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

Conditions

• Colitis, Ulcerative
• Inflammatory Bowel Diseases

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Placebo IV — DRUG
  Placebo will be administered as intravenous infusion.
• Placebo SC — DRUG
  Placebo will be administered Subcutaneously.
• Ustekinumab IV — DRUG
  Ustekinumab will be administered as intravenous infusion at Week 0 or Week 8 in Induction Study.
• Ustekinumab SC — DRUG
  Ustekinumab will be administered as subcutaneously.

Study Details

The purpose of this study is to evaluate the efficacy and safety of ustekinumab as intravenous (IV: into the vein) infusion in induction study in participants with moderately to severely active Ulcerative Colitis (UC) and as subcutaneous (SC) administration in maintenance study in participants with moderately to severely active Ulcerative Colitis (UC) who have demonstrated a clinical response to Induction treatment with IV ustekinumab.

Key Dates

Start date

Jul 10, 2015

Status verified

Apr 2025

Primary completion

Aug 10, 2018

Completion

Nov 30, 2021

Study Design

Enrollment

961 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Arms

• Placebo Comparator: Induction Study - Placebo Intravenous (IV)
  Participants will be randomized to receive single dose of placebo as Intravenous (IV: into the vein) infusion at Week 0. Participants with clinical response at Week 8 will be eligible to enter the Maintenance study, but will not be randomized.
• Experimental: Induction Study - Ustekinumab 130 milligram (mg) IV
  Participants will be randomized to receive single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 will be eligible to enter the Maintenance study and will be randomized.
• Experimental: Induction Study - Ustekinumab 6 mg/kg IV
  Participants will be randomized to receive ustekinumab approximating 6 mg/kg of body weight, as intravenous infusion at Week 0. Participants with clinical response at Week 8 will be eligible to enter the Maintenance study and will be randomized.
• Other: Induction Study- Placebo- Nonresponsders at Week 8
  Participants without clinical response to placebo at Week 8 will receive a single IV infusion of ustekinumab approximating 6mg/kg along with matching subcutaneous (SC) placebo (to maintain the blind). Participants in clinical response at Week 16 will be eligible to enter Maintenance study and will be randomized.
• Other: Induction study-Ustekinumab Nonresponders at Week 8
  Participants without clinical response to ustekinumab (130 mg or 6 mg/kg \[IV\]) at Week 8 will receive a single dose of ustekinumab 90 mg subcutaneously along with matching placebo intravenously (to maintain the blind). Participants in clinical response at Week 16 (that is, delayed responders) will be eligible to enter Maintenance study, but will not be randomized.
• Placebo Comparator: Maintenance Study - Placebo Subcutaneous (SC)
  Participants in clinical response (at Week 8 or Week 16) to Induction treatment with single IV infusion of Ustekinumab will be randomized to receive placebo subcutaneously, beginning Week 0 of Maintenance study through Week 44.
• Experimental: Maintenance Study - Ustekinumab 90mg SC every 12 weeks
  Participants in clinical response (at Week 8 or Week 16) to Induction treatment with single IV infusion of Ustekinumab will be randomized to receive ustekinumab 90 mg subcutaneously every 12 weeks, beginning Week 0 of Maintenance study through Week 44.
• Experimental: Maintenance Study - Ustekinumab 90mg SC every 8 weeks (q8w)
  Participants in clinical response (at Week 8 or Week 16) to Induction treatment with single IV infusion of Ustekinumab will be randomized to receive ustekinumab 90 mg subcutaneously every 8 weeks, beginning Week 0 of Maintenance study through Week 44.
• Other: Maintenance Study - Placebo IV - Responder - Placebo SC
  Participants in clinical response to Induction treatment with IV Placebo will receive placebo subcutaneously, beginning Week 0 of Maintenance study through Week 44. Participants are not randomized.
• Other: Maintenance Study-Delayed Responder-Ustekinumab 90mg SC q8w
  Participants without clinical response to induction treatment ustekinumab (130 mg or 6 mg/kg \[IV\]) at Week 8 but in clinical response at Week 16 after receiving Induction Ustekinumab at week 8 (delayed responders) will receive ustekinumab 90 mg subcutaneously every 8 weeks, beginning Week 0 of Maintenance study through Week 44. Participants are not randomized.

Primary Outcome Measure

Induction Study - Number of Participants With Clinical Remission at Week 8 (As Per Global Definition) [ Time Frame: Week 8 ]

Locations (68)

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