Proof of Concept Study of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05018806 |
|
Recruitment Status :
Recruiting
First Posted : August 24, 2021
Last Update Posted : February 14, 2023
|
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
| 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 Genetics related topics:
Atopic dermatitis
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 :
- 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 :
- 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 ]
- Proportion of participants achieving EASI-75 [ Time Frame: At Week 16 ]Defined as reduction of EASI score by ≥75% from baseline
- 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 ]
- 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
- Absolute change in EASI score [ Time Frame: From baseline to Week 16 ]
- Proportion of participants achieving EASI-50/90 [ Time Frame: At Week 16 ]Defined as reduction of EASI score by ≥50% or ≥90% from baseline
- Change in percent body surface area (BSA) of EASI [ Time Frame: From baseline to Week 16 ]
- 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
- 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 ]
- Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) [ Time Frame: Up to Week 17 ]
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts
| Contact: Trial Transparency email recommended (Toll free number for US & Canada) | 800-633-1610 ext Ext. option 6 | Contact-US@sanofi.com |
Locations
Show 36 study locations
Sponsors and Collaborators
Sanofi
Additional Information:
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
|
Dermatitis, Atopic Dermatitis Eczema Skin Diseases Skin Diseases, Genetic |
Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |