What side effects are associated with this type of intervention?

Common treatments for Chronic Urticaria, such as antihistamines, corticosteroids, and biologics like omalizumab, can have side effects including drowsiness, weight gain, increased blood pressure, injection site reactions, and potential anaphylaxis. Bruton's Tyrosine Kinase Inhibitors, like Rilzabrutinib, may cause gastrointestinal issues, headache, and potential immunosuppression.

What prior FDA approvals exist?

Currently, there are no FDA-approved Bruton's Tyrosine Kinase (BTK) inhibitors specifically for the treatment of Chronic Urticaria. However, other treatments for Chronic Urticaria include antihistamines, omalizumab (an anti-IgE monoclonal antibody), and corticosteroids. Omalizumab, in particular, has been approved for use in patients with Chronic Spontaneous Urticaria who remain symptomatic despite the use of H1 antihistamines. Rilzabrutinib, a BTK inhibitor, is being studied as a potential new treatment option for patients with Chronic Urticaria who do not respond to existing therapies.

What other types of research exist?

Promising novel alternatives to Rilzabrutinib for Chronic Urticaria patients include biologic agents such as omalizumab, which targets IgE, and other emerging biologics like ligelizumab, which also targets IgE but with potentially greater efficacy. Additionally, Janus kinase (JAK) inhibitors, such as tofacitinib, have shown benefit in treating recalcitrant cases of chronic urticaria.

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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

2020

Completed Phase 2

~190

0 / 9Eligibility criteria met

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.