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 - FUZIO

Janssen-Cilag International NV0 个研究点目标入组 280 人开始时间: 2022年6月1日最近更新: 2023年12月12日

适应症

试验速览

暂无简介。

•1. Aged 18 years or over.
•2. Diagnosis of Crohn’s disease with a minimum duration of at least 3 months
•3. At least one active draining perianal fistula as a complication of Crohn’s disease, confirmed by screening MRI results.
•4.2 Is naïve to biologics, or has previously demonstrated lack of initial response (ie, primary non-responders), responded initially but then lost response with continued therapy (ie, secondary non-responders), or were intolerant to a maximum of 2 classes of biologic agents at a dose approved for the treatment of Crohn's disease
•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)
•5.1 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).
•Please refer to protocol for the complete list of inclusion criteria.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 224
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 56

•1. Has a very severe luminal disease activity (defined as CDAI =350).
•2. Has any of the following:
•- history of or concurrent rectovaginal fistulas, rectal and/or anal stenosis (unless the participant undergoes surgical dilation prior to baseline), diverting stomas with anastomotic leakage, abscess or collections which are not properly drained.
•- colonic mucosal dysplasia or pre-cancerous lesions that have not been removed, demyelinating disease, or systemic lupus erythematosus.
•3. 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.
•Please refer to protocol for the complete list of exclusion criteria.

发起方