Status:
WITHDRAWN
Efficacy and Safety of LC51-0255 in Subjects With Ulcerative Colitis
Lead Sponsor:
LG Chem
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- Aged 18 to 80 years
- Active UC confirmed by endoscopy
- Moderately to severely active UC defined as a 3-component Mayo Clinic score
Exclusion
- 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)
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04096573
Start Date
April 1 2020
End Date
August 1 2022
Last Update
November 15 2021
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