Active not recruitingPHASE2INTERVENTIONAL

Study to Evaluate the Safety, Pharmacology and Efficacy of WIN378 in Adults With Moderate or Severe Asthma

This research study is for adults aged 18 to 75 with moderate or severe asthma. It's investigating a new medicine called WIN378 to find the best dose. WIN378 works by blocking a protein called TSLP, which can cause inflammation in the lungs and make asthma worse. Researchers will check how the body handles WIN378, its safety, and how it affects asthma symptoms, lung function, and inflammation markers in breath and blood. Participants will continue their current asthma treatment alongside the study medicine or a placebo (a dummy medicine) for 48 weeks, followed by a 12-week safety check. The aim is to see if WIN378 can improve asthma control.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Windward Bio

Enrolment target

136

Start

24 Jul 2025

Estimated completion

01 Oct 2027

Asthma (Diagnosis)

What is this study about?

This study is exploring a new medicine called WIN378 for adults who have asthma that is moderate or severe. If you have this type of asthma, you might find that your daily treatments don't always fully control your symptoms, or you might need strong medicines to manage it. This study aims to find the most effective dose of WIN378 to help people like you.

WIN378 works by targeting a specific protein in your body called TSLP. This protein can cause inflammation in the lungs, which is a key part of what makes asthma symptoms worse. By blocking TSLP, scientists hope WIN378 can reduce this inflammation and help improve asthma control. The study will look closely at how your body handles the medicine, whether it's safe to use, and if it helps improve your breathing and asthma symptoms.

This research is a 'Phase 2' study, which means it's one of the earlier stages of testing a new medicine. It's designed to gather important information about WIN378 before it can be considered for wider use. By taking part, you could contribute to developing new treatments that might benefit many people with asthma in the future.

Key takeaways

This study is testing a new medicine, WIN378, for moderate to severe asthma.
It aims to find the best dose of WIN378 to improve asthma control.
Participants will receive WIN378 or a placebo and continue their usual asthma care.
The study involves regular clinic visits for about a year.
It's a 'double-blind' study, meaning neither you nor your doctor will know if you're taking the active medicine or placebo.
WIN378 works by blocking a protein that causes lung inflammation.

Who may be eligible?

To join this study, you need to be an adult between 18 and 75 years old with a doctor's diagnosis of moderate or severe asthma. You'll need to show that your airways can improve after using an asthma inhaler (known as 'reversibility'). Your lung function, measured by a breathing test called FEV1, needs to be within a specific range.

You also need to be taking regular asthma medicines. This usually means you're using a low, medium, or high dose steroid inhaler, along with at least one other asthma control medicine like a LABA, LTRA, LAMA, chromone, or theophylline. If you are a woman who could become pregnant, you must be using a highly effective method of contraception or not be able to become pregnant.

There are also some reasons why you wouldn't be able to join. For example, if you have another significant lung condition that isn't asthma, or if you've had active tuberculosis within the last year. If you've smoked a lot in the past (more than 10 pack-years) or have a history of cancer, you wouldn't be eligible. Also, certain recent medications, vaccines, or specific infections would mean you couldn't take part. This ensures the study is as safe as possible for everyone involved.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult between 18 and 75 years old?
Do you have moderate or severe asthma diagnosed by a doctor?
Are you taking regular asthma control medicines, including a steroid inhaler?
Do you have a history of your breathing improving after using an asthma inhaler?
Are you a non-smoker, or have you smoked less than 10 pack-years in your lifetime?
Do you NOT have another serious lung condition apart from asthma?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll continue taking your usual asthma medicines. You'll be given either the study medicine, WIN378, or a 'placebo' (a dummy medicine that looks the same but contains no active drug). You won't know which one you're receiving, and neither will your study doctor, to make sure the results are fair.

The study medicine or placebo will be given by an injection under your skin. You'll receive these doses regularly over a period of 48 weeks. During this time, you'll have several visits to the clinic. At these visits, doctors and nurses will monitor your health, check your asthma symptoms, perform breathing tests, and take blood and breath samples to look at markers of inflammation.

After the 48 weeks of treatment, you'll have a further 12 weeks of follow-up visits. This is to make sure you're still doing well and to check for any delayed effects of the medicine. The total time you'd be involved in the study would be about one year.

Potential risks and benefits

Participating in this study might offer some potential benefits. You would receive close monitoring of your asthma by a team of healthcare professionals. There's a chance the new treatment, WIN378, could improve your asthma control and symptoms. However, it's also possible you might receive the placebo and not get the active medicine. As with any medicine, WIN378 could have side effects, and some might not be known yet. The study will carefully monitor for these. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (73)

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Los Angeles, United States
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San Jose, United States
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Melbourne, United States
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Miami, United States
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White Marsh, United States
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Stow, United States
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Detroit, United States
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Richfield, United States
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St Louis, United States
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Bellevue, United States
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Toledo, United States
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Edmond, United States

Common questions

What is a 'placebo'?

A placebo is a dummy medicine or treatment that looks exactly like the real study medicine but contains no active drug. It helps researchers fairly compare the new medicine's effects.

Will I know if I'm getting the real medicine or the placebo?

No, neither you nor your study doctor will know whether you are receiving WIN378 or the placebo. This is called 'double-blind' and helps ensure the study results are unbiased.

How will the medicine be given?

The study medicine, WIN378, or the placebo will be given by an injection under your skin (subcutaneously).

What does a 'Phase 2' study mean?

Phase 2 studies are early-stage trials that primarily look at how well a new medicine works, its safety, and finding the right dose in a larger group of people than in Phase 1.

Can I continue my regular asthma medicines?

Yes, you will continue taking your standard asthma medicines throughout the study as recommended by your doctor.