PRV-015 in Gluten-free Diet Non-responsive Celiac Disease

Study Purpose

This study will evaluate the efficacy and safety of PRV-015 in adult patients with non-responsive celiac disease (NRCD) who are on a gluten-free diet (GFD).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - A diagnosis of celiac disease by intestinal biopsy.
  • - Following a GFD for at least 12 consecutive months.
  • - Must have detectable (above the lower limit of detection) serum celiac-related antibodies.
  • - Must have human leukocyte antigen DQ (HLA-DQ) typing consistent with celiac disease (DQ2 and/or DQ8) - Subjects must have had at least one of the following symptoms at least once per week during the month before screening: diarrhea, loose stools, abdominal pain, abdominal cramping, bloating, or gas.
  • - Body weight between 35 and 120 kg.

Exclusion Criteria:

  • - 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 GI disease other than celiac disease.
  • - Presence of any active infection.
  • - Selective immunoglobulin A (IgA) deficiency, defined as having undetectable levels of IgA.
  • - Known or suspected exposure to coronavirus disease 2019 (COVID-19) infection in the 4 weeks before screening.
  • - Administration of a live vaccine within 14 days prior to randomization and the first administration of study drug.
  • - History or presence of any clinically significant disease that, in the opinion of the Investigator, may confound the subject's participation and follow-up in the clinical trial or put the subject at unnecessary risk.
- Females who are pregnant or planning to become pregnant during the study period, or who are currently breastfeeding

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04424927
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Provention Bio, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Chief Medical Officer
Principal Investigator Affiliation Provention Bio, Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Canada, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Celiac Disease
Study Website: View Trial Website
Additional Details

PRV-015-002b is a Phase 2b, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 3 dose regimens of PRV-015 in adult patients with NRCD who are on a GFD. Eligible subjects include male or female adults, 18 to 70 years of age, with a diagnosis of celiac disease and have followed a GFD for at least 12 consecutive months, yet continue to experience symptoms. Study drug (1 of the 3 doses of PRV-015 or placebo) will be administered in a double-blind fashion, followed by a safety follow-up period.

Arms & Interventions

Arms

Experimental: PRV-015 Low Dose

PRV-015 Low Dose, sterile solution for subcutaneous administration

Experimental: PRV-015 Medium Dose

PRV-015 Medium Dose, sterile solution for subcutaneous administration

Experimental: PRV-015 High Dose

PRV-015 High Dose, sterile solution for subcutaneous administration

Placebo Comparator: Placebo

Placebo, sterile solution for subcutaneous administration

Interventions

Biological: - PRV-015

Fully human monoclonal antibody against interleukin 15 (IL-15)

Other: - Placebo

Placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Clinical Site, Encinitas, California

Status

Recruiting

Address

Clinical Site

Encinitas, California, 92042

Clinical Site, Los Angeles, California

Status

Recruiting

Address

Clinical Site

Los Angeles, California, 90036

Clinical Site, Ventura, California

Status

Recruiting

Address

Clinical Site

Ventura, California, 93003

Clinical Site, Leesburg, Florida

Status

Recruiting

Address

Clinical Site

Leesburg, Florida, 34748

Clinical Site, Naples, Florida

Status

Withdrawn

Address

Clinical Site

Naples, Florida, 34102

Clinical Site, Tampa, Florida

Status

Recruiting

Address

Clinical Site

Tampa, Florida, 33613

Clinical Site, Winter Park, Florida

Status

Recruiting

Address

Clinical Site

Winter Park, Florida, 32789

Clinical Site, Annapolis, Maryland

Status

Recruiting

Address

Clinical Site

Annapolis, Maryland, 21401

Clinical Site, Chesterfield, Michigan

Status

Recruiting

Address

Clinical Site

Chesterfield, Michigan, 48047

Clinical Site, New Windsor, New York

Status

Recruiting

Address

Clinical Site

New Windsor, New York, 12553

Clinical Site, Raleigh, North Carolina

Status

Recruiting

Address

Clinical Site

Raleigh, North Carolina, 27607

Clinical Site, Philadelphia, Pennsylvania

Status

Recruiting

Address

Clinical Site

Philadelphia, Pennsylvania, 19104

Clinical Site, Uniontown, Pennsylvania

Status

Recruiting

Address

Clinical Site

Uniontown, Pennsylvania, 14401

Clinical Site, Warwick, Rhode Island

Status

Recruiting

Address

Clinical Site

Warwick, Rhode Island, 02886

Clinical Site, Nashville, Tennessee

Status

Recruiting

Address

Clinical Site

Nashville, Tennessee, 37212

Clinical Site, Garland, Texas

Status

Recruiting

Address

Clinical Site

Garland, Texas, 75044

Clinical Site, West Jordan, Utah

Status

Recruiting

Address

Clinical Site

West Jordan, Utah, 84088

Clinical Site, Bellevue, Washington

Status

Recruiting

Address

Clinical Site

Bellevue, Washington, 98004

Clinical Site, Tacoma, Washington

Status

Recruiting

Address

Clinical Site

Tacoma, Washington, 98405

International Sites

Clinical Site, Richmond Hill, Ontario, Canada

Status

Recruiting

Address

Clinical Site

Richmond Hill, Ontario, 14B 3P8

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