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)

AbbVie

Status and phase: Terminated; Phase 2

Conditions: Crohn's Disease

Treatments: Drug: ABBV-154; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05068284

M20-371

2021-002869-18 (EudraCT Number)

Details and patient eligibility

About

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 comprised 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.

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.

Enrollment: 176 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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176 participants in 10 patient groups, including a placebo group

Induction Phase: ABBV-154 Randomized Dose A

Experimental group

Description:

Varying doses of ABBV-154 as described in the protocol.

Treatment:

Drug: ABBV-154

Drug: ABBV-154

Induction Phase: ABBV-154 Randomized Dose B

Experimental group

Description:

Varying doses of ABBV-154 as described in the protocol.

Treatment:

Drug: ABBV-154

Drug: ABBV-154

Induction Phase: ABBV-154 Randomized Dose C

Experimental group

Description:

Varying doses of ABBV-154 as described in the protocol.

Treatment:

Drug: ABBV-154

Drug: ABBV-154

Induction Phase: ABBV-154 Randomized Dose D

Experimental group

Description:

Varying doses of ABBV-154 as described in the protocol.

Treatment:

Drug: ABBV-154

Drug: Placebo

Drug: Placebo

Drug: ABBV-154

Induction Phase: Randomized Placebo

Placebo Comparator group

Description:

Fixed dose placebo as described in the protocol.

Treatment:

Drug: Placebo

Drug: Placebo

Re-Induction Phase: ABBV-154 Randomized Dose A

Experimental group

Description:

Varying doses of ABBV-154 as described in the protocol.

Treatment:

Drug: ABBV-154

Drug: ABBV-154

Re-Induction Phase: ABBV-154 Randomized Dose B

Experimental group

Description:

Varying doses of ABBV-154 as described in the protocol.

Treatment:

Drug: ABBV-154

Drug: ABBV-154

Maintenance Phase: ABBV-154 Randomized Dose A

Experimental group

Description:

Fixed dose ABBV-154 every other week.

Treatment:

Drug: ABBV-154

Drug: ABBV-154

Maintenance Phase: ABBV-154 Randomized Dose B

Experimental group

Description:

Fixed dose ABBV-154 every other week.

Treatment:

Drug: ABBV-154

Drug: ABBV-154

Maintenance Phase: Randomized Placebo

Placebo Comparator group

Description:

Fixed dose placebo every other week.

Treatment:

Drug: Placebo

Drug: Placebo