Clinical Trials List
2018-11-01 - 2021-03-30
Phase III
Recruiting2
Terminated2
ICD-10K51.90
Ulcerative colitis, unspecified, without complications
ICD-10K51
Ulcerative colitis
ICD-9556.9
Ulcerative colitis, unspecified
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis
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Trial Applicant
AbbVie
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Sponsor
AbbVie Biopharmaceuticals GmbH Taiwan Branch
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Tsung-Yu Tsai Digestive System Department
- Chun-Lung Feng Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Hung-Hsin Lin Division of Colorectal Surgery
- 王煥昇 Division of Colorectal Surgery
- 張世慶 Division of Colorectal Surgery
- 姜正愷 Division of Colorectal Surgery
- 楊純豪 Division of Colorectal Surgery
The Actual Total Number of Participants Enrolled
1 Recruiting
Audit
None
Co-Principal Investigator
Audit
None
Chairman/Global PI
Co-Principal Investigator
Audit
CRO
Co-Principal Investigator
- YEN-HSUAN NI Division of Pediatrics
- 翁昭旼 Division of General Internal Medicine
- SHU-CHEN WEI Digestive System Department
- 謝銘鈞 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
None
Co-Principal Investigator
- Huang-Ming Hu Digestive System Department
- Wen-Hung Hsu Digestive System Department
- I-CHEN WU Digestive System Department
- Chien-Yu Lu Digestive System Department
- HSIANG YAO SHIH Digestive System Department
- Yu-Chung Su Digestive System Department
- Fang-Jung Yu Yu Digestive System Department
- Chao-Hung Kuo Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Inclution Criteria
2. Diagnosis of UC for 90 days or greater prior to Baseline, confirmed by colonoscopy during the Screening Period, with exclusion of current infection, colonic dysplasia and/or malignancy. Appropriate documentation of biopsy results consistent with the diagnosis of UC, in the assessment of the Investigator, must be available.
3. Active UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central reader).
4. Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following treatments including, oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologic therapies, in the opinion of the investigator
5. Female subjects of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Baseline Visit.
6. If female, subject must meet the criteria as stated in Contraception Recommendations.
Exclusion Criteria
1. Subject with current diagnosis of Crohn's disease (CD) or diagnosis of indeterminate colitis (IC).
2. Current diagnosis of fulminant colitis and/or toxic megacolon.
3. Subject with disease limited to the rectum (ulcerative proctitis) during the Screening endoscopy.
4. Received cyclosporine, tacrolimus, or mycophenolate mofetil within 30 days prior to Baseline.
5. Subject who received azathioprine or 6-MP within 10 days of Baseline.
6. Received intravenous corticosteroids within 14 days prior to Screening or during the Screening Period.
7. Subject with previous exposure to JAK inhibitor (e.g., tofacitinib, baricitinib, filgotinib, upadacitinib).
8. Screening laboratory and other analyses show any of the following abnormal results
The Estimated Number of Participants
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Taiwan
11 participants
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Global
462 participants
