EUCTR2020-002587-31-DE进行中（未招募）1 期
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
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
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
- •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)
- •b. White blood cells =3.5 x 103/µL (SI: =3.5 GI/L)
- •c. Neutrophils =1.5 x 103/µL (SI: =1.5 GI/L)
- •d. Platelets =100 x 103/µL (SI: =100 GI/L)
- •e. Serum creatinine =1.5 mg/dL (SI: =137 µmol/L)
- •f. Aspartate aminotransferase =2 × upper limit of normal (ULN)
- •g. Alanine aminotransferase =2 × ULN
- •h. Alkaline phosphatase =2 × ULN
- •10. Criterion modified per Amendment 1.
- •10.1 Agree to discontinue any topical medications, treatments, or therapies (excluding non prescription moisturizers, which are required for daily use) for AD within 1 week before the first administration of study intervention .
- •11. Criterion modified per Amendment 1.
- •11.1 Agree not to receive a live virus or live bacterial vaccination during the study, and for 90 days after the last administration of study intervention.
- •12. Agree not to receive a Bacille Calmette-Guérin (BCG) vaccination during the study, and for 12 months after the last administration of study intervention.
- •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 175
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
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.
研究者
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