VTX002 versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis

INTERVENTION: Intervention1: VTX002‐ 30mg: VTX002 30 mg, once daily, for the first 13 weeks of double‐blind treatment. Followed by 39 weeks long term extension phase. Intervention2: VTX002‐ 60mg: VTX002 60 mg, once daily, for the first 13 weeks of double‐blind treatment. Followed by 39 weeks long term extension phase. Open label acess is provide after long term extension phase for upto 3 years. Open label access provide up to 3 years for patients who lose response on VTX002 30mg and placebo. Control Intervention1: VTX002‐ Placebo: VTX002 Placebo, once daily, for the first 13 weeks of double‐blind treatment. Followed by 39 weeks long term extension phase. CONDITION: Health Condition 1: K519‐ Ulcerative colitis, unspecified PRIMARY OUTCOME: Clinical remission at 13 weeks [ Time Frame: Day 1 of Induction treatment period to week 13 ]Timepoint: The proportion of participants with clinical remission at Week 13 using modified Mayo ; score (MMS) SECONDARY OUTCOME: Assess the effect of VTX002 on health‐related quality of life (HRQoL) outcomes and ; biomarkersTimepoint: Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) score at ; Weeks 13 and 52 Assess the efficacy of VTX002 through the Long‐Term Extension (LTE) and Open‐Label ; Extension (OLE) Treatment Periods on endoscopic changes, symptomatic response and ; remission, histology, and mucosal healingTimepoint: Proportion of participants with clinical remission after 52 weeks of treatment ; Proportion of participants with symptomatic remission at Weeks 18, 26, 36, and 52 ; Proportion of participants with mucosal healing after 52 weeks of treatment ; Proportion of participants with clinical response after 52 weeks of treatment ; Proportion of participants with symptomatic response at Weeks 18, 26, 36, and 52 Assess the efficacy of VTX002 when administered for 13 weeks on endoscopic changes, ; symptomatic response and remission, histology, and mucosal healingTimepoint: Endoscopy will be performed at week 13 to complete the assessment Assess the safety of VTX002 after daily doses for 13 weeksTimepoint: The proportion of participants with symptomatic remission at Week 13 ; The proportion of participants with histologic remission at Week 13 ; The proportion of participants with mucosal healing at Week 13 INCLUSION CRITERIA: (1) Diagnosed with UC â?¥ 3 months prior to Screening. The diagnosis of UC must be confirmed by endoscopic and histologic evidence. (2) Active UC confirmed by endoscopy with â?¥ 10 cm rectal involvement. Moderately to severely active UC, defined as an MMS of 5 to 9, including an ES â?¥ 2 and an RB subscore â?¥ 1 (3) Surveillance colonoscopy within 12 months before baseline or at screening to rule out dysplasia, pancolitis, left‐sided colitis. Any adenomatous polyps must be removed prior to the first dose of study drug. (4) Demonstrated inadequate response to, loss of response to, or intolerance to at least 1 of the following therapies: Conventional therapy, Oral 5‐ASA compounds, Corticosteroids, Thiopurines, Biologic therapy/ JAK inhibitor therapy, TNFα antibodies, Anti‐interleukin (anti‐IL)12/23, Anti‐integrin antibodies, (5) Adequate hepatic function (6) Adequate renal function, with