Recruiting

Phase 2

WIN378A Study of WIN378 in Participants With Moderate to Severe COPD (Sirius)

Sponsor:

Windward Bio

Code:

NCT07646587

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

WIN378

Placebo

Study Details

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)

Study ID

NCT07646587

Start date

Jun 2, 2026

Status verified date

Sep, 2026

Completion date

Jan 7, 2028

Anticipated

Primary completion date

Dec 17, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

105 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

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

Placebo

Placebo matching WIN378

Primary outcome measure

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 ]
Change from baseline in clinical chemistry laboratory assessments [ Time Frame: Week 0 - Week 36 ]
Change from baseline in haematology laboratory parameters [ Time Frame: Week 0 - Week 36 ]
Change from baseline in coagulation laboratory parameters [ Time Frame: Week 0 - Week 36 ]
Change from baseline in urinalysis parameters [ Time Frame: Week 0 - Week 36 ]
Change from baseline in electrocardiogram QT interval [ Time Frame: Week 0 - Week 36 ]
WIN378 Serum concentration (PK) [ Time Frame: Week 0 to week 36 ]

Central Contacts and Locations

Central contacts

Juliana Hutchinson, MSc

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

Locations