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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 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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to week 17
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 17
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 moreTrial 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
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.
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Who is running the clinical trial?
SanofiLead Sponsor
2,171 Previous Clinical Trials
3,516,970 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with Alzheimer's disease according to the criteria of the American Academy of Dermatology.More than 10% of your body surface area is affected by atopic dermatitis.You must use contraception during the study as required by local regulations.Your eczema is moderate to severe, as measured by a specific score.You have been diagnosed with AD by a doctor and have had it for at least 12 months before starting the study.Your itch intensity score is 4 or higher.You are comfortable with having two pieces of tape placed on your skin to compare how your skin looks before and after treatment.Your itch intensity score at the beginning of the study is 4 or higher.You have taken specific medications for certain medical conditions within the last 3 months.You have been diagnosed with atopic dermatitis according to the American Academy of Dermatology Consensus Criteria.More than 10% of your body surface area is affected by atopic dermatitis at the beginning of the study.You have had a serious infection that needed to be treated with IV medication, or you currently have a moderate to severe infection, including active COVID-19.You cannot start using certain types of moisturizers, topical anesthetics, or antihistamines during the screening period.You have taken corticosteroid pills or injections within the past 4 weeks.You have had phototherapy for atopic dermatitis or used a tanning booth or parlor more than twice a week within the last 4 weeks or will need to use them during the study.You have used certain types of skin medications within one week before the start of the study.Your eczema severity score is 12 or higher at the beginning of the study.Your IGA score is 3 or higher at the beginning of the study.You have not had a good response or could not tolerate a certain type of treatment for your condition in the last 6 months.You have received a COVID-19 vaccine within 14 days before the study starts.You have had a live vaccine within the last 28 days, or plan to get one during the trial, except for the Bacille Calmette Guerin vaccine, which you have had within the last 12 months.Your lab test results are not normal when checked before the study starts.You have a condition that makes you likely to bleed too much.You have taken certain medications that affect the immune system within the last 6 months.You have used proton pump inhibitor drugs like omeprazole or esomeprazole within 3 days before the start of the study. If needed, you can switch to a different type of medication called H2 receptor blockers before the study starts.You are taking certain strong or moderate medications that affect the way the body processes other drugs.You have taken a BTK inhibitor before.You have active tuberculosis (TB) or a history of TB that wasn't fully treated, or you are at high risk for getting TB.You have ongoing severe nausea and vomiting, or have a condition that makes it hard for your body to absorb the study medication.Your acne is rated as severe (IGA score ≥ 3) on a scale from 0 to 4.You have skin conditions like psoriasis or lupus that could affect the study assessments.You have taken certain medications that weaken the immune system within the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Rilzabrutinib
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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