A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Subjects With Ulcerative Colitis (UC)



Status:Enrolling by invitation
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:2/10/2019
Start Date:January 31, 2017
End Date:August 28, 2024

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A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects With Ulcerative Colitis

This study is designed to evaluate the long-term safety and efficacy of Upadacitinib in
participants with ulcerative colitis (UC) who have not responded at the end of the induction
period in Study M14-234 Substudy 1, who have had loss of response during the maintenance
period of Study M14-234 Substudy 3, or who have successfully completed Study M14-234 Substudy
3.


Inclusion Criteria:

- 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.

- 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 or untreated latent tuberculosis.

- Participant with a poorly controlled medical condition, such as uncontrolled diabetes,
unstable ischemic heart disease, moderate or severe congestive heart failure, 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.
We found this trial at
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1653 West Congress Parkway
Chicago, Illinois 60612
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Ann Arbor, Michigan 48197
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191 Biltmore Avenue
Asheville, North Carolina 28801
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Baltimore, Maryland 21201
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Bountiful, Utah 84010
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Caro, Michigan 48723
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418 Folly Road
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Charlotte, North Carolina 28203
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Chicago, Illinois 60611
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Clearwater, Florida 33762
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3205 Fire Road
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411 West Highland Boulevard
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