A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433

Phase 3

Recruiting

• Conditions: Crohn's disease; form of Inflammatory Bowel Disease (IBD); 10017969

• Registration Number: NL-OMON54751
• Lead Sponsor: AbbVie B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 29

Inclusion Criteria

For Substudy 1:
- Subject achieved clinical response in Study M14-431 or Study M14-433.
- Subject completed Week 12 (in subjects who achieve response at Week 12) or
Week 24 (in subjects who achieve response at Week 24) visit and procedures in
Study M14-431 or Study M14-433. The final endoscopy for Studies M14-431 or
M14-433 may be missing, if the endoscopy cannot be performed during the
COVID-19 pandemic.
Note: Subjects completing Part 3/Cohort 3 of Study M14-431, who received
open-label Extended Treatment, should enroll in Substudy 2.

For Substudy 2:
- Subject completed Week 52 of the maintenance period of Study M14-430
(Substudy 1).Completion includes the Week 52 endoscopy of Substudy 1. The Week
52 endoscopy may be missing, if the endoscopy cannot be performed during the
COVID-19 pandemic or any state of emergency or pandemic situation.
- Subject achieved clinical response at Week 24 and completed Week 24 visit and
procedures in Part 3/Cohort 3 of Study M14-431.

Exclusion Criteria

For Sub-studies 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 Study M14-431 or Substudy 1 or 2 of
Study M14-430 that in the investigator's judgment makes the subject 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 subject an unsuitable candidate for the study. Subjects with ongoing
infections undergoing treatment may be enrolled BUT NOT dosed until the
infection treatment has been completed and the infection is cured, based on the
investigator's assessment.
- Participants with high grade colonic dysplasia or malignancy diagnosed at the
endoscopy performed at the final visit of Study M14-431, M14-433, or Substudy 1
or 2 of Study M14-430 (Week 52).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Sub-study 1:<br /><br>Proportion of subjects with clinical remission per PRO at Week 52, and<br /><br>Proportion of subjects with endoscopic response at Week 52<br /><br><br /><br>Sub-study2:<br /><br>Incidence of AEs over time</p><br>