IBD - Inflammatory Bowel DiseaseNCT07120152
A Pharmacokinetic-pharmacodynamic Modeling and Simulation Study of Subcutaneous Infliximab in Patients With Inflammatory Bowel Disease
An observational study of IBD - Inflammatory Bowel Disease and RA - Rheumatoid Arthritis, run by Erwin Dreesen.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- IBD - Inflammatory Bowel Disease, RA - Rheumatoid Arthritis
- What is being tested?
- Subcutaneous infliximab CT-P13 Remsima®SC
- Type of treatment
- Injection or infusion
- How many people
- 439 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients with inflammatory bowel disease
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Being tested
- Subcutaneous infliximab CT-P13 Remsima®SC
- Keywords
- pharmacokinetic-pharmacodynamic model, Model, IBD, Inflammatory Bowel Disease, Infliximab
- Medical subject headings
- Inflammatory Bowel Diseases, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous infliximab CT-P13 Remsima®SCDrug
Subcutaneous infliximab
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Subcutaneous infliximab CT-P13 Remsima®SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At least 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBD - Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 439 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erwin Dreesen
- Sponsor type
- University, hospital or other
- Collaborators
- San Raffaele University Hospital, Italy, University of Liverpool, Hospital Universitario La Fe, University of Southampton, Samsung Medical Center
- Responsible party
- Sponsor-investigator, Erwin Dreesen, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120152
- Sponsor's protocol ID
- G-2024-8508-R2(AMD)
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision that whether or not to share the IPD will depend of the modalities of the data transfer agreement.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic-pharmacodynamic Modeling and Simulation Study of Subcutaneous Infliximab in Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT07120152
- Acronym / sponsor ID
- G-2024-8508-R2(AMD)
- Keywords
- pharmacokinetic-pharmacodynamic model, Model, IBD, Inflammatory Bowel Disease, Infliximab
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 439 participants (estimated)
- Lead sponsor
- Erwin DreesenUniversity, hospital or other
- Collaborators
- San Raffaele University Hospital, Italy, University of Liverpool, Hospital Universitario La Fe, University of Southampton, Samsung Medical Center
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with IBD | – | Drug: Subcutaneous infliximab CT-P13 Remsima®SCPatients 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). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with inflammatory bowel disease
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subcutaneous infliximab CT-P13 Remsima®SCSubcutaneous infliximab | Drug | Patients with IBD |
Primary outcome
Dose-exposure-response relationship of subcutaneous infliximab
Time frame: At least 24 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The decision that whether or not to share the IPD will depend of the modalities of the data transfer agreement.
Related trials for IBD - Inflammatory Bowel Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
Recruiting
Effect of Mediterranean Diet in Inflammatory Bowel Disease
Inflammatory Bowel Disease
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of IBD - Inflammatory Bowel Disease and RA - Rheumatoid Arthritis, run by Erwin Dreesen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erwin Dreesen, Prof. Dr. (+32 16 37 27 53, erwin.dreesen@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-exposure-response relationship of subcutaneous infliximab (time frame: At least 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.