What side effects are associated with this type of intervention?

Common treatments for asthma, such as inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA), can cause side effects including oral thrush, hoarseness, and potential systemic effects like adrenal suppression. Bruton's Tyrosine Kinase Inhibitors, similar to Rilzabrutinib being studied for asthma, are known to cause side effects such as diarrhea, peripheral edema, dry eye, arthralgia, upper respiratory tract infections, hypertension, atrial fibrillation, and major hemorrhage.

What prior FDA approvals exist?

The FDA has approved various treatments for asthma, including inhaled corticosteroids (ICS), long-acting beta-agonists (LABA), and combination therapies such as ICS/LABA. While Rilzabrutinib, a Bruton's Tyrosine Kinase (BTK) inhibitor, is being studied for asthma, there are no specific FDA-approved BTK inhibitors for asthma treatment as of now. Other targeted therapies for asthma include biologics like omalizumab, mepolizumab, and dupilumab, which target specific pathways involved in the inflammatory process of asthma.

What other types of research exist?

Promising novel alternatives to Rilzabrutinib for asthma patients include biologics such as Tezepelumab, which targets thymic stromal lymphopoietin (TSLP), and Dupilumab, which targets the IL-4 and IL-13 pathways. Both have shown efficacy in reducing asthma exacerbations and improving lung function in clinical trials.

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Bruton's Tyrosine Kinase (BTK) Inhibitor

Rilzabrutinib for Moderate-to-Severe Asthma

Q: What is the mechanism of action of this treatment?

Common treatments for asthma include inhaled corticosteroids (ICS), which reduce inflammation in the airways, and long-acting beta agonists (LABA), which relax bronchial muscles to improve airflow. Leukotriene modifiers block chemicals that cause inflammation and bronchoconstriction. Biologics, such as mepolizumab and dupilumab, target specific pathways in the immune response to reduce severe asthma symptoms. These treatments are crucial for managing chronic inflammation and preventing asthma exacerbations. Bruton's Tyrosine Kinase (BTK) inhibitors like rilzabrutinib, though primarily studied in other conditions, may offer a novel approach by modulating immune cell signaling, potentially reducing inflammation and improving asthma control.

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

Must not have

History of serious infections requiring intravenous therapy with the potential for recurrence (as judged by Site Investigator), with less than 4 weeks interval between resolution of serious infection and first dose of study drug, or currently active moderate-to-severe infection at Screening (Grade 2 or higher)

Anti-immunoglobulin E (IgE) therapy (e.g., omalizumab [Xolair®]) within 130 days prior to Visit 1 or any other biologic therapy (including anti-IL4/4R or IL-5/5R monoclonal antibodies [mAb]) or systemic immunosuppressant (e.g., methotrexate) to treat inflammatory disease or autoimmune disease (e.g., rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis) and other diseases, within 2 months or 5 half-lives prior to Visit 1, whichever is longer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up until week 12

Summary

This trial is testing a new medicine called rilzabrutinib to help adults with moderate-to-severe asthma who don't get enough relief from their usual inhalers. The medicine works by reducing inflammation in the airways to improve breathing.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I've had serious infections recently or have an ongoing moderate-to-severe infection.

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I haven't taken any biologic or immunosuppressant medications for autoimmune or inflammatory diseases recently.

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I have had shingles symptoms within the last 3 months.

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I have previously used a BTK inhibitor medication.

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I have had severe asthma attacks requiring breathing tube insertion.

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I have liver disease.

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I haven't taken strong medication that affects liver enzymes recently.

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I am only using certain inhalers and not using LAMAs or mucolytics.

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I received a COVID-19 vaccine within the last 14 days.

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I have severe digestive issues that could affect medication absorption.

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I have a chronic lung condition or a disease that increases my eosinophil counts.

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I have moderate to severe liver problems.

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I haven't taken any experimental drugs or used experimental devices recently.

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I have had a solid organ transplant.

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I haven't had any cancer except for non-melanoma skin cancer or cervical cancer in situ in the last 5 years.

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My heart's electrical activity is normal and I don't have serious heart issues.

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I haven't used steroids or been hospitalized for asthma in the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ until week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~until week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and until week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Therapeutic procedure

Secondary study objectives

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 in Asthma Daytime Symptom Diary (ADSD) and Asthma Nighttime Symptom Diary (ANSD) scores from baseline to EOT and each week

Trial 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

~380

0 / 20Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for asthma include inhaled corticosteroids (ICS), which reduce inflammation in the airways, and long-acting beta agonists (LABA), which relax bronchial muscles to improve airflow. Leukotriene modifiers block chemicals that cause inflammation and bronchoconstriction. Biologics, such as mepolizumab and dupilumab, target specific pathways in the immune response to reduce severe asthma symptoms. These treatments are crucial for managing chronic inflammation and preventing asthma exacerbations. Bruton's Tyrosine Kinase (BTK) inhibitors like rilzabrutinib, though primarily studied in other conditions, may offer a novel approach by modulating immune cell signaling, potentially reducing inflammation and improving asthma control.