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

Primary Purpose

Ulcerative Colitis

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
LC51-0255
Placebo
Sponsored by
LG Chem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    LC51-0255 low dose

    LC51-0255 middle dose

    LC51-0255 high dose

    placebo

    Arm Description

    Oral, daily, low dose for induction period, high dose for OLE period

    Oral, daily, middle dose for induction period, high dose for OLE period

    Oral, daily, high dose for induction period, high dose for OLE period

    Oral, daily, placebo for induction period, high dose for OLE period

    Outcomes

    Primary Outcome Measures

    Clinical remission
    The proportion of subjects in clinical remission assessed by Mayo component sub-scores

    Secondary Outcome Measures

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

    Full Information

    First Posted
    September 18, 2019
    Last Updated
    November 7, 2021
    Sponsor
    LG Chem
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04096573
    Brief Title
    Efficacy and Safety of LC51-0255 in Subjects With Ulcerative Colitis
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    company decision
    Study Start Date
    April 2020 (Anticipated)
    Primary Completion Date
    November 2021 (Anticipated)
    Study Completion Date
    August 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    LG Chem

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ulcerative Colitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    LC51-0255 low dose
    Arm Type
    Experimental
    Arm Description
    Oral, daily, low dose for induction period, high dose for OLE period
    Arm Title
    LC51-0255 middle dose
    Arm Type
    Experimental
    Arm Description
    Oral, daily, middle dose for induction period, high dose for OLE period
    Arm Title
    LC51-0255 high dose
    Arm Type
    Experimental
    Arm Description
    Oral, daily, high dose for induction period, high dose for OLE period
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Oral, daily, placebo for induction period, high dose for OLE period
    Intervention Type
    Drug
    Intervention Name(s)
    LC51-0255
    Intervention Description
    LC51-0255
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo
    Primary Outcome Measure Information:
    Title
    Clinical remission
    Description
    The proportion of subjects in clinical remission assessed by Mayo component sub-scores
    Time Frame
    Week 12
    Secondary Outcome Measure Information:
    Title
    Clinical response
    Description
    The proportion of subjects in clinical response assessed by Mayo component sub-scores
    Time Frame
    Week 12
    Title
    Endoscopic improvement and remission
    Description
    The proportion of subjects in endoscopic improvement and remission assessed by Mayo endoscopic sub-score
    Time Frame
    Week 12
    Other Pre-specified Outcome Measures:
    Title
    Clinical response and remission
    Description
    The proportion of subjects in clinical response and remission assessed by Mayo component sub-scores
    Time Frame
    Week 52
    Title
    Endoscopic improvement and remission
    Description
    The proportion of subjects in endoscopic improvement and remission assessed by Mayo endoscopic sub-score
    Time Frame
    Week 52

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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)

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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