EUCTR2021-004320-16-PL
进行中（未招募）
1 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 - FRONTIER 2: Efficacy and Safety of JNJ-77242113 in Moderate to Severe Plaque Psoriasis
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
- 240
- 状态
- 进行中（未招募）
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Must have completed the Week 16 visit in Protocol 77242113PSO2001\.
- •2\. In the opinion of the investigator, may benefit from inclusion in this LTE study.
- •3\. Must agree to avoid prolonged sun exposure and avoid 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 PASI or IGA evaluation, other than nonmedicated emollient and salicylic acid shampoos, prior to first administration of study intervention.
- •5\. A woman of childbearing potential must have a negative urine pregnancy test at Week 0 prior to dispensing 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 216
- •F.1\.3 Elderly (\>\=65 years) yes
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 phototherapy or systemic treatment, with the exception of systemic corticosteroids taken \<2 weeks in duration, that could impact the assessment of psoriasis (PASI/IGA) since completion of the originating study, 77242113PSO2001, and within 4 weeks of the first administration of study intervention.
- •4\. Has received any live virus or bacterial vaccination within 12 weeks before the first administration of study intervention. For exclusions related to the bacille Calmette\-Guerin (BCG) vaccine, see Exclusion 5\.
- •5\. Has received the BCG vaccine within 12 months of the first administration of study intervention.
结局指标
主要结局
未指定
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