Clinical Trials List
2016-10-10 - 2022-08-31
Phase III
Recruiting3
Terminated3
ICD-10K51.90
Ulcerative colitis, unspecified, without complications
ICD-10K51
Ulcerative colitis
ICD-9556.9
Ulcerative colitis, unspecified
A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects With Ulcerative Colitis
-
Trial Applicant
AbbVie
-
Sponsor
AbbVie
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Chun-Lung Feng Digestive System Department
- Tsung-Yu Tsai Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 陳薏如 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Chien-Yu Lu Division of General Internal Medicine
- Huang-Ming Hu Division of General Internal Medicine
- Yu-Chung Su Division of General Internal Medicine
- I-CHEN WU Division of General Internal Medicine
- Chao-Hung Kuo Division of General Internal Medicine
- Wen-Hung Hsu Division of General Internal Medicine
- Fang-Jung Yu Yu Division of General Internal Medicine
- HSIANG YAO SHIH Division of General Internal Medicine
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
- 楊純豪 Division of Colorectal Surgery
- 姜正愷 Division of Colorectal Surgery
- Jen-Jyn Lin 未分科
- 張世慶 Division of Colorectal Surgery
- 林禎國 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
- 謝銘鈞 Digestive System Department
- SHU-CHEN WEI Digestive System Department
- 翁昭旼 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
None
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Assessing Treatment-Emergent Adverse Events [ Time Frame: Up to 288 Weeks ]
Treatment-emergent adverse events are defined as events that begin or worsen either on or after the first dose of the study drug and within 30 days after the last dose of the study drug in the analysis period.
Inclution Criteria
Note: Participants aged 16 or 17 may enroll in M14-234 or M14-675 where locally permissible
• Participant has not achieved clinical response at the end of the induction period (Week 8) in Study M14-234 Substudy 1, has had loss of response during the maintenance period of Study M14-234 Substudy 3, or has successfully completed Study M14-234 Substudy 3. During the COVID-19 pandemic, for participants with missing endoscopy at Week 8, Week 16 or Week 52 due to the COVID-19 pandemic in Studies M14-234 Substudy 2, M14-234 Substudy 3 and M14-675, participants may be enrolled if certain criteria are met.
• If female, participant must meet the criteria for Contraception Recommendations.
• Women of childbearing potential must have a negative urine pregnancy test at Week 0 visit.
• Participant is judged to be in otherwise good health as determined by the principal investigator based upon clinical evaluations performed during the preceding study (Study M14-234).
• Must be able and willing to give written informed consent and to comply with the requirements of this study protocol.
Exclusion Criteria
• For any reason participant is considered by the investigator to be an unsuitable candidate.
• Female participant with a positive pregnancy test at the final visit of Study M14-234 or who is considering becoming pregnant during the study or within 30 days after the last dose of study drug.
• Participant with an active or recurrent infection that based on the investigator's clinical assessment makes the participant an unsuitable candidate for the study. Participants with ongoing infections undergoing treatment may be enrolled BUT NOT dosed until the infection has been successfully treated.
• Current evidence of active tuberculosis (TB); current evidence of latent tuberculosis and for any reason the participant cannot take full course of TB prophylaxis treatment as required per protocol.
• Participant with a poorly controlled medical condition, such as uncontrolled diabetes, unstable ischemic heart disease, moderate or severe congestive heart failure (New York Heart Association class III or IV), recent cerebrovascular accidents and any other condition which, in the opinion of the investigator or sponsor, would put the subject at risk by participation in this study.
• Participants have malignancy, high-grade dysplasia, un-removed low-grade dysplasia of the gastrointestinal tract diagnosed at the endoscopy performed at the final visit of Study M14-234.
• History of any malignancy except for successfully treated nonmelanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix from evaluations performed in Study M14-234.
The Estimated Number of Participants
-
Taiwan
24 participants
-
Global
950 participants
