Upadacitinib for Crohn's Disease

Recruiting in Palo Alto (17 mi)

+108 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: AbbVie

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This is a open-label extension (OLE) study designed to evaluate the long-term efficacy, safety, and tolerability of Upadacitinib (ABT-494).

Eligibility Criteria

This trial is for individuals with Crohn's Disease who have completed the M13-740 study up to Week 52. Women must be postmenopausal, surgically sterile, or using birth control. Those unsuitable as per the investigator, pregnant women, or those planning pregnancy during the study are excluded.

Inclusion Criteria

I am a woman who is either postmenopausal, surgically sterile, or using birth control.

Participant must have completed Study M13-740 through Week 52.

I am a woman who is postmenopausal, surgically sterile, or using birth control.

Exclusion Criteria

Participant is not in compliance with prior and concomitant medication requirements and procedures throughout Study M13-740.

I am not pregnant nor planning to become pregnant during the study.

For any reason participant is considered by the investigator to be an unsuitable candidate

Participant Groups

The trial is testing Upadacitinib (ABT-494) for long-term effectiveness and safety in treating Crohn's Disease. It involves repeated doses of this medication over an extended period to monitor its sustained impact on patients.

2Treatment groups

Experimental Treatment

Group I: Upadacitinib (ABT-494) Dose BExperimental Treatment1 Intervention

Open label dose B QD

Group II: Upadacitinib (ABT-494) Dose AExperimental Treatment1 Intervention

Open label dose A once daily (QD)