A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn's Disease Who Completed the Studies M14-431 or M14-433

Conditions

• Crohn's Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Upadacitinib — DRUG
  Oral; Tablet
• Placebo for Upadacitinib — DRUG
  Oral; Tablet

Study Details

A multicenter study to evaluate the efficacy and safety of maintenance and long-term treatment administration of upadacitinib, an orally administered Janus kinase 1 inhibitor, in adult participants with Crohn's Disease.

Key Dates

Start date

Mar 21, 2018

Status verified

Apr 2026

Primary completion

Sep 30, 2027

Completion

Sep 30, 2027

Study Design

Enrollment

747 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Substudy 1: Cohort 1 Upadacitinib Dose A
  This is a maintenance group which includes participants who achieved clinical response to upadacitinib in studies M14-431 and M14-433 and will receive upadacitinib dose A for 52 weeks.
• Experimental: Substudy 1: Cohort 1 Upadacitinib Dose B
  This is a maintenance group which includes participants who achieved clinical response to upadacitinib in studies M14-431 and M14-433 and will receive upadacitinib dose B for 52 weeks.
• Experimental: Substudy 1: Cohort 1 Placebo
  This is a maintenance group which includes participants who achieved clinical response to upadacitinib in studies M14-431 and M14-433 and will receive placebo for 52 weeks.
• Experimental: Substudy 1: Cohort 2 Placebo
  This is a maintenance group which includes participants who received double-blind placebo in studies M14-431 and M14-433 and achieved clinical response will continue to receive blinded placebo for 52 Weeks.
• Experimental: Substudy 1: Cohort 3 Upadacitinib Dose B
  This is a maintenance group which includes participants who achieved clinical response to upadacitinib from the extended treatment period of studies M14-431 and M14-433 and will receive upadacitinib Dose B for 52 Weeks.
• Experimental: Substudy 2: Cohort 4 Upadacitinib Dose B
  This is a long-term extension group which includes participants who achieved clinical response in the open-label extended treatment period of study M14-431 and will receive upadacitinib dose B for 240 weeks.
• Experimental: Substudy 2: Cohort 5 Upadacitinib Dose A
  This is a long-term extension group which includes participants who complete Substudy 1 and will receive upadacitinib dose A for 240 weeks.
• Experimental: Substudy 2: Cohort 5 Upadacitinib Dose B
  This is a long-term extension group which includes participants who complete Substudy 1 and will receive upadacitinib dose B for 240 weeks.
• Experimental: Substudy 2: Cohort 5 Placebo
  This is a long-term extension group which includes participants who complete Substudy 1 and will receive placebo for 240 weeks.

Primary Outcome Measure

Sub-Study 1: Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) [ Time Frame: Week 52 ]

Locations (123)

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