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PRV-015 in Gluten-free Diet Non-responsive Celiac Disease (PROACTIVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04424927
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
Provention Bio, Inc.

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Celiac Disease Biological: PRV-015 Other: Placebo Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of PRV-015 in Adult Patients With Non-Responsive Celiac Disease as an Adjunct to a Gluten-free Diet
Actual Study Start Date : August 24, 2020
Estimated Primary Completion Date : July 11, 2022
Estimated Study Completion Date : July 11, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Arm Intervention/treatment
Experimental: PRV-015 Low Dose
PRV-015 Low Dose, sterile solution for subcutaneous administration
Biological: PRV-015
Fully human monoclonal antibody against interleukin 15 (IL-15)

Experimental: PRV-015 Medium Dose
PRV-015 Medium Dose, sterile solution for subcutaneous administration
Biological: PRV-015
Fully human monoclonal antibody against interleukin 15 (IL-15)

Experimental: PRV-015 High Dose
PRV-015 High Dose, sterile solution for subcutaneous administration
Biological: PRV-015
Fully human monoclonal antibody against interleukin 15 (IL-15)

Placebo Comparator: Placebo
Placebo, sterile solution for subcutaneous administration
Other: Placebo
Placebo




Primary Outcome Measures :
  1. 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 [ Time Frame: 24 weeks ]
    Celiac Disease Patient-Reported Outcome (CeD PRO)


Secondary Outcome Measures :
  1. Effect of treatment with PRV-015 on other measures of disease activity [ Time Frame: 24 weeks ]
    Intraepithelial lymphocyte (IEL) density

  2. Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: 28 weeks ]
    Safety endpoint

  3. Serum trough concentrations of PRV-015 at scheduled visits [ Time Frame: 28 weeks ]
    Characterize the pharmacokinetics (PK) of PRV-015

  4. Incidence of anti-PRV-015 antibodies [ Time Frame: 28 weeks ]
    Immunogenicity endpoint



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04424927


Contacts
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Contact: Doug Jacobstein (908) 941-0784 proactiveceliac@proventionbio.com
Contact: Study Director

Locations
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United States, California
Clinical Site Recruiting
Ventura, California, United States, 93003
United States, Florida
Clinical Site Recruiting
Leesburg, Florida, United States, 34748
Contact: Provention Bio         
Clinical Site Recruiting
Naples, Florida, United States, 34102
Contact: Provention Bio         
Clinical Site Recruiting
Winter Park, Florida, United States, 32789
Contact: Provention Bio         
United States, Michigan
Clinical Site Recruiting
Chesterfield, Michigan, United States, 48047
Contact: Provention Bio         
United States, New York
Clinical Site Recruiting
New Windsor, New York, United States, 12553
Contact: Clinical Site         
United States, Pennsylvania
Clinical Site Recruiting
Uniontown, Pennsylvania, United States, 14401
United States, Rhode Island
Clinical Site Recruiting
Warwick, Rhode Island, United States, 02886
Contact: Provention Bio         
United States, Utah
Clinical Site Recruiting
West Jordan, Utah, United States, 84088
United States, Washington
Clinical Site Recruiting
Bellevue, Washington, United States, 98004
Clinical Site Recruiting
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Provention Bio, Inc.
Investigators
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Study Director: Chief Medical Officer Provention Bio, Inc.
Additional Information:
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Responsible Party: Provention Bio, Inc.
ClinicalTrials.gov Identifier: NCT04424927    
Other Study ID Numbers: PRV-015-002b
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases