A Study to Access Activity and Safety With SAR445399 Compared With Placebo in Participants Aged 18 to 80 Years of Age With Non-Cystic Fibrosis Bronchiectasis

Part of paid clinical trials in Loxahatchee Groves, Florida.

Sponsor
Sanofi
Study ID
NCT07547436
Phase
PHASE2
Status
Recruiting
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Conditions

  • Non-cystic Fibrosis Bronchiectasis

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • SAR445399 — BIOLOGICAL
    Pharmaceutical form: solution for injection Route of administration: injection
  • Placebo — BIOLOGICAL
    Pharmaceutical form: solution for injection Route of administration: injection

Study Details

This is a randomized, double-blind, placebo-controlled study to measure the reduction in mucus plug score at 24 weeks of treatment with SAR445399 compared with placebo in adult participants aged 18 to 80 years with non-cystic fibrosis bronchiectasis (NCFB).

Key Dates

Start date
Jun 15, 2026
Status verified
Jun 2026
Primary completion
Oct 29, 2027
Completion
Aug 7, 2028

Study Design

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

Arms

  • Experimental: Arm A
    Participants will receive SAR445399
  • Placebo Comparator: Arm B
    Participants will receive placebo

Primary Outcome Measure

Change from baseline to Week 24 in mucus plug score (MPS) derived from chest high-resolution computerized tomography (HRCT) [ Time Frame: from baseline up to Week 24 ]

Central Contacts

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

Locations (3)

FacilityCityStateZIPSite coordinators
Advanced Pulmonary Research Institute- Site Number : 8400001Loxahatchee GrovesFlorida33470-
Hull and Hull Medical Specialists- Site Number : 8400002PlantationFlorida33324-
Clinical Research Associates of Central Pennsylvania- Site Number : 8400006DuBoisPennsylvania15801-

Find similar trials in Loxahatchee Groves, FL

By research site
Advanced Pulmonary Research Institute· Loxahatchee Groves, FLHull and Hull Medical Specialists· Plantation, FLClinical Research Associates of Central Pennsylvania· DuBois, PA

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