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Bruton's Tyrosine Kinase (BTK) Inhibitor

Rilzabrutinib for Hives (RILECSU Trial)

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
The presence of itch and hives for ≥6 consecutive weeks at any time prior to screening visit (Visit 1) despite the use of H1-AH during this time period
Participants who have a diagnosis of CSU refractory to H1-AH at the time of randomization
Must not have
Active malignancy or history of malignancy within 5 years
Has received any investigational drug (or is currently using an investigational device) within the 30 days before Day 1, or at least 5 times the respective elimination half-life time (whichever is longer)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects of rilzabrutinib may include increased risk of bleeding, potential immune system impacts leading to more frequent or prolonged infections, and possibly other reactions that are common with new medications being tested.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had itch and hives for 6 weeks or more, even while using antihistamines.
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My chronic hives do not improve with standard allergy medications.
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I have never taken omalizumab or it did not work well for me.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had cancer or still have it within the last 5 years.
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I haven't taken any experimental drugs or used experimental devices recently.
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I haven't had serious infections needing IV treatment recently.
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I have active atopic dermatitis.
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I have previously used a BTK inhibitor.
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I have tuberculosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Rilzabrutinib dose CExperimental Treatment1 Intervention
dose C
Group II: Rilzabrutinib dose BExperimental Treatment1 Intervention
dose B
Group III: Rilzabrutinib dose AExperimental Treatment1 Intervention
dose A
Group IV: PlaceboPlacebo Group1 Intervention
Matching placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
rilzabrutinib
2021
Completed Phase 2
~170

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
Bruton's Tyrosine Kinase (BTK) inhibitors, such as Rilzabrutinib, work by blocking the BTK enzyme, which is essential for the activation of immune cells like mast cells and B cells. This inhibition reduces the release of histamine and other inflammatory mediators, alleviating the symptoms of urticaria. Other common treatments include H1 antihistamines, which block histamine receptors to reduce itching and swelling, and corticosteroids, which suppress the overall immune response. Understanding these mechanisms helps Chronic Urticaria patients and their doctors choose the most effective treatment based on the specific cause and response to previous therapies.

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,187 Previous Clinical Trials
3,979,617 Total Patients Enrolled
3 Trials studying Chronic Urticaria
493 Patients Enrolled for Chronic Urticaria
Clinical Sciences & OperationsStudy DirectorSanofi
869 Previous Clinical Trials
2,020,471 Total Patients Enrolled
1 Trials studying Chronic Urticaria
397 Patients Enrolled for Chronic Urticaria

Media Library

Rilzabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05107115 — Phase 2
Chronic Urticaria Research Study Groups: Placebo, Rilzabrutinib dose B, Rilzabrutinib dose C, Rilzabrutinib dose A
Chronic Urticaria Clinical Trial 2023: Rilzabrutinib Highlights & Side Effects. Trial Name: NCT05107115 — Phase 2
Rilzabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05107115 — Phase 2
~42 spots leftby Sep 2025
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