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.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Canada, Netherlands, Spain, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Celiac Disease

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

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Clinical Trial Site, Scottsdale, Arizona

Status

Withdrawn

Address

Clinical Trial Site

Scottsdale, Arizona, 85260

Site Contact

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