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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
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
Screening 3 weeks
Treatment Varies
Follow Up until week 16
Awards & highlights


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 below
I have had severe asthma attacks requiring steroids or emergency care in the last 2 years.
My lung function improves significantly after using a bronchodilator or I've had a positive asthma test in the last 5 years.
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:
I've had serious infections recently or have an ongoing moderate-to-severe infection.
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.
I have liver disease.
I haven't taken strong medication that affects liver enzymes recently.
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 moderate to severe liver problems.
I haven't taken any experimental drugs or used experimental devices recently.
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.
My heart's electrical activity is normal and I don't have serious heart issues.
I haven't used steroids or been hospitalized for asthma in the last 4 weeks.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and until week 16 for reporting.

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 more

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
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 2

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.

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,173 Previous Clinical Trials
3,516,294 Total Patients Enrolled
46 Trials studying Asthma
26,726 Patients Enrolled for Asthma
Clinical Sciences & OperationsStudy DirectorSanofi
866 Previous Clinical Trials
2,020,013 Total Patients Enrolled
19 Trials studying Asthma
9,067 Patients Enrolled for Asthma

Media Library

Rilzabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05104892 — Phase 2
Asthma Research Study Groups: Rilzabrutinib, Placebo
Asthma Clinical Trial 2023: Rilzabrutinib Highlights & Side Effects. Trial Name: NCT05104892 — Phase 2
Rilzabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05104892 — Phase 2
~55 spots leftby Jul 2025