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Study on the Effects of Dexpramipexole for Adolescents and Adults with Severe Eosinophilic Asthma

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Dexpramipexole (KNS-760704) on individuals with severe eosinophilic asthma. Severe eosinophilic asthma is a type of asthma characterized by high levels of a specific type of white blood cell called eosinophils, which can lead to more frequent and severe asthma attacks. The medication being tested is taken orally in the form of a film-coated tablet.

The purpose of the study is to evaluate how effective Dexpramipexole is in reducing severe asthma attacks over a period of 52 weeks. Participants in the study will be randomly assigned to receive either the medication or a placebo, which is a tablet that looks like the medication but does not contain the active ingredient. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, to ensure unbiased results.

Throughout the study, participants will take the medication or placebo daily and attend regular visits to monitor their asthma symptoms and overall health. The study will assess various outcomes, including the frequency of severe asthma attacks and changes in lung function and asthma control over time. This research aims to provide valuable information on the potential benefits of Dexpramipexole for people living with severe eosinophilic asthma.

1 Joining the study

Upon joining the study, participants will be randomly assigned to receive either the active medication, dexpramipexole, or a placebo. This process is double-blind, meaning neither the participants nor the researchers know who receives the active medication or placebo.

2 Medication administration

Participants will take the assigned medication orally in the form of a film-coated tablet. The medication is taken regularly as prescribed for a duration of 52 weeks.

3 Regular assessments

Throughout the 52-week period, participants will undergo regular assessments to monitor the efficacy and safety of the treatment. These assessments will include measuring lung function and evaluating asthma control.

4 Primary outcome measurement

The primary outcome of the study is to measure the annualized rate of severe asthma exacerbations over the 52-week period.

5 Secondary outcome measurements

Secondary outcomes include changes in lung function and asthma control, as well as quality of life assessments at specified intervals during the study.

6 Completion of the study

At the end of the 52-week period, participants will complete a final assessment to evaluate the overall impact of the treatment on their asthma condition.

Who Can Join the Study?

  • Sign an informed consent form, which is a document that explains the study and confirms your agreement to participate.
  • If you are a woman who can have children, you must use a reliable method of birth control during the study. This can include options like abstinence, a partner who has had a vasectomy, certain birth control implants, sterilization, or birth control pills.
  • Be at least 12 years old. If you are in Poland, you must be at least 18 years old.
  • Have a doctor’s diagnosis of asthma for at least 12 months before the first screening visit.
  • Be using asthma medication regularly, including medium or high doses of inhaled corticosteroids, for at least 12 months before the first screening visit. You must also be on a stable dose for at least 3 months before the first screening visit and use additional asthma medications as needed.
  • Have a lung function test result (called FEV1) that is between 40% and 80% of what is expected for your age and size at the second screening visit. For those aged 12 to 17, it should be between 40% and 90%.
  • Show variable airflow obstruction, which means your lung function can change. This can be shown by improvement after using a bronchodilator (a medicine that helps open airways) or other tests done in the past 24 months.
  • Have a score of 1.5 or higher on the Asthma Control Questionnaire (ACQ-6) at the second screening visit. This questionnaire helps measure how well your asthma is controlled.
  • Have a history of at least two asthma flare-ups in the past year that required treatment with systemic corticosteroids, which are strong anti-inflammatory medications.
  • If you are a woman who can have children, you must have a negative pregnancy test at the screening and baseline visits.

Who Cannot Join the Study?

