There is one clinical trial.
This study will evaluate the efficacy and safety of PRV-015 in adult patients with non-responsive celiac disease (NRCD) who are on a gluten-free diet (GFD).
Description: Celiac Disease Patient-Reported Outcome (CeD PRO)
Measure: Efficacy of PRV-015 in attenuating the symptoms of celiac disease in adult patients with NRCD as measured by the Celiac Disease Patient-Reported Outcome (CeD PRO) questionnaire Time: 24 weeksDescription: Intraepithelial lymphocyte (IEL) density
Measure: Effect of treatment with PRV-015 on other measures of disease activity Time: 24 weeksDescription: Safety endpoint
Measure: Incidence of treatment-emergent adverse events (TEAEs) Time: 28 weeksDescription: Characterize the pharmacokinetics (PK) of PRV-015
Measure: Serum trough concentrations of PRV-015 at scheduled visits Time: 28 weeksDescription: Immunogenicity endpoint
Measure: Incidence of anti-PRV-015 antibodies Time: 28 weeks