A Randomized, Multi-center, Participant and Investigator-blinded, Placebo-controlled, Parallel-group Study to Assess the Efficacy Safety and Tolerability of LYS006 in Patients With Mild to Moderate Ulcerative Colitis

Purpose of this study?

The purpose of the study is to assess preliminary efficacy, safety, and tolerability of LYS006 in patients with mild to moderate ulcerative colitis and to determine if LYS006 has an adequate clinical profile for further development in this indication.

Key Inclusion Criteria:

• Male or female patients 18-75 years of age with an established diagnosis of ulcerative colitis at least 3 months prior to screening are eligible for the study.
• 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 a physician's global assessment of 1 or 2.
• Patients must have responded inadequately to conventional therapy with oral 5-ASA prior to screening.

Key Exclusion Criteria:

• Has previous diagnosis with Crohn's disease, indeterminate colitis, microscopic colitis or acute diverticulitis based on medical history.
• History of toxic megacolon, abdominal abscess, symptomatic colonic stricture, or stoma; history or is at risk of colectomy.
• Treatment with biologics within 3 months or 5 half-lives (whichever is longer) prior to screening endoscopy, non-biologics advanced therapies within 4 weeks prior to screening endoscopy, systemic immunosuppressant or immunomodulator within 6 week, topical treatment with 5-ASA or steroids within 2 weeks prior to screening endoscopy

Primary outcome measures:

Clinical remission rate at the end of Week 8 [ Time Frame: Week 8 ] proportion of the patients who achieve clinical remission after 8-week treatment. Clinical remission is defined as a full Mayo score of 2 points or lower, with no individual subscore exceeding one point.

Secondary outcome measures:

Number and severity of adverse events [ Time Frame: Week 8 ]

To assess safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis compared to placebo

Study Locations in Europe:

Bulgaria, Czech Republic, Germany, Hungary, Norway, Poland, Russian Federation, Slovakia, United Kingdom.

Estimated Study Completion Date: August 18, 2023

Further information on clinicaltrials.gov with trial number NCT04074590