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.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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).
Secondary outcome
• 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.
Background summary
Crohn's disease (CD) is a long-lasting condition causing inflammation that can
affect any part of the gut. CD may cause tiredness, loose stools with or
without bleeding, abdominal pain, weight loss, and fever. This study evaluates
how safe and effective ABBV-154 is in participants treated for moderately to
severely active CD.
Adverse events and change in the disease activity will be assessed.
Study 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.
Study design
Randomized, Double-Blind, Placebo-Controlled Study
Intervention
The study is compromised of a 12-week double-blind, placebo-controlled
induction period, followed by either a 12-week double-blind re-induction period
for non-responders or a 40-week double-blind placebo-controlled maintenance
period for responders. In the maintenance period, responders will be randomized
to receive subcutaneous placebo or ABBV-154 in 2 different doses every other
week. Participants in the placebo group
who are initial responders will receive ABBV-154 in the maintenance period.
Study burden and risks
There may be higher treatment burden for participants in this trial compared to
their standard of care due to study procedures. Participants will attend
regular visits during the study at a hospital or clinic. The effect of the
treatment will be checked by medical assessments, blood tests, checking
for side effects and completing questionnaires.
Knollstrasse 50
Ludwigshafen 67061
DE
Knollstrasse 50
Ludwigshafen 67061
DE
Listed location countries
Age
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, or ustekinumab.
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2021-002869-18-NL |
| ClinicalTrials.gov | NCT05068284 |
| CCMO | NL79420.028.21 |