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Efficacy and Safety of LC51-0255 in Subjects With Ulcerative Colitis
A Phase 2, Multi Center, Randomized, Placebo Controlled Parallel Group Study to Evaluate the Clinical Efficacy and Safety of LC51 0255 in Subjects With Moderately to Severely Active Ulcerative Colitis
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
This is a Phase 2, multi center, randomized, placebo controlled parallel group study to evaluate the clinical efficacy and safety of LC51 0255 in subjects with moderately to severely active ulcerative colitis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2020
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2019
CompletedFirst Posted
Study publicly available on registry
September 20, 2019
CompletedStudy Start
First participant enrolled
April 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedNovember 15, 2021
November 1, 2021
1.6 years
September 18, 2019
November 7, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical remission
The proportion of subjects in clinical remission assessed by Mayo component sub-scores
Week 12
Secondary Outcomes (2)
Clinical response
Week 12
Endoscopic improvement and remission
Week 12
Other Outcomes (2)
Clinical response and remission
Week 52
Endoscopic improvement and remission
Week 52
Study Arms (4)
LC51-0255 low dose
EXPERIMENTALOral, daily, low dose for induction period, high dose for OLE period
LC51-0255 middle dose
EXPERIMENTALOral, daily, middle dose for induction period, high dose for OLE period
LC51-0255 high dose
EXPERIMENTALOral, daily, high dose for induction period, high dose for OLE period
placebo
PLACEBO COMPARATOROral, daily, placebo for induction period, high dose for OLE period
Interventions
Eligibility Criteria
You may qualify if:
- Aged 18 to 80 years
- Active UC confirmed by endoscopy
- Moderately to severely active UC defined as a 3-component Mayo Clinic score
You may not qualify if:
- Severe extensive colitis
- Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
- Treatment with cyclosporine, tacrolimus, sirolimus, methotrexate, or mycophenolate mofetil within 16 weeks of screening
- Treatment with a biologic agent (ie, anti TNFs, anti integrins, and anti interleukin 23) within 8 weeks prior to screening endoscopy
- Any prior exposure to S1P receptor modulators, natalizumab, lymphocyte-depleting therapies (ie, alemtuzumab, anti CD4, cladribine, rituximab, ocrelizumab, cyclophosphamide, mitoxantrone, total body irradiation, bone marrow transplantation, alemtuzumab, daclizumab)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LG Chemlead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2019
First Posted
September 20, 2019
Study Start
April 1, 2020
Primary Completion
November 1, 2021
Study Completion
August 1, 2022
Last Updated
November 15, 2021
Record last verified: 2021-11