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

November 7, 2021 updated by: LG Chem

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LC51-0255 low dose
Oral, daily, low dose for induction period, high dose for OLE period
Drug: LC51-0255
LC51-0255
Experimental: LC51-0255 middle dose
Oral, daily, middle dose for induction period, high dose for OLE period
Drug: LC51-0255
LC51-0255
Experimental: LC51-0255 high dose
Oral, daily, high dose for induction period, high dose for OLE period
Drug: LC51-0255
LC51-0255
Placebo Comparator: placebo
Oral, daily, placebo for induction period, high dose for OLE period
Drug: Placebo
Placebo
Drug: LC51-0255
LC51-0255

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical response
Time Frame: Week 12
The proportion of subjects in clinical response assessed by Mayo component sub-scores
Week 12
Endoscopic improvement and remission
Time Frame: Week 12
The proportion of subjects in endoscopic improvement and remission assessed by Mayo endoscopic sub-score
Week 12

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LG Chem

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2020

Primary Completion (Anticipated)

November 1, 2021

Study Completion (Anticipated)

August 1, 2022

Study Registration Dates

First Submitted

September 18, 2019

First Submitted That Met QC Criteria

September 18, 2019

First Posted (Actual)

September 20, 2019

Study Record Updates

Last Update Posted (Actual)

November 15, 2021

Last Update Submitted That Met QC Criteria

November 7, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LG-SGCL002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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