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

• Status: Not yet recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LG Chem

Criteria

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)