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Bruton's Tyrosine Kinase (BTK) Inhibitor
Rilzabrutinib for Moderate-to-Severe Asthma
Phase 2
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have experienced, within 2 years prior to Visit 1, any of the following asthma exacerbation events at least once: Treatment with a systemic steroid (oral or parenteral) for worsening asthma OR Hospitalization or emergency medical care visit for worsening asthma
Participants with reversibility of at least 12% and 200 mL in FEV1 15 to 30 minutes after administration of 2 to 4 puffs (200-400 mcg) of albuterol/salbutamol or levalbuterol/levosalbutamol during screening or documented history of a reversibility test that meets this criterion within 5 years prior to Visit 1 or documented positive response to methacholine challenge (a decrease in FEV by 20% [PC20] of <8mg/mL) within 5 years prior to Visit 1/Screening is considered acceptable to meet this inclusion criterion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until week 16
Awards & highlights
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.
Who is the study for?
Adults aged 18-70 with moderate-to-severe asthma not well controlled on ICS/LABA therapy can join. They must have a history of reversible airflow obstruction or positive methacholine challenge, an asthma diagnosis for at least 12 months, and experienced an exacerbation in the past two years. BMI should be between ≥17.5 and ≤40 kg/m2, non-smokers for at least six months, completed COVID-19 vaccination, and stable on current asthma medications.Check my eligibility
What is being tested?
The trial is testing Rilzabrutinib's effectiveness compared to a placebo over 12 weeks in improving asthma control when added to standard treatment (ICS/LABA). Participants will stop their usual ICS/LABA during the study to see how well Rilzabrutinib works alone.See study design
What are the potential side effects?
Possible side effects of Rilzabrutinib may include digestive issues, headaches, increased risk of infections due to immune system changes, liver problems, bleeding risks or bruising more easily than normal.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had severe asthma attacks requiring steroids or emergency care in the last 2 years.
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My lung function improves significantly after using a bronchodilator or I've had a positive asthma test in the last 5 years.
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I have been diagnosed with asthma for at least a year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ until week 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until week 16
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Therapeutic procedure
Secondary outcome measures
Asthma Control Questionnaire-5 (ACQ-5) score change from baseline at EOT and at each assessment time point
Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ[S]) Self-administered score change from baseline at EOT and at each assessment time point
Change from baseline in peak expiratory flow [PEF] and forced expiratory flow [FEF] 25-75% at each spirometry endpoint
+8 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: RilzabrutinibExperimental Treatment1 Intervention
Rilzabrutinib BID or TID and ICS/LABA
Group II: PlaceboPlacebo Group1 Intervention
Placebo and ICS/LABA
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rilzabrutinib
2021
Completed Phase 2
~320
Find a Location
Who is running the clinical trial?
SanofiLead Sponsor
2,171 Previous Clinical Trials
3,516,898 Total Patients Enrolled
46 Trials studying Asthma
27,142 Patients Enrolled for Asthma
Clinical Sciences & OperationsStudy DirectorSanofi
864 Previous Clinical Trials
2,020,201 Total Patients Enrolled
19 Trials studying Asthma
9,437 Patients Enrolled for Asthma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Rilzabrutinib
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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.
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