2023-504740-33-00招募中3 期
A Phase 3, Randomized, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab in Participants with Fistulizing, Perianal Crohn’s Disease
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 190
- 试验地点
- 59
- 主要终点
- The primary endpoint of this study is the proportion of participants who achieve combined fistula remission at Week 24
研究概览
简要总结
To evaluate the clinical efficacy of guselkumab in fistulizing, perianal Crohn's disease
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Aged 18 years or over
- •Diagnosis of Crohn's disease with a minimum duration of at least 3 months
- •At least one active draining perianal fistula as a complication of Crohn's disease, confirmed by screening MRI results
- •Has previously demonstrated lack of initial response, responded initially but then lost response with continued therapy, or were intolerant to a maximum of 2 classes of biologic agents at a dose approved for the treatment of Crohn's disease. OR History of failure to respond to, or tolerate, at least 1 of the following therapies for the treatment of Crohn's disease: oral corticosteroids (including budesonide and beclomethasone dipropionate) or immunomodulators (AZA, 6-MP, MTX).
- •Had a history of failure to respond to, or tolerate, at least 1 of the following therapies for fistula treatment: antibiotics (ie, ciprofloxacin, metronidazole) and/or immunomodulators (AZA, 6-MP, MTX).
排除标准
- •Has a very severe luminal disease activity (defined as CDAI ≥350).
- •Has any of the following: - history of or concurrent rectovaginal fistulas, rectal and/or anal stenosis, stoma or functioning ostomy. - colonic mucosal dysplasia or pre-cancerous lesions that have not been removed, demyelinating disease, or systemic lupus erythematosus.
- •Has current complications of Crohn's disease, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation, that might be anticipated to require surgery, could preclude any fistula evaluation (both clinical and radiological) to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with guselkumab.
结局指标
主要结局
The primary endpoint of this study is the proportion of participants who achieve combined fistula remission at Week 24
The primary endpoint of this study is the proportion of participants who achieve combined fistula remission at Week 24
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 (59)
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