A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003123-32-GB

Enrollment

855

Registered

2017-07-20

Start date

2017-11-28

Completion date

Unknown

Last updated

2020-09-28

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

Conditions

Crohn's Disease MedDRA version: 20.0 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856

Interventions

Product Name: Risankizumab Product Code: ABBV-066 Pharmaceutical Form: Solution for infusion INN or Proposed INN: RISANKIZUMAB CAS Number: 1612838-76-2 Concentration unit: mg/ml milligram(s)/millilitr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male or female aged >=18 to =65 years) yes F.1.3.1 Number of subjects for this age range 17

Exclusion criteria

Exclusion criteria: - Subject with a current diagnosis of ulcerative colitis or indeterminate colitis - Subjects 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, stenosis, short bowel, etc) - Having an ostomy or ileoanal pouch

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of Study M16-006 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in subjects with moderately to severely active CD.;Secondary Objective: Not applicable;Primary end point(s): Co-Primary Endpoints: Proportion of subjects with clinical remission at Week 12 Proportion of subjects with endoscopic response at Week 12;Timepoint(s) of evaluation of this end point: Week 12 Week 12	—

Measure

Time frame

Main Objective: The objective of Study M16-006 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in subjects with moderately to severely active CD.;Secondary Objective: Not applicable;Primary end point(s): Co-Primary Endpoints: Proportion of subjects with clinical remission at Week 12 Proportion of subjects with endoscopic response at Week 12;Timepoint(s) of evaluation of this end point: Week 12 Week 12

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 1. Week 12 2. Week 4 3. Week 4 4. Week 12 5. Week 12 6. Week 12 7. Week 12 8. Week 12 9. Week 4 10. Week 12 11. Week 12 12. Week 12 13. Week 12 14. Week 12;Secondary end point(s): 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

Timepoint(s) of evaluation of this end point: 1. Week 12 2. Week 4 3. Week 4 4. Week 12 5. Week 12 6. Week 12 7. Week 12 8. Week 12 9. Week 4 10. Week 12 11. Week 12 12. Week 12 13. Week 12 14. Week 12;Secondary end point(s): 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

Argentina, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Ukraine, United Kingdom, United States

Contacts

Public ContactEU Clinical Trials Helpdesk

AbbVie Ltd

eu-clinical-trials@abbvie.com+44 1628 561090

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026