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

Phase 1

• Conditions: Crohn's disease; MedDRA version: 20.0Level: LLTClassification code 10013099Term: Disease CrohnsSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2016-003190-17-BG
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-28
• Last Update Posted: 26 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 579

Inclusion Criteria

- Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit
- Diagnosis of CD for at least 3 months prior to Baseline
- Crohn's disease activity index (CDAI) score at Baseline
- Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic Score for Crohn's Disease (SES-CD)
- Demonstrated intolerance or inadequate response to biologic therapy for CD
- If female, subject must meet the contraception recommendations
Are the trial subjects under 18? yes
Number of subjects for this age range: 18
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 543
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified