What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis, particularly those similar to Rilzabrutinib (a BTK inhibitor), include Janus kinase (JAK) inhibitors like tofacitinib and ruxolitinib, as well as biologic agents such as dupilumab. Known side effects of JAK inhibitors can include increased risk of infections, headaches, and gastrointestinal symptoms. Biologic agents like dupilumab may cause injection site reactions, conjunctivitis, and, less commonly, facial redness or new-onset head and neck dermatitis. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

The FDA has approved several treatments for Atopic Dermatitis, including biologics and small molecule inhibitors. Dupilumab, an IL-4 receptor alpha antagonist, is a notable biologic approved for moderate-to-severe Atopic Dermatitis. It works by inhibiting the signaling of IL-4 and IL-13, key cytokines involved in the inflammatory response. While Rilzabrutinib, a Bruton's Tyrosine Kinase Inhibitor, is still under investigation, it represents a novel approach targeting different pathways in the immune response. Other treatments include topical corticosteroids and calcineurin inhibitors, which have been mainstays in managing the condition.

What other types of research exist?

Promising novel alternatives to Rilzabrutinib for Atopic Dermatitis patients include Janus Kinase (JAK) inhibitors such as Baricitinib and Upadacitinib, which have shown efficacy in clinical trials. Additionally, biologics like Dupilumab, an IL-4 receptor alpha antagonist, continue to be a strong option due to their established efficacy and safety profile. Emerging therapies such as Lebrikizumab, an IL-13 inhibitor, and Tralokinumab, another IL-13 inhibitor, are also promising and may offer new options for patients by 2024.

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Bruton's Tyrosine Kinase (BTK) Inhibitor

Rilzabrutinib for Eczema

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (day 1) to week 16

Summary

This trial is testing rilzabrutinib, a new medication, to help adults with moderate-to-severe atopic dermatitis who don't respond well to standard treatments. The medication works by blocking proteins that cause inflammation. The study lasts several months for each participant.

Who is the study for?

Adults with moderate-to-severe atopic dermatitis (AD) who haven't responded well to topical corticosteroids can join this trial. They should have had AD for at least a year, an area of skin involvement of 10% or more, and significant itchiness. Participants must use approved contraception methods.

What is being tested?

The study is testing Rilzabrutinib's effectiveness compared to a placebo in treating AD. It's double-blind, meaning neither the researchers nor participants know who gets the real drug versus placebo. The trial includes two different dosing schedules and lasts about 21 weeks.

What are the potential side effects?

Possible side effects are not detailed here but may include typical reactions seen with new medications for autoimmune conditions such as infections due to immune system suppression, liver enzyme changes, or gastrointestinal symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (day 1) to week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (day 1) to week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1) to week 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score

Secondary study objectives

Absolute Change From Baseline to Week 16 In EASI Score

Absolute Change From Baseline to Week 16 in Weekly Average of Daily PP-NRS

Change From Baseline to Week 16 in Percent BSA of AD

+8 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: TID cohort: RilzabrutinibExperimental Treatment1 Intervention

Participants received rilzabrutinib 400 mg orally TID from Day 1 up to Week 16. Consecutive doses were ideally administered at least 6 hours apart (and not less than 4 hours apart).

Group II: BID cohort: RilzabrutinibExperimental Treatment1 Intervention

Participants received rilzabrutinib 400 milligrams (mg) orally BID from Day 1 up to Week 16. Consecutive doses were ideally administered 12 hours apart (and not less than 8 hours apart).

Group III: BID cohort: PlaceboPlacebo Group1 Intervention

Participants received placebo matched to rilzabrutinib orally BID from Day 1 up to Week 16. Consecutive doses were ideally administered 12 hours apart (and not less than 8 hours apart).

Group IV: TID cohort: PlaceboPlacebo Group1 Intervention

Participants received placebo matched to rilzabrutinib orally TID from Day 1 up to Week 16. Consecutive doses were ideally administered at least 6 hours apart (and not less than 4 hours apart).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rilzabrutinib

2021

Completed Phase 2

~380

Do I qualify?Apply below to find out

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

Common treatments for Atopic Dermatitis (AD) include Bruton's Tyrosine Kinase (BTK) inhibitors like Rilzabrutinib, Janus Kinase (JAK) inhibitors, and biologics. BTK inhibitors block the BTK enzyme, which plays a role in the activation of immune cells that contribute to inflammation. JAK inhibitors, such as baricitinib and upadacitinib, interfere with the JAK-STAT signaling pathway, reducing the production of inflammatory cytokines. Biologics like dupilumab target specific cytokines involved in the inflammatory response, such as IL-4 and IL-13. These targeted therapies are important for AD patients as they offer more precise control of the immune response, leading to better management of symptoms and potentially fewer side effects compared to broad-spectrum immunosuppressants.