A Phase 2b, Multicenter, Randomized, Placebo- and Active-comparator-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Bermekimab (JNJ-77474462) for the Treatment of Participants with Moderate to Severe Atopic Dermatitis - GENESIS

Janssen-Cilag International NV0 个研究点目标入组 200 人2020年12月30日

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: 未指定
发起方: Janssen-Cilag International NV
入组人数: 200
状态: 进行中（未招募）
最后更新: 4年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2020年12月30日

结束日期

待定

最后更新

4年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

Janssen-Cilag International NV

入排标准

入选标准

•1\. Be 18 (or the legal age of consent in the jurisdiction in which the study is taking place) years of age and be a male or female.
•2\. Be otherwise healthy on the basis of physical examination, medical history, vital signs, and 12\-lead electrocardiograms (ECGs) performed at screening. Any abnormalities, must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator.
•3\. Have AD for at least 1 year (365 days) prior to the first administration of study intervention as determined by the investigator through participant interview and/or review of the medical history.
•4\. Have a history of inadequate response to treatment for AD with topical medications or for whom topical treatments are otherwise medically inadvisable (eg, due to important side effects or safety risks).
•5\. Be considered, in the opinion of the investigator, a suitable candidate for dupilumab (DUPIXENT®) therapy according to their country's approved
•6\. Have an EASI score \=16 at screening and at baseline.
•7\. Have an IGA score \=3 at screening and at baseline.
•8\. Have an involved BSA \=10% at screening and at baseline.
•9\. Have screening laboratory test results within the following parameters, if one or more of the laboratory parameters is out of range, a single retest of laboratory values is permitted:
•a. Hemoglobin \=10 g/dL (SI: \=100 g/L)

排除标准

•1\. Has a current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances.
•2\. Has unstable cardiovascular disease, defined as a recent clinical deterioration (eg, unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months.
•3\. Has as a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance; or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly.
•4\. A history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with no evidence of recurrence for at least 3 months prior to the first administration of study intervention and with minimal risk of recurrence).
•5\. Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (eg, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers.
•6\. Has or has had a serious infection (eg, sepsis, pneumonia, or pyelonephritis), or has been hospitalized or received IV antibiotics for an infection during the 2 months before screening.
•7\. Has or has had herpes zoster within the 2 months before screening.
•8\. Has a history of an infected joint prosthesis or has received antibiotics for a suspected infection of a joint prosthesis, if that prosthesis has not been removed or replaced.
•9\. Has a history of being human immunodeficiency virus (HIV) antibody\-positive, or tests positive for HIV at screening.
•10\. Tests positive for hepatitis B virus (HBV) infection (see Appendix 4, \[Section 10\.4]) or who are seropositive for antibodies to hepatitis C virus (HCV) at screening.