A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease

Conditions

• Crohn's Disease

Eligibility Criteria

Sex

ALL

Age

16 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Placebo for Risankizumab SC — DRUG
  Placebo for Risankizumab SC Subcutaneous (SC) Injection
• Risankizumab IV — DRUG
  Risankizumab IV Intravenous (IV) infusion
• Placebo for Risankizumab IV — DRUG
  Placebo for Risankizumab IV Intravenous (IV) infusion
• Risankizumab SC — DRUG
  Risankizumab SC Subcutaneous (SC) injection
• Risankizumab On-Body Injector (OBI) — DRUG
  Subcutaneous (SC) injection; on-body injector (OBI)

Study Details

The study consists of 4 sub-studies, as follows: * Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in participants with moderately to severely active Crohn's disease (CD) who responded to intravenous risankizumab induction treatment in Study M16-006 or Study M15-991; * Sub-study 2 (Randomized, exploratory maintenance study) to evaluate the efficacy and safety of two different dosing regimens for risankizumab as maintenance therapy in participants who responded to induction treatment in Study M16-006 or Study M15-991; * Sub-study 3 (Open-label, long-term extension study) to evaluate long-term safety of risankizumab in participants who completed Sub-study 1, Sub-study 2, another AbbVie risankizumab Crohn's disease study, or participants who responded to induction treatment in Study M16-006 or Study M15-991 with no final endoscopy due to the Covid-19 pandemic. Additional objectives are to further investigate long-term efficacy and tolerability of risankizumab; * Sub-study 4 (Open-label On Body Injector (OBI) administration and long-term extension study) to evaluate patient-reported outcomes, efficacy, safety, tolerability, and pharmacokinetics of risankizumab administered via OBI in participants who are receiving maintenance treatment with risankizumab. * OL CTE to ensure uninterrupted care in accordance with local regulations until risankizumab is commercially available for participants who completed Sub-study 3, Sub-study 4.

Key Dates

Start date

Apr 9, 2018

Status verified

Aug 2025

Primary completion

May 31, 2026

Completion

May 31, 2026

Study Design

Enrollment

1,336 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Double-blind Placebo for Risankizumab (Sub-Study 1)
  Participants randomized to receive double-blind placebo for risankizumab for 52 weeks.
• Experimental: Double-blind Risankizumab Dose 1 (Sub-Study 1)
  Participants randomized to receive double-blind risankizumab dose 1 for 52 weeks.
• Experimental: Double-blind Risankizumab Dose 2 (Sub-Study 1)
  Participants randomized to receive double-blind risankizumab dose 2 for 52 weeks.
• Experimental: Maintenance Risankizumab Dose 1 (Sub-Study 2)
  Participants will receive double-blind subcutaneous (SC)risankizumab dose 1 and intravenous placebo at Week 0 followed by open-label SC risankizumab dose 1 from Week 8 through Week 52.
• Experimental: Maintenance Risankizumab Dose 2 (Sub-Study 2)
  Participants will receive double-blind subcutaneous placebo and intravenous risankizumab dose 3 at Week 0 followed by open-label SC risankizumab dose 1 from Week 8 through Week 52.
• Experimental: Open-label Risankizumab (Sub-Study 3)
  Participants who completed Sub-study 1 or Sub-study 2 or other AbbVie risankizumab Crohn's disease study or M16-006 or M15-991 without endoscopy will receive open-label risankizumab dose 1 or dose 2 depending on their preceding study beginning at Week 56.
• Experimental: Risankizumab On-Body Injector and Open Label (Sub-Study 4)
  Participants in Sub-study 3 who meet eligible criteria for Sub-study 4 will receive risankizumab dose 1 or dose 2 via on-body injectors on Weeks 0,8 and 16. Beginning Week 24, participants will receive risankizumab dose 1 or dose 2 via pre-filled syringes Q8W.
• Experimental: CTE: Open Label Continuous Treatment Extension
  Participants who tolerate and derive benefit from receiving risankizumab and complete Sub-study 3 or Sub-study 4 will receive risankizumab dose 1 or dose 2 Q8W.

Primary Outcome Measure

Sub-Study 1: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission [ Time Frame: Week 52 ]

Locations (111)

Find similar trials in Mesa, AZ

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