136 Participants Needed

WIN378 for Asthma

Recruiting at 4 trial locations
DK
Overseen ByDaniela Kopecka
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Windward Bio
Must be taking: ICS, LABA, LTRA
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 aims to determine the optimal dose of a new medication, WIN378, for individuals with moderate or severe asthma. WIN378 blocks a protein that can cause lung inflammation, potentially improving asthma symptoms and control. Participants will receive either WIN378 or a placebo (an inactive substance) to assess the medication's absorption and safety. This trial suits those with doctor-diagnosed asthma, who experience airflow limitations, and who regularly use asthma medications. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in asthma care.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it mentions that you should be on at least one maintenance asthma controller medication. It's best to discuss your specific medications with the trial team.

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

Research shows that WIN378 is being tested to help people with asthma by blocking a protein called TSLP, which causes lung inflammation. Early results from other studies indicate that patients have generally tolerated WIN378 well. Since the current research is in phase 2, earlier studies have shown it to be somewhat safe, allowing this stage to focus more on finding the right dose. However, as with any new treatment, more remains to be learned about its safety and effectiveness, so researchers will closely monitor trial participants for any side effects.12345

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

Unlike the standard asthma treatments, which often include inhaled corticosteroids and bronchodilators, WIN378 is delivered through subcutaneous injections. This method may offer more sustained and controlled delivery of the medication, potentially improving management of asthma symptoms. Researchers are excited about WIN378 because it represents a novel approach that could enhance convenience for patients who struggle with inhalers and might offer improved efficacy in controlling asthma over time.

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

Research has shown that blocking a protein called TSLP can improve asthma management. WIN378, a long-lasting medicine that participants in this trial may receive, is designed to achieve this by reducing lung inflammation, potentially controlling asthma symptoms. Previous studies found that targeting TSLP effectively treats asthma and similar conditions. This treatment could lead to better outcomes for asthma patients by reducing the need for frequent doses.23678

Who Is on the Research Team?

OK

Omar Khwaja, MD

Principal Investigator

Windward Bio

Are You a Good Fit for This Trial?

This trial is for adults with moderate or severe asthma. Participants should not have liver disease, acute viral respiratory infections, or other serious pulmonary conditions that could interfere with the study.

Inclusion Criteria

Written Informed Consent Form
I have asthma diagnosed by a doctor and proof of improved breathing in the last 2 years.
Airflow limitation as indicated by pre-BD FEV1 value of ≥ 30% and ≤ 90%, predicted at two visits at Screening
See 2 more

Exclusion Criteria

Participants who are pregnant, lactating or breastfeeding
I haven't taken immunosuppressive drugs in the last 3 months.
I have not had active tuberculosis or needed treatment for it in the last year.
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 WIN378 or placebo administered subcutaneously over a 48-week period

48 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 trial is testing WIN378, a long-acting medication intended to block TSLP protein which contributes to lung inflammation in asthma. It will compare the effects of different doses of WIN378 against a placebo on lung function and asthma control.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: WIN378Experimental Treatment1 Intervention
Group II: PlaceboExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Windward Bio

Lead Sponsor

Citations

Windward Bio Initiates Global Phase 2 Asthma Trial of ...Phase 2 POLARIS trial will evaluate the dosing, safety, and efficacy of WIN378 in patients with asthma, with a first data readout expected ...
Windward Bio Launches Global Phase 2 Asthma Trial of ...WIN378 aims to be the first twice-yearly anti-TSLP antibody for asthma and COPD, potentially improving patient outcomes by reducing treatment ...
HBM9378/WIN378, a Long-Acting, Fully Human Anti-TSLP ...Phase 2 POLARIS trial will evaluate the dosing, safety, and efficacy of HBM9378/WIN378 in patients with asthma, with an initial data readout ...
Windward Bio launches Phase II trial of asthma treatmentThe therapeutic blockade of TSLP has shown clinically meaningful efficacy in treating asthma, COPD, and chronic rhinosinusitis with nasal polyps ...
Windward Bio Initiates Global Phase 2 Asthma Trial ofPhase 2 POLARIS trial will evaluate the dosing, safety, and efficacy of WIN378 in patients with asthma, with a first data readout expected ...
HBM9378/WIN378, a Long-Acting, Fully Human Anti-TSLP ...HBM9378/WIN378, a Long-Acting, Fully Human Anti-TSLP Antibody, Enters Global Phase 2 POLARIS Trial for Asthma. July 23, 2025. Cambridge, MA, ...
Kelun-Biotech's Partner Windward Bio Announces Initiation ...Windward Bio has launched its Phase 2 POLARIS clinical study, assessing long-acting dosing of SKB378/WIN378 for people living with asthma.
Study to Evaluate the Safety, Pharmacology and Efficacy of ...WIN378 blocks the action of a protein called TSLP which causes inflammation in the lung and may contribute to your asthma control and symptoms.
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