the single-dose study and patients with moderate asthma (N = 23) to the multiple-dose study. Itepekimab was administered intravenously (0.3, 1, 3, or 10 mg/kg infusion) or subcutaneously (150 mg) in the single-dose study and subcutaneously (75 or 150 mg weekly for 4 weeks) in the multiple-dose study. Itepekimab exhibited linear PKs across studies and dose-proportional increases in mean maximum concentration in serum and area under the concentration-time curve following single intravenous or multiple subcutaneous doses. Itepekimab demonstrated mean subcutaneous bioavailability of 59-73% and a long terminal half-life (30.0-31.6 days). IL-33 concentrations in most healthy participants and patients with asthma were undetectable at baseline. Following administration of itepekimab in both studies, total IL-33 concentrations increased and blood eosinophils decreased, both with durable effect. Itepekimab was well-tolerated in both studies with no detection of treatment-emergent anti-drug antibody responses.
Efficacy and Safety of Itepekimab in Patients with Moderate-to-Severe Asthma. [2021]Monoclonal antibodies targeting IgE, interleukin-4 and -13, and interleukin-5 are effective in treating severe type 2 asthma, but new targets are needed. Itepekimab is a new monoclonal antibody against the upstream alarmin interleukin-33. The efficacy and safety of itepekimab as monotherapy, as well as in combination with dupilumab, in patients with asthma are unclear.
Adverse events of immunotherapy in non-small cell lung cancer: A systematic review and network meta-analysis. [2022]Immune checkpoint inhibitors have yielded significant treatment progress in non-small cell lung cancer (NSCLC), while some special adverse events (AEs) named immune-related adverse events (irAEs) were observed in clinical trials. We aimed to systematically assess the incidences of AEs in immunotherapy of NSCLC.
Tezepelumab in the Treatment of Uncontrolled Severe Asthma. [2023]To review the pharmacology, efficacy, and safety of subcutaneous tezepelumab in the treatment of severe uncontrolled asthma.
Non-small cell lung cancer with tumor proportion score > 90% could increase the risk of severe immune-related adverse events in first-line treatments with immune checkpoint inhibitors: A retrospective single-center study. [2023]Since 2015, immune checkpoint inhibitors have been a clinical treatment strategy for patients with advanced or recurrent non-small cell lung cancer (NSCLC). However, the relationship between immune-related adverse event (irAE) risk factors and patient clinical characteristics is unclear. This study aimed to evaluate the relationship between irAE risk and the clinical characteristics of patients with NSCLC.
Radiomic biomarkers from chest computed tomography are assistive in immunotherapy response prediction for non-small cell lung cancer. [2023]Immunotherapies, such as programmed death 1/programmed death ligand 1 (PD-1/PD-L1) antibodies have been shown to improve overall and progression-free survival (PFS) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). However, not all patients derive a meaningful clinical benefit. Additionally, patients receiving anti-PD-1/PD-L1 therapy can experience immune-related adverse events (irAEs). Clinically significant irAEs may require temporary pause or discontinuation of treatment. Having a tool to identify patients who may not benefit and/or are at risk for developing severe irAEs from immunotherapy will aid in an informed decision-making process for the patients and their physicians.