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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 Crohns Disease

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 Crohns Disease

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2031200117
Enrollment
600
Registered
2020-09-11
Start date
2020-09-01
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

Crohns Disease

Interventions

Biological: CT-P13 SC (Infliximab) Other: Placebo SC

Sponsors

Ishida Tetsuya
Lead Sponsor
Celltrion
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: -Patient who has previously received either a TNFa inhibitor or biological agent within 5 half-lives -Patient who has previously demonstrated inadequate response or intolerance to TNFa inhibitors for the treatment of CD

Design outcomes

Primary

MeasureTime frame
Clinical remission [ Time Frame: Week 54 ]—

Countries

Austria, Bulgaria, Croatia, Czech Republic, France, Germany, Greece, Hungary, Japan, Latvia, Poland, Spain, US

Contacts

Public ContactDaiki Kaneko

Celltrion Healthcare Japan K.K

daiki.kaneko@celltrionhc.com+81-3-6260-6840

Outcome results

None listed

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