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Rilzabrutinib for Moderate-to-Severe Asthma
Study Summary
This trial is designed to study whether the addition of rilzabrutinib to inhaled ICS/LABA therapy can improve asthma control in adults who are not well controlled on ICS/LABA therapy alone.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You have been smoking or quit smoking within the last 6 months before the first study visit.My lung function improves significantly after using a bronchodilator or I've had a positive asthma test in the last 5 years.I've had serious infections recently or have an ongoing moderate-to-severe infection.I have had severe asthma attacks requiring steroids or emergency care in the last 2 years.I have not had bronchial thermoplasty in the last 2 years nor plan to start it soon.I haven't taken any biologic or immunosuppressant medications for autoimmune or inflammatory diseases recently.I have had shingles symptoms within the last 3 months.I have previously used a BTK inhibitor medication.I have had severe asthma attacks requiring breathing tube insertion.My asthma control score is either below 1.25 or above 3.0.I have liver disease.You have smoked the equivalent of 10 packs of cigarettes a year for at least one year.I haven't taken strong medication that affects liver enzymes recently.I haven't taken drugs like omeprazole in the last 3 days.I am only using certain inhalers and not using LAMAs or mucolytics.I received a COVID-19 vaccine within the last 14 days.I have severe digestive issues that could affect medication absorption.I have a chronic lung condition or a disease that increases my eosinophil counts.I have been diagnosed with asthma for at least a year.I have moderate to severe liver problems.I haven't taken any experimental drugs or used experimental devices recently.You currently have a positive test for COVID-19.I have a condition that could cause me to bleed a lot.I have had a solid organ transplant.I haven't had any cancer except for non-melanoma skin cancer or cervical cancer in situ in the last 5 years.Your body mass index (BMI) is between 17.5 and 40.My heart's electrical activity is normal and I don't have serious heart issues.Your lung function test shows that you can breathe out a good amount of air.I haven't used steroids or been hospitalized for asthma in the last 4 weeks.I have not had a live vaccine within the last 28 days and won't get one during the trial.I've been on a stable dose of high-dose ICS and LABA for at least 1 month.
- Group 1: Rilzabrutinib
- Group 2: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
To what extent does Rilzabrutinib present a risk to patients?
"Research indicates that rilzabrutinib is relatively safe, garnering a score of 2 on the safety scale. This medicinal agent has been tested for its efficacy in Phase 2 trials but there are no results supporting its effectiveness yet."
Is eligibility for this experiment restricted to persons under 55 years of age?
"The parameters for this clinical trial necessitate that participants fall within the 18-70 age bracket. Subsequently, 113 studies are available to those under 18 and 198 for individuals over 65 years of age."
Is recruitment currently open for this experiment?
"Affirmative, clinicaltrials.gov confirms that this experiment is actively searching for participants. It was initially made available on December 12th 2021 and the listing has been updated as recently as October 26th 2022. 192 persons are required across 3 facilities."
Who is the ideal subject for this experiment?
"This medical study seeks 192 asthma patients aged between 18 and 70. The following criteria must all be met: a physician's diagnosis of the condition, ongoing treatment with ICS/LABA combination therapy for 3 months or more prior to screening, prebronchodilator FEV1 scores >40% to ≤85%, 12-200mL reversibility in FEV1 after albuterol inhalation at screening/history within last year, BMI ≥17.5 & ≤ 40kg/m2, consistent contraception use according to local regulations while participating in the trial, an exacerbation event requiring systemic steroid treatment or hospitalization"
How many participants are engaged in this experiment?
"Correct. The information hosted on clinicaltrials.gov reveals that this medical trial, first posted on December 12th 2021, is currently recruiting. 192 participants are needed from 3 different sites."
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