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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: RA - Rheumatoid Arthritis; IBD - Inflammatory Bowel Disease
• Intervention / Treatment: Drug: Subcutaneous infliximab CT-P13 Remsima®SC

• Study Type: Observational
• Enrollment (Estimated): 439

Contacts and Locations

• Study Contact: Name: Erwin Dreesen, Prof. Dr.; Phone Number: +32 16 37 27 53; Email: erwin.dreesen@kuleuven.be
• Study Contact Backup: Name: Vicky Steyfkens, MSc; Phone Number: +32 16 37 26 25; Email: vicky.steyfkens@kuleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with inflammatory bowel disease

Description

Inclusion Criteria:

• Patients with Crohns disease with a score on the Crohn's disease activity index between 220 and 450.
• Patients with active Ulcerative colitis as defined by a total Mayo score between 6 and 12 points (Part 2 only)

Exclusion Criteria:

• Patients who have previously received a biological agent for the treatment of CD and UC and/or a tumor necrosis factor-alpha (TNFa)-inhibitor for the treatment of other diseases.
• Patients who have allergies to any of the excipients of infliximab or any other murine and/or human proteins or patients with a hypersensitivity to immunoglobulin products.
• Patients who have a current or past history of infection with HIV, hepatitis B or C (carriers of hepatitis B and C are not permitted to enrol into the study, but past hepatitis B resolved can be enrolled).
• Patients who have acute infections requiring oral antibiotics within 2 weeks or parenteral injection of antibiotics within 4 weeks prior to the first administration of the study drug, other serious infection within 6 months prior to the first administration of the study drug or recurrent herpes zoster or other chronic or recurrent infection within 6 weeks prior to the first administration of the study drug.
• Patient who have an indeterminate result for interferon-y release assay (IGRA) or latent tuberculosis (TB) at Screening. For part 2, if IGRA result is indeterminate at the Screening, one retest will be possible during the screening. If the repeated IGRA result is negative, the patient can be included in the study.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with IBD; Patients who have active Crohn's disease with a score on the Crohn's disease activity index between 220 and 450 points. Or patient has active Ulcerative colitis defined by a total Mayo score between 6 and 12 points (part 2 only).	Drug: Subcutaneous infliximab CT-P13 Remsima®SC; Subcutaneous infliximab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose-exposure-response relationship of subcutaneous infliximab	To understand, describe, and predict the dose-exposure relationship of sibcutaneous infliximab in patients with inflammatory bowel diseased based on available data from previous clinical trials.	At least 24 weeks

Collaborators and Investigators

• Sponsor: Erwin Dreesen
• Collaborators: Samsung Medical Center; University of Southampton; University of Liverpool; Hospital Universitario La Fe; San Raffaele University Hospital, Italy

Publications and helpful links

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: August 6, 2025
• First Submitted That Met QC Criteria: August 6, 2025
• First Posted (Actual): August 13, 2025

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Inflammatory Bowel Disease; IBD; Infliximab; Model; pharmacokinetic-pharmacodynamic model
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Intestinal Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Skin and Connective Tissue Diseases; Arthritis, Rheumatoid; Inflammatory Bowel Diseases; Tumor Necrosis Factor Inhibitors; Anti-Inflammatory Agents; Gastrointestinal Agents; Antirheumatic Agents; Dermatologic Agents; Infliximab
• Other Study ID Numbers: G-2024-8508-R2(AMD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The decision that whether or not to share the IPD will depend of the modalities of the data transfer agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No