<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/NCT03827018</url>
  </required_header>
  <id_info>
    <org_study_id>KPL-301-C001</org_study_id>
    <nct_id>NCT03827018</nct_id>
  </id_info>
  <brief_title>KPL-301 for Subjects With Giant Cell Arteritis</brief_title>
  <official_title>A Phase 2, Randomized, Double-blind Placebo-controlled Study to Test the Efficacy and Safety of KPL-301 in Giant Cell Arteritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kiniksa Pharmaceuticals, Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kiniksa Pharmaceuticals, Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the study is to evaluate the efficacy of mavrilimumab (KPL-301)&#xD;
      versus placebo, co-administered with a 26-week corticosteroid taper, for maintaining&#xD;
      sustained remission for 26 weeks in subjects with new onset or relapsing/refractory giant&#xD;
      cell arteritis (GCA).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This Phase 2 randomized, double-blind, placebo-controlled proof of concept study will&#xD;
      evaluate the efficacy and safety of mavrilimumab co-administered with a 26-week&#xD;
      corticosteroid taper in subjects with GCA. The study will consist of a screening period (up&#xD;
      to 6 weeks), a 26-week double-blind placebo-controlled period during which subjects will&#xD;
      receive blinded mavrilimumab or placebo co-administered with a 26-week corticosteroid taper,&#xD;
      and a 12-week washout safety follow-up period during which subjects will discontinue and wash&#xD;
      off blinded mavrilimumab or placebo.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 20, 2018</start_date>
  <completion_date type="Actual">November 25, 2020</completion_date>
  <primary_completion_date type="Actual">August 13, 2020</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>
    <intervention_model_description>Upon successful completion of the screening procedures, diagnosis criteria will be entered into an interactive web response system, and eligible subjects will be stratified for randomized study treatment into two cohorts according to whether subjects have new-onset or relapsing/refractory disease.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to flare by Week 26, defined as time from randomization to the date of first flare occurring within the 26-week period, in the modified intent-to-treat population.</measure>
    <time_frame>week 26</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to flare by Week 26 in the per-protocol population.</measure>
    <time_frame>week 26</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects who have completed the 26-week corticosteroid taper and who have a normal erythrocyte sedimentation rate.</measure>
    <time_frame>week 26</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects who have completed the 26-week corticosteroid taper and who have a normal c-reactive protein level.</measure>
    <time_frame>week 26</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects who have completed the 26-week corticosteroid taper and who have no signs or symptoms of GCA.</measure>
    <time_frame>week 26</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to corticosteroid dose of zero mg/day.</measure>
    <time_frame>through study completion up to 26 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative steroid dose at week 26 and at the end of the washout safety follow-up period.</measure>
    <time_frame>through study completion up to 26 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Giant Cell Arteritis</condition>
  <arm_group>
    <arm_group_label>mavrilimumab</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects randomized to mavrilimumab will receive 150 mg every other week by subcutaneous injection co-administered with a 26-week corticosteroid taper.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects randomized to placebo will receive placebo every other week by subcutaneous injection co-administered with a 26-week corticosteroid taper.</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>mavrilimumab</intervention_name>
    <description>1 mL of 150 mg in a pre-filled syringe</description>
    <arm_group_label>mavrilimumab</arm_group_label>
    <other_name>KPL-301</other_name>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>1 mL of placebo in a pre-filled syringe</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>prednisone</intervention_name>
    <description>Prednisone tablets for oral administration containing either 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone United States Pharmacopeia (USP)</description>
    <arm_group_label>mavrilimumab</arm_group_label>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Selected Inclusion Criteria:&#xD;
&#xD;
          1. Subjects with new-onset or relapsing/refractory GCA.&#xD;
&#xD;
          2. Westergren erythrocyte sedimentation rate &gt; 30 mm/hour or c-reactive protein ≥ 1 mg/&#xD;
             dL.&#xD;
&#xD;
          3. Remission of GCA at or before Day 0.&#xD;
&#xD;
          4. Female subjects must be postmenopausal or permanently sterile following documented&#xD;
             hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or tubal ligation or&#xD;
             having a male partner with vasectomy as affirmed by the subject, or nonpregnant,&#xD;
             nonlactating, and if sexually active having agreed to use a highly effective method of&#xD;
             contraception.&#xD;
&#xD;
          5. Male subjects must have documented vasectomy or if sexually active must agree to use a&#xD;
             highly effective method of contraception with their partners of childbearing&#xD;
             potential.&#xD;
&#xD;
        Selected Exclusion Criteria:&#xD;
&#xD;
          1. Transplanted organs (except corneal transplant performed more than 3 months prior to&#xD;
             randomization).&#xD;
&#xD;
          2. Concurrent enrollment in another interventional clinical study.&#xD;
&#xD;
          3. Treatment with non-biologic investigational drug therapy within 4 weeks or 5&#xD;
             half-lives of the study agent, whichever was longer, prior to screening.&#xD;
