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 Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Primary Endpoint
- Clinical remission
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
LC51-0255 low dose
Oral, daily, low dose for induction period, high dose for OLE period
Intervention: LC51-0255 (Drug)
LC51-0255 middle dose
Oral, daily, middle dose for induction period, high dose for OLE period
Intervention: LC51-0255 (Drug)
LC51-0255 high dose
Oral, daily, high dose for induction period, high dose for OLE period
Intervention: LC51-0255 (Drug)
placebo
Oral, daily, placebo for induction period, high dose for OLE period
Intervention: LC51-0255 (Drug)
placebo
Oral, daily, placebo for induction period, high dose for OLE period
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Clinical remission
Time Frame: Week 12
The proportion of subjects in clinical remission assessed by Mayo component sub-scores
Secondary Outcomes
- Clinical response(Week 12)
- Endoscopic improvement and remission(Week 12)