What side effects are associated with this type of intervention?

Common treatments for Celiac Disease primarily involve a strict gluten-free diet, which generally has no direct side effects but can be challenging to maintain. For patients with non-responsive Celiac Disease, treatments like PRV-015 (an Anti-IL-15 Monoclonal Antibody) are being studied. Monoclonal antibody treatments can have side effects such as increased risk of infections, infusion reactions, and potential allergic responses. Other investigational treatments may include immunosuppressive drugs, which can lead to side effects like increased susceptibility to infections, liver toxicity, and gastrointestinal issues.

What prior FDA approvals exist?

As of now, there are no FDA-approved drug treatments specifically for Celiac Disease. The primary management strategy remains a strict gluten-free diet. PRV-015, an Anti-IL-15 Monoclonal Antibody, is currently being studied for its potential to treat non-responsive Celiac Disease, but it has not yet received FDA approval. Other investigational treatments are also being explored, but none have reached the approval stage.

What other types of research exist?

TAK-101 is a promising novel alternative to PRV-015 for Celiac Disease patients. It has shown efficacy in preventing gluten-induced immune activation and was well tolerated in clinical trials. This represents a novel approach that could be translatable to other immune-mediated diseases.

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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 below

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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).

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My weight is between 35 and 120 kg.

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I have experienced symptoms like diarrhea or abdominal pain weekly in the past month.

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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:

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I have a severe complication of celiac disease like RCD-I, RCD-II, EATL, ulcerative jejunitis, or GI perforation.

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I have a long-term stomach or intestine condition, but not celiac disease.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 weeks for reporting.

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 more

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PRV-015

2020

Completed Phase 2

~230

0 / 9Eligibility criteria met

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.