&#xD;
          4. Cell-depleting biological therapies within 12 months prior to Day 0, or&#xD;
             noncell-depleting biological therapies within 8 weeks (or 5 half-lives, whichever is&#xD;
             longer) prior to screening.&#xD;
&#xD;
          5. Treatment with alkylating agents within 12 weeks prior to screening.&#xD;
&#xD;
          6. Intramuscular, Intra-articular or IV corticosteroids within 4 weeks prior to&#xD;
             screening.&#xD;
&#xD;
          7. Receipt of live (attenuated) vaccine within the 4 weeks before Day 0.&#xD;
&#xD;
          8. Treatment with hydroxychloroquine, cyclosporine A, azathioprine, cyclophosphamide, or&#xD;
             mycophenolate mofetil (MMF) within 4 weeks of screening.&#xD;
&#xD;
          9. Female subjects who are pregnant, intending to become pregnant, or are breastfeeding.&#xD;
&#xD;
         10. Known history of allergy or reaction to any component of the mavrilimumab or placebo&#xD;
             formulation or to any other biologic therapy or prednisone or any of its excipients.&#xD;
&#xD;
         11. Positive (or 2 indeterminate) QuantiFERON test results.&#xD;
&#xD;
         12. Clinically significant active infection or infection requiring hospitalization or IV&#xD;
             antibiotics within 12 weeks before screening or opportunistic infection within 6&#xD;
             months before screening.&#xD;
&#xD;
         13. Chronic active hepatitis B infection.&#xD;
&#xD;
         14. Subjects at a high risk of infection, a history of an infected joint prosthesis still&#xD;
             in situ, leg ulcers, indwelling urinary catheter, or persistent or recurrent chest&#xD;
             infections.&#xD;
&#xD;
         15. History of cancer within the last 10 years, except for basal and squamous cell&#xD;
             carcinoma of the skin or in situ carcinoma of the cervix treated and considered cured.&#xD;
&#xD;
         16. Evidence of clinically-uncontrolled respiratory disease.&#xD;
&#xD;
         17. History of chronic respiratory tract infections.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John Paolini, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Kiniksa Pharmaceuticals, Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Site 1703</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1708</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1706</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1701</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1704</name>
      <address>
        <city>Saint Clair Shores</city>
        <state>Michigan</state>
        <zip>48081</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1702</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1705</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2102</name>
      <address>
        <city>Kogarah</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2106</name>
      <address>
        <city>Melbourne</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2105</name>
      <address>
        <city>Nedlands</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2101</name>
      <address>
        <city>Victoria Park</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2104</name>
      <address>
        <city>Woodville South</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2204</name>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2202</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2201</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2203</name>
      <address>
        <city>Yvoir</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2303</name>
      <address>
        <city>Zagreb</city>
        <zip>10 000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2401</name>
      <address>
        <city>Tallinn</city>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2402</name>
      <address>
        <city>Tartu</city>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2502</name>
      <address>
        <city>Tuebingen</city>
        <state>Baden-Württemberg</state>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2504</name>
      <address>
        <city>Erlangen</city>
        <state>Bayern</state>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2507</name>
      <address>
        <city>Freiburg</city>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2503</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2508</name>
      <address>
        <city>Jena</city>
        <zip>7747</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2501</name>
      <address>
        <city>Kirchheim Unter Teck</city>
        <zip>73230</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2601</name>
      <address>
        <city>Dublin</city>
        <zip>4</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2703</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2702</name>
      <address>
        <city>Reggio Emilia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2701</name>
      <address>
        <city>Rozzano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2704</name>
      <address>
        <city>Udine</city>
        <zip>33100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2802</name>
      <address>
        <city>Groningen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2801</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2902</name>
      <address>
        <city>Christchurch</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2901</name>
      <address>
        <city>Wellington</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1002</name>
      <address>
        <city>Kraków</city>
        <zip>31-121</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1103</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1101</name>
      <address>
        <city>Belgrade</city>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1102</name>
      <address>
        <city>Belgrade</city>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1201</name>
      <address>
        <city>Ljubljana</city>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1303</name>
      <address>
