Study on the Effects of Dexpramipexole in Adolescents and Adults with 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 eosinophilic asthma. Eosinophilic asthma is a type of asthma characterized by high levels of a specific type of white blood cell called eosinophils, which can cause inflammation and breathing difficulties. The purpose of the study is to evaluate how well Dexpramipexole can improve lung function in people with this condition.

Participants in the study will receive either Dexpramipexole or a placebo, which is a substance with no active medication. The medication is taken orally in the form of a film-coated tablet. The study will last for 24 weeks, during which participants will be monitored to assess the safety and effectiveness of the treatment. The maximum daily dose of Dexpramipexole will be either 75 milligrams or 150 milligrams, depending on the specific group within the study.

Throughout the study, participants will have regular check-ups to monitor their health and any changes in their asthma symptoms. The main focus will be on measuring improvements in lung function and overall asthma control. This trial aims to provide valuable information on whether Dexpramipexole can be a beneficial treatment option for people with eosinophilic asthma.

1 joining the study

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

2 medication administration

Participants take the assigned medication orally in the form of a film-coated tablet. The medication is taken regularly as prescribed for a duration of 24 weeks.

3 monitoring and assessments

Throughout the 24-week period, participants undergo regular assessments to monitor the effects of the medication. These assessments include measuring lung function and evaluating asthma control.

The primary focus is on the change in lung function, specifically the pre-bronchodilator forced expiratory volume (FEV1), which is measured at various points, particularly at weeks 20 and 24.

4 completion of the study

At the end of the 24-week period, participants complete the study. Final assessments are conducted to evaluate the overall impact of the treatment on asthma symptoms and quality of life.

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. If you are not able to have children, this does not apply to you.
Be at least 12 years old. In Poland, participants must be at least 18 years old.
Have a doctor’s diagnosis of asthma for at least 12 months before the first screening visit.
Need to use daily asthma medications, including a low dose of inhaled corticosteroids (a type of asthma medication) and at least one other asthma controller medication. In Poland, a medium dose of inhaled corticosteroids is required. You must have been using these medications for at least 12 weeks before the first screening visit, and the doses must be stable for at least 4 weeks before the first screening visit.
Have a lung function test result (called FEV1) that is less than 80% of what is predicted for your age and size, or less than 90% if you are between 12 and 17 years old, at the second screening visit.
Show improvement in lung function after using a bronchodilator (a medication that helps open the airways) at the second screening visit. This means an increase of at least 12% and 200 mL in FEV1, or 12% and 160 mL if you are between 12 and 17 years old. If you do not meet this requirement, you may have another chance to meet it during the screening period.
Have a score of 1.5 or higher on the Asthma Control Questionnaire (ACQ-6) at the second screening visit. This questionnaire measures how well your asthma is controlled.
Have an eosinophil count (a type of white blood cell) of at least 0.30×10⁹/L at the first screening visit. If your initial count is between 0.250×10⁹/L and 0.299×10⁹/L, you may have it checked again before the second screening visit.
If you are a woman who can have children, you must have a negative urine pregnancy test at the screening and baseline visits.

Who Cannot Join the Study?

Patients who do not have eosinophilic asthma, a type of asthma with high levels of a certain type of white blood cell called eosinophils.
Patients who are not within the specified age ranges for the study.
Patients who are not part of the specified clinical trial groups.
Patients who are not willing or able to follow the study procedures.
Patients who have other medical conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are taking medications that might interfere with the study drug.
Patients who have participated in another clinical trial recently.
Patients who have a history of drug or alcohol abuse.
Patients who have a known allergy to the study drug or its ingredients.

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
Santa Sp. z o.o.	Lodz	Poland
Specjalistyczna Przychodnia Lekarska Alergo Med Sp. z o.o.	Poznan	Poland
Centrum Medycyny Oddechowej Mroz Sp. j.	Bialystok	Poland
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.	Cracow	Poland
Clinmedica Research sp. z o.o.	Skierniewice	Poland
Theramed Healthcare S.R.L.	Brasov	Romania
Przychodnia Alergologiczno-Pulmonologiczna Alergopneuma Sp. z o.o.	Lublin	Poland
Gornoslaskie Centrum Mwdyczne	Katowice	Poland
Policlinica De Diagnostic Rapid S.A.	Brasov	Romania
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p.	Wroclaw	Poland
Pratia S.A.	Skorzewo	Poland
Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego W Lodzi SPZOZ	Lodz	Poland
GRAZYNA JASIENIAK-PINIS ATOPIA Niepubliczny Zaklad Opieki Zdrowotnei Poradnie Specjalistyczne	Cracow	Poland
VILTIS MEDICA SPECJALISTYCZNA PRAKTYKA LEKARSKA AGATA KOT	Trzebnica	Poland
Szsfyeqs Cpprei Dx Pyeplgrxrttzpiclx Cilutpeno	Palazu Mare	Romania
Oqczcpvtcrsg Crxvtak Mrhjleng Aogr Ookhk Cglobk Kjawlxlca Cprxfw ssnd	Ostrowiec Swietokrzyski	Poland
Hkrucvz Hbzgg Sfgqbfvt	Piaseczno	Poland
Cpghbri Hhfqthczsz Stac	Cracow	Poland
Crvtuoe Dsmsstlcdynubxdurmdsqw Pgzixhmkb Jsievv Moroyceduf	Bedzin	Poland
Sxcvk Udacvlwesbria Sogizmm Kyjeireun nd 1 iqi Ns Bjvsjevsgta w Łmocv	Lodz	Poland
Nyju Mhlinn Juekd Clvbbr	Giżycko	Poland
Uhrjzjmihdrgnj Cdmctuk Kqmdleucz	Gdansk	Poland
Msv Hbcystsp Sd zpm	Makow Podhalanski	Poland
Ezqg Cimjgul Uhiiq Mwjhhydobu Ewc Śqpsard	Rzeszow	Poland
Pqzojaff Pbkktbry Lfcxolht Glhjgqt Pywrdiclhsagjjhxsshmhepsgbs Aoqy Ppilildvh	Bialystok	Poland

Trial status

Country	Status	Recruitment Start
Poland	Not recruiting	04.01.2023
Romania	Not recruiting	04.01.2023

Trial locations

Investigated drugs:

Dexpramipexole Dihydrochloride Monohydrate

Dexpramipexole is a medication being studied for its potential to improve lung function in people with eosinophilic asthma. Eosinophilic asthma is a type of asthma characterized by high levels of eosinophils, a type of white blood cell, in the lungs. This medication is taken orally and is being tested to see if it can help reduce asthma symptoms and improve breathing over a 24-week period.

Investigated diseases:

Asthma

Eosinophilic asthma – Eosinophilic asthma is a type of asthma characterized by high levels of eosinophils, a type of white blood cell, in the lungs. This condition often leads to inflammation and swelling of the airways, causing symptoms such as wheezing, coughing, and shortness of breath. Unlike typical asthma, eosinophilic asthma may not respond well to standard asthma treatments. The disease can vary in severity, with some individuals experiencing frequent and severe asthma attacks. It is often associated with other allergic conditions, such as rhinitis or sinusitis. The progression of the disease can lead to chronic respiratory issues if not managed properly.

Trial ID:

2023-509739-22-00

Protocol code:

AR-DEX-22-03

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?