CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis (LIBERTY-UC)

Phase 3CompletedNCT04205643

Celltrion548 enrolled

Overview

This is Phase 3, Randomized, Placebo-controlled study to demonstrate superiority of CT-P13 SC over Placebo SC in Patients With Moderately to Severely Active Ulcerative Colitis

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

548

Conditions

Ulcerative Colitis

Interventions

CT-P13 SC (Infliximab)BIOLOGICAL

Subcutaneous injection of CT-P13 SC

Placebo SCOTHER

Subcutaneous injection of Placebo SC

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient is male or female aged 18 to 75 years, inclusive. * Patient has moderately to severely active UC with a modified Mayo score of 5 to 9 points with endoscopic subscore of ≥ 2 points Exclusion Criteria: * Patient who has previously received 2 or more biologic agents and/or JAK inhibitors * Patient who has previously received either a TNFα inhibitor or biologic agent within 5 half-lives

Locations (1)

Centrum Zdrowia MDM

Warsaw, Poland

Outcomes

Primary Outcomes

Percentage of Patients Achieving Clinical Remission at Week 54

Clinical remission defined by modified Mayo score which ranges from 0 to 9, including Stool frequency subscore, Rectal bleeding subscore and Endoscopic subscore but excluding Physician's global assessment subscore from the Total Mayo score. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter.

Time frame: Week 54

Secondary Outcomes

Percentage Patients Achieving Clinical Response at Week 54

Clinical response defined by decrease in modified Mayo score from baseline of at least 2 points and at least 30%, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1 point. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-responder.

Time frame: Week 54

Percentage of Patients Achieving Endoscopic-Histologic Mucosal Improvement at Week 54

Endoscopic-histologic mucosal improvement defined as an absolute endoscopic subscore of 0 or 1 point from modified Mayo score and an absolute RHI score of 3 points or less with an accompanying lamina propria neutrophils and neutrophils in epithelium subscore of 0 point. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as endoscopic-histologic mucosal improvement not achieved.

Time frame: Week 54

Percentage of Patients Achieving Corticosteroid-Free Remission at Week 54

Corticosteroid-free remission defined as being in clinical remission by modified Mayo score in addition to not requiring any treatment with corticosteroid for at least 8 weeks at Week 54, among the patients who used oral corticosteroids at baseline. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter.

Time frame: Week 54

Data from ClinicalTrials.gov

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