A study to evaluate the effects of KT-621 in adults with moderate to severe eosinophilic asthma

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What is this study about?

This study focuses on individuals living with Eosinophilic Asthma, a type of Asthma where the airways are inflamed due to high levels of eosinophils, which are a specific type of white blood cell. The condition being studied is specifically Uncontrolled Moderate to Severe Eosinophilic Asthma, meaning the symptoms are not well-managed by current standard treatments. The purpose of the study is to evaluate the efficacy of different doses of the experimental medication KT-621 compared to a placebo.

Participants in the study will take an oral tablet. Some will receive different doses of KT-621, while others will receive a placebo. To ensure the results are fair, the study is double blind, meaning neither the participants nor the researchers know which specific treatment is being administered at any given time. The study is organized into different groups that receive their assigned medication simultaneously to compare how well the drug works and to monitor its safety profile.

Who Can Join the Study?

  • You must have a history of at least one asthma exacerbation, which is a sudden worsening of asthma symptoms, that required either systemic corticosteroids (steroid medicines taken by mouth, through a vein, or by injection) and/or a hospital stay or emergency room visit within the last 52 weeks.
  • Your absolute blood eosinophil count, which is a measurement of a specific type of white blood cell involved in allergic reactions, must be 0.30 x 10^9/L or higher.
  • You can be any gender, but you must use contraception (methods to prevent pregnancy) in accordance with local rules for clinical study participants.
  • You must be between 18 and 75 years old at the time of signing the consent form.
  • You must have been officially diagnosed with asthma for at least 52 weeks before the start of the study.
  • You must be taking a stable dose of a medium- to high-dose inhaled steroid combined with a LABA (a long-acting medication that helps keep airways open) for at least 12 weeks, without changing your dose or schedule in the 4 weeks before the study begins.
  • Your FEV1, which is a test that measures how much air you can forcefully exhale in one second, must be between 40% and 80% of the normal expected value for your age and size.
  • Your ACQ-5 score, which is a questionnaire used to measure how well your asthma is controlled, must be 1.5 or higher.
  • Your FeNO level, which is a test that measures the amount of nitric oxide in your breath to check for airway inflammation, must be 25 parts per billion (ppb) or higher.
  • You must show evidence of reversible airway obstruction, meaning your breathing improves after using a bronchodilator (a quick-relief medicine like albuterol that opens the airways).

Who Cannot Join the Study?

