[M20-371]Moderate to Severe Crohn's Disease: A Phase 2 Safety and Efficacy Study of ABBV-154

JRCT ID: jRCT2051210135

Registered date:17/12/2021

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: Crohn's disease
• Date of first enrollment: 11/03/2022
• Target sample size: 265
• Countries of recruitment: United States,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,Bulgaria,Japan,Canada,Japan,France,Japan,Germany,Japan,Greece,Japan,Israel,Japan,Italy,Japan,Korea,Japan,Netherlands,Japan,New Zealand,Japan,Poland,Japan,Russian Federation,Japan,Slovakia,Japan,Spain,Japan,Taiwan,Japan,United Kingdom,Japan
• Study type: Interventional

Intervention(s)

Label: Induction Phase: ABBV-154 Randomized Dose A; Description: Varying doses of ABBV-154 as described in the protocol.

Label: Induction Phase: ABBV-154 Randomized Dose B; Description: Varying doses of ABBV-154 as described in the protocol.

Label: Induction Phase: ABBV-154 Randomized Dose C; Description: Varying doses of ABBV-154 as described in the protocol.

Label: Induction Phase: ABBV-154 Randomized Dose D; Description: Varying doses of ABBV-154 as described in the protocol.

Label: Induction Phase: Randomized Placebo; Description: Fixed dose placebo as described in the protocol.

Label: Re-Induction Phase: ABBV-154 Randomized Dose A; Description: Varying doses of ABBV-154 as described in the protocol.

Label: Re-Induction Phase: ABBV-154 Randomized Dose B; Description: Varying doses of ABBV-154 as described in the protocol.

Label: Maintenance Phase: ABBV-154 Randomized Dose A; Description: Fixed dose ABBV-154 every other week.

Label: Maintenance Phase: ABBV-154 Randomized Dose B; Description: Fixed dose ABBV-154 every other week.

Label: Maintenance Phase: Randomized Placebo; Description: Fixed dose placebo every other week.

Outcome(s)

• Primary Outcome: Achievement of endoscopic response at Week 12 in the Induction Period defined as a decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) > 50% from Baseline (or for subjects with isolated ileal disease and a Baseline.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include 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.

• Exclude criteria: - Participants with prior intolerance to adalimumab.

Related Information

• Primary Sponsor: Yamazaki Hayato
• Secondary ID(s): NCT05068284