Long-term safety study of dexpramipexole tablets in patients with severe eosinophilic asthma who completed EXHALE-2 or EXHALE-3 trials

3 1 1

What is this study about?

This study focuses on severe eosinophilic asthma, a serious form of asthma characterized by high levels of specific white blood cells called eosinophils. The research examines a medication called dexpramipexole, which is given as a film-coated tablet that patients take by mouth. The purpose is to evaluate the long-term safety and how well patients tolerate this treatment when taken over an extended period.

The study is a continuation of previous research and will involve patients who have already completed earlier phases of testing this medication. During the study, participants will take dexpramipexole tablets twice daily for up to 52 weeks. The medication aims to help control the symptoms of severe asthma and reduce the number of asthma attacks.

Throughout the study, researchers will monitor how the treatment affects participants’ asthma control, including how often they experience severe asthma attacks. They will also track changes in the levels of eosinophils in the blood and assess how well patients can manage their asthma symptoms. Regular check-ups will be conducted to monitor the participants’ overall health and any effects of the medication.

1 Initial visit and eligibility confirmation

If you completed either the EXHALE-2 or EXHALE-3 study, you may be eligible for this extension study.

During the first visit, a pregnancy test will be performed if you are a woman who can become pregnant.

You will need to review and sign consent documents to participate in the study.

2 Treatment initiation

You will receive dexpramipexole tablets that you will need to take by mouth.

The dosage is 150 mg twice daily.

The tablets are film-coated for easier swallowing.

3 Regular check-ups

Your health will be monitored through regular visits at weeks 16, 32, and 52.

During these visits, the following assessments will be performed:

– Blood tests to check your eosinophil levels (a type of white blood cell)

– Completion of an asthma control questionnaire

– Vital signs measurements

– Heart monitoring through ECG

– Laboratory tests

4 Asthma monitoring

Any severe asthma episodes will be recorded throughout the 52-week period.

Your asthma control will be assessed using a questionnaire at specified visits.

5 Safety monitoring

Throughout the study, any health changes or side effects will be monitored and recorded.

Regular safety assessments will include blood tests, vital signs, and heart monitoring.

6 Study completion

The study will conclude with a final visit after 52 weeks of treatment.

A final safety assessment will be performed during this visit.

Who Can Join the Study?

  • Must have completed participation in either the EXHALE-2 or EXHALE-3 Phase III clinical studies
  • Must sign an informed consent form (and assent form if applicable)
  • Women who can become pregnant must have a negative pregnancy test at the first visit
  • Women who can become pregnant must use one of these birth control methods throughout the study:
    • A highly effective method such as:
      • Complete sexual abstinence
      • Partner with vasectomy
      • Implant (Implanon)
      • Tubal ligation (female sterilization)
      • Intrauterine device (IUD)
      • Birth control pills
    • OR two acceptable contraception methods used together
  • Women are considered not able to become pregnant if they:
    • Have had surgery to remove the uterus (hysterectomy) or ovaries
    • Have not had menstrual periods for 12 or more months (if under 50 years old, additional hormone tests required)
    • Are 50 years or older and have not had periods for 12 or more months after stopping hormone treatments

Who Cannot Join the Study?

  • Participants who did not complete either EXHALE-2 or EXHALE-3 Phase III studies
  • Individuals who are not diagnosed with severe eosinophilic asthma (a type of asthma characterized by high levels of specific white blood cells called eosinophils)
  • Children below adolescent age (under 12 years old)
  • People with known allergic reactions to dexpramipexole or similar medications
  • Pregnant or breastfeeding women
  • Individuals who cannot take oral medications twice daily
  • People currently participating in other clinical trials
  • Those who have not provided informed consent to participate in the study
  • Individuals with severe kidney or liver problems
  • People who have experienced a severe asthma attack in the past 4 weeks
  • Participants who are unable to perform required study procedures or attend scheduled visits
  • Those with a history of non-compliance with medical treatments

