Testing WIN378 Safety and Effects in Adults with Moderate or Severe Asthma

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What is this study about?

This study is looking at asthma that is moderate or severe in adults. Asthma is a long-term condition that affects the airways in the lungs, causing breathing difficulties, wheezing, coughing, and chest tightness. The study will test a medication called WIN378, which is a type of medicine known as a monoclonal antibody that works against a substance in the body called TSLP. This substance is believed to play a role in causing inflammation in the airways of people with asthma. Some participants will receive WIN378 while others will receive placebo. The main goal of this study is to check how safe WIN378 is and how well it is tolerated by participants, and also to understand how the body processes the medication and whether the body develops any immune response to it.

During the study, participants will receive the medication or placebo as an injection under the skin using a device. The treatment will be given over a period of 48 weeks, with the total amount of medication not exceeding 600 milligrams. Participants will need to continue taking their regular asthma medications during the study, which may include inhaled corticosteroids and other controller medications such as long-acting bronchodilators, leukotriene modifiers, or other medicines prescribed by their doctor. To be part of this study, participants must have been diagnosed with asthma for at least 12 months and must have certain characteristics such as elevated levels of a type of white blood cell called eosinophils in their blood, which indicates a specific type of asthma inflammation. They must also have experienced at least one asthma worsening episode in the past year that required treatment with systemic corticosteroids, an emergency room visit, or hospitalization.

Throughout the study, doctors will monitor participants closely by checking various measurements including lung function tests such as FEV1, which measures how much air a person can forcefully exhale in one second, and FeNO, which measures the level of nitric oxide in exhaled breath as a marker of airway inflammation. Blood tests will be done to measure eosinophil counts and to check for any antibodies the body might make against the study medication. Participants will also complete questionnaires about their asthma symptoms, how well their asthma is controlled, and their quality of life. The study will track any side effects, changes in vital signs, laboratory test results, and heart rhythm measurements through electrocardiogram. The entire study participation will last approximately 60 weeks, which includes the treatment period and a follow-up period after the last dose of medication.

1 Initial screening and run-in period

This period begins after signing the consent form and lasts until randomization. During this time, your eligibility for the study will be confirmed through several visits.

At the first visit, your lung function will be tested using a breathing test called spirometry, which measures how much air you can breathe out and how quickly. You will perform this test before and after receiving a medication that opens your airways to see if your breathing improves by at least 12% and 200 milliliters.

A blood sample will be taken to measure the level of certain white blood cells called eosinophils. Your eosinophil count must be at least 150 cells per microliter, or you must have had a count of at least 300 cells per microliter in the past 12 months.

A breathing test called FeNO will be performed, which measures the level of nitric oxide in your breath. This helps determine the type of inflammation in your airways. Your FeNO level must be at least 25 parts per billion.

You will complete a questionnaire called the Asthma Control Questionnaire to assess how well your asthma is controlled. Your score must be at least 1.5 at two different visits during this period.

You will be given an electronic device to record your asthma symptoms twice daily in an Asthma Symptom Diary. You must complete at least 7 morning and 7 evening entries in the last 10 days of this period.

You will need to demonstrate proper technique in using your inhaler, peak flow meter, and performing spirometry tests.

You must show at least 70% compliance with taking your usual asthma medications during this period.

This screening period includes multiple visits to ensure you meet all requirements before starting the study medication.

2 Randomization and start of treatment

Once you complete the screening period successfully, you will be randomly assigned to receive either WIN378 or a placebo. A placebo looks identical to the study medication but contains no active ingredient.

This is a double-blind study, which means neither you nor your doctor will know which treatment you are receiving.

The study medication WIN378 is an antibody that targets a protein called TSLP, which is involved in the inflammation associated with asthma.

The medication will be given as an injection under the skin, similar to how insulin is administered for diabetes.

This visit marks Week 0 or Day 1 of the treatment period.

3 Treatment period

The treatment period will last for 48 weeks.

You will receive injections of either WIN378 or placebo under your skin at scheduled visits throughout this period.

