PN-943 in Adults With Moderate to Severe Active Ulcerative Colitis (UC)

The study consists of a 12-week double-blind, placebo-controlled treatment period. Participants will be randomized in a 1:1:1 ratio to PN-943 450 mg BID, PN-943 150 mg BID, or matching placebo BID.

Participants who successfully complete the double-blind period may be eligible for an extended treatment period of 40 weeks duration.

Key Inclusion Criteria:

• Male and female subjects age 18 (or the minimum country specific age of consent if >18) to 75 years.
• Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
• Diagnosis of UC supported by appropriate documentation of biopsy results consistent with UC.
• Moderate to severe active UC.
• Demonstrated inadequate response, loss of response, or intolerance of at least 1 of oral aminosalicylates (5-ASAs), corticosteroids, immunomodulators, or a biologic (excluding vedolizumab).

Key Exclusion Criteria:

• Subject with a current diagnosis of Crohn's disease (CD), indeterminate colitis (IC), microscopic colitis, ischemic colitis, radiation colitis.
• History of colonic dysplasia other than completely removed low-grade dysplastic lesion.
• History of active bacterial, viral, fungal or mycobacterial infection requiring hospitalization or IV antibiotic/anti-infective treatment within 4 weeks of screening or oral antibiotics/anti-infectives within 2 weeks of screening.
• Prior treatment with vedolizumab, natalizumab, or any agent targeting the α4β7 or β1 integrin or planned during the study.
• Positive stool test for C. difficile.
• Chronic recurrent or serious infection.
• Known primary or secondary immunodeficiency.
• Pregnant or lactating female or considering becoming pregnant during the study or within 30 days after the last dose of study medication.
• History of any major neurological disorders.