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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
BSA of AD involvement ≥ 10% at baseline
AD as defined by the American Academy of Dermatology Consensus Criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 17
Awards & highlights

Study Summary

This trial is testing a new drug, rilzabrutinib, for adults with moderate-to-severe atopic dermatitis who haven't responded well to other treatments. The trial will last about 21 weeks and will compare the new drug to a placebo.

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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
More than 10% of your body surface area is affected by atopic dermatitis at the beginning of the study.
Select...
You have been diagnosed with atopic dermatitis according to the American Academy of Dermatology Consensus Criteria.
Select...
You have not had a good response or could not tolerate a certain type of treatment for your condition in the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 17
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 17 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent change in Eczema Area and Severity Index (EASI) score
Secondary outcome measures
Absolute change in EASI score
Change in percent body surface area (BSA) of EASI
Change on weekly average of daily PP-NRS
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RilzabrutinibExperimental Treatment1 Intervention
Rilzabrutinib BID or TID
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rilzabrutinib
2021
Completed Phase 2
~320

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,158 Previous Clinical Trials
3,514,224 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: Rilzabrutinib, Placebo
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study taking place exclusively in the United States?

"To make participation as convenient as possible for patients, this clinical trial has set up 29 sites in locations across the country. If you are interested in enrolling, choose the site that is closest to your location from places like Colorado Springs, Ridgeland and Northridge."

Answered by AI

Can anyone enroll in this clinical trial at this time?

"Indeed, the clinical trial is still recruiting patients according to information available on clinicaltrials.gov. This specific study was posted on September 9th, 2021 and edited October 24th, 2022. So far, 136 people have signed up at 29 different locations."

Answered by AI

When might the FDA give their okay to Rilzabrutinib?

"While there is some limited data to support Rilzabrutinib's safety, it does not yet have any efficacy data. Therefore, it received a score of 2."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
Therapeutics Clinical Research - Investigational Site Number: 8400010
Florida International Research Center - Investigational Site Number: 8400002
How many prior treatments have patients received?
0
~35 spots leftby Mar 2025