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 Ulcerative Colitis

CT-P13 3.7

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

2020-09-01

2022-07-07

2023-07-11

Completed

Early phase I

548

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 548, 'type': 'ACTUAL'}}

2023-09-28