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Protocol PTG-100-02
Title A Phase 2b Randomized, Double-Blind, PLACEBO-Controlled, Parallel Adaptive 2-Stage Study Evaluating the Safety and Efficacy of Oral PTG-100 Induction in Subjects with Moderate to Severe Active Ulcerative Colitis
Phase 2B
Area Large Intestine
Indication Moderate to Severe Active Ulcerative Colitis
Treatment PTG-100 (also known as PN-10884A) is a peptide dimer comprised of natural and unnatural amino acids and a homologated amide bond. PTG-100 binds specifically to 􊨹 on lymphocytes that may inhibit leukocyte trafficking in the gut, potentially reducing large bowel inflammation and reducing the signs and symptoms of UC
Requirement Subject population includes men or women 18 to 70 years of age diagnosed with moderate to severely active UC of at least 2 months duration. Subject must have demonstrated over the previous 5 year period an inadequate response to immunomodulators, TNF- antagonists, and/or corticosteroids. Study lasts up to 12 weeks with subjects randomized in a 1:1:1:1 fashion
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