A Clinical Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Chronic Inflammatory Bowel Disease That Affects the Lining of the Digestive Tract

INTERVENTION: Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 Pharmaceutical Form: Solution for injection in pre‐filled syringe INN or Proposed INN: Ustekinumab CAS Number: 815610‐63‐0 Current Sponsor code: CNTO1275 Other descriptive name: USTEKINUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90‐ Pharmaceutical form of the placebo: Solution for injection in pre‐filled syringe Route of administration of the placebo: Subcutaneous use Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Ustekinumab CAS Number: 815610‐63‐0 Current Sponsor code: CNTO1275 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5‐ Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use CONDITION: Crohn’s Disease ; MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 ‐ Gastrointestinal disorders Therapeutic area: Diseases [C] ‐ Immune System Diseases [C20] PRIMARY OUTCOME: ; Secondary Objective: The secondary objectives are to:; ? Evaluate the achievement of clinical response and clinical remission, as well as the reduction in inflammatory biomarkers (serum C‐reactive protein [CRP] and fecal calprotectin [FeCa] levels), after IV ustekinumab re‐induction.; ? Assess the overall safety of IV ustekinumab re‐induction.; Main Objective: The primary objective is to evaluate the achievement of clinical response at Week 16 following a single intravenous (IV) re‐induction dose of 6 milligram per kilogram (mg/kg) ustekinumab, compared with continuing regular subcutaneous (SC) dosing every 8 weeks (q8w) 90 milligram (mg) ustekinumab administration, in participants with secondary loss of response (LoR) to SC q8w 90 mg ustekinumab maintenance therapy. Primary end point(s): The primary endpoint is clinical response at Week 16, defined as a =100‐point reduction from the baseline CDAI score or a CDAI score <150 points. Timepoint(s) of evaluation of this end point: At week 16 SECONDARY OUTCOME: ; Secondary end point(s): 1. Clinical remission at Week 16, defined as a CDAI score of <150 points. ; 2. Clinical response at Week 8, defined as a =100‐point reduction from the baseline CDAI score or a CDAI score <150. ; 3. Clinical remission at Week 8, defined as a CDAI score of <150 points. ; 4. Normalization of CRP and/or FeCa concentration(s) at Week 16, among participants with an elevated CRP and/or FeCa at baseline. ; 5. Clinical remission at Week 24, defined as a CDAI score of <150 points. ; 6. Clinical response at Week 24, defined as a =100‐point reduction from the baseline CDAI score or a CDAI score <150. ; 7. Normalization of CRP and/or FeCa concentration(s) at Week 24, among participants with an elevated CRP and/or FeCa at baseline. ; 2 & 3. At week 8 ; 5, 6 & 7. At week 24 ; 8. Throughout the study (Screening to week 24 or early termination); ; 8. Safety endpoints, including the proportion of participants with at least one adverse event and subcategories of adverse events (all infections, all serious adverse events and serious infections), as well as changes in vital signs and clinical laboratory test results.; ; Timepoint(s) of evaluation of this end point: 1 & 4. At week 16 INCLUSION CRITERIA: Each potential participant must satisfy all the following criteria to be enrolled in the study: 1. Male or female aged =18 years (or the legal age of consent in the jurisdiction in which the study is taking place if older than 18 years). 2. A history of Crohn’s disease or fistulizing Crohn’s disease of at least 3 months’ duration, with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy. 3. Initially responded to ustekinumab induction therapy (a), administered according to the local label, followed by secondary LoR to ustekinumab (b). a) Initial response to ustekinumab as defined in Section 10.2. b) Secondary LoR to ustekinumab is defined as active disease at study baseline, proven by a crohn’s disease activity index (CDAI) score of =220 and =450 with at least one of the following: