A 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 1

• Conditions: Crohn's Disease (CD); Therapeutic area: Diseases [C] - Digestive System Diseases [C06]; MedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders

• Registration Number: EUCTR2017-001225-41-IT
• Lead Sponsor: ABBVIE DEUTSCHLAND GMBH & CO. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-17
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 738

Inclusion Criteria

For Substudy 1:
- Subject who receive double-blind treatment in Study M14- 431 or Study
M14-433 and achieve clinical response.
- Subject completes Week 12 or Week 24 study 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
coronavirus SARS-CoV-2 pandemic.
For Substudy 2:
- Subject completes Substudy 1 of Study M14-430. The week 52
endoscopy may be missing, if the endoscopy cannot be performed during
the coronavirus SARS-CoV-2 pandemic.
- Subject achieved clinical response at Week 24 and completed Week 24
visit and procedures in Part 3/Cohort 3 of Study M14-431.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 710
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 37

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 of Study M14-430 that in the investigator's judgment makes the subject unsuitable for this study.
- Participant 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 (Week 24) or Substudy 1 of Study M14-430 (Week 52).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified