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

Celltrion Healthcare

Status and phase: Completed; Phase 3

Conditions: Ulcerative Colitis

Treatments: Biological: CT-P13 SC (Infliximab); Other: Placebo SC

Study type: Interventional

Funder types: Industry

Identifiers

NCT04205643

2019-003849-15 (EudraCT Number)

CT-P13 3.7

Details and patient eligibility

About

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

Enrollment: 548 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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548 participants in 2 patient groups, including a placebo group

CT-P13 SC

Experimental group

Treatment:

Biological: CT-P13 SC (Infliximab)

Placebo SC

Placebo Comparator group

Treatment:

Other: Placebo SC