<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04424927</url>
  </required_header>
  <id_info>
    <org_study_id>PRV-015-002b</org_study_id>
    <nct_id>NCT04424927</nct_id>
  </id_info>
  <brief_title>PRV-015 in Gluten-free Diet Non-responsive Celiac Disease</brief_title>
  <acronym>PROACTIVE</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Provention Bio, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Provention Bio, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the efficacy and safety of PRV-015 in adult patients with&#xD;
      non-responsive celiac disease (NRCD) who are on a gluten-free diet (GFD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRV-015-002b is a Phase 2b, randomized, double-blind, placebo-controlled, parallel-group&#xD;
      study to evaluate the efficacy and safety of 3 dose regimens of PRV-015 in adult patients&#xD;
      with NRCD who are on a GFD.&#xD;
&#xD;
      Eligible subjects include male or female adults, 18 to 70 years of age, with a diagnosis of&#xD;
      celiac disease and have followed a GFD for at least 12 consecutive months, yet continue to&#xD;
      experience symptoms.&#xD;
&#xD;
      Study drug (1 of the 3 doses of PRV-015 or placebo) will be administered in a double-blind&#xD;
      fashion, followed by a safety follow-up period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 24, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>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</measure>
    <time_frame>24 weeks</time_frame>
    <description>Celiac Disease Patient-Reported Outcome (CeD PRO)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect of treatment with PRV-015 on other measures of disease activity</measure>
    <time_frame>24 weeks</time_frame>
    <description>Intraepithelial lymphocyte (IEL) density</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of treatment-emergent adverse events (TEAEs)</measure>
    <time_frame>28 weeks</time_frame>
    <description>Safety endpoint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum trough concentrations of PRV-015 at scheduled visits</measure>
    <time_frame>28 weeks</time_frame>
    <description>Characterize the pharmacokinetics (PK) of PRV-015</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of anti-PRV-015 antibodies</measure>
    <time_frame>28 weeks</time_frame>
    <description>Immunogenicity endpoint</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">220</enrollment>
  <condition>Celiac Disease</condition>
  <arm_group>
    <arm_group_label>PRV-015 Low Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PRV-015 Low Dose, sterile solution for subcutaneous administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PRV-015 Medium Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PRV-015 Medium Dose, sterile solution for subcutaneous administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PRV-015 High Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PRV-015 High Dose, sterile solution for subcutaneous administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo, sterile solution for subcutaneous administration</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PRV-015</intervention_name>
    <description>Fully human monoclonal antibody against interleukin 15 (IL-15)</description>
    <arm_group_label>PRV-015 High Dose</arm_group_label>
    <arm_group_label>PRV-015 Low Dose</arm_group_label>
    <arm_group_label>PRV-015 Medium Dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A diagnosis of celiac disease by intestinal biopsy&#xD;
&#xD;
          -  Following a GFD for at least 12 consecutive months&#xD;
&#xD;
          -  Must have detectable (above the lower limit of detection) serum celiac-related&#xD;
             antibodies&#xD;
&#xD;
          -  Must have human leukocyte antigen DQ (HLA-DQ) typing consistent with celiac disease&#xD;
             (DQ2 and/or DQ8)&#xD;
&#xD;
          -  Subjects must have had at least one of the following symptoms at least once per week&#xD;
             during the month before screening: diarrhea, loose stools, abdominal pain, abdominal&#xD;
             cramping, bloating, or gas.&#xD;
&#xD;
          -  Body weight between 35 and 120 kg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current diagnosis of any severe complication of celiac disease, such as refractory&#xD;
             celiac disease type 1 (RCD-I) or RCD-II, enteropathy-associated T-cell lymphoma&#xD;
             (EATL), ulcerative jejunitis, or gastrointestinal (GI) perforation&#xD;
&#xD;
          -  Diagnosis of any chronic, active GI disease other than celiac disease&#xD;
&#xD;
          -  Presence of any active infection&#xD;
&#xD;
          -  Selective immunoglobulin A (IgA) deficiency, defined as having undetectable levels of&#xD;
             IgA&#xD;
&#xD;
          -  Known or suspected exposure to coronavirus disease 2019 (COVID-19) infection in the 4&#xD;
             weeks before screening&#xD;
&#xD;
          -  Administration of a live vaccine within 14 days prior to randomization and the first&#xD;
             administration of study drug&#xD;
&#xD;
          -  History or presence of any clinically significant disease that, in the opinion of the&#xD;
             Investigator, may confound the subject's participation and follow-up in the clinical&#xD;
             trial or put the subject at unnecessary risk&#xD;
&#xD;
          -  Females who are pregnant or planning to become pregnant during the study period, or&#xD;
             who are currently breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chief Medical Officer</last_name>
    <role>Study Director</role>
    <affiliation>Provention Bio, Inc.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Doug Jacobstein</last_name>
    <phone>(908) 941-0784</phone>
    <email>proactiveceliac@proventionbio.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Study Director</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85260</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Encinitas</city>
        <state>California</state>
        <zip>92042</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90036</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94127</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Ventura</city>
        <state>California</state>
        <zip>93003</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80209</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Provention Bio</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Leesburg</city>
        <state>Florida</state>
        <zip>34748</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Provention Bio</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Naples</city>
        <state>Florida</state>
        <zip>34102</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Winter Park</city>
        <state>Florida</state>
        <zip>32789</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Provention Bio</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Provention Bio</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Northbrook</city>
