Ulcerative ColitisPhase 2NCT05121402
Safety and Efficacy Study of TLL018 in the Treatment of Ulcerative Colitis
A Phase 2 study testing TLL018 in people with Ulcerative Colitis, run by TLL Pharmaceutical, LLC at 1 site in United States.
Trial summary
A study to investigate the safety and efficacy of TLL018 compared with placebo in subjects with moderate to severe ulcerative colitis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- TLL018
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Dec 2022to 30 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Gastroenterology Research of San Antonio (GERSA)
San Antonio, Texas, 78229
About this study
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
A study to investigate the safety and efficacy of TLL018 compared with placebo in subjects with moderate to severe ulcerative colitis.
Read the 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
- Being tested
- TLL018, Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLL018Drug
a TYK2/JAK1 inhibitor
PlaceboOther
a TLL018 Placebo
| Study group | Role | What they receive |
|---|---|---|
| Low dose TLL018,BID | Experimental | Drug: TLL018 all subjects will receive TLL018 for 8 weeks Receives: Drug: TLL018 |
| Middle dose TLL018,BID | Experimental | Drug: TLL018 all subjects will receive TLL018 for 8 weeks Receives: Drug: TLL018 |
| High dose TLL018,BID | Experimental | Drug: TLL018 all subjects will receive TLL018 for 8 weeks Receives: Drug: TLL018 |
| Placebo | Placebo comparator | Placebo twice daily for 8 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects who achieved clinical remission per adapted Mayo score at Week 8
Measured: 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.
Measured: Up to 8 weeks
Incidence of Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 8 weeks
Secondary outcomes (11)
Percentage of subjects with endoscopic improvement at Week 8
Measured: Week 8
Percentage of subjects with endoscopic remission at Week 8
Measured: Week 8
Percentage of subjects achieving clinical response per adapted Mayo score at Week 8
Measured: Week 8
Percentage of subjects achieving clinical response per partial adapted Mayo score at Week 2
Measured: Week 2
Percentage of subjects who achieved histologic-endoscopic mucosal improvement (as defined by endoscopic subscore and Geboes score) at Week 8
Measured: Week 8
Percentage of subjects with mucosal healing (as defined by the endoscopic and histologic variables) at Week 8
Measured: Week 8
Percentage of subjects who achieved histologic improvement (as defined by Geboes score) at Week 8
Measured: Week 8
Percentage of subjects who reported no bowel urgency (as monitored electronically via a handheld device) at Week 8
Measured: Week 8
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Score
The IBDQ is used to measure disease specific quality of life on a 32 Likert-scaled items questionnaire. The IBDQ scale contains 4 component subscales: bowel symptoms, systemic symptoms, emotional function and social function with scores ranging from 10 to 70, 5 to 35, 12 to 84 and 5 to 35 respectively and the total score ranges from 32 to 224. Higher scores indicate better health related quality of life.
Measured: Baseline to Week 8
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Questionnaire Score
The FACIT system is a collection of quality of life (QOL) questionnaires targeted to the management of cancer and other chronic illnesses.
Measured: Baseline to Week 8
Time to improvement as measured by rectal bleeding via handheld device
Measured: Baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start30 Dec 2022 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Why it stopped: Decisions made by senior management of the company
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- TLL Pharmaceutical, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121402
- Sponsor's protocol ID
- TLL018-202
- Status last verified
- May 2022
- First submitted
- 5 Nov 2021
- Last updated
- 13 May 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05121402
- Acronym / sponsor ID
- TLL018-202
- Conditions
- Ulcerative Colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Decisions made by senior management of the company
- Enrolment
- 0 participants (actual)
- Lead sponsor
- TLL Pharmaceutical, LLCIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2022 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dose TLL018,BID | Experimental | Drug: TLL018Drug: TLL018 all subjects will receive TLL018 for 8 weeks |
| Middle dose TLL018,BID | Experimental | Drug: TLL018Drug: TLL018 all subjects will receive TLL018 for 8 weeks |
| High dose TLL018,BID | Experimental | Drug: TLL018Drug: TLL018 all subjects will receive TLL018 for 8 weeks |
| Placebo | Placebo comparator | Other: PlaceboPlacebo twice daily for 8 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TLL018a TYK2/JAK1 inhibitor | Drug | High dose TLL018,BID, Low dose TLL018,BID, Middle dose TLL018,BID |
| Placeboa TLL018 Placebo | Other | Placebo |
Primary outcome
Percentage of subjects who achieved clinical remission per adapted Mayo score at Week 8
Time frame: Baseline to Week 8
Number of treatment-emergent adverse events (TEAEs)
Time frame: Up to 8 weeks
TEAE defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
Incidence of Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)
Time frame: Up to 8 weeks
Number of Participants With Clinically Significant Changes in clinical laboratory data
Time frame: Up to 8 weeks
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.
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time frame: Up to 8 weeks
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.
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings
Time frame: Up to 8 weeks
Clinically significant ECG criteria included QT interval corrected using the Fridericia's formula (QTCF) value 450 msec and 30<=change<60.
11 secondary outcomes
Percentage of subjects with endoscopic improvement at Week 8
Time frame: Week 8
Percentage of subjects with endoscopic remission at Week 8
Time frame: 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 who achieved histologic-endoscopic mucosal improvement (as defined by endoscopic subscore and Geboes score) at Week 8
Time frame: Week 8
Percentage of subjects with mucosal healing (as defined by the endoscopic and histologic variables) at Week 8
Time frame: 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
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Score
Time frame: Baseline to Week 8
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Questionnaire Score
Time frame: Baseline to Week 8
Time to improvement as measured by rectal bleeding via handheld device
Time frame: Baseline to Week 8
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TLL018 in people with Ulcerative Colitis, run by TLL Pharmaceutical, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects who achieved clinical remission per adapted Mayo score at Week 8 (time frame: Baseline to Week 8). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2022.