A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis

Conditions

• Ulcerative Colitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Placebo — DRUG
  Participants will receive matching placebo IV or SC.
• Guselkumab — DRUG
  Participants will receive guselkumab IV or SC.

Study Details

The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (UC).

Key Dates

Start date

Sep 26, 2019

Status verified

Jun 2026

Primary completion

Sep 19, 2023

Completion

Sep 29, 2027

Study Design

Enrollment

1,064 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Induction Study 1: Guselkumab Dose 1
  Participants will receive guselkumab dose 1 intravenously (IV) in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12.
• Experimental: Induction Study 1: Guselkumab Dose 2
  Participants will receive guselkumab dose 2 IV in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12.
• Placebo Comparator: Induction Study 1: Placebo IV
  Participants will receive matching placebo IV in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12. Clinical nonresponders will be administered guselkumab IV.
• Experimental: Induction Study 2: Guselkumab IV
  Participants will receive guselkumab IV in Induction Study 2. Subsequent study treatment will be determined by the participant's clinical response status at Week 12.
• Placebo Comparator: Induction Study 2: Placebo IV
  Participants will receive matching placebo IV in Induction Study 2. Subsequent study treatment will be determined by the participant's clinical response status at Week 12. Clinical nonresponders will be administered guselkumab IV.
• Experimental: Maintenance Study: Maintenance Dose Regimen 1
  Participants will receive guselkumab maintenance dose regimen 1 subcutaneously (SC) every 4 weeks (q4w).
• Experimental: Maintenance Study: Maintenance Dose Regimen 2
  Participants will receive guselkumab maintenance dose regimen 2 SC every 8 weeks (q8w).
• Placebo Comparator: Maintenance Study: Placebo SC
  Participants will receive matching placebo SC q4w.

Primary Outcome Measure

Induction Study 1: Percentage of Participants With Clinical Response at Week I-12 [ Time Frame: At Week I-12 ]

Locations (52)

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