A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease

CT-P13 3.8

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

2019-10-28

2022-08-23

2023-08-22

Completed

Early phase I

396

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 396, 'type': 'ACTUAL'}}

2023-10-23