At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 388 enrolled
Drug / intervention
PRV-015 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating PRV-015 and Placebo for Celiac Disease. Completed, enrolled 388 participants across 38 sites in 4 countries.
Detailed Summary
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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCeliac Disease
CountriesCanada, Netherlands, Spain, United States
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedJun 2020
Enrollment StartAug 2020
Primary CompletionJul 2024
TodayJul 2026
First PostedJun 11, 2020
Enrollment StartAug 24, 2020
Primary CompletionJul 30, 2024
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 6.1 years ago
Interventions
PRV-015biological
Fully human monoclonal antibody against interleukin 15 (IL-15)
Placeboother
Placebo