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A Pharmacokinetic-pharmacodynamic Modeling and Simulation Study of Subcutaneous Infliximab in Patients With Inflammatory Bowel Disease

NCT07120152 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 439

Last updated 2025-09-03

No results posted yet for this study

Summary

A subcutaneous formulation of infliximab CT-P13 (Remsima, Celltrion) has been approved for clinical use in inflammatory bowel disease (IBD) and rheumatoid arthritis (RA) after demonstration of pharmacokinetic (PK) non-inferiority compared to intravenous CT-P13. The added value of the subcutaneous formulation of CT-P13 has been recognized by IBD physician expert, patients and nurses. However, further investigation is needed to select the right patients and timing for switching to the new subcutaneous formulation. Before investing resources into the design and execution of a prospective clinical trial to address these remaining clinical questions and concerns, an in silica simulation study using a population pharmacokinetic-pharmacodynamic (popPK-PD) model of CT-P13 would be highly informative. While popPK models of subcutaneous infliximab CT-P13 have been developed for both IBD and RA, a popPK-PD model is still awaited. The development of a popPK-PD model would allow us to bridge infliximab exposure and response, and address clinically relevant questions by focussing on therapeutic outcomes.

Conditions

  • IBD - Inflammatory Bowel Disease
  • RA - Rheumatoid Arthritis

Interventions

DRUG

Subcutaneous infliximab CT-P13 Remsima®SC

Subcutaneous infliximab

Sponsors & Collaborators

  • San Raffaele University Hospital, Italy

    collaborator OTHER

  • University of Liverpool

    collaborator OTHER

  • Hospital Universitario La Fe

    collaborator OTHER

  • University of Southampton

    collaborator OTHER

  • Samsung Medical Center

    collaborator OTHER

  • Erwin Dreesen

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-09-01
Completion
2027-03-01
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07120152 on ClinicalTrials.gov