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

LG Chem

Status and phase: Withdrawn; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: LC51-0255; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04096573

LG-SGCL002

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 4 patient groups, including a placebo group

LC51-0255 low dose

Experimental group

Description:

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

Treatment:

Drug: LC51-0255

LC51-0255 middle dose

Experimental group

Description:

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

Treatment:

Drug: LC51-0255

LC51-0255 high dose

Experimental group

Description:

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

Treatment:

Drug: LC51-0255

placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: LC51-0255

Drug: Placebo