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

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ClinicalTrials.gov Identifier: NCT05018806
Recruitment Status : Recruiting
First Posted : August 24, 2021
Last Update Posted : February 14, 2023
Information provided by (Responsible Party):

Brief 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). In parallel to the main study, Japanese participants will be enrolled in a separate sub-study and randomized to receive: Rilzabrutinib TID, Rilzabrutinib BID, or Matching Placebo TID.

The total study duration per participant is expected to be approximately 21 weeks, including up to 4 weeks of screening, 16 weeks of on-treatment double-blind period, 1 week of post-treatment follow-up.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Placebo Drug: Rilzabrutinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Proof-of-concept Study Evaluating Efficacy and Safety of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis Who Are Inadequate Responders or Intolerant to Topical Corticosteroids
Actual Study Start Date : September 9, 2021
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Rilzabrutinib
Rilzabrutinib BID or TID
Drug: Rilzabrutinib
Pharmaceutical form: Tablet Route of administration: Oral
Other Name: PRN1008/SAR444671

Placebo Comparator: Placebo
Matching placebo
Drug: Placebo
Pharmaceutical form: Tablet Route of administration: Oral

Primary Outcome Measures :
  1. Percent change in Eczema Area and Severity Index (EASI) score [ Time Frame: From baseline to Week 16 ]
    The EASI is a composite index with scores ranging from 0 to 72. A higher score means more severe condition.

Secondary Outcome Measures :
  1. Proportion of participants with Investigator's Global Assessment (IGA) of 0 or 1 (disease free or almost disease free) compared to placebo [ Time Frame: At Week 16 ]
  2. Proportion of participants achieving EASI-75 [ Time Frame: At Week 16 ]
    Defined as reduction of EASI score by ≥75% from baseline

  3. Proportion of participants with reduction of weekly average of daily peak pruritus Numerical Rating Scale (PP-NRS) of ≥4 points [ Time Frame: From baseline to Week 16 ]
  4. Time to onset of effect on pruritus [ Time Frame: Until Week 16 ]
    Defined as ≥4 points reduction of weekly average of daily PP-NRS from baseline during the 16-week treatment period

  5. Absolute change in EASI score [ Time Frame: From baseline to Week 16 ]
  6. Proportion of participants achieving EASI-50/90 [ Time Frame: At Week 16 ]
    Defined as reduction of EASI score by ≥50% or ≥90% from baseline

  7. Change in percent body surface area (BSA) of EASI [ Time Frame: From baseline to Week 16 ]
  8. Change on weekly average of daily PP-NRS [ Time Frame: From baseline to Week 16 ]
    Based on daily participant assessments documented in their electronic diary

  9. Proportion of participants achieving IGA*BSA-50/75/90 (reduction of IGA*BSA by ≥50% or 75% or 90% from baseline) at Week 16 [ Time Frame: At Week 16 ]
  10. Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) [ Time Frame: Up to Week 17 ]
  11. Incidence of study investigational medicinal product (IMP) discontinuation and withdrawals due to TEAEs [ Time Frame: From baseline to Week 16 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05018806

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Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext Ext. option 6 Contact-US@sanofi.com

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Sponsors and Collaborators
Additional Information:
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT05018806    
Other Study ID Numbers: ACT17207
U1111-1261-7565 ( Registry Identifier: ICTRP )
2021-001704-15 ( EudraCT Number )
First Posted: August 24, 2021    Key Record Dates
Last Update Posted: February 14, 2023
Last Verified: February 13, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases