105 Participants NeededMy employer runs this trial

WIN378 for COPD

(Sirius Trial)

Recruiting at 11 trial locations
JH
Overseen ByJuliana Hutchinson, MSc
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Windward Bio
Must be taking: ICS/LABA/LAMA
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medicine called WIN378 to aid individuals with moderate to severe chronic obstructive pulmonary disease (COPD). Researchers aim to determine the optimal dose of this medicine, which blocks a protein responsible for lung inflammation. The study will examine how the body processes WIN378 and assess its safety, effects on lung health, and COPD symptoms. Individuals with COPD who are former smokers and have maintained stable inhaled therapy might be suitable candidates. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial requires participants to be on stable triple inhaled therapy (ICS/LABA/LAMA) for at least 3 months, so you will need to continue taking these medications. If you have been on any biologic therapies for COPD, there is a required washout period (time without taking these medications) of at least 5 half-lives before joining the study.

Is there any evidence suggesting that WIN378 is likely to be safe for humans?

Research has shown that WIN378 was safe in earlier studies. These studies tested WIN378 in various conditions, including advanced solid tumors, and found it was generally well-tolerated, meaning most participants did not experience severe side effects. The trials also suggested that WIN378 could serve as a long-lasting treatment targeting TSLP, a protein linked to lung inflammation.

Although complete safety data for COPD is not yet available, ongoing research aims to ensure WIN378 is safe for individuals with moderate to severe COPD. As this trial is in an early stage, it primarily focuses on safety and determining the correct dose. Past studies suggest a promising safety profile, but more data from this trial will help confirm its safety for COPD patients.12345

Why do researchers think this study treatment might be promising for COPD?

Unlike the standard treatments for COPD, which typically include bronchodilators and corticosteroids, WIN378 is unique because it is delivered through subcutaneous (SC) injections. This method targets inflammation in a novel way, potentially offering more direct and sustained relief. Researchers are excited about WIN378 because it could provide a new option for patients who don't respond well to existing treatments, offering hope for improved management of COPD symptoms.

What evidence suggests that WIN378 might be an effective treatment for COPD?

Research shows that WIN378, which participants in this trial may receive, could help treat COPD by blocking a protein called TSLP, which causes lung inflammation. Studies of similar treatments targeting proteins like TSLP have shown varying success in people with asthma and COPD. By reducing inflammation, WIN378 might improve lung function and manage COPD symptoms. Early results from other trials suggest that targeting TSLP can effectively address similar breathing problems.16789

Who Is on the Research Team?

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Omar Khwaja, MD

Principal Investigator

Windward Bio

Are You a Good Fit for This Trial?

This trial is for adults aged 40-80 with moderate to severe COPD who have quit smoking for at least 6 months, are on stable inhaler therapy, and meet certain lung function and blood test criteria. Participants must also be within a specific weight range.

Inclusion Criteria

Elevated eosinophil count
Weight/BMI within allowed range
I am between 40 and 80 years old.
See 3 more

Exclusion Criteria

Clinically significant comorbid medical conditions or infections that could affect participant safety or interfere with study conduct
Pregnancy or breastfeeding
Smoking or diagnosed substance use disorder
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive doses of WIN378 or placebo over a 24-week period

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • WIN378

Trial Overview

The study tests different doses of WIN378, a long-acting medicine that blocks lung inflammation, compared to placebo in people with COPD. It looks at how the drug is processed by the body and its effects on symptoms and lung health.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: WIN378 Dose 2Experimental Treatment1 Intervention
Group II: WIN378 Dose 1Experimental Treatment1 Intervention
Group III: PlaceboExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Windward Bio

Lead Sponsor

Citations

Rejuvenate Biomed Completes Recruitment in Phase 2 ...

A therapy that can reduce muscle weakness and sarcopenia in COPD patients could lead to better long-term outcomes and quality of life." Jean- ...

Potential of alarmin-targeted bispecific and combination ...

Targeted inhibition of these proteins has demonstrated varying degrees of efficacy in patients with asthma and COPD. As the biology of ...

3.

withpower.com

withpower.com/t/ovide

Ovide: Everything you need to know | Power

... WIN378 for people with moderate - severe chronic obstructive pulmonary disease (COPD). WIN378 blocks the action of a protein called TSLP that causes ...

Harbour BioMed Reports 2025 Interim Results

In July 2025, Windward Bio initiated the global phase 2 POLARIS trial to evaluate the dosing, safety, and efficacy of HBM9378/WIN378 in patients ...

Harbour BioMed Reports 2025 Interim Results

In July 2025, Windward Bio initiated the global phase 2 POLARIS trial to evaluate the dosing, safety, and efficacy of HBM9378/WIN378 in patients ...

Follow the Money: Obesity, COPD, Universal AI for Biology

WIN378 is a potential best-in-class, long-acting monoclonal antibody targeting the ligand of thymic stromal lymphopoietin (TSLP) that has the ...

HBM-7020 - Drug Targets, Indications, Patents

Positive efficacy and safety data have been observed in the monotherapy trial targeting advanced solid tumors, as well as in combination ...

Kelun-Biotech Partner Windward Bio Announces First ...

It is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SKB378/WIN378 in patients with moderate-to-severe ...

Harbour BioMed Reports Full Year 2025 Financial Results

In November 2024, the Company submitted an IND application for HBM9378 for chronic obstructive pulmonary disease (COPD) to the NMPA, which was ...