A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis

Conditions

• Ulcerative Colitis (UC)

Eligibility Criteria

Sex

ALL

Age

16 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• risankizumab IV — DRUG
  risankizumab intravenous (IV) infusion
• placebo for risankizumab — DRUG
  placebo for risankizumab
• risankizumab SC — DRUG
  risankizumab subcutaneous (SC) injection

Study Details

The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2. The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.

Key Dates

Start date

Mar 7, 2018

Status verified

Jan 2025

Primary completion

Nov 9, 2022

Completion

May 11, 2023

Study Design

Enrollment

1,558 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Substudy 1, Induction Period 1: Double-blind Placebo IV
  Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
• Experimental: Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV
  Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.
• Experimental: Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV
  Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
• Experimental: Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV
  Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion.
• Experimental: Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV
  Participants receive risankizumab 1800mg administered by intravenous (IV) infusion.
• Experimental: Substudy 1, Induction Period 2: Double-blind Risankizumab 180mg SC
  Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 180mg administered by subcutaneous (SC) injection in Induction 2.
• Experimental: Substudy 1, Induction Period 2: Double-blind Risankizumab 360mg SC
  Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 360mg administered by subcutaneous (SC) injection in Induction 2.
• Experimental: Substudy 1, Induction Period 2: Double-blind Risankizumab 1800mg IV
  Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion in Induction 2.
• Experimental: Substudy 1, Induction Period 2: Double-blind Risankizumab 1800mg IV Pbo
  Participants who received placebo with inadequate response in Induction 1 receive risankizumab 1800mg administered by intravenous (IV) infusion in Induction 2.
• Placebo Comparator: Substudy 2, Induction Period 1: Double-blind Placebo IV
  Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
• Experimental: Substudy 2, Induction Period 1: Double-blind Risankizumab 1200mg IV
  Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.
• Experimental: Substudy 2, Induction Period 2: Double-blind Risankizumab 180mg SC
  Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 180mg administered by subcutaneous (SC) injection in Induction 2.
• Experimental: Substudy 2, Induction Period 2: Double-blind Risankizumab 360mg SC
  Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 360mg administered by subcutaneous (SC) injection in Induction 2.
• Experimental: Substudy 2, Induction Period 2: Double-blind Risankizumab 1200mg IV
  Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion in Induction 2.
• Experimental: Substudy 2, Induction Period 2: Double-blind Risankizumab 1200mg IV Pbo
  Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion in Induction 2.

Primary Outcome Measure

Sub-Study 1: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score [ Time Frame: Week 12 ]

Locations (82)

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