Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06426160
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-05-14
Brief Title:
Tocilizumab for Painful Chronic Pancreatitis
Sponsor:
Soren Schou Olesen
Organization:
Aalborg University Hospital
Study Overview
Official Title:
Tocilizumab for Painful Chronic Pancreatitis A Randomised Placebo-Controlled Double-blinded Investigator Initiated Trial TOPAC Trial
Status:
RECRUITING
Status Verified Date:
2024-06
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:
TOPAC
Brief Summary:
This placebo-controlled study will investigate the effect of tocilizumab an anti-interleukin-6 receptor antibody on symptom burden physical functioning and quality of life in patients with chronic pancreatitis
Detailed Description:
Recent independent research has emphasized the crucial role of immune cell infiltration and its interaction with pancreatic stellate cells in driving the inflammatory process and fibrogenesis in chronic pancreatitis CP The cytokine Interleukin 6 IL-6 has been identified as a key mediator in this process and preclinical studies have indicated that inhibiting IL-6 signaling can lead to favorable therapeutic outcomes Consequently targeting IL-6 signaling therapeutically holds great promise as a disease-modifying treatment for CP
Until now there have been no placebo-controlled trials in humans to test immune-modulating treatments for CP However there have been some promising results in preclinical studies For example administering an anti-IL-6 receptor antibody to an animal model of CP reduced pancreatitis-related pain indicating a potential therapeutic effect Blocking IL-6 signaling in an in-silico model of CP was also shown to have disease-modifying effects Recent anecdotal evidence indicates that using tocilizumab to treat patients with COVID-19 and concomitant pancreatitis can decrease inflammation and pain in the pancreas Additionally blocking IL-6 signaling has been demonstrated to have anti-fibrotic effects in patients with systemic sclerosis Taken together these findings suggest that targeting IL-6 signaling could be a promising approach for reducing inflammation and fibrogenesis in CP Tocilizumab RoActemra is an anti-IL-6 receptor antibody currently used to treat several inflammatory diseases
Objectives
The investigators hypothesize that treatment with tocilizumab compared with a placebo will reduce symptom burden CP-related pain and improve physical functioning and quality of life in patients with CP In addition the investigators hypothesize that the clinical effects will be linked to a decrease in pancreatic inflammation and fibrosis as well as systemic inflammation The investigators also hypothesize that the pain-relieving effect of tocilizumab will lead to the normalization of pain processing in CP patients To test these hypotheses the project is organized into four sub-studies
Sub-study 1 main study - randomized placebo-controlled trial The objective of sub-study 1 is to conduct an investigator-initiated phase 2b double-blinded placebo-controlled randomized clinical trial to investigate the clinical effect of tocilizumab on patient-reported outcomes
Sub-study 2 inflammatory biomarkers The objective of sub-study 2 is to investigate the effects of tocilizumab on systemic inflammation using blood-based immune and fibrosis markers
Sub-study 3 quantitative imaging biomarkers The objective of sub-study 3 is to investigate the effect of tocilizumab on pancreatic inflammation and fibrosis using Magnetic Resonance Imaging MRI of the pancreas
Sub-study 4 pain processing The objective of sub-study 4 is to investigate the effect of tocilizumab on pain processing using Pancreatic Quantitative Sensory Testing P-QST and electrophysiological methods EEG and ECG
Until now there have been no placebo-controlled trials in humans to test immune-modulating treatments for CP However there have been some promising results in preclinical studies For example administering an anti-IL-6 receptor antibody to an animal model of CP reduced pancreatitis-related pain indicating a potential therapeutic effect Blocking IL-6 signaling in an in-silico model of CP was also shown to have disease-modifying effects Recent anecdotal evidence indicates that using tocilizumab to treat patients with COVID-19 and concomitant pancreatitis can decrease inflammation and pain in the pancreas Additionally blocking IL-6 signaling has been demonstrated to have anti-fibrotic effects in patients with systemic sclerosis Taken together these findings suggest that targeting IL-6 signaling could be a promising approach for reducing inflammation and fibrogenesis in CP Tocilizumab RoActemra is an anti-IL-6 receptor antibody currently used to treat several inflammatory diseases
Objectives
The investigators hypothesize that treatment with tocilizumab compared with a placebo will reduce symptom burden CP-related pain and improve physical functioning and quality of life in patients with CP In addition the investigators hypothesize that the clinical effects will be linked to a decrease in pancreatic inflammation and fibrosis as well as systemic inflammation The investigators also hypothesize that the pain-relieving effect of tocilizumab will lead to the normalization of pain processing in CP patients To test these hypotheses the project is organized into four sub-studies
Sub-study 1 main study - randomized placebo-controlled trial The objective of sub-study 1 is to conduct an investigator-initiated phase 2b double-blinded placebo-controlled randomized clinical trial to investigate the clinical effect of tocilizumab on patient-reported outcomes
Sub-study 2 inflammatory biomarkers The objective of sub-study 2 is to investigate the effects of tocilizumab on systemic inflammation using blood-based immune and fibrosis markers
Sub-study 3 quantitative imaging biomarkers The objective of sub-study 3 is to investigate the effect of tocilizumab on pancreatic inflammation and fibrosis using Magnetic Resonance Imaging MRI of the pancreas
Sub-study 4 pain processing The objective of sub-study 4 is to investigate the effect of tocilizumab on pain processing using Pancreatic Quantitative Sensory Testing P-QST and electrophysiological methods EEG and ECG
Study Oversight
Has Oversight DMC:
None
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-510084-35-00 | CTIS | None | None |