Not recruiting

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

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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
Step 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.
Step 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.
Step 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 trial?

13 criteria

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 trial?

12 criteria

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

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Fakultni Nemocnice Brno
Brno, Czechia
Verified
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy
Verified
Hospital Universitario Marques De Valdecilla
Santander, Spain

Trial locations

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Investigated drugs

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.

Dexpramipexole Dihydrochloride Monohydrate

What is already known about the treatment

Dexpramipexole – An investigational oral medication administered twice daily (BID) that is currently being studied in Phase III clinical trials for the treatment of severe eosinophilic asthma. The drug belongs to the class of small molecule therapeutics and works by reducing blood eosinophil levels through a mechanism that affects eosinophil production and survival. This medication represents a novel approach to treating severe asthma by targeting the underlying inflammatory process, specifically focusing on eosinophils which are white blood cells that play a key role in allergic inflammation and asthma symptoms. Currently undergoing long-term safety and tolerability assessment in clinical trials, dexpramipexole is being evaluated as a potential treatment option for patients with severe eosinophilic asthma who have completed previous Phase III studies.

Investigated diseases

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.