Menu
Recruiting NCT07646587

A Study of WIN378 in Participants With Moderate to Severe COPD (Sirius)

Phase II Interventional COPD (Chronic Obstructive Pulmonary Disease)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: WIN378, Placebo.
Who it may be relevant to
Registry conditions: COPD (Chronic Obstructive Pulmonary Disease). Basic parameters: 40 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 2 Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of WIN378 in Participants With Moderate - Severe Chronic Obstructive Pulmonary Disease

Overview

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)

Detailed description

This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, and pharmacokinetics of WIN378 in adult participants with moderate - severe chronic obstructive pulmonary disease (COPD). Participants will continue their standard background COPD therapy. Eligible participants will receive doses of WIN378 or placebo over a 24-week treatment period.

Interventions

  • Drug WIN378
    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
  • Drug Placebo
    Placebo matching WIN378

Primary outcome measures

  • Number of participants with Adverse Events (AEs) [Time frame: Week 0 - Week 36]
  • Number of participants with Serious Adverse Events (SAEs) [Time frame: Week 0 - Week 36]
  • Change from baseline in systolic blood pressure (mmHg) [Time frame: Week 0 - Week 36]
  • Change from baseline in diastolic blood pressure (mmHg) [Time frame: Week 0 - Week 36]
  • Change from baseline in pulse rate (beats/minute) [Time frame: Week 0 - Week 36]
  • Change from baseline in respiratory rate (breaths/minute) [Time frame: Week 0 - Week 36]
  • Change from baseline in oxygen saturation (%) [Time frame: Week 0 - Week 36]
  • Change from baseline in body weight (kg) [Time frame: Week 0 - Week 36]
  • Change from baseline in body mass index (kg/m^2) [Time frame: Week 0 - Week 36]
  • Change from baseline in body temperature (°C) [Time frame: Week 0- Week 36]
Secondary outcome measures (5)
  • Change from baseline in Blood Eosinophil Count [Time frame: Week 0 to Week 24]
  • Change in Fractional Exhaled Nitric Oxide (FeNO) [Time frame: Week 0 to Week 24]
  • Change in Pre and Post Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) [Time frame: Week 0 to Week 24]
  • Change in Pre and Post Bronchodilator Forced Vital Capacity (FVC) [Time frame: Week 0 to Week 24]
  • Incidence and magnitude of anti-drug antibodies to WIN 378 [Time frame: Week 0 to Week 36]

Eligibility criteria

Inclusion criteria

  • Adults aged 40 to 80 years
  • Post-BD spirometry at screening FEV1/FVC < 0.70 and FEV1 30-80% predicted
  • On stable triple inhaled therapy (ICS/LABA/LAMA) for ≥ 3 months
  • Former smoker (≥ 10 pack-year history) and abstinence from smoking for ≥ 6 months
  • Elevated eosinophil count
  • Weight/BMI within allowed range

Exclusion criteria

  • Clinically significant pulmonary disease other than chronic obstructive pulmonary disease (COPD)
  • Clinically significant comorbid medical conditions or infections that, in the investigator's judgment, could affect participant safety or interfere with study conduct
  • Clinically significant cardiovascular disease
  • Recent respiratory infection or COPD exacerbation
  • Exposure to approved or experimental biologic therapies for COPD with less than 5 half-life washout period
  • Pregnancy or breastfeeding
  • Smoking or diagnosed substance use disorder
  • Any condition or circumstance that, in the investigator's opinion, would make participation unsafe or compromise study integrity

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 4 centers
  • WB Contracted Clinical Research Site — Miami Lakes
  • WB Contracted Clinical Research Site — North Dartmouth
  • WB Contracted Clinical Research Site — Charlotte
  • WB Contracted Clinical Research Site — McKinney

Identifiers

NCT: NCT07646587 · WB-2102 · U1111-1333-4974

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