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Clinical Trials List

Protocol NumberM14-430

NCT Number(ClinicalTrials.gov Identfier)NCT03345823

2018-04-01 - 2028-12-31

Phase III

Recruiting3

Terminated1

ICD-10K50.90

Crohn's disease, unspecified, without complications

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

Trial Applicant

AbbVie
Sponsor

AbbVie
Trial scale

Multi-Regional Multi-Center
Update

2023/03/10

Investigators and Locations

Principal Investigator Jen-Wei Chou Digestive System Department

China Medical University Hospital

Co-Principal Investigator

Chun-Lung Feng Digestive System Department

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator CHUNG-HSIN CHANG Digestive System Department

Taichung Veterans General Hospital

Co-Principal Investigator

陳家昌 Digestive System Department
FAN -FENG CHIANG Division of General Internal Medicine
趙德馨 Division of Colorectal Surgery

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jen-Wei Chou 未分科

China Medical University Hospital-Taipei

Co-Principal Investigator

Audit

None

Principal Investigator SHU-CHEN WEI Digestive System Department

National Taiwan University Hospital

Co-Principal Investigator

YEN-HSUAN NI Division of Pediatrics
謝銘鈞 Division of Hematology & Oncology
翁昭旼 Division of General Internal Medicine

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Principal Investigator Chia-Jung Kuo Digestive System Department

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

Puo-Hsien Le Digestive System Department
Ming-Yao Su Digestive System Department
Cheng-Tang Chiu Digestive System Department
林偉彬 Digestive System Department

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Condition/Disease

Crohn's Disease

Objectives

Objectives: Study M14-430 comprises two substudies. Substudy 1 (randomized, double-blind, placebo-controlled maintenance): To evaluate the efficacy and safety of two doses of upadacitinib versus placebo as maintenance therapy in subjects with moderately to severely active Crohn's disease (CD) who responded to upadacitinib induction treatment in Studies M14-431 or M14-433. Substudy 2 (long-term extension [LTE]): To evaluate safety and efficacy of long-term administration of upadacitinib in subjects with moderately to severely active CD who participated in the Phase 3 upadacitinib induction and maintenance studies.

Test Drug

Upadacitinib (ABT-494)

Active Ingredient

Upadacitinib (ABT-494)

Dosage Form

Tablet

Dosage

30mg/15mg

Endpoints

Efficacy:
Substudy 1, Cohort 1 (Upadacitinib vs Placebo)
Co-Primary Endpoints:
 Proportion of subjects with clinical remission at Week 52, AND
 Proportion of subjects with endoscopic response at Week 52

Substudy 2
Primary Endpoint: Incidence of AEs over time

Inclution Criteria

Main Inclusion:
Substudy 1
1. Subject achieved clinical response in Study M14-431 or Study M14-433.
2. 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.
Note: Subjects completing Part 3/Cohort 3 of Study M14-431, who received open-label Extended
Treatment, should enroll in Substudy 2.
Substudy 2
3. Subject completed Week 52 of the maintenance period of Study M14-430 (Substudy 1).
Completion includes the Week 52 endoscopy of Substudy 1.
4. 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

Main Exclusion:
Substudy 1 and 2
1. Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
2. Subject who has a known hypersensitivity to upadacitinib or its excipients, or had an AE during
Study M14-431, M14-433, or Substudy 1 of Study M14-430 that in the investigator's judgment
makes the subject unsuitable for this study.
3. Subject 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.
4. Subjects 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 of Study M14-430 (Week 52).

The Estimated Number of Participants

Taiwan

14 participants
Global

747 participants