  • Having any serious lung disease other than asthma, such as COPD (a condition that makes it hard to breathe), bronchiectasis (damaged airways), pulmonary fibrosis (scarring of the lungs), cystic fibrosis (a genetic disease affecting mucus), lung cancer, or infections in the lungs.
  • Having conditions that cause high levels of eosinophils (a type of white blood cell involved in allergies and asthma) in the blood, such as Churg Strauss syndrome or hypereosinophilic syndrome.
  • Having any medical or mental health condition that, in the doctor’s opinion, could make participation unsafe or prevent the study results from being accurate.
  • A history of using drugs or alcohol excessively within the last 2 years.
  • Current use of nicotine, including smoking tobacco, using vaping products, or electronic cigarettes. People who used to smoke must have stopped for at least 26 weeks.
  • Having any type of cancer within the last 5 years, unless it was a specific type of skin or cervix cancer that was completely removed by surgery.
  • Having a severe asthma flare-up in the 4 weeks before the study starts that required systemic corticosteroids (strong medicines like pills or injections used to reduce inflammation), a hospital visit, or emergency care.
  • Testing positive for HIV (a virus that attacks the immune system), Hepatitis B, Hepatitis C, or having an active or untreated tuberculosis (TB) infection.
  • Having abnormal blood results, such as low platelets (cells that help blood clot), low hemoglobin (a protein in red blood cells that carries oxygen), or low neutrophils (white blood cells that fight infection).
  • Having abnormal liver tests, such as high levels of AST or ALT (enzymes that indicate liver health) or high bilirubin (a yellow substance produced by the liver).
  • A known or suspected immunodeficiency disorder (a condition where the immune system is weak) or a history of frequent or severe infections.
  • A current or recent parasitic infection (an infection caused by tiny organisms like worms) or having traveled to areas where these infections are common in the last 3 months.
  • Having had major surgery in the 8 weeks before the study starts or planning to have any surgery during the study.
  • Having any current infection (like a chest or throat infection) that required antibiotics, antifungals (medicine for fungus), or antivirals (medicine for viruses) in the recent weeks.
  • Any other health condition that might make the study unsafe, such as uncontrolled diabetes, heart failure, high blood pressure, kidney disease requiring dialysis, or autoimmune diseases like lupus or rheumatoid arthritis.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
Centre Hospitalier Regional De La Citadelle Liege Belgium
CHU Saint Pierre Brussels Belgium
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Universitario Puerta Del Mar Cadiz Spain
Az Maria Middelares Gent Gent Belgium
Alergologia Plus Sp. z o.o. Poznan Poland
Hospital Universitario Infanta Leonor Madrid Spain
Alian s.r.o. Bardejov Slovakia
Lekarze Specjalisci J. Malolepszy I Partnerzy Wroclaw Poland
Pneumocare Namur Belgium
POIS Sachsen GmbH Leipzig Germany
Theramed Healthcare S.R.L. Brasov Romania
Clinica Vitae Sp. z o.o. Gdansk Poland
Bio Zdrowie Sp. z o.o. Bialystok Poland
Uniwersytecki Szpital Kliniczny W Bialymstoku Bialystok Poland
CENTRUM MEDYCZNE LUCYNA ANDRZEJ DYMEK Zawadzkie Poland
IRCCS Ospedale Policlinico San Martino Genoa Italy
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo Milan Italy
Klinik Hietzing Vienna Austria
Uniwersytecki Szpital Kliniczny Nr 1 Im Norberta Barlickiego Uniwersytetu Medycznego W Lodzi SPZOZ Lodz Poland
Berufsausuebungsgemeinschaft Bag Prof Dr. Med Gerhard Hoheisel Dr. Med Andreas Bonitz GbR Leipzig Germany
Hospital Universitario De Canarias La Laguna Spain
Santa Sp. z o.o. Lodz Poland
Centermed Sp. z o.o. Lublin Poland
Neoclinic Concept S.R.L. Timisoara Romania
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari Bari Italy
Cdqzxgwmt Ueyjupxuslngnh Svjjdfbcy Woluwe-Saint-Lambert Belgium
Ujnk Cbyfqyfe Tbyzpn Sfv z onlw Lodz Poland
Hkntaexd Uygwfzvwlnpbv Mxdrjdw Do Vzvgzhxzzp Santander Spain
Pmthsaclobgbv Hncdp Halle (Saale) Germany
Anywnn sqkxgk Kosice Slovakia
Pvkqizyg acpzcofuri Huhiccgn soxcmm Spisska Nova Ves Slovakia
Nxpl Hgylx Mwtknct Bialystok Poland
Nvd Seg Jqlhrf Bnwdohsp nmvf Bardejov Slovakia
Sfvwzfig Cmoqsp Dh Btga Idibzeurnyd Sj Pcoquvvzeknwslfkm Vjnscf Bjivz Ceoihpz Craiova Romania

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

Trial status

Country Status Recruitment Start
Austria Austria
Not yet recruiting
31.03.2026
Belgium Belgium
Not yet recruiting
31.03.2026
Germany Germany
Recruiting
31.03.2026
Italy Italy
Not yet recruiting
31.03.2026
Poland Poland
Recruiting
31.03.2026
Romania Romania
Recruiting
31.03.2026
Slovakia Slovakia
Recruiting
31.03.2026
Spain Spain
Recruiting
31.03.2026

Trial locations

KT-621 is an experimental medicine taken as a pill by mouth. It is being studied to see if it can help improve symptoms and manage health in adults who have moderate to severe asthma caused by high levels of a specific type of white blood cell called eosinophils.

Uncontrolled Moderate to Severe Eosinophilic Asthma – This is a type of chronic lung disease characterized by inflammation in the airways. It occurs when a specific type of white blood cell, called an eosinophil, builds up in the lungs. This buildup causes the airways to become swollen and narrow, making it difficult to breathe. The condition is considered uncontrolled when symptoms persist despite standard management. Over time, this ongoing inflammation can lead to frequent breathing difficulties and airway sensitivity.

Trial ID:
2025-523180-38-00
Protocol code:
KT621-AS-202
Trial Phase:
Therapeutic exploratory (Phase II)

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