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

NCT05121402 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: TLL018-202
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (6)

• Percentage of subjects who achieved clinical remission per adapted Mayo score at Week 8

  Baseline to Week 8

• Number of treatment-emergent adverse events (TEAEs)

  TEAE defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.

  Up to 8 weeks

• Incidence of Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)

  Up to 8 weeks

• Number of Participants With Clinically Significant Changes in clinical laboratory data

  Laboratory investigation included hematology, biochemistry, urinalysis and coagulation. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in laboratory parameters were reported.

  Up to 8 weeks

• Number of Participants With Clinically Significant Change From Baseline in Vital Signs

  Vital signs included body temperature, systolic and diastolic blood pressure, pulse rate, respiratory rate, weight and height. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in vital signs were reported.

  Up to 8 weeks

• Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings

  Clinically significant ECG criteria included QT interval corrected using the Fridericia's formula (QTCF) value 450 msec and 30\<=change\<60.

  Up to 8 weeks

Secondary Outcomes (11)

• Percentage of subjects with endoscopic improvement at Week 8

  Week 8

• Percentage of subjects with endoscopic remission at Week 8

  Week 8

• Percentage of subjects achieving clinical response per adapted Mayo score at Week 8

  Week 8

• Percentage of subjects achieving clinical response per partial adapted Mayo score at Week 2

  Week 2

• Percentage of subjects who achieved histologic-endoscopic mucosal improvement (as defined by endoscopic subscore and Geboes score) at Week 8

  Week 8

Study Arms (4)

Low dose TLL018,BID

EXPERIMENTAL

Drug: TLL018 all subjects will receive TLL018 for 8 weeks

Drug: TLL018

Middle dose TLL018,BID

EXPERIMENTAL

Drug: TLL018 all subjects will receive TLL018 for 8 weeks

Drug: TLL018

High dose TLL018,BID

EXPERIMENTAL

Drug: TLL018 all subjects will receive TLL018 for 8 weeks

Drug: TLL018

Placebo

PLACEBO COMPARATOR

Placebo twice daily for 8 weeks.

Other: Placebo

Interventions

TLL018 DRUG

a TYK2/JAK1 inhibitor

High dose TLL018,BID; Low dose TLL018,BID; Middle dose TLL018,BID

Placebo OTHER

a TLL018 Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• TLL Pharmaceutical, LLC: lead

Study Sites (1)

Gastroenterology Research of San Antonio (GERSA)

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: November 16, 2021
• Study Start: December 30, 2022
• Primary Completion: July 1, 2023
• Study Completion: December 30, 2023
• Last Updated: May 13, 2022

Record last verified: 2022-05

Locations

US (1)