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New oral drug could offer hope for Tough-to-Treat eczema

NCT ID NCT05018806

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This phase 2 study tests whether rilzabrutinib, an oral medication, can reduce eczema severity in adults with moderate-to-severe atopic dermatitis who do not respond well to or cannot tolerate topical corticosteroids. Participants receive either rilzabrutinib or a placebo for 16 weeks. The main goal is to measure changes in the Eczema Area and Severity Index (EASI) score from the start to week 16.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
rilzabrutinib
What this could lead to
If successful, rilzabrutinib could offer a new oral treatment option for people with moderate-to-severe eczema who do not get enough relief from topical steroids.
What could go wrong
This is an early-phase proof-of-concept study with a small number of participants. The drug may not prove effective or could have side effects that outweigh benefits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

124 people

The number who actually took part.

Started

Sep 2021

Finished

Jun 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * AD as defined by the American Academy of Dermatology Consensus Criteria. * History of AD for at least 12 months prior to baseline as determined by the Investigator through patient interview. * Eczema Area and Severity Index (EASI) score ≥ 12 at screening and at baseline. * IGA score ≥ 3 (on the 0 to 4 IGA scale) at baseline. * BSA of AD involvement ≥ 10% at baseline. * Documented inadequate response or intolerance to TCS within 6 months prior to baseline visit * Baseline PP-NRS score for maximum itch intensity ≥4. * All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * For optional substudy only: Willingness to have 2 tape strips for comparison of baseline and treatment response. Exclusion Criteria: * Skin comorbidities that may interfere with study assessments such as psoriasis, tinea corporis, lupus erythematosus. * Conditions that may predispose the patient to excessive bleeding. * Any other clinically significant disease, condition, or medical history that, in the opinion of the Investigator, would interfere with participant safety, trial evaluations, and/or trial procedures. * Laboratory abnormalities at the screening visit * History of serious infections requiring intravenous therapy with the potential for recurrence (as judged by the Site Investigator and the Sponsor Medical Monitor), with less than 4 weeks interval between resolution of serious infection and first dose of study drug, or currently active moderate to severe infection at Screening (Grade 2 or higher) including active coronavirus disease 2019 (COVID-19). * Live vaccine except Bacille Calmette Guerin-vaccination within 28 days prior to Day 1 or plan to receive one during the trial; Bacille Calmette Guerin-vaccination within 12 months prior to Screening. * COVID-19 vaccine within 14 days prior to Study Day 1. * Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate rilzabrutinib/placebo absorption. * Initiation of prescription moisturizers (with or without additives such as ceramide, hyaluronic acid, urea, or filaggrin), topical anesthetics or antihistamines during the screening period. * Use of TCS, topical calcineurin (tacrolimus, and/or pimecrolimus) or topical phosphodiesterase 4 inhibitor within 1 week prior to baseline and as concomitant medication. * Use of systemic corticosteroids within 4 weeks prior to baseline and as concomitant medication. * Phototherapy for AD or regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks prior to baseline or likely to be required as concomitant procedure during the study. * Use of mycophenolate mofetil, azathioprine, methotrexate, cyclosporine, dapsone, intravenous immunoglobulin (IVIG), Kineret (anakinra), Enbrel (etanercept), or any other immunosuppressant not mentioned in this exclusion criterion within 4 weeks prior to baseline. * Use of infliximab, adalimumab, golimumab, abatacept, tocilizumab, certolizumab, secukinumab, IFN-γ, JAK inhibitors, dupilumab, and any other biologic or targeted-synthetic disease modifier drug not mentioned in this exclusion criterion or in exclusion criterion, as well as plasmapheresis within 12 weeks prior to baseline. * Use of anti-CD20 drugs such as rituximab, ofatumumab, other long-acting biologics within 6 months prior to baseline (or shorter if there is documented B cell reconstitution for anti-CD20 drugs). * Use of proton pump inhibitor drugs such as omeprazole and esomeprazole within 3 days of baseline (it is acceptable to change participant to H2 receptor blocking drugs prior to baseline). * Concomitant use of known systemic strong-to-moderate inhibitors and inducers of cytochrome P450 3A (CYP3A) within 14 days or 5 half-lives (whichever is longer) prior to baseline. * Previous use of a BTK inhibitor. * Had received any investigational drug (or is currently using an investigational device) within the 30 days before baseline, or at least 5 times the respective elimination half-life time (whichever is longer). * Active TB or a history of incompletely treated TB, Quantiferon positive patients, Clinically significant abnormality consistent with prior/active TB infection based upon chest radiograph with at least posterior-anterior view, Suspected extrapulmonary TB infection, or patients at high risk of contracting TB. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

atopic eczema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atopic dermatitis

Contacts and locations

Locations

  • Antelope Valley Clinical Trials Site Number : 8400001

    Northridge, California, 91325, United States

  • Asthma and Allergy Associates, PC Site Number : 8400008

    Colorado Springs, Colorado, 80907, United States

  • DS Research of Kentucky, LLC Site Number : 8400004

    Louisville, Kentucky, 40241, United States

  • E.P.I.M.R.D dba Western Sky Research, Inc. Site Number : 8400009

    El Paso, Texas, 79903, United States

  • Florida International Research Center Site Number : 8400002

    Miami, Florida, 33173, United States

  • Integrative Skin Care of MS/SKYCRNG Site Number : 8400011

    Ridgeland, Mississippi, 39157, United States

  • Investigational Site Number : 1240001

    London, Ontario, N6A2C2, Canada

  • Investigational Site Number : 1240002

    Markham, Ontario, L3P 1X3, Canada

  • Investigational Site Number : 1240004

    Québec, G1V 4T3, Canada

  • Investigational Site Number : 1240007

    Toronto, Ontario, M3H 5Y8, Canada

  • Investigational Site Number : 1240008

    Red Deer, Alberta, T4P 1K4, Canada

  • Investigational Site Number : 1240011

    Toronto, Ontario, M2N 3A6, Canada

  • Investigational Site Number : 1240013

    Greater Sudbury, Ontario, P3E 5M4, Canada

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 7640881, Chile

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 8420383, Chile

  • Investigational Site Number : 1520004

    Santiago, Reg Metropolitana de Santiago, 7580206, Chile

  • Investigational Site Number : 2030001

    Prague, 160 00, Czechia

  • Investigational Site Number : 2030002

    Pilsen, 30599, Czechia

  • Investigational Site Number : 2030003

    Pardubice, 53002, Czechia

  • Investigational Site Number : 2030004

    Olomouc, 779 00, Czechia

  • Investigational Site Number : 2760001

    Bad Bentheim, 48455, Germany

  • Investigational Site Number : 2760002

    Friedrichshafen, 88045, Germany

  • Investigational Site Number : 5280001

    Utrecht, 3584 CX, Netherlands

  • Investigational Site Number : 6160001

    Lodz, Lódzkie, 90-436, Poland

  • Investigational Site Number : 6160002

    Lodz, 93-530, Poland

  • Investigational Site Number : 6160004

    Warsaw, 00-215, Poland

  • Investigational Site Number : 6160005

    Gdansk, Pomeranian Voivodeship, 80-546, Poland

  • Investigational Site Number : 6160008

    Chojnice, 89600, Poland

  • National Allergy and Asthma Research, LLC. Site Number : 8400007

    North Charleston, South Carolina, 29420, United States

  • Orion Clinical Research Site Number : 8400003

    Austin, Texas, 78759, United States

  • Skin Sciences, PLLC Site Number : 8400005

    Louisville, Kentucky, 40217, United States

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