A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Ulcerative Colitis

Ulcerative Colitis

Primary Efficacy Endpoint • Mean change from Baseline in mMS at Week 12

1. Secondary Efficacy Endpoints • Proportion of subjects achieving clinical remission (defined as a mMS ≤ 2, with a stool frequency subscore (SFS) ≤ 1, RBS = 0, and endoscopic subscore ≤ 1 without friability) at Week 12, 2. Secondary Efficacy Endpoints •Proportion of subjects showing endoscopic improvement (defined as an endoscopy subscore ≤ 1 without friability) at Week 12, 3. Secondary Efficacy Endpoints •Proportion of subjects achieving a clinical response (defined as a decrease from Baseline in mMS ≥ 2 points and ≥ 30% with a decrease from Baseline in RBS ≥ 1 point or an absolute RBS ≤ 1) at Week 12, 4. Exploratory Efficacy Endpoints • Proportion of subjects achieving endoscopic remission (defined as an endoscopy subscore = 0) at Weeks 12, 24 and 50, 5. Exploratory Efficacy Endpoints • Proportion of subjects achieving histologic-endoscopic mucosal improvement (defined as an endoscopic subscore of 0 and a Geboes score ≤2) at Weeks 12, 24 and 50, 8. Exploratory Efficacy Endpoints • Mean change from Baseline in the following assessments at each time point indicated in the SoAs (Table 1 and Table 2): o mMS o pmMS o IBDQ o Individual mMS subscores (RBS, SFS, and endoscopy subscore) o Geboes score, 9. Safety Endpoints • Incidence, type, and severity of AEs, SAEs, and AEs leading to treatment discontinuation and study withdrawal, 10. Safety Endpoints • Change from Baseline in vital signs and clinical laboratory parameters, 11. Exploratory PK Endpoints • Mean observed predose (trough) rosnilimab concentration (Ctrough) at each time point indicated in the SoAs (Table 1 and Table 2), 12. Exploratory PD Endpoints • Mean change from Baseline in exploratory biomarkers at each time point indicated in the SoAs (Table 1 and Table 2), 13. Exploratory Immunogenicity Endpoints • Number and percentage of subjects at each time point indicated in the SoAs (Table 1 and Table 2) with confirmed positive ADA status and corresponding titer, 6. Exploratory Efficacy Endpoints • Proportion of subjects achieving clinical remission (defined as a mMS ≤ 2, with a stool frequency subscore (SFS) ≤ 1, RBS = 0, and endoscopic subscore ≤ 1 without friability) at Weeks 24 and 50, 7. Exploratory Efficacy Endpoints • Proportion of subjects showing endoscopic improvement (defined as an endoscopy subscore ≤ 1 without friability) at Weeks 24 and 50

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