PRV-015 for Celiac Disease

Clinical Site, Seville, Spain
Celiac DiseasePRV-015 - Biological
18 - 70
All Sexes
What conditions do you have?

Study 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.

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 28 weeks

24 weeks
Effect of treatment with PRV-015 on other measures of disease activity
Efficacy of PRV-015 in attenuating the symptoms of celiac disease in adult patients with NRCD as measured by the Celiac Disease Patient-Reported Outcome (CeD PRO) questionnaire
28 weeks
Incidence of anti-PRV-015 antibodies
Incidence of treatment-emergent adverse events (TEAEs)
Serum trough concentrations of PRV-015 at scheduled visits

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Trial Design

4 Treatment Groups

PRV-015 Medium Dose
1 of 4
PRV-015 Low Dose
1 of 4
PRV-015 High Dose
1 of 4
1 of 4

Experimental Treatment

Non-Treatment Group

220 Total Participants · 4 Treatment Groups

Primary Treatment: PRV-015 · Has Placebo Group · Phase 2

PRV-015 Medium Dose
Experimental Group · 1 Intervention: PRV-015 · Intervention Types: Biological
PRV-015 Low Dose
Experimental Group · 1 Intervention: PRV-015 · Intervention Types: Biological
PRV-015 High Dose
Experimental Group · 1 Intervention: PRV-015 · Intervention Types: Biological
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 28 weeks

Who is running the clinical trial?

Provention Bio, Inc.Lead Sponsor
9 Previous Clinical Trials
828 Total Patients Enrolled
Chief Medical OfficerStudy DirectorProvention Bio, Inc.
115 Previous Clinical Trials
19,908 Total Patients Enrolled

Eligibility Criteria

Age 18 - 70 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You weigh between 77 and 264 pounds.
You have followed a gluten-free diet for at least 12 months in a row.
You have experienced stomach and bowel issues such as diarrhea, stomach pain, bloating or gas at least once a week for the month prior to screening.

Who else is applying?

What state do they live in?
How old are they?
18 - 6540.0%
< 1820.0%
What site did they apply to?
Clinical Site33.3%
What portion of applicants met pre-screening criteria?
Met criteria57.1%
Did not meet criteria42.9%
What questions have other patients asked about this trial?
  • "How long does the screening visit take and what does it consist of? If found eligible, what is the timeline of the study, and what is expected of me? Is there any compensation for participation?"
How many prior treatments have patients received?

How responsive is this trial?

Most responsive sites:
  1. Clinical Site: < 48 hours
Average response time
  • < 2 Days
Typically responds via

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" - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

Will participants be able to join this research endeavor at the present moment?

"Per the information hosted on, this research is actively recruiting participants with an initial posting date of August 24th 2020 and most recent update occurring July 25th 2022." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.