Ignite Creation Date:
2024-05-06 @ 4:09 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04897282
Status:
RECRUITING
Last Update Posted:
2023-08-18
First Post:
2021-04-26
Brief Title:
Prospective Multicenter Trial to Determine the Efficacy and Outcome of the UCRI Biomarker Panel and Algorithm to Detect Mucosal Healing in Moderate to Severe Ulcerative Colitis Patients
Sponsor:
Glycominds LLC
Organization:
Glycominds LLC
Study Overview
Official Title:
Prospective Multicenter Trial to Determine the Efficacy and Outcome of the UCRI In-vitro Diagnostics Device to Detect Treatment Response Measured by Endoscopic Healing in Moderate to Severe Ulcerative Colitis Patients Treated With Anti-TNF-a
Status:
RECRUITING
Status Verified Date:
2023-08
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:
None
Brief Summary:
The purpose of this research study is to determine the efficacy and outcome of the UCRI an in-vitro diagnostics device in the form of a blood test and an algorithm as a tool to detect mucosal healing level of inflammation in the colon in people with moderate-to-severe ulcerative colitis treated with anti-TNFα Another reason is to explore additional biomarkers in blood stool or voice to detect disease activity andor mucosal healing A tool to detect the level of inflammation in the colon based on blood stool or voice biomarkers may reduce the need or the number of invasive endoscopic procedures This is an observational study and no treatment decision nor clinical intervention will be done based on results during this study and all collected data will be used only for the goal of the study and for obtaining FDA IDE for a follow-up study
Detailed Description:
At the early stage of mucosal inflammation in patients with inflammatory Bowel Diseases IBD neutrophils flood into intestinal mucosa phagocytose pathogenic microbes and promote mucosal healing and resolution of inflammation However large numbers of neutrophils infiltrating in the inflamed mucosa and accumulating in the epithelium cause damage of mucosal architecture compromised epithelial barrier and production of inflammatory mediators Novel neutrophil-related serum markers are emerging in the literature and are valid candidates to surrogate markers for mucosal healing MH NGAL is an anti-bacterial protein whereas MMP-9 is a protein with enzymatic activity towards extracellular matrix ECM and non-ECM components and is involved in cell signaling
By formation of a complex between NGAL and MMP-9 NGAL is thought to protect MMP-9 from autodegradation Cathelicidin LL37 is the 37 amino acids C-terminal part of human cationic antimicrobial protein hCAP18 and acts as an antimicrobial protein AMP It is found in lysosomes of macrophages and polymorphonuclear leukocytes PMNs as well as keratinocytes and plays a role in the early host response against invading pathogens via its broad-spectrum anti-microbial activity The expression of LL37 was found to be increased in the inflamed mucosa of patients with UC and CD3 Moreover increased colonic LL37 expression in macrophages and epithelium was observed during colitis in UC patients Chitinase 3 like 1 CHI3L1 also known as YKL-40 is a 39 kDa secreted glycoprotein member of the glycosyl hydrolase 18 family although it does not show chitotriosidase activity It is secreted by macrophages and neutrophils and acts as a growth factor for vascular endothelial cells and fibroblasts
In previous retrospective single-site study consisting of serum samples and endoscopic evaluation before and after anti-TNFa treatment from 176 moderate-to-severe UC patients and 75 healthy controls showed that the combined use of these markers is statistically significant and can accurately correlate with the Mayo endoscopic subscore MES and identify endoscopic response to infliximab IFX and adalimumab ADM An algorithm the Ulcerative Colitis Response Index UCRI a unit-less index ranging from 0 likely a responder to 10 likely a non-responder was constructed and identified accentually the anti-TNFa non-responders patients as measured by endoscopic assessment MES 2
Glycominds LLC the Sponsor in support of the Crohns and Colitis Foundation CCF IBD Venture will conduct this prospective multicenter longitudinal study in the US Following screening and patient enrollment based on the inclusion and exclusion criteria Imaging blood serum and fecal samples will be collected at certain predefined time points from bio naïve naïve and from anti-TNFa previously exposed exposed active MES 2 UC patients that will start an anti-TNFa treatment or switch from one anti-TNFa type to another infliximab-IFX or biosimilars adalimumab-ADM golimumab-GOM at time of recruitment Collected blood and stool samples will be used to determine the accuracy and prediction value of the UCRI biomarker panel and algorithm in comparison with endoscopic healing measured as end point of MES 2 and in comparison to fecal Calprotectin The IFXADMGOM treatment decision and endoscopic evaluations before and after treatment initiationswitching will be done according to current clinical practice and Sponsor will not have any influence or responsibilities on those decisions
By formation of a complex between NGAL and MMP-9 NGAL is thought to protect MMP-9 from autodegradation Cathelicidin LL37 is the 37 amino acids C-terminal part of human cationic antimicrobial protein hCAP18 and acts as an antimicrobial protein AMP It is found in lysosomes of macrophages and polymorphonuclear leukocytes PMNs as well as keratinocytes and plays a role in the early host response against invading pathogens via its broad-spectrum anti-microbial activity The expression of LL37 was found to be increased in the inflamed mucosa of patients with UC and CD3 Moreover increased colonic LL37 expression in macrophages and epithelium was observed during colitis in UC patients Chitinase 3 like 1 CHI3L1 also known as YKL-40 is a 39 kDa secreted glycoprotein member of the glycosyl hydrolase 18 family although it does not show chitotriosidase activity It is secreted by macrophages and neutrophils and acts as a growth factor for vascular endothelial cells and fibroblasts
In previous retrospective single-site study consisting of serum samples and endoscopic evaluation before and after anti-TNFa treatment from 176 moderate-to-severe UC patients and 75 healthy controls showed that the combined use of these markers is statistically significant and can accurately correlate with the Mayo endoscopic subscore MES and identify endoscopic response to infliximab IFX and adalimumab ADM An algorithm the Ulcerative Colitis Response Index UCRI a unit-less index ranging from 0 likely a responder to 10 likely a non-responder was constructed and identified accentually the anti-TNFa non-responders patients as measured by endoscopic assessment MES 2
Glycominds LLC the Sponsor in support of the Crohns and Colitis Foundation CCF IBD Venture will conduct this prospective multicenter longitudinal study in the US Following screening and patient enrollment based on the inclusion and exclusion criteria Imaging blood serum and fecal samples will be collected at certain predefined time points from bio naïve naïve and from anti-TNFa previously exposed exposed active MES 2 UC patients that will start an anti-TNFa treatment or switch from one anti-TNFa type to another infliximab-IFX or biosimilars adalimumab-ADM golimumab-GOM at time of recruitment Collected blood and stool samples will be used to determine the accuracy and prediction value of the UCRI biomarker panel and algorithm in comparison with endoscopic healing measured as end point of MES 2 and in comparison to fecal Calprotectin The IFXADMGOM treatment decision and endoscopic evaluations before and after treatment initiationswitching will be done according to current clinical practice and Sponsor will not have any influence or responsibilities on those decisions
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?:
None
Is an FDA AA801 Violation?:
None