Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years - 70 Years|
- - 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.
- - 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.
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Provention Bio, Inc.|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Canada, Netherlands, Spain, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
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
Biological: - PRV-015
Fully human monoclonal antibody against interleukin 15 (IL-15)
Other: - 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.