A Study to Assess the Safety, Tolerability, PK and PD of WIN378 in Participants With Moderate - Severe COPD

Part of paid clinical trials in Miami Lakes, Florida.

Sponsor
Windward Bio
Study ID
NCT07646587
Phase
PHASE2
Status
Recruiting
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Conditions

  • COPD (Chronic Obstructive Pulmonary Disease)

Eligibility Criteria

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

Interventions

  • WIN378 — DRUG
    WIN378 is a fully human, long-acting monoclonal antibody that targets the ligand of thymic stromal lymphopoietin (TSLP), blocking its activity and thereby reducing airway inflammation and improving COPD control over an extended dosing interval
  • Placebo — DRUG
    Placebo matching WIN378

Study Details

This study is trying to identify the right dose of a long-acting medicine called WIN378 for people with moderate - severe chronic obstructive pulmonary disease (COPD). WIN378 blocks the action of a protein called TSLP that causes inflammation in the lung and may contribute to COPD control and symptoms. The study will test how doses of WIN378 are handled by the body (pharmacokinetics) and assess the safety of the medicine and markers of COPD inflammation in exhaled breath and blood, lung function and COPD control (pharmacodynamics)

Key Dates

Start date
Jun 2, 2026
Status verified
Jun 2026
Primary completion
Dec 17, 2027
Completion
Jan 7, 2028

Study Design

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

Arms

  • Experimental: WIN378 Dose 1
    WIN378 SC injections will be administered
  • Experimental: WIN378 Dose 2
    WIN378 SC injections will be administered
  • Experimental: Placebo
    Placebo SC injections will be administered

Primary Outcome Measure

Number of participants with Adverse Events (AEs) [ Time Frame: Week 0 - Week 36 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
WB Contracted Clinical Research SiteMiami LakesFlorida33014-
WB Contracted Clinical Research SiteCharlotteNorth Carolina28277-
WB Contracted Clinical Research SiteMcKinneyTexas75069-

Find similar trials in Miami Lakes, FL

By research site
WB Contracted Clinical Research Site· Miami Lakes, FLWB Contracted Clinical Research Site· Charlotte, NCWB Contracted Clinical Research Site· McKinney, TX

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