Mechanistic Study of the Effect of Itepekimab on Airway Inflammation in Patients With COPD

Part of paid clinical trials in Torrance, California.

Sponsor
Sanofi
Study ID
NCT05326412
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Itepekimab SAR440340 — DRUG
    Pharmaceutical form: solution for injection in pre-filled syringe; Route of administration: subcutaneous

Study Details

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). Part A will consist of participants who are former smokers with COPD; Part B will consist of participants who are current smokers with COPD. 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

Key Dates

Start date
May 19, 2022
Status verified
Mar 2026
Primary completion
Mar 5, 2025
Completion
Jul 25, 2025

Study Design

Enrollment
49 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Itepekimab
    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

Primary Outcome Measure

Change from baseline in itepekimab pharmacodynamic normalized enrichment score (NES) derived from former smokers in endobronchial biopsies in current smokers with COPD [ Time Frame: Baseline to Week 12 ]

Locations (11)

FacilityCityStateZIPSite coordinators
UCLA Medical Center - Harbor- Site Number : 8400006TorranceCalifornia90509-
National Jewish Health Medical Center- Site Number : 8400012DenverColorado80206-
University of Miami UHealth Tower- Site Number : 8400015MiamiFlorida33125-
Harvard Medical School - Massachusetts General Hospital (MGH) - Medical Practice Evaluation Center (MPEC)- Site Number : 8400007BostonMassachusetts02114-
Pulmonary and Medicine Associates- Site Number : 8400020WarrenMichigan48088-
University of Kansas Medical Center- Site Number : 8400004Kansas CityMissouri66160-
Allergy, Asthma and Clinical Research- Site Number : 8400010Oklahoma CityOklahoma73120-
Clinical Research Associates of Central PA - Dubois- Site Number : 8400011DuBoisPennsylvania15801-
Penn Medicine: University of Pennsylvania Health System- Site Number : 8400016PhiladelphiaPennsylvania19104-
University of Texas - Southwestern Medical Center- Site Number : 8400014DallasTexas75390-
University of Texas Medical Branch- Site Number : 8400001GalvestonTexas77555-

Find similar trials in Torrance, CA

By condition
COPD
By specialty
PulmonologyLung disease
By research site
UCLA Medical Center - Harbor· Torrance, CANational Jewish Health Medical Center· Denver, COUniversity of Miami UHealth Tower· Miami, FLHarvard Medical School - Massachusetts General Hospital (MGH) - Medical Practice Evaluation Center (MPEC)· Boston, MAPulmonary and Medicine Associates· Warren, MIUniversity of Kansas Medical Center· Kansas City, MO

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