CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease (LIBERTY-CD)

Celltrion Healthcare

Status and phase: Completed; Phase 3

Conditions: Crohn's Disease

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03945019

CT-P13 3.8

2019-001087-30 (EudraCT Number)

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 Crohn's Disease

Enrollment: 396 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 who has moderately to severely active CD with a score on the CDAI of 220 to 450 points

Exclusion criteria

• Patient who has previously received either a TNFα inhibitor or biological agent within 5 half-lives
• Patient who has previously demonstrated inadequate response or intolerance to TNFα inhibitors for the treatment of CD.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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396 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