Our center is conducting a clinical trial testing the safety and efficacy of the investigational medication PRV-015, an antibody designed to block an immune system protein called interleukin 15 (IL-15). In people with celiac disease, this immune response can be caused by eating gluten. In a previous study, PRV-015 showed a reduction in inflammation in the intestine and improvement in symptoms of celiac disease triggered by gluten exposure.

 

Eligibility criteria:

  • 18-70 years old, and
  • Biopsy-confirmed celiac disease, and
  • On a gluten free diet for at least the last 12 months, and
  • Still experiencing celiac disease symptoms at least one of the following per week; diarrhea, loose stools, abdominal pain, abdominal cramping, bloating, or gas

 

What is expected from you?

  • Remain on your current Gluten-Free Diet!
  • Blood samples
  • Stool samples
  • Urine samples
  • Esophagogastroduodenoscopy (EGD) and Biopsy procedures
  • Questionnaires

 

Recruitment Status:

Currently recruiting

 

Study Duration:

9 months

 

Compensation:

Compensation will be provided for travel expenses, including a free parking pass for each visit

 

If you are interested, please contact:

Research Coordinator: Shilpa Tandon, tandos1@mcmaster.ca

Phone: 905-525-9140 ext. 21875

 

Sponsor:

Provention Bio Inc.

 

Research Team:

Dr. Ines Pinto-Sanchez, Dr. Premsyl Bercik, Dr. Emily Ching, Dr. Sapna Makhija, Dr. Avantika Marwaha, Shilpa Tandon (Research Staff), Dr. Mark Khaouli (Research Staff)

This study was approved by the Hamilton Integrated Research Ethics Board under Project #13594.




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