Crohn's Disease
Conditions
Sponsors
Sakamoto Takehiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Diagnosis of Crohn's disease (CD) for at least 3 months prior to baseline - Confirmed diagnosis of moderate to severe CD as assessed by Crohn's disease activity index (CDAI), stool frequency (SF), abdominal pain (AP) score and simple endoscopic score for Crohn's disease (SES-CD) - Demonstrated inadequate response, loss of response, or intolerance to at least one biologic approved for the treatment of Crohn's disease - If female and of childbearing potential, must meet the contraception and reproduction requirements
Exclusion criteria
Exclusion criteria: - Complications of CD that may be anticipated to require surgery - Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline, or 8 weeks before baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery - Has had any kind of bowel resection within 24 weeks, or any other intra-abdominal or other major surgery within 12 weeks - Has a draining (example, functioning) stoma or ostomy - Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer or cervical carcinoma in situ that has been adequately treated with no evidence of recurrence for greater than or equal do (>=) 12 months before the first dose of study intervention) - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Clinical Remission at Week 48:Week 48 Percentage of participants with clinical remission at Week 48 will be reported. Clinical remission is based on the Crohn's Disease Activity Index (CDAI). Percentage of Participants with Endoscopic Response at Week 48:Week 48 Percentage of participants with endoscopic response at Week 48 will be reported. Endoscopic response is based on change from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD),as assessed by central endoscopy reading. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Patient-reported Outcomes (PRO)-2 Remission at Week 48:Week 48 Percentage of participants with PRO-2 remission at Week 48 will be reported. PRO-2 remission is based on the average daily abdominal pain (AP) and stool frequency (SF) scores. Percentage of Participants with Endoscopic Remission at Week 48:Week 48 Percentage of participants with endoscopic remission at Week 48 will be reported. Endoscopic remission is based on the SES-CD, as assessed by central endoscopy reading. Percentage of Participants with Corticosteroid-Free Clinical Remission at Week 48:Week 48 Percentage of participants with corticosteroid-free (60-day) clinical remission at Week 48 will be reported. Secondary Comparison:Percentage of Participants with Clinical Remission at Week 48:Week 48 Percentage of participants with clinical remission at Week 48 will be reported. Clinical remission is based on the Crohn's Disease Activity Index (CDAI). Secondary Comparison:Percentage of Participants with Endoscopic Response at Week 48:Week 48 Percentage of participants with endoscopic response at Week 48 will be reported. Endoscopic response is based on change from baseline in the SES-CD, as assessed by central endoscopy reading. Percentage of Participants with Adverse Events (AEs):Up to Week 48 An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Percentage of Participants with Serious Adverse Events (SAEs):Up to Week 48 A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important. Clin | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czechia, Denmark, Estonia, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Korea Republic Of, Netherlands, Norway, Poland, Portugal, Slovenia, Spain, Sweden, Switzerland, Taiwan Province Of China, United Kingdom Of Great Britain, United States Of America
Contacts
Public ContactMedical Information Center
Janssen Pharmaceutical K.K.
Outcome results
None listed