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 (U-ENDURE)

AbbVie

Status and phase: Active, not recruiting; Phase 3

Conditions: Crohn's Disease

Treatments: Drug: Placebo for Upadacitinib; Drug: Upadacitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03345823

2023-504951-29 (Other Identifier)

M14-430

Details and patient eligibility

About

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.

Enrollment: 747 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

For Substudy 1:

• Participant who achieve clinical response in Study M14-431 or Study M14-433.
• Participant completes study procedures in the parent study. The final endoscopy for Studies M14-431 or M14-433 may be missing, if the endoscopy cannot be performed during the COVID-19 pandemic.

For Substudy 2:

• Participant completes Substudy 1. The Week 52 endoscopy may be missing, if the endoscopy cannot be performed during the COVID-19 pandemic.
• Participant who achieved clinical response at the time described in the protocol and completes study procedures in the parent study/ substudy.

Exclusion criteria

For Substudies 1 and 2:

• Participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
• Participant who has a known hypersensitivity to upadacitinib or its excipients, or had an adverse event during Studies M14-431 and M14-433 or Substudy 1 or 2 of Study M14-430 that in the investigator's judgment makes the participant unsuitable for this study.
• Participant at the final visit of M14-431 or M14-433 with any active or chronic recurring infections based on the investigator's assessment that makes the participant an unsuitable candidate for the study. Participants with serious infections undergoing treatment may be enrolled BUT NOT dosed until the infection treatment has been completed and the infection is resolved, based on the investigator's assessment.
• Participants with high grade colonic dysplasia or malignancy diagnosed at the endoscopy performed at the final visit of Studies M14-431, M14-433 or Substudy 1 of Study M14-430 (Week 52).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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747 participants in 9 patient groups

Substudy 1: Cohort 1 Upadacitinib Dose A

Experimental group

Description:

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.

Treatment:

Drug: Upadacitinib

Substudy 1: Cohort 1 Upadacitinib Dose B

Experimental group

Description:

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.

Treatment:

Drug: Upadacitinib

Substudy 1: Cohort 1 Placebo

Experimental group

Description:

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.

Treatment:

Drug: Placebo for Upadacitinib

Substudy 1: Cohort 2 Placebo

Experimental group

Description:

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.

Treatment:

Drug: Placebo for Upadacitinib

Substudy 1: Cohort 3 Upadacitinib Dose B

Experimental group

Description:

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.

Treatment:

Drug: Upadacitinib

Substudy 2: Cohort 4 Upadacitinib Dose B

Experimental group

Description:

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.

Treatment:

Drug: Upadacitinib

Substudy 2: Cohort 5 Upadacitinib Dose A

Experimental group

Description:

This is a long-term extension group which includes participants who complete Substudy 1 and will receive upadacitinib dose A for 240 weeks.

Treatment:

Drug: Upadacitinib

Substudy 2: Cohort 5 Upadacitinib Dose B

Experimental group

Description:

This is a long-term extension group which includes participants who complete Substudy 1 and will receive upadacitinib dose B for 240 weeks.

Treatment:

Drug: Upadacitinib

Substudy 2: Cohort 5 Placebo

Experimental group

Description:

This is a long-term extension group which includes participants who complete Substudy 1 and will receive placebo for 240 weeks.

Treatment:

Drug: Placebo for Upadacitinib