        <city>A Coruña</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1301</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1304</name>
      <address>
        <city>Bilbao</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1302</name>
      <address>
        <city>Santa Cruz De Tenerife</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1604</name>
      <address>
        <city>Edinburgh</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1602</name>
      <address>
        <city>Leytonstone</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1601</name>
      <address>
        <city>Newcastle Upon Tyne</city>
        <zip>NE7 7DN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1603</name>
      <address>
        <city>Southend</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Croatia</country>
    <country>Estonia</country>
    <country>Germany</country>
    <country>Ireland</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>New Zealand</country>
    <country>Poland</country>
    <country>Serbia</country>
    <country>Slovenia</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <disposition_first_submitted>August 2, 2021</disposition_first_submitted>
  <disposition_first_submitted_qc>August 2, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">August 4, 2021</disposition_first_posted>
  <last_update_submitted>August 30, 2021</last_update_submitted>
  <last_update_submitted_qc>August 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>GCA</keyword>
  <keyword>temporal arteritis</keyword>
  <keyword>Horton's disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polymyalgia Rheumatica</mesh_term>
    <mesh_term>Giant Cell Arteritis</mesh_term>
    <mesh_term>Arteritis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prednisone</mesh_term>
    <mesh_term>Mavrilimumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>August 2, 2023</submitted>
    <returned>August 28, 2023</returned>
  </pending_results>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT03827018
org study id: KPL-301-C001
nct id: NCT03827018
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: Yes
The primary objective of the study is to evaluate the efficacy of mavrilimumab (KPL-301)
      versus placebo, co-administered with a 26-week corticosteroid taper, for maintaining
      sustained remission for 26 weeks in subjects with new onset or relapsing/refractory giant
      cell arteritis (GCA).
This Phase 2 randomized, double-blind, placebo-controlled proof of concept study will
      evaluate the efficacy and safety of mavrilimumab co-administered with a 26-week
      corticosteroid taper in subjects with GCA. The study will consist of a screening period (up
      to 6 weeks), a 26-week double-blind placebo-controlled period during which subjects will
      receive blinded mavrilimumab or placebo co-administered with a 26-week corticosteroid taper,
      and a 12-week washout safety follow-up period during which subjects will discontinue and wash
      off blinded mavrilimumab or placebo.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Upon successful completion of the screening procedures, diagnosis criteria will be entered into an interactive web response system, and eligible subjects will be stratified for randomized study treatment into two cohorts according to whether subjects have new-onset or relapsing/refractory disease.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Time to flare by Week 26, defined as time from randomization to the date of first flare occurring within the 26-week period, in the modified intent-to-treat population.
time frame: week 26
measure: Time to flare by Week 26 in the per-protocol population.
time frame: week 26
measure: Percentage of subjects who have completed the 26-week corticosteroid taper and who have a normal erythrocyte sedimentation rate.
time frame: week 26
measure: Percentage of subjects who have completed the 26-week corticosteroid taper and who have a normal c-reactive protein level.
time frame: week 26
measure: Percentage of subjects who have completed the 26-week corticosteroid taper and who have no signs or symptoms of GCA.
time frame: week 26
measure: Time to corticosteroid dose of zero mg/day.
time frame: through study completion up to 26 weeks
measure: Cumulative steroid dose at week 26 and at the end of the washout safety follow-up period.
time frame: through study completion up to 26 weeks
arm group label: mavrilimumab
arm group type: Active Comparator
description: Subjects randomized to mavrilimumab will receive 150 mg every other week by subcutaneous injection co-administered with a 26-week corticosteroid taper.
arm group label: placebo
arm group type: Placebo Comparator
description: Subjects randomized to placebo will receive placebo every other week by subcutaneous injection co-administered with a 26-week corticosteroid taper.
intervention type: Combination Product
intervention name: mavrilimumab
description: 1 mL of 150 mg in a pre-filled syringe
arm group label: mavrilimumab
other name: KPL-301
intervention type: Combination Product
intervention name: placebo
description: 1 mL of placebo in a pre-filled syringe
arm group label: placebo
intervention type: Drug
intervention name: prednisone
description: Prednisone tablets for oral administration containing either 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone United States Pharmacopeia (USP)
arm group label: mavrilimumab
arm group label: placebo
criteria: 
gender: All
minimum age: 50 Years
maximum age: 85 Years
healthy volunteers: No
last name: John Paolini, M.D.
role: Study Director
affiliation: Kiniksa Pharmaceuticals, Ltd.
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country: Australia
country: Belgium
country: Croatia
country: Estonia
country: Germany
country: Ireland
country: Italy
country: Netherlands
country: New Zealand
country: Poland
country: Serbia
country: Slovenia
country: Spain
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Polymyalgia Rheumatica
mesh term: Giant Cell Arteritis
mesh term: Arteritis
mesh term: Prednisone
mesh term: Mavrilimumab
sharing ipd: No
submitted: August 2, 2023
returned: August 28, 2023