You must continue taking your regular asthma controller medications as prescribed by your doctor throughout the study.

You will continue to complete the Asthma Symptom Diary twice daily using the electronic device provided.

Regular study visits will be scheduled throughout the 48 weeks to monitor your condition and collect data.

4 Assessments during treatment

At various visits during the 48-week treatment period, several tests and assessments will be performed.

Blood samples will be taken to measure eosinophil levels, check for antibodies against the study medication, and measure the amount of study medication in your blood.

Lung function tests will be performed before and after receiving a bronchodilator medication at Week 24 and Week 48. These tests measure FEV1, which is the amount of air you can forcefully exhale in one second, and FVC, which is the total amount of air you can exhale.

FeNO measurements will be taken at Week 24 and Week 48 to assess airway inflammation.

You will complete the Asthma Control Questionnaire at Week 48 to evaluate how well your asthma is controlled.

You will complete quality of life questionnaires called the Asthma Quality of Life Questionnaire and the European Quality of Life questionnaire at Week 48 to assess how asthma affects your daily life.

Your vital signs, including blood pressure, heart rate, and temperature, will be checked at each visit.

An electrocardiogram, a test that records the electrical activity of your heart, will be performed at certain visits.

Laboratory tests will be conducted on your blood samples to monitor your overall health and safety.

Any worsening of your asthma that requires treatment with oral steroids for at least 3 days, an emergency room visit, or hospitalization will be recorded as an asthma exacerbation.

5 End of treatment

After completing the 48-week treatment period, you will stop receiving injections of the study medication or placebo.

A final assessment will be performed at Week 48 to evaluate your condition at the end of the treatment period.

6 Follow-up period

After the treatment period ends at Week 48, you will enter a follow-up period that continues until Week 60.

This 12-week follow-up period allows monitoring of your safety and any effects of the study medication after treatment has stopped.

You will attend follow-up visits during this period for safety assessments.

Any adverse events or health changes will continue to be recorded during this time.

The total duration of your participation in the study, from the first visit to the end of follow-up, will be approximately 60 weeks plus the screening period.

Who Can Join the Study?

  • You must be between 18 and 75 years old at the time you sign the consent form
  • You must have been diagnosed with asthma by a doctor for at least 12 months before starting the study
  • Your lung function must improve by at least 12% and 200 milliliters after using a bronchodilator medicine, which is a medicine that opens up your airways, either during screening or documented in the past 24 months
  • You must have a specific type of asthma with elevated blood eosinophils, which are white blood cells involved in allergic reactions, with a count of at least 150 cells per microliter at screening, or a documented count of at least 300 cells per microliter in the past 12 months
  • Your lung function before using bronchodilator medicine must be between 30% and 90% of what is predicted as normal for you
  • Your asthma must not be well controlled, shown by an ACQ-6 score, which is a questionnaire measuring asthma control, of at least 1.5 on two separate occasions during screening
  • You must be taking prescribed asthma maintenance medicines including inhaled corticosteroids, which are anti-inflammatory medicines you breathe in, plus at least one other controller medicine for at least 3 months before starting the study
  • You must have had at least one asthma exacerbation, which is a sudden worsening of asthma symptoms, in the past 12 months that required steroid pills for at least 3 days, an emergency room visit, or hospitalization
  • You must be able to properly use inhalers, a peak flow meter which measures how fast you can blow air out, and spirometry equipment which measures lung function during the screening period
  • You must take your usual asthma medicines at least 70% of the time during the screening period
  • You must complete an electronic asthma symptom diary at least 70% of the time, meaning at least 7 mornings and 7 evenings in the last 10 days of screening
  • You must have a FeNO, which measures inflammation in your airways through your breath, of at least 25 parts per billion
  • If you are a woman able to become pregnant, you must use highly effective birth control starting 28 days before the first dose and continuing until at least 36 weeks after the last dose, and have negative pregnancy tests before each dose
  • If you are a woman able to become pregnant, you must not be pregnant or breastfeeding
  • You must not donate or freeze sperm if you are male, or eggs if you are female, from the start of the study until 60 weeks
  • Your body mass index, which is a measure of body fat based on height and weight, must be between 18 and 40, and you must weigh at least 40 kilograms
  • You must provide written consent before any study procedures are performed

Who Cannot Join the Study?

