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

NCT ID: NCT05121402

Last Updated: 2022-05-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-30
• Study Completion Date: 2023-12-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Low dose TLL018,BID

Drug: TLL018 all subjects will receive TLL018 for 8 weeks

Group Type: EXPERIMENTAL

TLL018

Intervention Type: DRUG

a TYK2/JAK1 inhibitor

Middle dose TLL018,BID

Drug: TLL018 all subjects will receive TLL018 for 8 weeks

Group Type: EXPERIMENTAL

TLL018

Intervention Type: DRUG

a TYK2/JAK1 inhibitor

High dose TLL018,BID

Drug: TLL018 all subjects will receive TLL018 for 8 weeks

Group Type: EXPERIMENTAL

TLL018

Intervention Type: DRUG

a TYK2/JAK1 inhibitor

Placebo

Placebo twice daily for 8 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

a TLL018 Placebo

Interventions

TLL018

a TYK2/JAK1 inhibitor

Intervention Type: DRUG

Placebo

a TLL018 Placebo

Intervention Type: OTHER

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TLL Pharmaceutical, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gastroenterology Research of San Antonio (GERSA)

San Antonio, Texas, United States

Countries

United States

Other Identifiers

TLL018-202

Identifier Type: -

Identifier Source: org_study_id