|E.1 Medical condition or disease under investigation
|Medical condition(s) being investigated
|Subjects with moderately to severely active Crohn's disease
|Medical condition in easily understood language
|Diseases [C] - Immune System Diseases [C20]
|E.1.2 Medical condition or disease under investigation
|System Organ Class
|10017947 - Gastrointestinal disorders
|Condition being studied is a rare disease
|E.2 Objective of the trial
|Main objective of the trial
|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 objectives of the trial
|The secondary objectives are to assess the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ABBV 154.
|Trial contains a sub-study
|Full title, date and version of each sub-study and their related objectives
|Wearable Device Substudy, to collect data for sleep parameters, daily physical activity, and stool frequency data.
|Principal 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.
|Principal 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.
|E.5 End points
|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
|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.
• 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.
• Achievement of endoscopic response per SES-CD at Week 40 in the Maintenance Period.
• Achievement of clinical remission per CDAI at Week 40 in the Maintenance Period.
• Achievement of clinical remission per SF/AP at Week 40 in the Maintenance Period.
|Timepoint(s) of evaluation of this end point
|E.6 and E.7 Scope of the trial
|Scope of the trial
|Other scope of the trial description
|Also assess Immunogenicity of ABBV-154
|Trial type and phase
|Human pharmacology (Phase I)
|First administration to humans
|Other trial type description
|Therapeutic exploratory (Phase II)
|Therapeutic confirmatory (Phase III)
|Therapeutic use (Phase IV)
|E.8 Design of the trial
| Comparator of controlled trial
|Other medicinal product(s)
|Number of treatment arms in the trial
The trial involves single site in the Member State concerned
| The trial involves multiple sites in the Member State concerned
|Number of sites anticipated in Member State concerned
|The trial involves multiple Member States
|Number of sites anticipated in the EEA
|E.8.6 Trial involving sites outside the EEA
|Trial being conducted both within and outside the EEA
|Trial being conducted completely outside of the EEA
|If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
|Korea, Republic of
|Trial has a data monitoring committee
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|The end-of-study is defined as the date of the last subject's last visit or the actual date of follow-up contact, whichever is later; and in the last country where the study was conducted.
|E.8.9 Initial estimate of the duration of the trial
|In the Member State concerned years
|In the Member State concerned months
|In the Member State concerned days
|In all countries concerned by the trial months