Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 1:45 AM
Study NCT ID:
NCT06274294
Status:
RECRUITING
Last Update Posted:
2024-07-31
First Post:
2024-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous as Induction Therapy in Patients With Active CD or UC
Sponsor:
CMC Ambroise Paré
Organization:
Study Overview
Official Title:
The "PASSPORT Trial": Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous as Induction Therapy in Patients With Active Crohn's Disease or Ulcerative Colitis.
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PASSPORT
Brief Summary:
The goal of this clinical trial is to compare induction treatment with CT-P13 SC to induction treatment with CT-P13 IV in terms of pharmacokinetics in adult patients with inflammatory bowel disease (IBD) who have been diagnosed for at least 3 months and for whom the physician has decided to initiate treatment with infliximab CT-P13 as part of the standard of care.
The main aim of this study is to demonstrate that induction treatment with CT-P13 SC is non-inferior to CT-P13 IV in terms of pharmacokinetics at Week 6.
The main aim of this study is to demonstrate that induction treatment with CT-P13 SC is non-inferior to CT-P13 IV in terms of pharmacokinetics at Week 6.
Detailed Description:
The subcutaneaous formulation of infliximab CT-P13 represents a promising approach in the treatment of inflammatory bowel disease (IBD), with an efficacy/safety/immunogenicity profile similar or even improved compared to the intravenous formulation of CT-P13. For patients, SC administration can offer benefits over their daily activities by reducing the frequency of days spent in the hospital to receive infusions. The SC administration may offer convenience for the healthcare system, optimizing the organizational impact due to the preparation and administration of the IV infusion, allowing resources to be used more efficiently, and reducing direct costs associated with the infusion. There are no clinical trials with Remsima® 120 mg given subcutaneously without IV loading doses of CT-P13 in patients with IBD. However, population pharmacokinetic and pharmacokinetic/pharmacodynamic modelling and simulation predicted comparable CT-P13 exposure (AUC over 8 weeks) and efficacy from Week 6 onward in rheumatoid arthritis patients treated with Remsima® 120 mg given without IV loading doses of CT-P13 when compared with Remsima® 3 mg/kg given intravenously at weeks 0, 2 and 6, and then every 8 weeks. For the dosing regimen with subcutaneous loading in patients with rheumatoid arthritis, the predicted median AUC value was 17,400 μg·h/mL from Week 0 to 6 which was approximately 1.8 fold lower than the predicted median AUC value for the dosing regimen with CT-P13 IV loading doses (32,100 μg·h/mL). Whereas the predicted median AUC values from Week 6 to 14 were comparable between the two dosing regimens with SC loading and IV loading (19,600 and 18,100 μg·h/mL, respectively).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: