This is a study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Crohn's Disease (CD)

Phase 1

Conditions: Subjects with moderately to severely active Crohn's disease
MedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2021-002869-18-BG

Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 265

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
F.1.3.1 Number of subjects for this age range 26

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to assess the efficacy, safety, and tolerability of ABBV 154 in comparison with placebo in subjects with moderately to severely active CD who had inadequate response to or were intolerant of prior biologics.;Secondary Objective: The secondary objectives are to assess the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ABBV 154.;Primary end point(s): The primary endpoint is the achievement of endoscopic response at Week 12 in the Induction Period defined as a decrease in Simple Endoscopic Score for Crohn’s Disease (SES-CD17) > 50% from Baseline (or for subjects with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).;Timepoint(s) of evaluation of this end point: Week 12

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Achievement of clinical remission per Crohn’s Disease Activity Index (CDAI) at Week 12 in the Induction Period defined as CDAI < 150.<br>•Achievement of clinical remission per average daily liquid or very soft stool frequency (SF) and average daily abdominal pain (AP) score (SF/AP) at Week 12 in the Induction Period defined as average daily liquid or very soft SF = 2.8 and not worse than Baseline AND average daily AP score = 1 and not worse than Baseline.<br>•Achievement of endoscopic response per SES-CD at Week 40 in the Maintenance Period.<br>•Achievement of clinical remission per CDAI at Week 40 in the Maintenance Period.<br>•Achievement of clinical remission per SF/AP at Week 40 in the Maintenance Period.<br>;Timepoint(s) of evaluation of this end point: Week 12 and Week 40

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