Rilzabrutinib for Hives

(RILECSU Trial)

Recruiting at 128 trial 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 oral medication called rilzabrutinib to see if it can help adults with Chronic Spontaneous Urticaria (CSU) who suffer from frequent and severe itching and hives. The medication works by calming the immune system to reduce these symptoms. Participants will be monitored to ensure safety and effectiveness.

Research Team

Clinical Sciences & Operations

Principal Investigator

Sanofi

Eligibility Criteria

Adults aged 18+ with Chronic Spontaneous Urticaria (CSU) who still have itch and hives despite using H1 Antihistamines for over 6 weeks. They must not have other skin conditions or severe illnesses that could affect the study, no recent serious infections, and cannot be on certain medications like BTK inhibitors or investigational drugs.

Inclusion Criteria

Participants must be willing and able to complete a daily symptom e-diary for the duration of the study

I am using or can switch to a study-approved allergy medication for my chronic hives.

I have had itch and hives for 6 weeks or more, even while using antihistamines.

Exclusion Criteria

I have skin conditions that could affect the study's results.

You have tested positive for HIV.

I have a condition that could cause me to bleed a lot.

Treatment Details

Interventions

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

Trial Overview The trial is testing three oral doses of a drug called rilzabrutinib against a placebo to see if it can reduce itchiness and hives in CSU patients. It's a double-blind study initially lasting 12 weeks, followed by an optional open-label phase where all participants receive rilzabrutinib for up to 40 additional weeks.

Participant Groups

Group I: Rilzabrutinib dose C Experimental Treatment 1 Intervention

dose C

Group II: Rilzabrutinib dose B Experimental Treatment 1 Intervention

dose B

Group III: Rilzabrutinib dose A Experimental Treatment 1 Intervention

dose A

Group IV: Placebo Placebo Group 1 Intervention

Matching placebo

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University