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

Single-arm, Open-label, Phase 3, Multi-center Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Ulcerative Colitis in Japan - CT-P13 3.13

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031250197

Enrollment

Registered

2025-07-04

Start date

2025-08-25

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

Ulcerative Colitis

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 the following modified Mayo score at Screening. (1)Stool frequency subscore of 0 or 1 point, and (2)Rectal bleeding subscore of 0 point, and (3)Endoscopic subscore of 0 or 1 point -Patient who has been being treated with the standard dose of IV infliximab, for the treatment of UC 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 targeted small molecules (e.g., Janus kinase [JAK] inhibitors, sphingosin-1-phosphate receptor antagonist, alpha 4 integrin antagonist) or 2 or more of both biologic agents and targeted small molecules. -Patient who has previously received CT-P13 SC formulation.

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy of CT-P13 SC based on clinical remission at Week 44	—

Contacts

Public ContactMichihiro Matsuoka

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