2023-509560-16-00招募中3 期
A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study to Evaluate the Safety of Guselkumab in Pediatric Participants with Crohn’s Disease, Ulcerative Colitis, or Juvenile Psoriatic Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 19
- 主要终点
- No primary or secondary endpoints will be collected in this study.
研究概览
简要总结
To evaluate the long-term safety of guselkumab in pediatric participants with moderately to severely active ulcerative colitis (UC), or with moderately to severely active Crohn’s disease, or with juvenile psoriatic arthritis (jPsA)
入排标准
- 年龄范围
- 0 years 至 64 years（0-17 Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Must have completed the dosing planned in the primary pediatric guselkumab study.
- •Received benefit from continued guselkumab therapy in the opinion of the investigator.
- •Before enrollment, a participant must be either: a. not of childbearing potential. OR b. Of childbearing potential and not sexually active, practicing abstinence or a highly effective method of contraception and agrees to remain on a highly effective method while receiving study intervention and until 12 weeks after the last dose - the end of relevant systemic exposure.
- •Parent(s) or their legally designated representative must sign an ICF indicating that they understand the purpose of, and procedures required for, the study and is/are willing to allow the child to participate in the study. Assent is also required of children capable of understanding the nature of the study. An adolescent who signs the assent form will be given the opportunity to sign an adult ICF at a later visit when they reach the age of majority during the study indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study.
- •Must be willing and able to adhere to the lifestyle restrictions specified in the protocol.
排除标准
- •Is ≥18 years of age and resides in a country where 2 years have elapsed post marketing authorization for the respective adult indication. Is <18 years of age and resides in a county where 2 years have elapsed post marketing authorization for the respective pediatric indication.
- •Are pregnant, nursing, or planning pregnancy or fathering a child.
- •Taken any disallowed therapies before the planned first LTE dose of study intervention.
结局指标
主要结局
No primary or secondary endpoints will be collected in this study.
No primary or secondary endpoints will be collected in this study.
次要结局
未报告次要终点
研究者
CTIS Point of Contact
Scientific
Janssen Cilag International
研究点 (19)
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