A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ANB032 in the Treatment of Subjects with Moderate to Severe Atopic Dermatitis - ANB032-201

Anaptysbio Inc.0 个研究点目标入组 161 人开始时间: 2023年11月13日最近更新: 2024年7月22日

适应症

试验速览

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•Male or female aged 18 to 65 years and in good general health, Moderate or severe atopic dermatitis continuously for at least 6 months prior to randomization, History of inadequate response to both topical corticosteroids and topical calcineurin inhibitors or for whom topical treatments are otherwise medically inadvisable, EASI score >=16 at Screening and at Randomization, vIGA-AD score >=3 at Screening and at Randomization, AD-involved BSA>=10% at Screening and at Randomization

•Any factors that in the Investigator's opinion would predispose the subject to develop an infection, Known or suspected congenital or acquired immunodeficiency state, or condition that would compromise the subject's immune status, Not able to tolerate SC drug administration, Tanning booth use or extended sun exposure that could affect disease severity or interfere with disease assessments within 4 weeks before Randomization, Received or plans to initiate during the study any of the following prescribed medications or therapies: Systemic Janus kinase (JAK) inhibitors at any time prior to Day 1, Immunomodulatory biologic agents received within 12 weeks or 5 half lives (t1/2; whichever is longer) before Day 1, Phototherapy treatment or laser therapy that could affect disease severity or interfere with disease assessments within 4 weeks before Day 1, Systemic therapy for AD, including but not limited to, corticosteroids, methotrexate, cyclosporine, azathioprine, phosphodiesterase type 4 (PDE 4) inhibitors, IFN ?, and mycophenolate mofetil within 4 weeks before Day 1, Use of topical treatments for AD including but not limited to corticosteroids, tacrolimus, pimecrolimus, JAK inhibitors, or PDE-4 inhibitors within 14 days before Day 1, Live or live attenuated vaccines within 12 weeks before Day 1

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