Clinical Trials

Inclusion Criteria:

For Substudy 1:

• Subject achieved clinical response in Study M14-431 or Study M14-433.
• Subject completed Week 12 (in subjects who achieve response at Week 12) or Week 24 (in subjects who achieve response at Week 24) visit and procedures in Study M14-431 or Study M14-433.
  • Note: Subjects completing Part 3/Cohort 3 of Study M14-431, who received open-label Extended Treatment, should enroll in Substudy 2.

For Substudy 2:

• Subject completed Week 52 of the maintenance period of Study M14-430 (Substudy 1).  Completion includes the Week 52 endoscopy of Substudy 1.
• Subject achieved clinical response at Week 24 and completed Week 24 visit and procedures in Part 3/Cohort 3 of Study M14-431.

Substudy 1 and 2:

• Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
• Subject who has a known hypersensitivity to upadacitinib or its excipients, or had an AE during Study M14-431, M14-433, or Substudy 1 of Study M14-430 that in the investigator's judgment makes the subject unsuitable for this study.
• Subject with any active or chronic recurring infections based on the investigator's assessment that makes the subject an unsuitable candidate for the study. Subjects with serious infections undergoing treatment may be enrolled BUT NOT dosed until the infection treatment has been completed, and the infection is resolved, based on the investigator's assessment.
• Subjects with high grade colonic dysplasia or malignancy diagnosed at the endoscopy performed at the final visit of Study M14-431, M14-433, or Substudy 1 of Study M14-430 (Week 52).

Exclusion Criteria:

Substudy 1 and 2

• Subject is  considered by the  investigator, for any reason, to be an unsuitable candidate for the study.
• Subject who has a known hypersensitivity to upadacitinib or its excipients, or had an AE during Studies M14-431, M14-433, or Substudy 1 of Study M14-430 that, in the investigator's judgment, makes the subject unsuitable for this study.
• Anticipated requirement or receipt of any live vaccine during study participation including up to 30 days after the last dose of study drug.
• Female subjects with a confirmed positive pregnancy test at the final visit in Studies M14-431, M14-433, or Substudy 1 of Study M14-430, or who is considering becoming pregnant during the study.
• Subject is not in compliance with prior and concomitant medication requirements throughout Studies M14-431, M14-433, or Substudy 1 of Study M14-430.
• Subject with any active or chronic recurring infections based on the investigator's assessment makes the subject an unsuitable candidate for the study. Subjects with serious infections undergoing treatment may be enrolled BUT NOT dosed until the infection treatment has been completed, and the infection is resolved, based on the investigator's assessment.
• Current evidence of active or untreated latent tuberculosis.
• Subjects with high grade colonic dysplasia or malignancy diagnosed at the endoscopy performed at the final visit of Studies M14-431, M14-433, or Substudy 1 of Study M14-430 (Week 52).
• Current or history of malignancy or lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly; except for successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma, and/or localized carcinoma in situ of the cervix.
• 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.
• Laboratory values from the visit immediately prior to the Week 0 Visit meeting the following criteria:
  • AST or ALT > 3 × upper limit of normal (ULN);
  • Estimated glomerular filtration rate (eGFR) by simplified 4-variable;
  • Modification of Diet in Renal Disease (MDRD) formula < 30 mL/min/1.73 m2;
  • Total WBC count < 2,000/μL;
  • Absolute neutrophil count (ANC) < 1,000/μL;
  • Platelet count < 50,000/μL;
  • Absolute lymphocyte count < 500/μL;
  • Hemoglobin < 8 g/dL.
• Enrollment in another interventional clinical study while participating in this study.