Ulcerative ColitisPhase 2NCT04096573
Efficacy and Safety of LC51-0255 in Subjects With Ulcerative Colitis
A Phase 2 study testing LC51-0255 in people with Ulcerative Colitis, run by LG Chem.
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- LC51-0255
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2020to Aug 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 80 years
- Active UC confirmed by endoscopy
- Moderately to severely active UC defined as a 3-component Mayo Clinic score
Who cannot join
- 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)
About this study
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
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
- Conditions
- Ulcerative Colitis
- Being tested
- LC51-0255, Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LC51-0255Drug
LC51-0255
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| LC51-0255 low dose | Experimental | Oral, daily, low dose for induction period, high dose for OLE period Receives: Drug: LC51-0255 |
| LC51-0255 middle dose | Experimental | Oral, daily, middle dose for induction period, high dose for OLE period Receives: Drug: LC51-0255 |
| LC51-0255 high dose | Experimental | Oral, daily, high dose for induction period, high dose for OLE period Receives: Drug: LC51-0255 |
| placebo | Placebo comparator | Oral, daily, placebo for induction period, high dose for OLE period Receives: Drug: LC51-0255; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission
The proportion of subjects in clinical remission assessed by Mayo component sub-scores
Measured: Week 12
Secondary outcomes (2)
Clinical response
The proportion of subjects in clinical response assessed by Mayo component sub-scores
Measured: Week 12
Endoscopic improvement and remission
The proportion of subjects in endoscopic improvement and remission assessed by Mayo endoscopic sub-score
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study startApr 2020 (estimated)
- Primary completionNov 2021 (estimated)
- Study completionAug 2022 (estimated)
Why it stopped: company decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096573
- Sponsor's protocol ID
- LG-SGCL002
- Status last verified
- Nov 2021
- First submitted
- 18 Sep 2019
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04096573
- Acronym / sponsor ID
- LG-SGCL002
- Conditions
- Ulcerative Colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: company decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- Apr 2020 (estimated)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 20 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LC51-0255 low dose | Experimental | Drug: LC51-0255Oral, daily, low dose for induction period, high dose for OLE period |
| LC51-0255 middle dose | Experimental | Drug: LC51-0255Oral, daily, middle dose for induction period, high dose for OLE period |
| LC51-0255 high dose | Experimental | Drug: LC51-0255Oral, daily, high dose for induction period, high dose for OLE period |
| placebo | Placebo comparator | Drug: LC51-0255, Drug: PlaceboOral, daily, placebo for induction period, high dose for OLE period |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 to 80 years
- Active UC confirmed by endoscopy
- Moderately to severely active UC defined as a 3-component Mayo Clinic score
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LC51-0255LC51-0255 | Drug | LC51-0255 high dose, LC51-0255 low dose, LC51-0255 middle dose, placebo |
| PlaceboPlacebo | Drug | placebo |
Primary outcome
Clinical remission
Time frame: Week 12
The proportion of subjects in clinical remission assessed by Mayo component sub-scores
2 secondary outcomes
Clinical response
Time frame: Week 12
Endoscopic improvement and remission
Time frame: Week 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LC51-0255 in people with Ulcerative Colitis, run by LG Chem.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2021; AzTrials last refreshed its copy on 8 Nov 2026.