CNTO1959ISD3001: 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
- 196
- 试验地点
- 68
- 主要终点
- Number of Participants with Treatment-Emergent Adverse Events as Assessment of Safety
研究概览
简要总结
The purpose of this study is to evaluate long-term safety of subcutaneous guselkumab in pediatric participants with moderately to severely active ulcerative colitis, or moderately to severely active Crohn's disease, or juvenile psoriatic arthritis (jPsA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have completed the dosing planned in the primary pediatric guselkumab study
- •Must have 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 acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to allow the child to participate in the study. Assent is required from participants who are capable of understanding the nature of the study, typically those aged 7 years and older, to ensure their willingness to participate. An adolescent who provides assent will have the opportunity to sign an adult ICF upon reaching the age of majority, thereby affirming their understanding of the study's purpose and procedures, as well as their willingness to participate.
排除标准
- •Participant is greater than or equal to (>=) 18 years of age and resides in a country where 2 years have elapsed post marketing authorization for the respective adult indication
- •Participant 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
- •Have taken any disallowed therapies before the planned first long-term extension (LTE) dose of study intervention
- •Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator
- •Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments
研究组 & 干预措施
Guselkumab (Every 4 weeks)
Participants treated with guselkumab in one of the three primary studies (CNTO1959PUC3001 [NCT06260163], CNTO1959PBCRD3007 [NCT05923073], CNTO1275JPA3001 [NCT05083182]) will be enrolled in this LTE study, if in the investigator's opinion, the participant will benefit from continued guselkumab therapy. Participants will have continued access to guselkumab (q4w). Participants coming from the open-label arm of the primary studies CNTO1959PUC3001 and CNTO1959PBCRD3007 will be assigned to q4w dosing. No dose adjustments are permitted. Participants coming from the jPsA primary study (CNTO1275JPA3001) will continue the same dosing regimen from the primary study (q4w) and cannot change their dosing interval during the LTE study.
干预措施: Guselkumab (Drug)
Guselkumab (Every 8 weeks)
Participants treated with guselkumab in one of the three primary studies (CNTO1959PUC3001 [NCT06260163], CNTO1959PBCRD3007 [NCT05923073], CNTO1275JPA3001 [NCT05083182]) will be enrolled in this long-term extension (LTE) study, if in investigator's opinion, participant will benefit from continued guselkumab therapy and will have continued access to guselkumab (every 8 weeks [q8w]). Participants coming from double-blinded arm of primary studies CNTO1959PUC3001 and CNTO1959PBCRD3007 will be assigned to q8w dosing. Based on investigator's discretion and participant's clinical status, they have option to switch to q4w once during LTE study prior to unblinding of primary study assignment. Once the primary study is unblinded, dosing frequency may be adjusted to match what the participant had received before enrolling in LTE study. Participants coming from study CNTO1275JPA3001 will continue same dosing regimen from primary study (q8w) and cannot change their dosing interval during LTE study.
干预措施: Guselkumab (Drug)
结局指标
主要结局
Number of Participants with Treatment-Emergent Adverse Events as Assessment of Safety
时间窗: Up to 6 years and 9 months
Treatment-emergent adverse events will be reported to analyze the long-term safety of guselkumab in pediatric participants.
次要结局
未报告次要终点