A phase 3 multicenter, long-term extension study to evaluate the long-term safety and efficacy of Upadacitinib (ABT-494) in subjects with ulcerative colitis (UC).

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

1. Subject has not responded at the end of the induction period (Week 8) in
study M14-234 (substudie 1), who has been an inadequate responder during the
maintenance period of study M14-234 (Substudy 3), or who has responded and
successfully completed study M14-234.

During the COVID-19 pandemic, for subjects with missing endoscopy due to the
COVID-19 pandemic in studies M14-234 SS2, SS3 and M14-675 those following
subjects may be enrolled if the below criteria is met:
* Subjects who achieved clinical response defined by Partial Adapted Mayo Score
at Week 8 of Studies M14-234 SS2 and M14-675
* Subjects who achieved clinical response defined by Partial Adapted Mayo Score
at Week 16 in the extended treatment period of Studies
M14-234 SS2 and M14-675
Note: If endoscopy is missing at Week 8 but can be performed at Week 16, Week
16 endoscopy should be performed. However, the status of
clinical response will be defined by Partial Adapted Mayo Score and clinical
responders may enter Study M14-533 Cohort 1.
* Subjects who have completed the 52-week treatment in Study M14-234 SS3 if the
PI considers it is safe to continue based on phone/video
call, subject's medical history and findings from the last endoscopy.

2. Women of childbearing potential (refer to section 5.2.4 of the protocol)
must have a negative urine pregnancy test at Week 0 visit.

3. If female, subject must meet the contraception criteria.

4. Subject is judged to be in otherwise good health as determined by the
principal investigator based upon clinical evaluations performed during the
preceding studies.

5. Must be able and willing to give written informed consent and to comply with
the requirements of this study protocol.

Exclusion Criteria

1. For any reason subject is considered by the investigator to be an unsuitable
candidate.

2. Female subject with a positive pregnancy test at Baseline (final visit of
the preceding studies) or who is considering becoming pregnant during the study
and within 30 days after the last dose of study drug.

3. Known hypersensitivity to upadacitinib or its excipients or had any adverse
event (AE) during the preceding studies, that in the investigator's judgment
makes the participant unsuitable for this study

4. Subject with an active or recurrent infection that based on the
investigator's clinical assessment makes the subject an unsuitable candidate
for the study. Subjects with ongoing infections undergoing treatment may be
enrolled BUT NOT dosed until the infection has been successfully treated.

5. Current evidence of active tuberculosis; Current evidence of latent
tuberculosis and for any reason the subject cannot take full course of TB
prophylaxis treatment

6. Subject 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of the study is to evaluate the long-term safety and<br /><br>tolerability of upadacitinib through the assessment of the incidence of<br /><br>treatment-emergent adverse events, changes in vital signs, physical examination<br /><br>results, and clinical laboratory data.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The clinical remission or response will be evaluated using the Mayo Scoring<br /><br>System for Assessment of Ulcerative Colitis Activity (Full Mayo score), Adapted<br /><br>Mayo score (Full Mayo score excluding Physician's Global Assessment), or<br /><br>Partial Mayo score (Full Mayo score excluding endoscopic subscore).</p><br>