  • Patients who have a different type of asthma that is not severe eosinophilic asthma. This type of asthma involves a high number of a specific type of white blood cell called eosinophils.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or take the study medication as required.
  • Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding, as the effects of the study medication on unborn babies or infants are not known.
  • Patients who are currently participating in another clinical trial, as this could affect the results of the study.
  • Patients who have a history of allergic reactions to the study medication or similar medications.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Medical Center Hera EOOD Sofia Bulgaria
Alergologia Plus Sp. z o.o. Poznan Poland
Santa Sp. z o.o. Lodz Poland
Specjalistyczna Przychodnia Lekarska Alergo Med Sp. z o.o. Poznan Poland
Centrum Medyczne All-Med Badania Kliniczne Cracow Poland
Centrum Medycyny Oddechowej Mroz Sp. j. Bialystok Poland
Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov-Ruse Ruse Bulgaria
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. Cracow Poland
Clinmedica Research sp. z o.o. Skierniewice Poland
GRAZYNA JASIENIAK-PINIS ATOPIA Niepubliczny Zaklad Opieki Zdrowotnei Poradnie Specjalistyczne Cracow Poland
Theramed Healthcare S.R.L. Brasov Romania
Przychodnia Alergologiczno-Pulmonologiczna Alergopneuma Sp. z o.o. Lublin Poland
Multiprofile Hospital For Active Treatment Sveta Ekaterina-Dimitrovgrad EOOD Dimitrovgrad Bulgaria
Medical Center New Rehabilitation Center EOOD Stara Zagora Bulgaria
Multi-Profile Hospital For Active Treatment Dr. Stamen Iliev AD Montana Bulgaria
Gornoslaskie Centrum Mwdyczne Katowice Poland
Santa Sp. z o.o. sp. K.Polimedica PTG Kielce Kielce Poland
Policlinica De Diagnostic Rapid S.A. Brasov Romania
Mcm Polimedica 2 Sp. z o.o. Warsaw Poland
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p. Wroclaw Poland
Pratia S.A. Skorzewo Poland
University Multiprofile Hospital For Active Treatment Eurohospital Plovdiv Ltd. Plovdiv Bulgaria
Medical Center Zdrave-1 OOD Kozloduy Bulgaria
Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego W Lodzi SPZOZ Lodz Poland
University First multiprofile hospital for active treatment Sofia St. Joan Krastitel EAD Sofia Bulgaria
Panuvumzf 2ljg Mbxjf Stara Zagora Bulgaria
Otjurzocgohh Cutvopi Mwarnxay Aury Odpzn Cnqmgs Kmeszndeh Canaje sedo Ostrowiec Swietokrzyski Poland
Hifeyst Hspyw Sifsivso Piaseczno Poland
Cmgcqtb Dfyqppzjnigvzpjhdlvppp Pkamsioql Jpgixu Mbgkbqpapo Bedzin Poland
Cnkwgqp Hbgheufkxo Szoo Cracow Poland
Szstybxukvw Hcojpaua Fgj Aksqpm Tinvcoqqh Ox Pzzxvybps Dyiggazj Pzfqmt Evsm Pernik Bulgaria
Dwqdxxblmy Cstvsuzpis Cuodjb 1 Sdnqte Eieq Sliven Bulgaria
Mrvxkcd Cigcoz Ssv Issx Rqcsru Emnb Vidin Bulgaria
Mzvadebvf Izttciznnm Cazcklyi Sonhsmeh Sdf z obmy Warsaw Poland
Nzhy Mkixdq Judpu Csaidu Giżycko Poland
Mpqatz Biyeslq – Divfnayvs Wroclaw Poland
Mskjhyxu Mjoejrj Axqwyws Pleven Bulgaria
Uflhemtfnovlbu Czilnbv Kusaxqmri Gdansk Poland
May Hnmrtuds Sx zek Makow Podhalanski Poland
Ejci Cmwntdo Ueokl Mjnctskcfx Eed Śahiela Rzeszow Poland
Paetzwya Pwbmtxsx Lvdbujux Gotusgf Pohbqgdyjlruwfzshsghgoqbngi Asjy Pqdcwezhb Bialystok Poland

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

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
23.02.2023
Poland Poland
Not recruiting
23.02.2023
Romania Romania
Not recruiting
23.02.2023

Trial locations

Investigated drugs:

Dexpramipexole is a medication being studied for its potential to help people with severe eosinophilic asthma. This type of asthma is characterized by high levels of eosinophils, a type of white blood cell, which can cause inflammation and worsen asthma symptoms. The trial aims to see if dexpramipexole can reduce the number of severe asthma attacks over a year. Participants take this medication orally, and researchers are also looking at how safe and tolerable it is for those who use it.

Investigated diseases:

Severe Eosinophilic Asthma – This is a type of asthma characterized by high levels of eosinophils, a type of white blood cell, in the lungs. It often leads to frequent and severe asthma attacks, which can cause difficulty in breathing, wheezing, and coughing. The condition is chronic and can significantly impact daily activities and quality of life. Symptoms may worsen over time, especially if not managed properly. It is often resistant to standard asthma treatments, requiring specialized care. The disease can vary in severity and may require ongoing monitoring and adjustments in management strategies.

Trial ID:
2023-507665-25-00
Protocol code:
AR-DEX-22-01
Trial Phase:
Therapeutic confirmatory (Phase III)

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