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
Alergologia Plus Sp. z o.o. Poznan Poland
Hospital Universitario Infanta Leonor Madrid Spain
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
MediTrial s.r.o. Jindřichův Hradec Czechia
Theramed Healthcare S.R.L. Brasov Romania
Multi-Profile Hospital For Active Treatment Dr. Stamen Iliev AD Montana Bulgaria
Multiprofile Hospital For Active Treatment Sveta Ekaterina-Dimitrovgrad EOOD Dimitrovgrad Bulgaria
Plicni Stredisko Teplice s.r.o. Teplice Czechia
POIS Sachsen GmbH Leipzig Germany
MECS Medical and Clinical Studies Cottbus GmbH Cottbus Germany
Medical Center Hera EOOD Sofia Bulgaria
Fakultni Nemocnice Brno Brno Czechia
Policlinica De Diagnostic Rapid S.A. Brasov Romania
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p. Wroclaw Poland
University Multiprofile Hospital For Active Treatment Eurohospital Plovdiv Ltd. Plovdiv Bulgaria
University Hospital Olomouc Olomouc Czechia
Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego W Lodzi SPZOZ Lodz Poland
GRAZYNA JASIENIAK-PINIS ATOPIA Niepubliczny Zaklad Opieki Zdrowotnei Poradnie Specjalistyczne Cracow Poland
University First multiprofile hospital for active treatment Sofia St. Joan Krastitel EAD Sofia Bulgaria
ÜBAG Pneumology Center (Klifeck GmbH) Delitzsch Germany
Pmpboiahx 2bun Mrprf Stara Zagora Bulgaria
Httendme Ueyahlvmufnlt Mqhqknj De Vjutvwyyde Santander Spain
Obbgghoiimbl Crlmlej Msdeiptu Aewr Otfei Ckwsqm Kehlcygxz Cqkxaa scaq Ostrowiec Swietokrzyski Poland
Hywkycs Hounc Sjbcvskl Piaseczno Poland
Cftfacc Hxazkalrgq Scyh Cracow Poland
Sxbomnvahma Hndpneix Fuq Aenujy Tgqsruzbw Ov Pvbzrugnm Dledryvp Ptsndq Exby Pernik Bulgaria
Dfnvgvtefl Cohpnakchl Ccqtmx 1 Svrnwl Edof Sliven Bulgaria
Mjncxzs Ccwwem Sck Imey Rsffkx Ekcf Vidin Bulgaria
Pilptv Rgodpngkdso Hpqiho Smqv Barcelona Spain
Pjmdxjvueyizlts Sikpztrbbhrmzf Mwh dquxqglnuapssau Berlin Germany
Nkdw Mvyulj Jqtyb Cvrmsk Giżycko Poland
Mvsixwbx Mvxhoxd Aymlsmj Pleven Bulgaria
Myv Htkkwipo Sl zin Makow Podhalanski 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
09.09.2024
Czechia Czechia
Not recruiting
09.09.2024
Germany Germany
Not recruiting
09.09.2024
Italy Italy
Not recruiting
09.09.2024
Poland Poland
Not recruiting
09.09.2024
Romania Romania
Not recruiting
09.09.2024
Spain Spain
Not recruiting
09.09.2024

Trial locations

Dexpramipexole is a medication being studied for people with severe eosinophilic asthma. This medication works by reducing the number of eosinophils, which are white blood cells that can cause inflammation in the airways. The medication is being tested to evaluate its long-term safety and how well patients tolerate it when used for extended periods. It is taken orally and is being investigated as a potential treatment option for patients whose asthma is specifically related to high levels of eosinophils.

Severe eosinophilic asthma – A chronic respiratory condition characterized by inflammation of the airways with a significant presence of eosinophils (a type of white blood cell). The airways become swollen and narrow, leading to recurring episodes of breathing difficulties, chest tightness, and coughing. This form of asthma is distinguished by higher than normal levels of eosinophils in the blood or airways, making breathing particularly challenging. Patients experience repeated flare-ups where symptoms become more intense and may have difficulty performing daily activities due to shortness of breath. The condition tends to be persistent and can affect people of any age.

Trial ID:
2024-510810-33-00
Protocol code:
AR-DEX-22-04
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • GB-0895 for Severe Uncontrolled Asthma in Adults and Adolescents

    Recruiting

    3 1
    Investigated diseases:
    Bulgaria Croatia Czechia Germany Greece Hungary +4
  • Testing WIN378 Safety and Effects in Adults with Moderate or Severe Asthma

    Recruiting

    2 1
    Investigated diseases:
    Bulgaria France Germany Spain Sweden