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

Ulcerative Colitis Clinical Trial

Official title:
A Phase 2 Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of TLL018 for Induction Therapy in Subjects With Moderate to Severe Ulcerative Colitis

Clinical Trial Summary

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

Clinical Trial Description

This is a phase 2, multicenter, randomized, double-blind, parallel dose groups, placebo-controlled dose ranging study to evaluate the safety and efficacy of 3 doses of TLL018 as an induction therapy in subjects with moderate to severe UC. Eligible subjects will be randomized to receive one of the following treatments: TLL018 low dose, TLL018 middle dose, TLL018 high dose, or placebo. All subjects may remain on a stable dose of conventional therapy used prior to enrollment. Subjects will be assessed for safety, tolerability, and response to treatment. Samples for pharmacokinetics (PK) and pharmacodynamics (PD) biomarker analyses will be collected throughout the study according to the Schedule of Assessments (SoA) for potential correlation to clinical outcomes. Further participation may continue beyond the initial 8 weeks for another 5-week Extension Period of therapy. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05121402
Study type Interventional
Source Hangzhou Highlightll Pharmaceutical Co., Ltd
Contact
Status Withdrawn
Phase Phase 2
Start date December 30, 2022
Completion date December 30, 2023
View Details
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