Rilzabrutinib for Moderate-to-Severe Asthma

Recruiting in Palo Alto (17 mi)

+98 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Sanofi

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Clinical Sciences & Operations

Principal Investigator

Sanofi

Eligibility Criteria

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.

Inclusion Criteria

My lung function improves significantly after using a bronchodilator or I've had a positive asthma test in the last 5 years.

I have had severe asthma attacks requiring steroids or emergency care in the last 2 years.

Participants must have completed COVID-19 vaccination per current regional health authority recommendations prior to screening

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Exclusion Criteria

Is not up-to-date with recommended vaccinations per local guidelines

You have been smoking or quit smoking within the last 6 months before the first study visit.

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

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Treatment Details

Interventions

Rilzabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor)

Trial OverviewThe 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.

Participant Groups

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