Ensayos clínicos

Inclusion Criteria:

• Must have completed Study M13-740 through week 52.
• If female, subject must be either postmenopausal, OR permanently surgically sterile OR for women of childbearing potential practicing at least one protocolspecified method of birth control that is effective from Study Day 1 through at least 30 days after the last dose of study drug.
• Subject must be able and willing to give written informed consent and to comply with the requirements of this study protocol.
  • Subject is judged to be in otherwise good health as determined by the Principal Investigator based upon clinical evaluations performed during the preceding Study M13-740.

Exclusion Criteria:

• For any reason subject is considered by the Investigator to be an unsuitable candidate.
• Female subject with a positive pregnancy test at baseline or who is considering becoming pregnant during the study.
• Known hypersensitivity to upadacitinib or its excipients.
• 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.
• Current or history of malignancy other than a successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma and/or localized carcinoma in situ of the cervix. If the Week 12/Week 16 or Week 52 (Study M13-740) colonoscopy shows evidence of dysplasia or a malignancy, subject must not be enrolled in the study.
• 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 Baseline Visit meeting the following criteria:
  • Serum AST or ALT > 3.0 × upper limit of normal (ULN) with a total bilirubin > 2 × ULN or international normalized ratio (INR) > 1.5 Estimated glomerular filtration rate by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula < 40 mL/min/1.73 m2;
  • Total WBC < 2,000/μL;
  • Absolute neutrophil count (ANC) < 1,000/μL;
  • Platelet count < 50,000/μL;
  • Absolute lymphocytes count < 500/μL;
  • Hemoglobin < 8 gm/dL.
• Subject is not in compliance with prior and concomitant medication requirements and procedures throughout Study M13-740.
• Anticipated requirement or receipt of any live vaccine during study participation including up to 30 days after the last dose of study drug.
• Enrollment in another interventional clinical study while participating in this study: