EUCTR2021-001704-15-CZ进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 93
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 53
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •-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 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, 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 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
研究者
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