[M20-371]Moderate to Severe Crohn's Disease: A Phase 2 Safety and Efficacy Study of ABBV-154

Phase 2

Suspended

• Conditions: Crohn's disease

• Registration Number: JPRN-jRCT2051210135
• Lead Sponsor: Yamazaki Hayato

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-17
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 265

Inclusion Criteria

Confirmed diagnosis of Crohn's Disease (CD) for at least 3 months prior to Baseline of the Induction Period.
- Crohn's Disease Activity Index (CDAI) score 220 to 450 at Baseline of the Induction Period.
- Endoscopic evidence of mucosal inflammation as documented by an Simple Endoscopic Score for Crohn's
Disease (SES-CD) of >= 6 for ileocolonic or colonic disease or SES-CD of >= 4 for isolated ileal disease as scored by a central reader. All eligible scores must exclude the presence of narrowing component.
- Demonstrated intolerance or inadequate response to one or more of the following biologic agents: infliximab, adalimumab, certolizumab pegol, vedolizumab, natalizumab, or ustekinumab.

Exclusion Criteria

- Participants with prior intolerance to adalimumab.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Achievement of endoscopic response at Week 12 in the Induction Period defined as a decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) > 50% from Baseline (or for subjects with isolated ileal disease and a Baseline.