chronic bowel inflammation ulcerative colitis
Conditions
Interventions
All subjects receive upadacitinib tablets (oral) once a day, until end of study
or discontinuation.
Sponsors
AbbVie B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is to evaluate the long-term safety and tolerability of upadacitinib through the assessment of the incidence of treatment-emergent adverse events, changes in vital signs, physical examination results, and clinical laboratory data. | — |
Secondary
| Measure | Time frame |
|---|---|
| The clinical remission or response will be evaluated using the Mayo Scoring System for Assessment of Ulcerative Colitis Activity (Full Mayo score), Adapted Mayo score (Full Mayo score excluding Physician's Global Assessment), or Partial Mayo score (Full Mayo score excluding endoscopic subscore). | — |
Countries
Netherlands
Outcome results
None listed