A Study to Evaluate the Safety and Efficacy of the Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis

INTERVENTION:

Product Name: Ustekinumab Product Code: CNTO1275 Pharmaceutical Form: 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 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 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

CONDITION:

Therapeutic area: Diseases [C] ‐ Immune System Diseases [C20] Ulcerative Colitis ; MedDRA version: 19.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

PRIMARY OUTCOME:

Main Objective: Induction study:; ‐To evaluate the efficacy of IV ustekinumab in inducing clinical remission in subjects with moderately to severely active ulcerative colitis (UC).; ‐To evaluate the safety of IV ustekinumab in subjects with moderately to severely active UC.; ; Maintenance study:; ‐ To evaluate clinical remission for SC maintenance regimens of ustekinumab in subjects with moderately to severely active UC induced into clinical response with ustekinumab.; ‐ To evaluate the safety of SC maintenance regimens of ustekinumab in subjects with moderately to severely active UC induced into clinical response with ustekinumab. Primary end point(s): Induction study:; ‐ Number of Participants With Clinical Remission; ; Maintenance study:; ‐ Number of Participants with Clinical Remission Among Participants in Clinical Response to IV Ustekinumab Induction Treatment Secondary Objective: Induction ; ‐ efficacy of IV ustekinumab in inducing endoscopic healing, clinical response ; ‐ impact of IV ustekinumab on disease‐specific health‐related quality of life; ‐ efficacy of ustekinumab on mucosal healing; ‐ efficacy of induction therapy with IV ustekinumab by biologic failure status; ‐ PK, immunogenicity, and PD of ustekinumab induction therapy ; ; Maintenance ; ‐ efficacy in maintaining clinical response in subjects induced into clinical response with ustekinumab; ‐ endoscopic healing in subjects induced into clinical response ; ‐ efficacy of ustekinumab in achieving corticosteroid‐free clinical remission; ‐ efficacy of ustekinumab in maintaining clinical remission; ‐ efficacy of ustekinumab treatment on mucosal healing ; ‐ impact of SC ustekinumab on disease‐specific health‐related quality of life; ‐ efficacy of maintenance therapy with SC ustekinumab by biologic failure status; ‐ PK, immunogenicity, and PD of ustekinumab maintenance therapy Timepoint(s) of evaluation of this end point: Induction study:; ‐ Week 8 ; ; Maintenance study:; ‐ Week 44

SECONDARY OUTCOME:

Secondary end point(s): Induction study: ; 1) Number of Participants with Clinical Response ; 2) Number of Participants With Endoscopic Healing ; 3) Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score ; ; Maintenance study: ; 1) Participants with Clinical Response Among Participants in Clinical Response to IV Ustekinumab Induction Treatment ; 2) Number of Participants with Endoscopic Healing Among Participants in Clinical Response to IV Ustekinumab Induction Treatment ; 3) Number of Participants with Clinical Remission and not receiving concomitant corticosteroids at Week 44 ; 4) Number of Participants with Clinical Remission Among those who Achieved Clinical Remission at Maintenance Study Baseline Timepoint(s) of evaluation of this end point: Induction study: ; 1‐3) Week 8 ; ; Maintenance study: ; 1‐4) Week 44 ;

INCLUSION CRITERIA:

‐ Has a clinical diagnosis of Ulcerative Colitis (UC) at least 3 months before Screening ‐ Has moderately to severely active UC, defined as a Baseline (Week 0) Mayo score of 6 to 12, including a Screening endoscopy subscore of the Mayo score greater than or equal to (>=) 2 as determined by a central reading of the video endoscopy ‐ Have failed biologic therapy, that is, have received treatment with 1 or more tumour necrosis factor (TNF) antagonists or vedolizumab at a dose approved for the treatment of UC, and have a documented history of failure to respond to or tolerate such treatment; OR Be naïve to biologic therapy (TNF antagonists or vedolizumab) or have received biologic therapy but have not demonstrated a history of failure to respond to, or tolerate, a biologic therapy and have a prior or current UC medication history that includes at least 1 of the following: a. Inadequate response to or failure to tolerate current treatment with oral