Single-arm, Open-label, Phase 3, Multi-center Study to Evaluate the Safety and Efficacy of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Crohns Disease in Japan

JRCT ID: jRCT2031230707

Registered date:15/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Crohn Disease
• Date of first enrollment: 01/04/2024
• Target sample size: 60
• Study type: Interventional
• Intervention(s): CT-P13 SC (Infliximab)

Outcome(s)

• Primary Outcome: Incidence rate of grade 3 or higher TEAEs

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

- Patient is Japanese male or female aged 18 to 75 years, inclusive.
- Patient is in clinical remission defined as Crohns Disease Activity Index score of <150 points at Screening.
- Patient who has been being treated with the standard dose of IV infliximab, for the treatment of CD for more than 6 months prior to the first administration of the study drug .

Exclude criteria

- Patient who has previously received 2 or more biologic agents (except for infliximab), 2 or more Janus kinase (JAK) inhibitors, or 2 or more of both biologic agents and JAK inhibitors.
- Patient who has previously received CT-P13 SC formulation

Related Information

• Primary Sponsor: Katsuyoshi Matsuoka
• Secondary Sponsor: Celltrion