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

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

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)

Study Overview

• Status: Recruiting
• Conditions: COPD (Chronic Obstructive Pulmonary Disease)
• Intervention / Treatment: Drug: WIN378; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 105
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Juliana Hutchinson, MSc; Phone Number: +4161 551 75 75; Email: clinical.trial.enquiry@windwardbio.com

Study Locations

• United States
  • Florida
    • Miami Lakes, Florida, United States, 33014
      • Recruiting
      • WB Contracted Clinical Research Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • Recruiting
      • WB Contracted Clinical Research Site
  • Texas
    • McKinney, Texas, United States, 75069
      • Recruiting
      • WB Contracted Clinical Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WIN378 Dose 1; WIN378 SC injections will be administered	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
Experimental: WIN378 Dose 2; WIN378 SC injections will be administered	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
Experimental: Placebo; Placebo SC injections will be administered	Drug: Placebo; Placebo matching WIN378

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Windward Bio
• Investigators: Study Director: Omar Khwaja, MD, Windward Bio

Publications and helpful links

Helpful Links

• Link to Sponsor Website

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2026
• Primary Completion (Estimated): December 17, 2027
• Study Completion (Estimated): January 7, 2028

Study Registration Dates

• First Submitted: June 2, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Inflammation; COPD; Chronic Obstructive Pulmonary Disease; Monoclonal Antibody; Respiratory Disease; TSLP; Moderate - Severe
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Inflammation; Respiration Disorders
• Other Study ID Numbers: WB-2102; U1111-1333-4974 (Other Identifier: UTN, World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No