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

NCT07646587 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: WB-2102U1111-1333-4974
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 3

Brief Summary

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)

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Keywords

COPD; Chronic Obstructive Pulmonary Disease; Respiratory Disease; Monoclonal Antibody; Inflammation; TSLP; Moderate - Severe

Outcome Measures

Primary Outcomes (16)

• Number of participants with Adverse Events (AEs)

  Week 0 - Week 36

• Number of participants with Serious Adverse Events (SAEs)

  Week 0 - Week 36

• Change from baseline in systolic blood pressure (mmHg)

  Week 0 - Week 36

• Change from baseline in diastolic blood pressure (mmHg)

  Week 0 - Week 36

• Change from baseline in pulse rate (beats/minute)

  Week 0 - Week 36

• Change from baseline in respiratory rate (breaths/minute)

  Week 0 - Week 36

• Change from baseline in oxygen saturation (%)

  Week 0 - Week 36

• Change from baseline in body weight (kg)

  Week 0 - Week 36

• Change from baseline in body mass index (kg/m^2)

  Week 0 - Week 36

• Change from baseline in body temperature (°C)

  Week 0- Week 36

• Change from baseline in clinical chemistry laboratory assessments

  Clinical chemistry assessments will include serum chemistry (such as sodium, potassium, urea, creatinine) and liver function parameters, including alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin.

  Week 0 - Week 36

• Change from baseline in haematology laboratory parameters

  Haematology assessments will include haemoglobin, white blood cell count, differential white blood cell counts and platelet count

  Week 0 - Week 36

• Change from baseline in coagulation laboratory parameters

  Coagulation assessments will include activated partial thromboplastin time, international normalised ratio, prothrombin time and fibrinogen

  Week 0 - Week 36

• Change from baseline in urinalysis parameters

  Urinalysis assessments will include protein, pH, blood, glucose and leucocytes

  Week 0 - Week 36

• Change from baseline in electrocardiogram QT interval

  Electrocardiogram assessments will include evaluation of QT interval corrected using Fridericia's formula (QTcF)

  Week 0 - Week 36

• WIN378 Serum concentration (PK)

  Week 0 to week 36

Secondary Outcomes (5)

• Change from baseline in Blood Eosinophil Count

  Week 0 to Week 24

• Change in Fractional Exhaled Nitric Oxide (FeNO)

  Week 0 to Week 24

• Change in Pre and Post Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)

  Week 0 to Week 24

• Change in Pre and Post Bronchodilator Forced Vital Capacity (FVC)

  Week 0 to Week 24

• Incidence and magnitude of anti-drug antibodies to WIN 378

  Week 0 to Week 36

Study Arms (3)

WIN378 Dose 1

EXPERIMENTAL

WIN378 SC injections will be administered

Drug: WIN378

WIN378 Dose 2

EXPERIMENTAL

WIN378 SC injections will be administered

Drug: WIN378

Placebo

EXPERIMENTAL

Placebo SC injections will be administered

Drug: Placebo

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

WIN378 Dose 1; WIN378 Dose 2

Placebo DRUG

Placebo matching WIN378

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Windward Bio: lead

Study Sites (3)

WB Contracted Clinical Research Site

Miami Lakes, Florida, 33014, United States

RECRUITING

WB Contracted Clinical Research Site

Charlotte, North Carolina, 28277, United States

RECRUITING

WB Contracted Clinical Research Site

McKinney, Texas, 75069, United States

RECRUITING

Related Links

• Link to Sponsor Website

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Respiration Disorders; Inflammation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Omar Khwaja, MD

  Windward Bio

  STUDY DIRECTOR

Central Study Contacts

Juliana Hutchinson, MSc

CONTACT

+4161 551 75 75; clinical.trial.enquiry@windwardbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sequential Assignment

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 12, 2026
• Study Start: June 2, 2026
• Primary Completion (Estimated): December 17, 2027
• Study Completion (Estimated): January 7, 2028
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)