Study of Efficacy, Safety, and Tolerability of LYS006, in Patients With Mild to Moderate Ulcerative Colitis

Key Inclusion Criteria:

Male and female subjects 18-65 years of age with an established diagnosis of ulcerative colitis at least 3 months prior to screening
Patients must have active disease with a full Mayo Score between 5 and 10 (inclusive) with an endoscopy score of 2 or 3, rectal bleeding and stool frequency scores 1 to 3, and physician's global assessment with a maximum of 1or 2.
Patients must have responded inadequately to conventional therapy with oral 5-ASA prior to screening.

Key Exclusion Criteria:

Has severe UC at screening, as defined by an average bloody stool frequency of ≥ 6 bloody stools per day and at least one of the following:
Oral temperature of >37.8°C
Hemoglobin of <10.5 g/dL
CRP > 30 mg/L
Erythrocyte sedimentation rate (ESR) > 33 mm/h
Has previous diagnosis with Crohn's disease, indeterminate colitis, microscopic colitis or acute diverticulitis based on medical history
Previous treatment with biologics (such as anti-TNFα agents) within 3 months or 5 half-lives (whichever is longer) prior to screening endoscopy, or anti-IL12/23 blocking agents within 6 months prior to screening endoscopy
Any systemic immunosuppressant or immunomodulator, such as cyclosporine, methotrexate, azathioprine within 4 weeks and cyclophosphamide within 3 months, prior to screening endoscopy
A dose of > 10 mg/d prednisone or equivalent in the last 4 weeks prior to screening endoscopy