Efficacy and Safety of LC51-0255 in Subjects With Ulcerative Colitis

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: LC51-0255
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 to 80 years Active UC confirmed by endoscopy Moderately to severely active UC defined as a 3-component Mayo Clinic score Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LC51-0255 low dose<br>Oral, daily, low dose for induction period, high dose for OLE period | Drug: LC51-0255<br>* LC51-0255<br>|
| Experimental: LC51-0255 middle dose<br>Oral, daily, middle dose for induction period, high dose for OLE period | Drug: LC51-0255<br>* LC51-0255<br>|
| Experimental: LC51-0255 high dose<br>Oral, daily, high dose for induction period, high dose for OLE period | Drug: LC51-0255<br>* LC51-0255<br>|
| Placebo Comparator: placebo<br>Oral, daily, placebo for induction period, high dose for OLE period | Drug: LC51-0255<br>* LC51-0255<br>Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical remission | The proportion of subjects in clinical remission assessed by Mayo component sub-scores | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response | The proportion of subjects in clinical response assessed by Mayo component sub-scores | Week 12 | 
| Endoscopic improvement and remission | The proportion of subjects in endoscopic improvement and remission assessed by Mayo endoscopic sub-score | Week 12 |