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

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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04096573

Enrollment

Registered

2019-09-20

Start date

2020-04-30

Completion date

2022-08-31

Last updated

2021-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

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

Interventions

DRUGLC51-0255

LC51-0255

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Clinical remission	Week 12	The proportion of subjects in clinical remission assessed by Mayo component sub-scores

Secondary

Measure	Time frame	Description
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

Other

Measure	Time frame	Description
Clinical response and remission	Week 52	The proportion of subjects in clinical response and remission assessed by Mayo component sub-scores
Endoscopic improvement and remission	Week 52	The proportion of subjects in endoscopic improvement and remission assessed by Mayo endoscopic sub-score

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026