AIM-CD

A Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Intravenous (IV) Infusion and Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Crohn's Disease

Brief 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. ABBV-154 is an investigational drug being evaluated for the treatment of CD. In the induction period, there is a 1 in 5 chance that participants will be assigned to placebo. Depending on the dose received in the induction period, there is a 1 in 2 or 1 in 3 chance that participants will be assigned to placebo in the maintenance period. Around 265 participants 18-75 years of age with moderately to severely active CD will be enrolled in the study at approximately 200 sites worldwide. 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. Participants with inadequate response at/after Week 4 of the maintenance period will be eligible to receive ABBV-154 rescue therapy. 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.

Interventional study

Status:
Recruiting
Conditions:
Crohn's Disease
Enrollment:
265 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M20-371
Allocation:
Randomized
Intervention model:
Sequential Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Purpose:
Treatment

 

Eligibility criteria

Participant attributes:
Male and Female

Age:

From 18 Years to 75 Years.

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.

All the cities where the clinical studies are located

Calgary - T2N 4Z6
Edmonton - T5R 1W2
Halifax - B3H 1V7
London - N6A 5W9
North Bay - P1B 2H3
Vaughan - L4L 4Y7

More information about this study

clinicaltrials.gov