A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severly Active Crohn's Disease Who Failed Prior Biologic Treatment

A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severly Active Crohn's Disease Who Failed Prior Biologic Treatment - M15-991

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50663

Enrollment

Registered

2017-08-10

Start date

2018-05-31

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's disease form of Inflammatory Bowel Disease (IBD)

Interventions

Subjects receive risankizumab or placebo, via IV, during the 12 week induction period (weeks 0 to 12)

subjects with inadequate response receive risankizumab, via IV or SC, during the 12 week induction period 2 (week 12 to 24).

Eligibility

Age

12 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Male or female aged >= 18 to

Exclusion criteria

Exclusion criteria: - Subject with a current diagnosis of ulcerative colitis or indeterminate colitis - Sujects with unstable doses of concomitant Crohn's disease therapy - Receipt of Crohn's disease approved biologic agents prior to Baseline (as detailed in protocol), or any investigational biologic or other agent or procedure within minimally 35 days prior to the Baseline - Prior exposure to p19 inhibitors (e.g., risankizumab) - Complications of Crohn's disease (strictures, short bowel, etc)

Design outcomes

Primary

Measure	Time frame
Proportion of subjects with clinical remission at Week 12 and proportion of subjects with endoscopic response at Week 12.	—

Secondary

Measure	Time frame
1. Proportion of subjects with CDAI clinical remission at Week 12 2. Proportion of subjects with CDAI clinical response at Week 4 3. Proportion of subjects with clinical remission at Week 4 4. Proportion of subjects with CDAI clinical response at Week 12 5. Mean change from baseline of induction in FACIT fatigue at Week 12 6. Mean change from baseline of induction in IBDQ total score at Week 12 7. Proportion of subjects with enhanced clinical response and endoscopic response at Week 12 8. Proportion of subjects with endoscopic remission at Week 12 9. Proportion of subjects with enhanced clinical response at Week 4 10. Proportion of subjects with ulcer-free endoscopy at Week 12 11. Enhanced clinical response at Week 12 12. Proportion of subjects with resolution of extra-intestinal manifestations (EIMs) at Week 12, in subjects with any EIMs at Baseline 13. Proportion of subjects with CD-related hospitalization through Week 12 14. Proportion of subjects without draining fistulas at Week 12 in subjects with draining fistulas at Baseline	—

Measure

Time frame

1. Proportion of subjects with CDAI clinical remission at Week 12 2. Proportion of subjects with CDAI clinical response at Week 4 3. Proportion of subjects with clinical remission at Week 4 4. Proportion of subjects with CDAI clinical response at Week 12 5. Mean change from baseline of induction in FACIT fatigue at Week 12 6. Mean change from baseline of induction in IBDQ total score at Week 12 7. Proportion of subjects with enhanced clinical response and endoscopic response at Week 12 8. Proportion of subjects with endoscopic remission at Week 12 9. Proportion of subjects with enhanced clinical response at Week 4 10. Proportion of subjects with ulcer-free endoscopy at Week 12 11. Enhanced clinical response at Week 12 12. Proportion of subjects with resolution of extra-intestinal manifestations (EIMs) at Week 12, in subjects with any EIMs at Baseline 13. Proportion of subjects with CD-related hospitalization through Week 12 14. Proportion of subjects without draining fistulas at Week 12 in subjects with draining fistulas at Baseline

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)