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Upadacitinib is a novel selective Janus kinase (JAK) 1 inhibitor. JAK1 inhibition blocks the signaling of many important pro-inflammatory cytokines, including interleukin (IL)-2, IL-6, IL-7, and IL-15, which are known contributors to inflammatory disorders. This is a Phase 2b/3, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy, safety, and pharmacokinetics of upadacitinib as induction and maintenance therapy in adult subjects with moderately to severely active UC. The study comprises 3 substudies: a Phase 2b dose-ranging induction substudy (Substudy 1), a Phase 3 dose-confirming induction substudy (Substudy 2), and a Phase 3 maintenance substudy (Substudy 3). The study is designed to enroll approximately 844 subjects in Substudy 1 and Substudy 2 to meet scientific and regulatory objectives without enrolling an undue number of subjects in alignment with ethical considerations. Therefore, if the target number of subjects has been enrolled, there is a possibility that additional subjects in screening will not be enrolled. The study duration could be up to 77 weeks (excluding a possible washout period), including a Screening Period of up to 5 weeks, an 8-week double-blind Induction Period, an 8-week, open-label, Extended Treatment Period (for eligible subjects), a 52-week Maintenance Period, and a 30-day Follow-up Period. For subjects who meet criteria for loss of response during the Maintenance Period (Substudy 3), the Week 52/PD Visit should be conducted.

For more information on this study, you may go to the ClinicalTrials.gov website.  If you have further questions or are interested in participating, please Contact Us.

Meet the Doctors

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Christina L. Errichiello

PA-C
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Michael J. DiGiovanna

D.O, CPI.
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Dr. Omer K. Masood, M.D.

Gastroenterologist