Accidental gluten exposure is inevitable.
When it comes to your celiac disease symptoms and long-term health, be PROACTIVE.
Requirements
18 – 70
years old
Biopsy-confirmed
celiac disease
On a gluten-free diet for at least the last 12 months
Still experiencing celiac disease symptoms
About
Are you still experiencing celiac disease symptoms despite your best efforts to follow a gluten-free diet?
The goal of this phase 2 clinical trial is to test the safety and effects of the investigational medication PRV-015. In combination with a gluten-free diet, PRV-015 aims to reduce symptoms and intestinal inflammation caused by accidental gluten exposure.
What to expect with participation in this study?
If you qualify and choose to take part in this study, your participation will last about 9 months. You will continue to follow your usual gluten-free diet throughout the entire study. If you change your mind about participating, you can choose to leave the study at any time for any reason.
Participation in this study includes:
Screening Period
(up to 28 days):
During the screening period, the study doctor will confirm your eligibility to participate in the study with a full physical exam, including your medical history and laboratory tests from blood and urine samples.
Treatment Period
(about 28 weeks):
During the treatment period, you will come to the clinic to receive the study drug or placebo at each visit. The study doctor will monitor your health by performing physical exams and collecting blood, urine, and stool samples. You will have one endoscopy with biopsy at the beginning of the study and one at the end. You will also be given an electronic diary, similar to a smart phone, to track your symptoms throughout the study.
Follow-up Period
(about 4 weeks):
During the follow-up period, you will continue to complete the symptom diary and return to the clinic for one more visit.
FAQs
PRV-015 is an antibody designed to block an immune system protein called interleukin 15 (IL-15). In celiac patients, gluten consumption results in the production of IL-15 which triggers intestinal inflammation, leading to destruction of intestinal cells.
Yes. PRV-015 has been tested in approximately 250 people in six completed research studies. These studies show that PRV-015 has been well tolerated and, in celiac patients, it may reduce inflammation in the intestine and improve the symptoms of celiac disease in those who continue to experience symptoms despite following a gluten-free diet. As with all medications, some patients may experience adverse events.
This study is sponsored by Provention Bio, Inc., a clinical-stage biopharmaceutical company developing novel therapeutics aimed at intercepting and preventing immune-mediated diseases.
No, there is no gluten challenge. You will be asked to continue your usual gluten-free diet for the entire study.
There are several clinical sites located throughout the continental US (excluding Alaska and Hawaii). If you qualify through the online screening survey, we will work with you to determine the most convenient available clinical site to complete your in-office visits. Some of the visits may also be completed from your home, depending on location and availability.
Yes. Your participation is completely voluntary. If at any point you decide you no longer wish to participate, you can leave the study.
A placebo is an inactive substance that has no known medical effects. A placebo will be used in this study.
Placebos are used in clinical trials to help determine whether any changes observed during the study are truly an effect of the study drug or not. Without a placebo, scientists cannot prove that the study drug helps patients more than if they took nothing at all.
75% of enrolled participants will receive PRV-015 and 25% will receive a placebo.
Neither you nor the study doctor or staff will know if you are receiving a placebo or study drug.
No. All of your trial-related medical expenses will be paid for.
Yes. You will be reimbursed for eligible travel expenses.
Qualified patients may receive compensation after enrollment in the study.
Contact the PROACTIVE Celiac Study Team at 818-716-1513 x 101, or by email at info@proactiveceliac.com.