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PRV-015-002b


Title 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
Therapeutic Area Celiac Disease
Principal Investigator John Leung, MD
Min Age 18 Years
Max Age 70 Years
Gender All
Contact Selma Sinanovic
617-636-2392
ssinanovic@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04424927

Overview

The purpose of this study is to learn about the safety and effectiveness of an investigational study drug called PRV-015.

PRV 015 is an antibody designed to block an immune system protein called interleukin-15 (IL 15). IL 15 is made in the small intestine and is one trigger that causes intestinal inflammation followed by death of the intestinal cells. This immune response can be caused by eating gluten. In previous studies, PRV 015 has been shown to reduce inflammation in the intestine and improve the symptoms of celiac disease when used together with a GFD.

Study Details

Inclusion Criteria

  • Subjects must have a diagnosis of celiac disease by intestinal biopsy at least 12 months prior to screening as confirmed by medical records or written physician statement.
  • Subjects must have reported attempting to follow a GFD for at least the 12 consecutive months prior to screening and must be willing to maintain their current diet for the duration of study participation.
  • Subjects must have a Gastrointestinal Symptom Rating Scale, Celiac Disease portion (CeD-GSRS) score of >2 at the screening visit.

Exclusion Criteria

  • Current diagnosis of any severe complication of celiac disease, such as RCD-I or RCD-II, enteropathy-associated T-cell lymphoma (EATL), ulcerative jejunitis, or GI perforation.
  • Diagnosis of any chronic, active GI disease other than celiac disease, such as active, untreated peptic ulcer, eosinophilic esophagitis, erosive esophagitis , ulcerative colitis or Crohn’s disease, microscopic colitis, irritable bowel syndrome, small intestinal bacterial overgrowth, tropical sprue, or other GI and non-GI disorder or prior GI surgery that may, in the Investigator’s opinion, interfere with the assessment of symptoms of abdominal pain, diarrhea, or other components of celiac disease.
  • Any known, symptomatic food allergy that, in the opinion of the Investigator, may interfere with the conduct or interpretation of the study.

Study Requirements

We expect that subjects will be in this research study for about 9 months. Subjects will be asked to visit the clinic up to 17 times. If approved by the study doctor, 4 of these visits may be conducted remotely by a visiting nurse. Subjects will have one EKG during this study in the screening period. There will be 2 endoscopies throughout the duration of the study. There will be 10 visits throughout the study requiring blood draw.