計劃書編號78934804UCO2001
NCT Number(ClinicalTrials.gov Identfier)NCT05242484
試驗執行中
2022-11-30 - 2028-12-31
Phase II
尚未開始5
召募中1
ICD-10K51.90
潰瘍性結腸炎未伴有併發症
ICD-10K51.911
潰瘍性結腸炎併直腸出血
ICD-10K51.912
潰瘍性結腸炎併腸阻塞
ICD-10K51.913
潰瘍性結腸炎併廔管
ICD-10K51.914
潰瘍性結腸炎併膿瘍
ICD-10K51.918
潰瘍性結腸炎併其他併發症
ICD-10K51.919
潰瘍性結腸炎併未明示之併發症
ICD-9556.9
潰瘍性結腸炎
一項第2b 期、隨機分配、雙盲、活性和安慰劑對照、平行分組、多中心試驗，評估Guselkumab 和Golimumab 誘導和維持合併治療用於中度至重度活動性潰瘍性結腸炎參與者的療效和安全性
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試驗申請者
百瑞精鼎國際股份有限公司
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試驗委託 / 贊助單位名稱
百瑞精鼎國際股份有限公司
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臨床試驗規模
多國多中心
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更新日期
2026/02/01
試驗主持人及試驗醫院
實際收案人數
0 尚未開始
實際收案人數
0 尚未開始
適應症
潰瘍性結腸炎
試驗目的
本試驗的目的是評估 JNJ-78934804 與 guselkumab 和 golimumab 相比，在中度至重度活動性潰瘍性結腸炎參與者中的療效和安全性，這些參與者對一種或多種已批准的進階治療曾出現初始反應不佳、失去反應或不耐受的情況。
藥品名稱
預充填式注射劑
預充填式注射劑
預充填式注射劑
預充填式注射劑
預充填式注射劑
主成份
Guselkumab
Golimumab
Guselkumab and Golimumab co-formulation
Golimumab
Guselkumab and Golimumab co-formulation
劑型
Prefilled syringe with UltraSafe Plus
Prefilled syringe with UltraSafe
Prefilled syringe with UltraSafe Plus
Prefilled syringe with UltraSafe
Prefilled syringe with UltraSafe Plus
劑量
100 mg/mL
100 mg/mL
100mg Guselkumab and 100mg Golimumab/2mL
100 mg/mL
100mg Guselkumab and 100mg Golimumab/2mL
評估指標
第48週時達到臨床緩解的參與者百分比
主要納入條件
•在基線前至少3個月確診潰瘍性結腸炎（UC）
•根據修正Mayo評分評估為中度至重度活動性UC
•證實對至少一種生物製劑或具有類似生物製劑活性的新型口服藥物反應不佳、失去反應或不耐受
•若為具有生育能力的女性，必須符合避孕和生育相關要求
•根據修正Mayo評分評估為中度至重度活動性UC
•證實對至少一種生物製劑或具有類似生物製劑活性的新型口服藥物反應不佳、失去反應或不耐受
•若為具有生育能力的女性，必須符合避孕和生育相關要求
主要排除條件
Exclusion Criteria:
Has severe extensive colitis as defined in the protocol
Extent of inflammatory disease limited to the rectum
Participants with current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease (CD)
Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, sinopulmonary infections, bronchiectasis, recurrent renal/urinary tract infections (example, pyelonephritis, cystitis), an open, draining, or infected skin wound, or an ulcer
Currently has a malignancy or a history of malignancy within 5 years before screening (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ that has been treated with no evidence of recurrence within 12 months of first dose of study intervention)
Has severe extensive colitis as defined in the protocol
Extent of inflammatory disease limited to the rectum
Participants with current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease (CD)
Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, sinopulmonary infections, bronchiectasis, recurrent renal/urinary tract infections (example, pyelonephritis, cystitis), an open, draining, or infected skin wound, or an ulcer
Currently has a malignancy or a history of malignancy within 5 years before screening (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ that has been treated with no evidence of recurrence within 12 months of first dose of study intervention)
試驗計畫預計收納受試者人數
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台灣人數
6 人
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全球人數
550 人
