Study of OSE-127 vs Placebo in Patients With Moderate to Severe Active Ulcerative Colitis

Inclusion criteria

• . Provision of signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrollment
• . Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
• . Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose
• . Male or female 18 to 75 years of age, inclusive
• . Diagnosis of moderate to severe active UC made at least 3 months before the screening visit. The diagnosis of UC must have been confirmed by endoscopy, with a minimal extent of 15 cm from anal margin and histology (Moderate to severe active UC is defined by a modified Mayo score between 4 and 9, inclusive. The modified Mayo score is defined by the addition of the rectal bleeding subscore, the stool frequency sub-score, and the endoscopic sub-score. Thus, to be included, a patient must have the following:
• . a rectal bleeding score ≥ 1,
• . a stool frequency score ≥ 1 (sub-score calculated before bowel preparation), and
• . an endoscopic sub-score ≥ 2

Exclusion criteria