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Monoclonal Antibodies
PRV-015 for Celiac Disease (PROACTIVE Trial)
Phase 2
Waitlist Available
Research Sponsored by Provention Bio, a Sanofi Company
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)
Must not have
Current diagnosis of any severe complication of celiac disease, such as refractory celiac disease type 1 (RCD-I) or RCD-II, enteropathy-associated T-cell lymphoma (EATL), ulcerative jejunitis, or gastrointestinal (GI) perforation
Diagnosis of any chronic, active gastrointestinal (GI) disease other than celiac disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 weeks
Summary
This trial is testing PRV-015, a medication for adults with celiac disease who still have symptoms despite avoiding gluten. The study includes people aged 18 to 70 who have been on a gluten-free diet for a significant period. PRV-015 aims to reduce gut inflammation and immune response to help alleviate their symptoms.
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with celiac disease through a biopsy.
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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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a severe complication of celiac disease like RCD-I, RCD-II, EATL, ulcerative jejunitis, or GI perforation.
Select...
I have a long-term stomach or intestine condition, but not celiac disease.
Select...
I currently have an active infection.
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I am not pregnant, planning to become pregnant, or breastfeeding during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 moreTrial 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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PRV-015
2020
Completed Phase 2
~230
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The primary treatment for Celiac Disease is a strict gluten-free diet, which eliminates the trigger (gluten) that causes the autoimmune response. For patients who do not respond to a gluten-free diet, treatments like PRV-015, an anti-IL-15 monoclonal antibody, are being explored.
IL-15 is a cytokine involved in the immune response to gluten, and inhibiting it can reduce inflammation and the activation of pathogenic T cells. This is significant for Celiac Disease patients as it offers a potential therapeutic option for those with non-responsive Celiac Disease, addressing the immune mechanisms and potentially improving their quality of life.
Association between innate response to gliadin and activation of pathogenic T cells in coeliac disease.Celiac disease: a model autoimmune disease with gene therapy applications.
Association between innate response to gliadin and activation of pathogenic T cells in coeliac disease.Celiac disease: a model autoimmune disease with gene therapy applications.
Find a Location
Who is running the clinical trial?
Provention Bio, a Sanofi CompanyLead Sponsor
4 Previous Clinical Trials
314 Total Patients Enrolled
Provention Bio, Inc.Lead Sponsor
10 Previous Clinical Trials
1,120 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
876 Previous Clinical Trials
2,021,528 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.I have a long-term stomach or intestine condition, but not celiac disease.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.You have followed a gluten-free diet for at least 12 months in a row.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.You have very low levels of a specific type of antibody called IgA.
Research Study Groups:
This trial has the following groups:- Group 1: PRV-015 Medium Dose
- Group 2: Placebo
- Group 3: PRV-015 Low Dose
- Group 4: PRV-015 High Dose
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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.
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