PRV-015 has previously been studied for its potential to reduce symptoms and inflammation triggered by gluten in people with celiac disease
Provention Bio, Inc. launched its Phase 2b study of PRV-015 in August 2020. The PROACTIVE (PROvention-Amgen Celiac protecTIVE) Study continues to recruit participants across the United States, Canada and the European Union.
PRV-015 (formerly studied as AMG-714) is an investigational anti-interleukin 15 antibody. Interleukin-15 (IL-15) is a cytokine released by the immune system when someone with celiac disease is exposed to gluten. IL-15 has been shown to create inflammation and damage to the small intestine, which can cause symptoms in people with celiac disease. PRV-015 is designed to block IL-15, with the goal of limiting the inflammation, damage, and symptoms.
“Celiac disease research remains important even in the current pandemic,” noted clinical lead for the PROACTIVE Study at Provention Bio, Doug Jacobstein, MD. “Despite best efforts at a gluten-free diet, patients with celiac disease are still at risk for inadvertent exposure to gluten leading to persistent symptoms and ongoing inflammation. Therapeutic options in conjunction with the gluten-free diet are desperately needed as none currently exist.”
The PROACTIVE Study is testing how well three different doses of PRV-015 work to reduce symptoms and other measures of disease activity, compared to a placebo. The trial is designed to determine the optimal dose for Phase 3 clinical trials, which are the next step a drug must go through in development. Participants enroll in the study for 9 months and complete 16 study visits while continuing their gluten-free diet and taking either the study drug or placebo. Participants will be periodically asked to record their symptoms on a handheld electronic device similar to a smartphone.
The PROACTIVE Study allows participants to potentially complete up to 4 visits at home. A home nursing service will travel to participants’ homes to conduct the necessary assessments at those visits. Participants in the trial will be compensated for their time and travel reimbursement, including mileage and parking, is available for the visits that are conducted at the study site. Additional services, such as transportation, accommodations, and meals are provided if they are needed by the participant.
The COVID-19 pandemic caused changes to clinical research around the world, with new required safety protocols in place. All PROACTIVE study sites are following regional/local COVID guidelines, including having cleaning, sanitizing, and social distancing protocols. Additionally, study participants are permitted to receive the COVID-19 vaccines while participating in the trial. Thus far, there is no evidence that people with celiac disease are at higher risk of becoming infected with COVID-19 or at increased risk of severe outcomes if infected.
The study is currently taking place at sites across the United States, Canada, and the European Union. If you’re interested in participating, visit the study website to learn more and fill out the eligibility survey. Beyond Celiac is recruiting for this clinical trial as part of our commitment to accelerating clinical trials.