Itepekimab for Chronic Obstructive Pulmonary Disease (COPD)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Chronic Obstructive Pulmonary Disease (COPD)Itepekimab SAR440340 - Drug
Eligibility
40 - 70
All Sexes
What conditions do you have?
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Study Summary

This study is an exploratory, two-part, 12-week, Phase 2a study to evaluate the mechanism of action of Itepekimab (anti-IL-33-mAb) and its impact on airway inflammation in former and current smokers with COPD, aged 40 to 70 years. This study consists of participants who have been on a standard-of-care (SoC) mono (long-acting β2-agonist [LABA]) or long-acting muscarinic antagonist [LAMA]), double (inhaled corticosteroid [ICS] + LABA, LABA + LAMA or ICS + LAMA), or triple (ICS + LABA + LAMA) controller therapy for COPD for at least 3 months prior to Screening (Visit 1) with stable dose and regimen for controller therapy for ≥1 month prior to Screening (Visit 1) and during the screening period. Participants will stay on their established controller medications for COPD throughout the duration of the study, with the exception of systemic corticosteroids and/or antibiotics used for acute exacerbation of COPD (AECOPD). The total study duration for each part (Part A and Part B) is approximately 36 weeks: 4-week screening period 12-week treatment period 20-week followup period

Eligible Conditions
  • Chronic Obstructive Pulmonary Disease (COPD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 29 Secondary · Reporting Duration: Baseline up to end of study (Week 32)

Baseline to Week 12
Part A: Change from baseline in IL-33 treated eosinophil and mast cell-derived NES in endobronchial biopsies
Part A: Change from baseline in IL-33 treated eosinophil and mast cell-derived NES in endobronchial biopsies at Week 12
Part A: Change from baseline in blood eosinophil count
Part A: Change from baseline in blood eosinophil count at Week 12
Part A: Change from baseline in bronchial allergen challenge-derived NES in endobronchial biopsies
Part A: Change from baseline in bronchial allergen challenge-derived NES in endobronchial biopsies at Week 12
Part A: Change from baseline in preclinical mouse models-derived NES in endobronchial biopsies
Part A: Change from baseline in preclinical mouse models-derived NES in endobronchial biopsies at Week 12
Part A: Log2 relative change from baseline in gene expression in endobronchial biopsies
Part A: Log2 relative change from baseline in gene expression in endobronchial biopsies at Week 12
Part B: Change from baseline in IL-33 treated eosinophil and mast cell-derived NES in endobronchial biopsies
Part B: Change from baseline in IL-33 treated eosinophil and mast cell-derived NES in endobronchial biopsies at Week 12
Part B: Change from baseline in Itepekimab treatment normalized enrichment score (NES) developed in Part A in endobronchial biopsies
Part B: Change from baseline in Itepekimab treatment normalized enrichment score (NES) developed in Part A in endobronchial biopsies at Week 12
Part B: Change from baseline in blood eosinophil count
Part B: Change from baseline in blood eosinophil count at Week 12
Part B: Change from baseline in bronchial allergen challenge-derived NES in endobronchial biopsies
Part B: Change from baseline in bronchial allergen challenge-derived NES in endobronchial biopsies at Week 12
Part B: Change from baseline in preclinical mouse models-derived NES in endobronchial biopsies
Part B: Change from baseline in preclinical mouse models-derived NES in endobronchial biopsies at Week 12
Biopsy
Part B: Log2 relative change from baseline in gene expression in endobronchial biopsies at Week 12 in former and current smokers with COPD
Part B: Log2 relative change from baseline in gene expression in endobronchial biopsies at Week 12 in former smokers with COPD (pooled Part A and B)
Part B: Log2 relative change from baseline in gene expression in endobronchial biopsies in current smokers
Part B: Log2 relative change from baseline in gene expression in endobronchial biopsies in former and current smokers with COPD
Part B: Log2 relative change from baseline in gene expression in endobronchial biopsies in former smokers with COPD (pooled Part A and B)
Week 32
Part A: Incidence of potentially clinically significant abnormalities in clinical laboratory tests, vital signs and electrocardiogram (ECG) in the treatment-emergent period
Part A: Incidence of treatment-emergent adverse events (TEAEs), adverse event of special interests (AESIs), serious adverse events (SAEs), and adverse events (AEs) leading to permanent treatment discontinuation
Part A: Incidence of treatment-emergent anti-Itepekimab antibody responses throughout the study
Part B: Incidence of TEAEs, AESIs, SAEs, and AEs leading to permanent treatment discontinuation
Part B: Incidence of potentially clinically significant laboratory tests, vital signs and ECG abnormalities in the treatment-emergent period
Part B: Incidence of treatment-emergent anti-Itepekimab antibody responses throughout the study
Week 0 (Baseline)
Part B: Gene expression in endobronchial biopsies at Baseline

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Itepekimab
1 of 1

Experimental Treatment

60 Total Participants · 1 Treatment Group

Primary Treatment: Itepekimab · No Placebo Group · Phase 2

Itepekimab
Drug
Experimental Group · 1 Intervention: Itepekimab SAR440340 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline up to end of study (week 32)

Who is running the clinical trial?

SanofiLead Sponsor
2,042 Previous Clinical Trials
2,959,095 Total Patients Enrolled
8 Trials studying Chronic Obstructive Pulmonary Disease (COPD)
9,893 Patients Enrolled for Chronic Obstructive Pulmonary Disease (COPD)
Regeneron PharmaceuticalsIndustry Sponsor
549 Previous Clinical Trials
200,303 Total Patients Enrolled
5 Trials studying Chronic Obstructive Pulmonary Disease (COPD)
4,376 Patients Enrolled for Chronic Obstructive Pulmonary Disease (COPD)
Clinical Sciences & OperationsStudy DirectorSanofi
801 Previous Clinical Trials
1,634,195 Total Patients Enrolled
5 Trials studying Chronic Obstructive Pulmonary Disease (COPD)
4,376 Patients Enrolled for Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

Age 40 - 70 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are 40 to 70 years of age.
You have a physician diagnosis of COPD for at least 1 year.
You have a smoking history of at least 10 pack-years.