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

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 - CT-P13 3.12

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031230707

Enrollment

Registered

2024-03-15

Start date

2024-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease Crohn Disease

Interventions

CT-P13 SC (Infliximab)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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 .

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Incidence rate of grade 3 or higher TEAEs	—

Contacts

Public ContactMatsuoka Michihiro

Celltrion Healthcare Japan K.K

Michihiro.Matsuoka@celltrionhc.com+81-3-6260-6840

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026