Safety and Efficacy Study of TLL018 in the Treatment of Ulcerative Colitis

• Status: Not yet recruiting
• Trial end date: 2023-12-30
• Target enrollment: 0
• Participant gender: All

Summary

A study to investigate the safety and efficacy of TLL018 compared with placebo in subjects with moderate to severe ulcerative colitis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hangzhou Highlightll Pharmaceutical Co., Ltd
• Collaborator: TLL Pharmaceutical, LLC

Criteria

Inclusion Criteria:

• Male and female subjects ≥ 18 and ≤ 75 years of age at baseline.

• Capable of giving informed consent and complying with study procedures.

• Normal renal function or mild renal impairment as determined by the Investigator following review of clinical laboratory test results.

• Laboratory and medical history parameters within the protocol-defined ranges.

• Diagnosis of UC for 90 days or greater prior to baseline, confirmed by colonoscopy during the screening period, with exclusion of current infection, colonic dysplasia, and/or malignancy. Appropriate documentation of biopsy results consistent with the diagnosis of UC, in the assessment of the Investigator, must be available.

• Active UC with a full Mayo score of 6 to 12 points and endoscopic subscore of 2 or higher confirmed by central reader.

• Subject must have received COVID-19 vaccine >2 months before first dose of study drug.

Exclusion Criteria:

• Pregnant or nursing women.

• Clinically significant history of cardiovascular, hematologic, renal, hepatic, bronchopulmonary, immunologic, lipid metabolism disorders, or drug hypersensitivity as determined by the Investigator.

• Current and/or recent history of a clinically significant infection.

• Any history of malignancies, except for non-melanoma skin cancers (unless it is metastatic).

• Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody.

• Any condition or finding that in the Investigator's opinion would put the subjects or study conduct at risk if the subjects were to participate in the study.

• Current diagnosis of Crohn's disease (CD) or diagnosis of indeterminate colitis (IC).

• Current diagnosis of fulminant colitis and/or toxic megacolon, or active Clostridium difficile colitis.

• Subject with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy.

• Subject with previous exposure to JAK inhibitor (eg, tofacitinib, baricitinib, filgotinib, upadacitinib).