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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 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

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.

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,216 Previous Clinical Trials
4,047,508 Total Patients Enrolled

Media Library

Rilzabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05018806 — Phase 2
Atopic Dermatitis Research Study Groups: BID cohort: Placebo, BID cohort: Rilzabrutinib, TID cohort: Placebo, TID cohort: Rilzabrutinib
Atopic Dermatitis Clinical Trial 2023: Rilzabrutinib Highlights & Side Effects. Trial Name: NCT05018806 — Phase 2
Rilzabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05018806 — Phase 2
~29 spots leftby Dec 2025