A Phase 2a, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Interventional Study to Assess the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of Multiple IV doses of Bermekimab for the Treatment of Adult Participants with Moderate-to-Severe Atopic Dermatitis

Janssen-Cilag International NV0 个研究点目标入组 60 人开始时间: 2021年7月5日最近更新: 2022年4月19日

适应症

试验速览

暂无简介。

•1. =18 to =65 years old
•2. be otherwise healthy on the basis of physical examination and medical history.
•3. have AD for at least 1 year prior to the first administration of study intervention.
•4. have a history of inadequate response to treatment for AD with topical medications, or for whom topical treatments are otherwise medically inadvisable.
•5. have an EASI score =16 at screening and at baseline.
•6. have an IGA score =3 at screening and at baseline.
•7. have an involved BSA =10% at screening and at baseline.
•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 7

•1. has a current diagnosis or signs or symptoms of severe, progressive, or uncontrolled systemic disturbances.
•2. has unstable cardiovascular disease.
•3. has signs and symptoms or a history of lymphoproliferative disease.
•4. a history of malignancy within 5 years before screening.
•5. has a history of chronic or recurrent infectious disease.
•6. has or has had a serious infection during the 2 months before screening.

发起方