Atopic Dermatitis Clinical Trial
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
Verified date | December 2023 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 124 |
Est. completion date | June 23, 2023 |
Est. primary completion date | June 23, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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-?, 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Investigational Site Number : 1240001 | London | Ontario |
Canada | Investigational Site Number : 1240002 | Markham | Ontario |
Canada | Investigational Site Number : 1240004 | Quebec | |
Canada | Investigational Site Number : 1240008 | Red Deer | Alberta |
Canada | Investigational Site Number : 1240013 | Sudbury | Ontario |
Canada | Investigational Site Number : 1240007 | Toronto | Ontario |
Canada | Investigational Site Number : 1240011 | Toronto | Ontario |
Chile | Investigational Site Number : 1520001 | Santiago | Reg Metropolitana De Santiago |
Chile | Investigational Site Number : 1520002 | Santiago | Reg Metropolitana De Santiago |
Chile | Investigational Site Number : 1520004 | Santiago | Reg Metropolitana De Santiago |
Czechia | Investigational Site Number : 2030004 | Olomouc | |
Czechia | Investigational Site Number : 2030003 | Pardubice | |
Czechia | Investigational Site Number : 2030002 | Plzen | |
Czechia | Investigational Site Number : 2030001 | Praha 6 | |
Germany | Investigational Site Number : 2760001 | Bad Bentheim | |
Germany | Investigational Site Number : 2760002 | Friedrichshafen | |
Netherlands | Investigational Site Number : 5280001 | Utrecht | |
Poland | Investigational Site Number : 6160008 | Chojnice | |
Poland | Investigational Site Number : 6160005 | Gdansk | Pomorskie |
Poland | Investigational Site Number : 6160001 | Lodz | Lódzkie |
Poland | Investigational Site Number : 6160002 | Lodz | |
Poland | Investigational Site Number : 6160004 | Warszawa | |
United States | Orion Clinical Research Site Number : 8400003 | Austin | Texas |
United States | Asthma and Allergy Associates, PC Site Number : 8400008 | Colorado Springs | Colorado |
United States | E.P.I.M.R.D dba Western Sky Research, Inc. Site Number : 8400009 | El Paso | Texas |
United States | DS Research of Kentucky, LLC Site Number : 8400004 | Louisville | Kentucky |
United States | Skin Sciences, PLLC Site Number : 8400005 | Louisville | Kentucky |
United States | Florida International Research Center Site Number : 8400002 | Miami | Florida |
United States | National Allergy and Asthma Research, LLC. Site Number : 8400007 | North Charleston | South Carolina |
United States | Antelope Valley Clinical Trials Site Number : 8400001 | Northridge | California |
United States | Integrative Skin Care of MS/SKYCRNG Site Number : 8400011 | Ridgeland | Mississippi |
United States | Therapeutics Clinical Research Site Number : 8400010 | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
United States, Canada, Chile, Czechia, Germany, Netherlands, Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent change in Eczema Area and Severity Index (EASI) score | The EASI is a composite index with scores ranging from 0 to 72. A higher score means more severe condition. | From baseline to Week 16 | |
Secondary | Proportion of participants with Investigator's Global Assessment (IGA) of 0 or 1 (disease free or almost disease free) compared to placebo | At Week 16 | ||
Secondary | Proportion of participants achieving EASI-75 | Defined as reduction of EASI score by =75% from baseline | At Week 16 | |
Secondary | Proportion of participants with reduction of weekly average of daily peak pruritus Numerical Rating Scale (PP-NRS) of =4 points | From baseline to Week 16 | ||
Secondary | Time to onset of effect on pruritus | Defined as =4 points reduction of weekly average of daily PP-NRS from baseline during the 16-week treatment period | Until Week 16 | |
Secondary | Absolute change in EASI score | From baseline to Week 16 | ||
Secondary | Proportion of participants achieving EASI-50/90 | Defined as reduction of EASI score by =50% or =90% from baseline | At Week 16 | |
Secondary | Change in percent body surface area (BSA) of EASI | From baseline to Week 16 | ||
Secondary | Change on weekly average of daily PP-NRS | Based on daily participant assessments documented in their electronic diary | From baseline to Week 16 | |
Secondary | Proportion of participants achieving IGA*BSA-50/75/90 (reduction of IGA*BSA by =50% or 75% or 90% from baseline) at Week 16 | At Week 16 | ||
Secondary | Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) | Up to Week 17 | ||
Secondary | Incidence of study investigational medicinal product (IMP) discontinuation and withdrawals due to TEAEs | From baseline to Week 16 |
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