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Gluten · 1 trial · 1 indication
Peripheral blood mononuclear cells (PBMC) collected prior to gluten challenge were stained with phycoerythrin (PE)-labeled human leukocyte antigen (HLA)-DQ2.5: gluten tetramers (DQ2.5-glia-α1 and DQ2.5-glia-α2) to identify antigen-specific cluster of differentiation (CD)4-positive thymus lymphocyte (T cells) reactive to gliadin (tetramer+ T cells) by flow cytometry. PBMC were also labeled with a 20-antibody panel for cell surface antigen staining to further define tetramer+ T cell subsets. Antigens included in the analysis were CD25, CD38, CD39, programmed cell death receptor 1 (PD-1), and integrin beta-7 (B7).
Peripheral blood mononuclear cells (PBMC) collected on Day 14 following gluten challenge were stained with phycoerythrin (PE)-labeled human leukocyte antigen (HLA)-DQ2.5: gluten tetramers (DQ2.5-glia-α1 and DQ2.5-glia-α2) to identify antigen-specific cluster of differentiation (CD)4-positive thymus lymphocyte (T cells) reactive to gliadin (tetramer+ T cells) by flow cytometry. PBMC were also labeled with a 20-antibody panel for cell surface antigen staining to further define tetramer+ T cell subsets. Antigens included in the analysis were CD25, CD38, CD39, programmed cell death receptor 1 (PD-1), and integrin beta-7 (B7).
Lymphocytes from duodenal biopsies collected on Day 14 following gluten challenge were stained with a phycoerythrin (PE)-labeled human leukocyte antigen (HLA)-DQ2.5: gluten tetramer (DQ2.5-glia-α1) to identify antigen-specific cluster of differentiation (CD)4-positive thymus lymphocyte (T cells) reactive to gliadin (tetramer+ T cells) by flow cytometry. Lymphocytes were also labeled with a 20-antibody panel for cell surface antigen staining to further define tetramer+ T cell subsets. Antigens included in the analysis were CD25, CD38, CD39, programmed cell death receptor 1 (PD-1), and integrin beta-7 (B7).
| Arm | Type | Description |
|---|---|---|
| Gluten challenge | EXPERIMENTAL | Participants will receive a gluten 4 g powder twice daily (BID), for 13 consecutive days |
| Name | Type | Description |
|---|---|---|
| Gluten powder 4g | DIETARY_SUPPLEMENT | Gluten powder 4g oral BID |
Inclusion Criteria: 1. Participant must have documented diagnosis with celiac disease (CeD) by duodenal/jejunal biopsy at least 6 months prior to entrance into the study. 2. Participant must be on a gluten-free diet (GFD) for at least the past 12 months. 3. Female participants must not be pregnant ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE2 | Amlitelimab |
| Forte Biosciences Inc. | FBRX | 1 | PHASE2 | FB102 |
| Teva Pharmaceutical Industries Limited Sponsored ADR | TEVA | 1 | PHASE2 | TEV-53408 |
| Barinthus Biotherapeutics plc Sponsored ADR | BRNS | 1 | EARLY_PHASE1 | VTP-1000 |
| TScan Therapeutics, Inc. | TCRX | 1 | - | Undisclosed |
Gluten is an investigational agent being studied for use in Celiac Disease. It is currently in early Phase 1 clinical development. The drug is being evaluated in a gluten challenge study to assess its effects in participants with Celiac Disease. It is not yet approved and remains under investigation.
Gluten is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical research on this investigational agent for Celiac Disease. As of now, the drug is in early Phase 1 development and has not been approved for commercial use.
Gluten is in early Phase 1 clinical development. A single trial, NCT04054544, has been completed with 18 participants. This trial was an uncontrolled, non-randomized study that was not double-blind. The drug remains investigational and has not received regulatory approval.
Gluten has one completed clinical trial, NCT04054544, titled 'Gluten Challenge Study in Celiac Disease Participants (MK-0000-402)'. This early Phase 1 study enrolled 18 participants in the United States, all aged 18 years or older, with Celiac Disease. The trial was uncontrolled and has been completed.
Gluten is not FDA approved. It is an investigational agent currently in early Phase 1 clinical development for Celiac Disease. The only completed trial, NCT04054544, involved 18 participants and was an uncontrolled study. Further research is needed before any regulatory approval could be considered.