Fistulizing perianal Crohn's Disease MedDRA version: 20.0 Level: LLT Classification code 10075465 Term: Fistulizing Crohn's disease System Organ Class: 100000004856 MedDRA version: 20.0 Level: LLT Classification code 10075465 Term: Fistulizing Crohn's disease System Organ Class: 100000004856
Conditions
Interventions
Product Name: Guselkumab
Product Code: [CNTO1959]
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Guselkumab
Current Sponsor code: CNTO1959
Other descriptive name: GUSELKUMAB
Concentr
Sponsors
JANSSEN CILAG INTERNATIONAL NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 4.1 Is naïve to biologics, or has previously demonstrated lack of initial response non-responders, 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) 5.1 Had a history of failure to respond to, or tolerate, at least 1 of the following therapies for fistula treatment: antibiotics. Please refer to protocol section 5.1 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
Exclusion criteria
Exclusion criteria: 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, 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 section 5.2 for the complete list of exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To evaluate the clinical efficacy of guselkumab in fistulizing, perianal Crohn's disease - To assess the overall safety of guselkumab;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint of this study is the proportion of participants who achieve combined fistula remission at Week 24;Timepoint(s) of evaluation of this end point: At Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Major Secondary Endpoints: 1 Combined fistula remission 2 Clinically assessed fistula remission 3 Radiological fistula remission based on radiological findings assessed by MRI 4 Clinically assessed fistula response at Week 24 5 clinically assessed fistula response at Week 12;Timepoint(s) of evaluation of this end point: Timepoints of Major Secondary Endpoints: 1 - Combined fistula remission at Week 48 2 - Clinically assessed fistula remission at Week 24 3 - Radiological fistula remission based on radiological findings assessed by MRI at Week 24 4 - Clinically assessed fistula response at Week 12 and 24 | — |
Countries
Australia, Belgium, Canada, Czechia, Czech Republic, Egypt, France, Germany, Greece, Hungary, Israel, Italy, Japan, Jordan, Korea, Republic of, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Trials Information
Parexel International
Outcome results
None listed