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

• Register: ClinicalTrials.gov
• Last refreshed on: 7 August 2023
• Main ID: NCT05068284
• Date of registration: 27/09/2021
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• Public title: 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 AIM-CD
• Scientific title: 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
• Date of first enrolment: January 31, 2022
• Target sample size: 176
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/ct2/show/NCT05068284
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Australia, Austria, Belgium, Bulgaria, Canada, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, New Zealand, Poland, Portugal, Puerto Rico, Russian Federation, Slovakia, Spain, Taiwan, Turkey, United Kingdom, United States

Contacts

• Name: ABBVIE INC.
• Affiliation: AbbVie

Key inclusion & exclusion criteria

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,
ustekinumab, or risankizumab.

Exclusion Criteria:

- Participants with prior intolerance to adalimumab.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: ABBV-154

Drug: Placebo

Primary Outcome(s)

Percentage of Participants Achieving Endoscopic Response per Simple Endoscopic Score for Crohn's Disease (SES-CD) [Time Frame: Week 12 in the Induction Period]

Secondary Outcome(s)

Percentage of Participants Achieving Endoscopic Response per SES-CD [Time Frame: Week 40 in the Maintenance Period]

Percentage of Participants Achieving Clinical Remission per Average Daily Liquid or Very Soft Stool Frequency (SF) and Average Daily Abdominal Pain (AP) Score (SF/AP) [Time Frame: Week 12 in the Induction Period]

Percentage of Participants Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI) [Time Frame: Week 12 in the Induction Period]

Percentage of Participants Achieving Clinical Remission per SF/AP [Time Frame: Week 40 in the Maintenance Period]

Percentage of Participants Achieving Clinical Remission per CDAI [Time Frame: Week 40 in the Maintenance Period]

Secondary ID(s)

M20-371

2021-002869-18

Source(s) of Monetary Support

Please refer to primary and secondary sponsors