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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 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.
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I've been on a stable dose of high-dose ICS and LABA for at least 1 month.

Timeline

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
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
2,158 Previous Clinical Trials
3,514,152 Total Patients Enrolled
46 Trials studying Asthma
27,142 Patients Enrolled for Asthma
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,018,759 Total Patients Enrolled
19 Trials studying Asthma
9,437 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI

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."

Answered by AI
~60 spots leftby Mar 2025