An interventional study of Gluten Powder in Celiac Disease, sponsored by Regeneron Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-06-27.
Sponsored by Regeneron Pharmaceuticals · Not applicable, Interventional, and Other
The primary objectives are:
The secondary objectives are:
339 studies on the registry are indexed under Celiac Disease; 80 are open to participants now.
This study's enrollment of 24 is below the median of 50 across 207 interventional studies indexed under Celiac Disease.
Browse Celiac Disease studies →Regeneron Pharmaceuticals is the lead sponsor of 409 studies on the registry; 92 are open to participants now.
Of its 123 completed or terminated interventional studies of FDA-regulated products, 79 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined inclusion/ exclusion criteria apply
Dietary Supplement: Gluten Powder
Administered orally daily for 14 days
Change from Baseline in small intestine TCR repertoire
Change in the T-cell receptor repertoire (measured by T cell receptor sequencing) in the small intestine after gluten challenge
Time frame: Up to 30 days post challenge
Change from Baseline in peripheral blood TCR repertoire
Change in the T-cell receptor repertoire (measured by T cell receptor sequencing) in peripheral blood after gluten challenge
Time frame: Up to 30 days post challenge
Changes from baseline in small intestine and peripheral blood transcriptome
Change in the gene expression profile (transcriptomic analysis by ribonucleic acid \[RNA\] sequencing and cellular indexing of transcriptomes and epitopes by sequencing \[CITEseq\]) of the small intestine and peripheral blood after gluten challenge
Time frame: Up to 30 days post challenge
Change from Baseline in Small Intestine Histology Based on Intraepithelial Lymphocytes (IEL) Count per 100 epithelial cells
IELs are white blood cells (WBCs) interspersed between epithelial cells of the small and large intestine where they function to preserve the integrity of the mucosal barrier by protecting the epithelium against pathogen or immune-induced pathology. Increased IELs count indicated more extreme CeD disease symptoms. Baseline values are defined as the last observed value before the first dose of gluten.
Time frame: Baseline and Day 15
Change from Baseline in Small Intestine Histology Based on Villous Height (Microns), Crypt Depth (Microns) and Villous Height to Crypt Depth Ratio (Vh:Cd)
Villi are the small finger like projections that line the small intestine and promote nutrient absorption and are often shortened in active CeD. Crypts are grooves between the villi that are often elongated in CeD. A decreased Vh:Cd ratio indicates more extreme CeD disease symptoms. Baseline values (Microns) will be defined as the last observed value before the first dose of gluten.
Time frame: Baseline and Day 15
Identification and ex vivo functional validation of gluten-specific T cells
Clonality of peripheral blood mononuclear cell (PBMC)-derived gluten-specific T cells (measured by T cell receptor sequencing) after ex vivo expansion with gluten peptides
Time frame: Up to 30 days post challenge
Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
Access criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Ran from Nov 2020 to primary completion in May 2024, 42 months.
Of 80 interventional studies with no phase under Celiac Disease, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 56. This study's 42 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Glutens