        <state>Illinois</state>
        <zip>60062</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Provention Bio</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Annapolis</city>
        <state>Maryland</state>
        <zip>21401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Chevy Chase</city>
        <state>Maryland</state>
        <zip>20815</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Provention Bio</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Provention Bio</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Chesterfield</city>
        <state>Michigan</state>
        <zip>48047</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Provention Bio</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Provention Bio</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07960</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Provention Bio</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11235</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Provention Bio</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>New Windsor</city>
        <state>New York</state>
        <zip>12553</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Provention Bio</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Dublin</city>
        <state>Ohio</state>
        <zip>43016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Provention Bio</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Uniontown</city>
        <state>Pennsylvania</state>
        <zip>14401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Warwick</city>
        <state>Rhode Island</state>
        <zip>02886</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Provention Bio</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>North Charleston</city>
        <state>South Carolina</state>
        <zip>29405</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Provention Bio</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37212</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Cedar Park</city>
        <state>Texas</state>
        <zip>78613</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Provention Bio</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Garland</city>
        <state>Texas</state>
        <zip>75044</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77043</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>West Jordan</city>
        <state>Utah</state>
        <zip>84088</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Bellevue</city>
        <state>Washington</state>
        <zip>98004</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8S4K1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Provention Bio</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Richmond Hill</city>
        <state>Ontario</state>
        <zip>14B 3P8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Amsterdam</city>
        <zip>1105 AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Provention Bio</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Seville</city>
        <state>Andalusia</state>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Provention Bio</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Leon</city>
        <state>Castilla Y Leon</state>
        <zip>24071</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Provention Bio</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Terrassa</city>
        <state>Catalunya</state>
        <zip>082211</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Provention Bio</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Reus</city>
        <state>Tarragona</state>
        <zip>43204</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Girona</city>
        <zip>17007</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Provention BIo</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Huesca</city>
        <zip>22004</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Lleida</city>
        <zip>25196</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Provention Bio</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Provention Bio</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Provention Bio</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Madrid</city>
        <zip>28222</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Provention Bio</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Netherlands</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://proactiveceliac.com/</url>
    <description>Proactive Celiac Study website for patient information.</description>
  </link>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 30, 2023</last_update_submitted>
  <last_update_submitted_qc>June 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Celiac Disease</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04424927
org study id: PRV-015-002b
nct id: NCT04424927
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
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).
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: 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
description: Celiac Disease Patient-Reported Outcome (CeD PRO)
measure: Effect of treatment with PRV-015 on other measures of disease activity
time frame: 24 weeks
description: Intraepithelial lymphocyte (IEL) density
measure: Incidence of treatment-emergent adverse events (TEAEs)
time frame: 28 weeks
description: Safety endpoint
measure: Serum trough concentrations of PRV-015 at scheduled visits
time frame: 28 weeks
description: Characterize the pharmacokinetics (PK) of PRV-015
measure: Incidence of anti-PRV-015 antibodies
time frame: 28 weeks
description: Immunogenicity endpoint
arm group label: PRV-015 Low Dose
arm group type: Experimental
description: PRV-015 Low Dose, sterile solution for subcutaneous administration
arm group label: PRV-015 Medium Dose
arm group type: Experimental
description: PRV-015 Medium Dose, sterile solution for subcutaneous administration
arm group label: PRV-015 High Dose
arm group type: Experimental
description: PRV-015 High Dose, sterile solution for subcutaneous administration
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo, sterile solution for subcutaneous administration
intervention type: Biological
intervention name: PRV-015
description: Fully human monoclonal antibody against interleukin 15 (IL-15)
arm group label: PRV-015 High Dose
arm group label: PRV-015 Low Dose
arm group label: PRV-015 Medium Dose
intervention type: Other
intervention name: Placebo
description: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Chief Medical Officer
role: Study Director
affiliation: Provention Bio, Inc.
last name: Doug Jacobstein
phone: (908) 941-0784
email: proactiveceliac@proventionbio.com
last name: Study Director
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Canada
country: Netherlands
country: Spain
country: United States
url: https://proactiveceliac.com/
description: Proactive Celiac Study website for patient information.
responsible party type: Sponsor
mesh term: Celiac Disease