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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04096573
• Other study ID #: LG-SGCL002
• Status: Withdrawn
• Phase: Phase 2
• Start date: April 2020
• Est. completion date: August 2022

Study information

• Verified date: November 2021
• Source: LG Chem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2022
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• LC51-0255
LC51-0255
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
LG Chem

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical response and remission	The proportion of subjects in clinical response and remission assessed by Mayo component sub-scores	Week 52
Other	Endoscopic improvement and remission	The proportion of subjects in endoscopic improvement and remission assessed by Mayo endoscopic sub-score	Week 52
Primary	Clinical remission	The proportion of subjects in clinical remission assessed by Mayo component sub-scores	Week 12
Secondary	Clinical response	The proportion of subjects in clinical response assessed by Mayo component sub-scores	Week 12
Secondary	Endoscopic improvement and remission	The proportion of subjects in endoscopic improvement and remission assessed by Mayo endoscopic sub-score	Week 12