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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

548 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2023-07-11

Brief Summary

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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

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Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CT-P13 SC

Group Type EXPERIMENTAL

CT-P13 SC (Infliximab)

Intervention Type BIOLOGICAL

Subcutaneous injection of CT-P13 SC

Placebo SC

Group Type PLACEBO_COMPARATOR

Placebo SC

Intervention Type OTHER

Subcutaneous injection of Placebo SC

Interventions

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CT-P13 SC (Infliximab)

Subcutaneous injection of CT-P13 SC

Intervention Type BIOLOGICAL

Placebo SC

Subcutaneous injection of Placebo SC

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No