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

Phase 2

Withdrawn

• Conditions: Ulcerative Colitis
• Interventions: Drug: LC51-0255; Drug: Placebo

• Registration Number: NCT04096573
• Lead Sponsor: LG Chem

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-18
• Study First Submitted QC: 2019-09-18
• Study First Posted: 2019-09-20
• Study Start: 2020-04
• Status Verified: 2021-11
• Primary Completion: 2021-11
• Last Update Submitted: 2021-11-07
• Last Update Posted: 2021-11-15
• Study Completion: 2022-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LC51-0255 high dose	LC51-0255	Oral, daily, high dose for induction period, high dose for OLE period
LC51-0255 low dose	LC51-0255	Oral, daily, low dose for induction period, high dose for OLE period
LC51-0255 middle dose	LC51-0255	Oral, daily, middle dose for induction period, high dose for OLE period
placebo	LC51-0255	Oral, daily, placebo for induction period, high dose for OLE period
placebo	Placebo	Oral, daily, placebo for induction period, high dose for OLE period

Primary Outcome Measures

Name	Time	Method
Clinical remission	Week 12	The proportion of subjects in clinical remission assessed by Mayo component sub-scores

Secondary Outcome Measures

Name	Time	Method
Clinical response	Week 12	The proportion of subjects in clinical response assessed by Mayo component sub-scores
Endoscopic improvement and remission	Week 12	The proportion of subjects in endoscopic improvement and remission assessed by Mayo endoscopic sub-score