  • The study information provided does not list specific reasons why patients cannot participate in this clinical trial
  • If you are interested in this study, the research team will review your complete medical history to determine if you are eligible to take part
  • General factors that often prevent participation in asthma studies (a condition where airways become narrow and swollen, making breathing difficult) may include having other serious health conditions, taking certain medications, being pregnant or planning to become pregnant, or having had severe allergic reactions in the past
  • The study doctors will assess each person individually to see if they can safely participate

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Hm Sanchinarro Madrid Spain
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
CHU Grenoble Alpes La Tronche France
Pneumologisches Studienzentrum München-West Munich Germany

Other Sites

Site Name City Country Status
Diagnostics And Consultation Center Convex Ltd. Sofia Bulgaria
Pneumo Studien Darmstadt GmbH Darmstadt Germany
Halsoklustret AB Stockholm Sweden
IKF Pneumologie GmbH & Co. KG Frankfurt Germany
Studienpraxis Berlin-Brandenburg Cornelia Seelbinder Und Lennart Schaper GbR Berlin Germany
Medical Center New Rehabilitation Center EOOD Stara Zagora Bulgaria
POIS Sachsen GmbH Leipzig Germany
Velocity Clinical Research Luebeck GmbH Luebeck Germany
Medical Center Excelsior OOD Sofia Bulgaria
Multiprofile Hospital For Active Treatment Knyaginya Klementina Sofia EAD Sofia Bulgaria
Region Skane Skanes Universitetssjukhus Lund Sweden
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Universitaire De Nantes Nantes France
Hospital Vithas Xanit Internacional Benalmadena Spain
Medical Center Teodora EOOD Ruse Bulgaria
Pneumologie Odeonsplatz Munich Germany
Hospital Universitario Virgen De La Victoria Malaga Spain
Usfdromrqcjljbobhjlod Eutlf Axs Essen Germany
Myaauxs Cisgky Piimdy Cnrmtj Ehdd Lovech Bulgaria
Cywcxmffyl Mbitqrh Spyiaqq Ao Linkoping Sweden
Mmgbhbidfp Aa Malmo Sweden
Ccamyn Hcdbmnsxucz Udzjhnihjyzam Dz Djvbb Dijon France
Hikriwhx Ukudimdafvyea Dnchrigb Donostia / San Sebastian Spain
Kznc Glak Bendorf Germany
Snnskzznltdxgg Dkg Khavun Frankfurt Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Recruiting
05.11.2025
France France
Not recruiting
05.11.2025
Germany Germany
Recruiting
05.11.2025
Spain Spain
Recruiting
05.11.2025
Sweden Sweden
Not recruiting
05.11.2025

Trial locations

WIN378 is an investigational medication being studied for the treatment of moderate or severe asthma in adults. This medication is being tested to see how safe it is, how well it is tolerated by patients, how the body processes it, and whether it causes an immune response. The study will also look at whether WIN378 can help improve asthma symptoms and control in people with moderate or severe asthma.

Placebo is an inactive substance that looks like the real medication but contains no active treatment. It is used in this study to compare the effects of WIN378 against no treatment, helping researchers understand if WIN378 actually works better than receiving no active medication.

Investigated diseases:

Asthma – Asthma is a chronic respiratory condition that affects the airways in the lungs. The airways become inflamed and narrowed, making it difficult to breathe. During an asthma episode, the muscles around the airways tighten and the lining of the airways swells, producing extra mucus. This leads to symptoms such as wheezing, coughing, chest tightness, and shortness of breath. The condition can vary in severity from person to person and may worsen over time if not properly managed. Asthma symptoms can be triggered by various factors including allergens, exercise, cold air, or respiratory infections.

Trial ID:
2025-521391-58-00
Protocol code:
WB-2101
Trial Phase:
Therapeutic exploratory (Phase II)

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