Covid 19 Research using Clinical Trials (Home Page)
Report for D002446: Celiac Disease NIH
(Synonyms: Celiac Disease)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (3)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug840 | Data collection and clinical testing of subjects Wiki | 1.00 |
| drug2036 | PRV-015 Wiki | 1.00 |
| drug2122 | Placebo Wiki | 0.05 |
Correlated MeSH Terms (0)
| Name (Synonyms) | Correlation |
|---|
There is one clinical trial.
Clinical Trials
1 A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of PRV-015 in Adult Patients With Non-Responsive Celiac Disease as an Adjunct to a Gluten-free Diet
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).
NCT04424927 Celiac Disease Biological: PRV-015 Other: Placebo MeSH:Celiac Disease
HPO:Celiac disease Gluten intolerance
Primary Outcomes
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 weeks
Secondary Outcomes
Description: Intraepithelial lymphocyte (IEL) density
Measure: Effect of treatment with PRV-015 on other measures of disease activity Time: 24 weeks
Description: Safety endpoint
Measure: Incidence of treatment-emergent adverse events (TEAEs) Time: 28 weeks
Description: Characterize the pharmacokinetics (PK) of PRV-015
Measure: Serum trough concentrations of PRV-015 at scheduled visits Time: 28 weeks
Description: Immunogenicity endpoint
Measure: Incidence of anti-PRV-015 antibodies Time: 28 weeks
HPO Nodes
Primary Outcomes
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 weeksSecondary Outcomes
Description: 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