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2022年10月11日
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Plaque psoriasis
- 发起方
- Janssen (Belgium)
- 入组人数
- 227
- 状态
- 已完成
- 最后更新
- 去年
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 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
结局指标
主要结局
未指定
相似试验
进行中（未招募）
1 期
A Long-Term Extension Study of JNJ-77242113 in Participants with Moderate-to-Severe Plaque PsoriasisPlaque PsoriasisMedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Immune System Diseases [C20]EUCTR2021-004320-16-DEJanssen-Cilag International NV240
进行中（未招募）
1 期
A Long-Term Extension Study of JNJ-77242113 in Participants with Moderate-to-Severe Plaque PsoriasisEUCTR2021-004320-16-PLJanssen-Cilag International NV240
尚未招募
2 期
A Long-term Extension Study of JNJ-77242113 in Participants with Moderate-to-Severe Plaque PsoriasisPlaque PsoriasisJPRN-jRCT2031220202akano Masayoshi228
未知
2 期
A long-term extension study of TAK-385 in the treatment of endometriosisJPRN-jRCT2080221549TAKEDA PHARMACEUTICAL COMPANY LTD.397
进行中（未招募）
1 期
ong-term safety and tolerability study of atacicept in patients with Systemic Lupus Erythematosus who completed protocol EMR-700461-023 (ADDRESS II)Systemic Lupus Erythematosus (SLE)MedDRA version: 17.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Body processes [G] - Immune system processes [G12]EUCTR2013-002758-62-DEMerck KGaA213