VTP-1000 in Adults with Celiac Disease

Launched by BARINTHUS BIOTHERAPEUTICS · Mar 7, 2024

Keywords

ClinConnect Summary

The clinical trial titled "VTP-1000 in Adults With Celiac Disease" is studying a new treatment called VTP-1000 to see how safe it is and how well it might work for adults with celiac disease. Celiac disease is a condition where eating gluten—a protein found in wheat, barley, and rye—causes the immune system to attack the lining of the intestines. This trial involves giving participants different doses of VTP-1000 and comparing the results to a placebo (a treatment that has no active ingredients). Some participants will also undergo a gluten challenge to see how their bodies respond to gluten after receiving the treatment.

To join this trial, participants need to be diagnosed with celiac disease and must have certain genetic markers. They should be following a gluten-free diet and have low levels of specific antibodies in their blood. The trial is open to adults aged 18 to 75 who are not pregnant or breastfeeding, and who don't have other serious health issues. Participants will be closely monitored for any side effects and changes in their health during the study. This is an important step in finding new treatments for celiac disease, and those who qualify may have the opportunity to contribute to this research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of celiac disease as confirmed by positive serology and intestinal histology
• • Presence of Human Leukocyte Antigen (HLA)-DQ2.5 genotype
• • Participants who are on a well controlled gluten restricted diet
• • Negative or weak positive anti-tissue transglutaminase (tTG) IgA antibodies and negative or weak positive anti-deamidated gliadin peptide IgG (anti-DGP)-IgA/IgA antibodies
• • Non-pregnant or breast feeding females
• • No other clinical significant findings at screening
• Exclusion Criteria:
• • Refractory celiac disease
• • Selective IgA deficiency
• • Positive for HLA-DQ8
• • Known wheat allergy or that is Type I hypersensitivity
• • Active inflammatory bowel disease or other condition with symptoms that will be similar to celiac disease