EUCTR2021-002869-18-BE
Active, Not Recruiting
Phase 1
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Crohn's Disease (CD): AIM-CD - Moderate to Severe Crohn’s Disease: A Phase 2 Safety and Efficacy Study of ABBV-154
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Subjects with moderately to severely active Crohn's disease
- Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Enrollment
- 265
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female between 18 and 75 years of age inclusive at the time of Screening.
- •2\. Confirmed diagnosis of CD for at least 3 months prior to Baseline of the Induction Period.
- •3\. CDAI score 220 to 450 at Baseline of the Induction Period.
- •4\. Endoscopic evidence of mucosal inflammation as documented by an 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.
- •5\. Demonstrated intolerance or inadequate response to one or more of the following biologic agents: infliximab, adalimumab, certolizumab pegol, vedolizumab, natalizumab, ustekinumab or risankizumab.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 239
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •1\. Subjects with prior intolerance to adalimumab are not eligible to enroll.
- •2\. Subjects who discontinued biologic agents only for reasons other than inadequate response or intolerance (e.g., change of insurance) are not eligible to enroll.
Outcomes
Primary Outcomes
Not specified
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