NCT07646587 A Study of WIN378 in Participants With Moderate to Severe COPD (Sirius)
| NCT ID | NCT07646587 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Windward Bio |
| Condition | COPD (Chronic Obstructive Pulmonary Disease) |
| Study Type | INTERVENTIONAL |
| Enrollment | 105 participants |
| Start Date | 2026-06-02 |
| Primary Completion | 2027-12-17 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 105 participants in total. It began in 2026-06-02 with a primary completion date of 2027-12-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
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
Contact & Investigator
Omar Khwaja, MD
STUDY DIRECTOR
Windward Bio
Frequently Asked Questions
Who can join the NCT07646587 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 80 Years, studying COPD (Chronic Obstructive Pulmonary Disease). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07646587 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07646587 currently recruiting?
Yes, NCT07646587 is actively recruiting participants. Contact the research team at clinical.trial.enquiry@windwardbio.com for enrollment information.
Where is the NCT07646587 trial being conducted?
This trial is being conducted at Miami Lakes, United States, North Dartmouth, United States, Charlotte, United States, McKinney, United States.
Who is sponsoring the NCT07646587 clinical trial?
NCT07646587 is sponsored by Windward Bio. The principal investigator is Omar Khwaja, MD at Windward Bio. The trial plans to enroll 105 participants.
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