Upadacitinib Maintenance Therapy for Crohn's Disease
(U-ENDURE Trial)

Recruiting in Palo Alto (17 mi)

+782 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AbbVie

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults with Crohn's Disease who showed improvement in previous studies (M14-431 or M14-433) and completed certain study procedures. Participants can still join if their final endoscopy was missed due to COVID-19.

Inclusion Criteria

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.

+3 more

Exclusion Criteria

My recent colonoscopy shows significant inflammation.

I haven't started new medication or increased my current Crohn's disease medication dose in the last 3 months.

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.

+3 more

Participant Groups

The trial tests the long-term effectiveness and safety of Upadacitinib, a pill that targets specific proteins involved in inflammation, compared to a placebo in maintaining Crohn's Disease treatment effects.

9Treatment groups

Experimental Treatment

Group I: Substudy 2: Cohort 5 Upadacitinib Dose BExperimental Treatment1 Intervention

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

Group II: Substudy 2: Cohort 5 Upadacitinib Dose AExperimental Treatment1 Intervention

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

Group III: Substudy 2: Cohort 5 PlaceboExperimental Treatment1 Intervention

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

Group IV: Substudy 2: Cohort 4 Upadacitinib Dose BExperimental Treatment1 Intervention

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.

Group V: Substudy 1: Cohort 3 Upadacitinib Dose BExperimental Treatment1 Intervention

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.

Group VI: Substudy 1: Cohort 2 PlaceboExperimental Treatment1 Intervention

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.

Group VII: Substudy 1: Cohort 1 Upadacitinib Dose BExperimental Treatment1 Intervention

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.

Group VIII: Substudy 1: Cohort 1 Upadacitinib Dose AExperimental Treatment1 Intervention

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.

Group IX: Substudy 1: Cohort 1 PlaceboExperimental Treatment1 Intervention

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.

Upadacitinib is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Rinvoq for: