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临床试验/ISRCTN15135908
ISRCTN15135908已完成2 期

A Phase 2b Multicenter, Long-Term Extension, Dose-ranging Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis.

Janssen (Belgium)0 个研究点目标入组 227 人开始时间: 2022年10月11日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
227

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. Must have completed the Week 16 visit in Protocol 77232114PSO2001
  • 2. In the opinion of the investigator, may benefit from inclusion in this long-term extension (LTE) study
  • 3. Must agree to avoid prolonged sun exposure and avoid the use of tanning booths or other ultraviolet light sources during the study
  • 4. Must agree to discontinue all topical therapies that could affect psoriasis or the psoriasis area severity index (PASI) or Investigator’s global assessment (IGA) evaluation, other than nonmedicated emollient and salicylic acid shampoos, prior to first administration of study intervention.
  • 5. Agree not to receive a live virus or live bacterial vaccination during the study, or within 4 weeks after the last administration of the study intervention

排除标准

  • 1. Was permanently discontinued from study intervention in Protocol 77242113PSO2001 for any reason
  • 2. Has received any biologic therapy or experimental therapy since completion of the originating study 77242113PSO2001
  • 3. Has received any live virus or bacterial vaccination within 12 weeks before the first administration of study intervention
  • 4. Has received the bacille Clamette-Guerin (BCG) vaccine within 12 months of the first administration of study intervention
  • 5. Currently has hepatitis B surface antigen (HBsAg) or hepatitis C antibody (antiHCV) positive, or has another clinically active liver disease, or tests positive for HBsAg or anti-HCV

研究者

发起方
Janssen (Belgium)

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