NCT05121402

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: TLL Pharmaceutical, LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	TLL018	a TYK2/JAK1 inhibitor
OTHER	Placebo	a TLL018 Placebo

Timeline

• Start date: 2022-12-30
• Primary completion: 2023-07-01
• Completion: 2023-12-30
• First posted: 2021-11-16
• Last updated: 2022-05-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study