Primary Investigator: Dr. Marian Pfefferkorn, Dr. Gitit Tomer, Dr. Chetan Mandelia, Dr. Michael Kurtz

Purpose: The investigational product, Budesonide Extended-Release tablet, is a glucocorticosteroid that is administered orally. UCERIS® (budesonide) extended release 9mg tablets was approved for adults in 2013 for the induction of remission in adult patients with active, mild-to-moderate UC, and may provide a useful therapeutic option for pediatric patients with UC.
It's an advantageous therapy because it has a hard enteric capsule that inhibits systemic absorption as it travels through the patient's body to the site of disease activity, where it will be 90% absorbed and delivered along the inflamed areas of the colon, thus making it possible to be used as a long-term therapy. Typical steroid therapies risk systemic exposure in the body and are not a long-term solution for children because they disrupt hormones, growth, etc. This medicine is also an alternative to costly biologic therapies. Various formulations of budesonide are approved in the US for therapeutic areas including allergic rhinitis, asthma, and inflammatory bowel disease (IBD; including both Crohn's disease [CD] and Ulcerative colitis (UC).

Aims & Hypothesis: This study aims to put inflammation into remission without the cost of biologics or risk of other systemic steroids. The primary objective of this study is to evaluate the efficacy and safety of a low and a high dose of budesonide extended-release tablets in pediatric subjects with active, mild to moderate UC. The secondary objective is to evaluate the pharmacokinetics of budesonide after oral administration of budesonide extended-release tablets in pediatric subjects with active, mild to moderate UC. The primary efficacy endpoint is the proportion of subjects who achieve clinical remission at Day 56, defined as a total Mayo score of ≤ 1 with subscores of 0 for both rectal bleeding and stool frequency, and a subscore of ≤ 1 for endoscopy.

Study Period: May 2024

Contact: [email protected] 

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