A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Phase 2 Induction Study with Long-Term Extension to Evaluate the Clinical Activity and Safety of Oral NX-13 in Participants with Moderate to Severe Ulcerative Colitis

Ulcerative Colitis

Change from baseline in Modified Mayo Score (MMS) at Week 12

Safety and tolerability - Proportion of participants with TEAEs in induction period - Proportion of participants with SAEs in induction period - Change from baseline in clinical laboratory results, vital signs, and ECGs over time in induction period, Clinical remission - Proportion of participants with MMS ≤2 at Week 12, Clinical response - Proportion of participants with ≥2 points and ≥30% decrease from baseline in MMS with ≥1 point decrease in rectal bleeding subscore RBS or RBS ≤1 at Week 12, Endoscopic response - Proportion of participants with endoscopic subscore ES ≤1 at Week 12, Endoscopic remission - Proportion of participants with endoscopic subscore ES = 0 at Week 12, Endoscopic-histologic mucosal improvement - Proportion of participants with ES ≤1 and Geboes score <2.0 at Week 12, Symptomatic remission - Proportion of participants with RBS = 0 and (i) stool frequency subscore SFS = 0 or (ii) SFS = 1 with baseline SFS ≥2, at Week 12

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Belgium, Italy, Poland