← Back to Search

Monoclonal Antibodies

PRV-015 for Celiac Disease (PROACTIVE Trial)

Phase 2
Waitlist Available
Research Sponsored by Provention Bio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A diagnosis of celiac disease by intestinal biopsy
Must have human leukocyte antigen DQ (HLA-DQ) typing consistent with celiac disease (DQ2 and/or DQ8)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 weeks
Awards & highlights

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.

Who is the study for?
Adults with celiac disease not responding to a gluten-free diet can join. They must have specific genetic markers (HLA-DQ2/DQ8), weigh between 35-120 kg, and experience certain symptoms like diarrhea or abdominal pain weekly. They should be on a gluten-free diet for at least one year and have detectable celiac-related antibodies but no severe complications of celiac disease or other chronic GI diseases.Check my eligibility
What is being tested?
The trial is testing PRV-015's effectiveness and safety against a placebo in adults with non-responsive celiac disease who are already following a strict gluten-free diet. Participants will randomly receive either the actual drug or an inactive substance to compare outcomes.See study design
What are the potential side effects?
While the side effects of PRV-015 aren't detailed here, common side effects in trials may include reactions at the injection site, gastrointestinal discomfort, headaches, fatigue, and potential allergic responses.

PROACTIVE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with celiac disease through a biopsy.
Select...
My genetic testing shows I have the celiac disease markers (DQ2/DQ8).
Select...
My weight is between 35 and 120 kg.
Select...
I have experienced symptoms like diarrhea or abdominal pain weekly in the past month.
Select...
I have experienced symptoms like diarrhea, abdominal pain, or bloating at least once a week in the past month.
Select...
I have experienced symptoms like diarrhea, abdominal pain, or bloating at least once a week in the past month.
Select...
My genetic testing shows I have the celiac disease markers (DQ2/DQ8).
Select...
My weight is between 35 and 120 kg.
Select...
I have been diagnosed with celiac disease through a biopsy.

PROACTIVE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Secondary outcome measures
Effect of treatment with PRV-015 on other measures of disease activity
Incidence of anti-PRV-015 antibodies
Incidence of treatment-emergent adverse events (TEAEs)
+1 more

PROACTIVE Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: PRV-015 Medium DoseExperimental Treatment1 Intervention
PRV-015 Medium Dose, sterile solution for subcutaneous administration
Group II: PRV-015 Low DoseExperimental Treatment1 Intervention
PRV-015 Low Dose, sterile solution for subcutaneous administration
Group III: PRV-015 High DoseExperimental Treatment1 Intervention
PRV-015 High Dose, sterile solution for subcutaneous administration
Group IV: PlaceboPlacebo Group1 Intervention
Placebo, sterile solution for subcutaneous administration

Find a Location

Who is running the clinical trial?

Provention Bio, Inc.Lead Sponsor
9 Previous Clinical Trials
856 Total Patients Enrolled
Chief Medical OfficerStudy DirectorProvention Bio, Inc.
122 Previous Clinical Trials
21,298 Total Patients Enrolled

Media Library

PRV-015 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04424927 — Phase 2
Celiac Disease Research Study Groups: PRV-015 Medium Dose, Placebo, PRV-015 Low Dose, PRV-015 High Dose
Celiac Disease Clinical Trial 2023: PRV-015 Highlights & Side Effects. Trial Name: NCT04424927 — Phase 2
PRV-015 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04424927 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
Ohio
Other
Florida
How old are they?
< 18
18 - 65
65+
What site did they apply to?
Clinical Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

Why did patients apply to this trial?

want to get better from celiac. I have had celiac Disease over 4 years.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Clinical Site: < 48 hours
Average response time
  • < 2 Days
~24 spots leftby Aug 2024