Your session is about to expire
← Back to Search
PRV-015 for Celiac Disease (PROACTIVE Trial)
PROACTIVE Trial Summary
This trial will test a new drug, PRV-015, to see if it helps adults with celiac disease who can't seem to get better even after following a gluten-free diet.
PROACTIVE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPROACTIVE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PROACTIVE Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- You have followed a gluten-free diet for at least 12 months in a row.I have been diagnosed with celiac disease through a biopsy.My genetic testing shows I have the celiac disease markers (DQ2/DQ8).I have not received a live vaccine in the last 14 days.I have a severe complication of celiac disease like RCD-I, RCD-II, EATL, ulcerative jejunitis, or GI perforation.You have followed a gluten-free diet for at least 12 months in a row.I have a long-term stomach or intestine condition, but not celiac disease.You weigh between 77 and 265 pounds.I currently have an active infection.My weight is between 35 and 120 kg.I have experienced symptoms like diarrhea or abdominal pain weekly in the past month.You have been on a gluten-free diet for at least 12 months in a row.I am not pregnant, planning to become pregnant, or breastfeeding during the study.I have experienced symptoms like diarrhea, abdominal pain, or bloating at least once a week in the past month.I have experienced symptoms like diarrhea, abdominal pain, or bloating at least once a week in the past month.You have followed a gluten-free diet for at least 12 months in a row.You must have measurable levels of celiac-related antibodies in your blood.I might have been exposed to COVID-19 in the last 4 weeks.You must have measurable levels of celiac-related antibodies in your blood.My genetic testing shows I have the celiac disease markers (DQ2/DQ8).You have very low levels of a specific type of antibody called IgA.My weight is between 35 and 120 kg.I have been diagnosed with celiac disease through a biopsy.
- Group 1: PRV-015 Medium Dose
- Group 2: Placebo
- Group 3: PRV-015 Low Dose
- Group 4: PRV-015 High Dose
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the maximum number of participants that are being accepted into this research project?
"Affirmative. The study, which was first announced on August 24th 2020 and recently updated on July 25th 2022, is currently in need of 220 patients from 29 different sites across the country. This information can be found via clinicaltrials.gov."
How many centers are monitoring this trial?
"This clinical trial is being hosted at 29 different locations throughout the US, three of which are New york City, Cedar Park and Boston. We recommend that participants choose a nearby clinic in order to reduce any travel-related inconveniences."
Has this approach ever been tested before?
"PRV-015 has been a subject of scientific inquiry since the year 2020, when Provention Bio, Inc. sponsored its first trial involving 220 participants. This initial study granted PRV-015 Phase 2 drug approval and presently there are two active trials spanning 4 nations and 46 cities."
Will participants be able to join this research endeavor at the present moment?
"Per the information hosted on clinicaltrials.gov, this research is actively recruiting participants with an initial posting date of August 24th 2020 and most recent update occurring July 25th 2022."
To what degree does PRV-015 pose a risk to human health?
"There is some safety data available on PRV-015, therefore it achieved a score of 2. This medication has not yet reached Phase 3 trials and thus lacks efficacy information."
Could you explain what other investigations have been conducted regarding PRV-015?
"PRV-015 was initially trialled in 2020 at Clinical Trial Site, with 18,322 studies already completed. At present, two medical trials of PRV-015 are underway; many of these tests are occuring in New york City."
Am I eligible to participate in this research study?
"This celiac disease clinical trial is currently welcoming 220 enrollees of age between 18 and 70. To qualify, individuals must have had at least one specified symptom weekly in the month leading up to screening, as well as a body weight that falls within the range of 35-120 kilograms."
Does this investigation seek out participants aged over 30?
"Patients between the ages of 18 and 70 are eligible to join this clinical trial. For those below 18, there is a total of 12 trials available; 24 such medical studies exist for seniors above 65 years old."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
What questions have other patients asked about this trial?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Clinical Site: < 48 hours
Average response time
- < 2 Days
Share this study with friends
Copy Link
Messenger