Proof of Concept Study of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis

  • STATUS
    Recruiting
  • End date
    Apr 29, 2023
  • participants needed
    120
  • sponsor
    Sanofi
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Updated on 29 July 2022
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corticosteroids
eczema
topical corticosteroid
topical agents

Summary

This is a parallel, treatment, Phase 2, double-blind, 2-arm, placebo-controlled study with 2 staggered cohorts (2 arms in each cohort) to evaluate the efficacy and safety of rilzabrutinib in adult participants (aged at least 18 years) with moderate-to-severe AD and intolerance or inadequate response to topical corticosteroids (TCS).

The total study duration per participant is expected to be approximately 21 weeks, including:

Screening: up to 4 weeks On-treatment double-blind period: 16 weeks Post-treatment follow-up: 1 week

Details
Condition Atopic Dermatitis
Treatment Placebo, rilzabrutinib
Clinical Study IdentifierNCT05018806
SponsorSanofi
Last Modified on29 July 2022

Eligibility

 Yes No Not Sure

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 ≥ 16 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 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
Has 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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