A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease.

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Sanofi
Study ID
NCT07053423
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab — DRUG
    Pharmaceutical form:Solution for injection-Route of administration:SC injection
  • Placebo — DRUG
    Pharmaceutical form:Solution for injection-Route of administration:SC injection

Study Details

LPS18583 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 4 study with 2 treatment groups. The purpose of this study is to assess the effect of dupilumab compared with placebo on airway inflammation, resistance, and remodeling including mucus plugging and its association with improvement on lung function, exacerbations, and quality of life improvement in participants aged 40 years of age up to 85 years of age (inclusive). Study details include: The study duration will be up to 40 weeks. The treatment duration will be up to 24 weeks. The number of visits will be 9.

Key Dates

Start date
Sep 22, 2025
Status verified
May 2026
Primary completion
Dec 23, 2028
Completion
Feb 2, 2029

Study Design

Enrollment
218 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dupilumab
    Subcutaneous injection as per protocol
  • Placebo Comparator: Placebo
    Subcutaneous injection as per protocol

Primary Outcome Measure

Change from baseline to Week 24 in global lung mucus score (UCSF mucus scoring) [ Time Frame: Baseline to Week 24 ]

Central Contacts

  • Trial Transparency email recommended (Toll free for US & Canada)
    800-633-1610
    [email protected]

Locations (9)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham - School of Medicine- Site Number : 8400003BirminghamAlabama35233-
Finlay Medical Research- Site Number : 8400010MiamiFlorida33126-
Private Practice - Dr. David Kavtaradze- Site Number : 8400017CordeleGeorgia31015-
Johns Hopkins Bayview Medical Center- Site Number : 8400009BaltimoreMaryland21224-
Brigham & Women's Hospital- Site Number : 8400014BostonMassachusetts02115-
American Health Research - Charlotte- Site Number : 8400013CharlotteNorth Carolina28277-
Atrium Health Wake Forest Baptist Pulmonary, Sleep And Allergy- Site Number : 8400004Winston-SalemNorth Carolina27103-
Clinical Research Associates of Central Pennsylvania- Site Number : 8400002DuBoisPennsylvania15801-
REX Clinical Trials - Beaumont- Site Number : 8400011BeaumontTexas77701-

Find similar trials in Birmingham, AL

By condition
COPD
By specialty
PulmonologyLung disease
By research site
University of Alabama at Birmingham - School of Medicine· Birmingham, ALFinlay Medical Research· Miami, FLPrivate Practice - Dr. David Kavtaradze· Cordele, GAJohns Hopkins Bayview Medical Center· Baltimore, MDBrigham & Women's Hospital· Boston, MAAmerican Health Research - Charlotte· Charlotte, NC

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