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

• Register: ClinicalTrials.gov
• Last refreshed on: 23 May 2022
• Main ID: NCT05121402
• Date of registration: 05/11/2021
• Prospective Registration: Yes
• Primary sponsor: TLL Pharmaceutical, LLC
• Public title: Safety and Efficacy Study of TLL018 in the Treatment of Ulcerative Colitis
• Scientific 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
• Date of first enrolment: December 30, 2022
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT05121402
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion 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).



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Other: Placebo

Drug: TLL018

Primary Outcome(s)

Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings [Time Frame: Up to 8 weeks]

Number of Participants With Clinically Significant Changes in clinical laboratory data [Time Frame: Up to 8 weeks]

Incidence of Adverse Events (AEs) and Adverse Events of Special Interest (AESIs) [Time Frame: Up to 8 weeks]

Number of Participants With Clinically Significant Change From Baseline in Vital Signs [Time Frame: Up to 8 weeks]

Number of treatment-emergent adverse events (TEAEs) [Time Frame: Up to 8 weeks]

Percentage of subjects who achieved clinical remission per adapted Mayo score at Week 8 [Time Frame: Baseline to Week 8]

Secondary Outcome(s)

Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Questionnaire Score [Time Frame: Baseline to Week 8]

Percentage of subjects achieving clinical response per adapted Mayo score at Week 8 [Time Frame: Week 8]

Percentage of subjects achieving clinical response per partial adapted Mayo score at Week 2 [Time Frame: Week 2]

Percentage of subjects with mucosal healing (as defined by the endoscopic and histologic variables) at Week 8 [Time Frame: Week 8]

Time to improvement as measured by rectal bleeding via handheld device [Time Frame: Baseline to Week 8]

Percentage of subjects with endoscopic remission at Week 8 [Time Frame: Week 8]

Percentage of subjects with endoscopic improvement at Week 8 [Time Frame: Week 8]

Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Score [Time Frame: Baseline to Week 8]

Percentage of subjects who achieved histologic improvement (as defined by Geboes score) at Week 8 [Time Frame: Week 8]

Percentage of subjects who reported no bowel urgency (as monitored electronically via a handheld device) at Week 8 [Time Frame: Week 8]

Percentage of subjects who achieved histologic-endoscopic mucosal improvement (as defined by endoscopic subscore and Geboes score) at Week 8 [Time Frame: Week 8]

Secondary ID(s)

TLL018-202

Source(s) of Monetary Support

Please refer to primary and secondary sponsors