xml: <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/NCT06041269</url>
    </required_header>
    <id_info>
      <org_study_id>ANB030-203</org_study_id>
      <nct_id>NCT06041269</nct_id>
    </id_info>
    <brief_title>Study of Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Rheumatoid Arthritis (Renoir)</brief_title>
    <official_title>A Phase 2, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Rheumatoid Arthritis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>AnaptysBio, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>AnaptysBio, Inc.</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Renoir Study: This study will evaluate the safety, tolerability, and efficacy of ANB 030 in&#xD;
        subjects with moderate to severe Rheumatoid Arthritis (RA)&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a Phase 2 global, Randomized, Double-Blind, Placebo-Controlled Study to&#xD;
        Evaluate the Efficacy and Safety of Rosnilimab as an add on therapy in Subjects with Moderate&#xD;
        to Severe Rheumatoid Arthritis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 31, 2023</start_date>
    <completion_date type="Anticipated">October 8, 2025</completion_date>
    <primary_completion_date type="Anticipated">March 8, 2025</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>Mean change from Baseline in 28-Joint Disease Activity Score based on CRP (DAS28-CRP) at Week 12</measure>
      <time_frame>Baseline to Week 12</time_frame>
      <description>The DAS28-CRP is a validated composite assessment that assesses RA disease activity based on tender and swollen joint counts of 28 joints</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>American College of Rheumatology 20%, Improvement Criteria (ACR20) response rate at Week 12</measure>
      <time_frame>Baseline to Week 12</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>American College of Rheumatology 50% and 70% Improvement Criteria (ACR50 and ACR70) response rates at Week 12</measure>
      <time_frame>Baseline to Week 12</time_frame>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">420</enrollment>
    <condition>Rheumatoid Arthritis</condition>
    <arm_group>
      <arm_group_label>ANB030 SC Dose 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This arm will receive treatment SC</description>
    </arm_group>
    <arm_group>
      <arm_group_label>ANB030 SC Dose 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This arm will receive treatment SC</description>
    </arm_group>
    <arm_group>
      <arm_group_label>ANB030 SC Dose 3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This arm will receive treatment SC</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>This arm will receive Placebo</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>ANB030</intervention_name>
      <description>PD-1 agonist antibody</description>
      <arm_group_label>ANB030 SC Dose 1</arm_group_label>
      <arm_group_label>ANB030 SC Dose 2</arm_group_label>
      <arm_group_label>ANB030 SC Dose 3</arm_group_label>
      <other_name>Rosnilimab</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Key Inclusion Criteria:&#xD;
  &#xD;
            -  Aged 18 years or older.&#xD;
  &#xD;
            -  A diagnosis of Rheumatoid Arthritis based on ACR/EULAR 2010 classification criteria,&#xD;
               for at least 3 months before participating in the trial.&#xD;
  &#xD;
            -  Must be receiving treatment with at least 1, but not more than 2 csDMARDs for at least&#xD;
               3 months and be on stage dosages for at least 8 weeks prior to joining and throughout&#xD;
               the trial&#xD;
  &#xD;
          Key Exclusion Criteria:&#xD;
  &#xD;
            -  History of an inflammatory joint disease other than Rheumatoid Arthritis&#xD;
  &#xD;
            -  Prior exposure to a PD-1 or PD-L1 agonist, antagonist, or modulator&#xD;
  &#xD;
            -  History of cancer within the last 5 years (except for some skin cancers)&#xD;
  &#xD;
            -  Any known or suspected condition that would compromise immune status.&#xD;
  &#xD;
            -  Pregnant or breastfeeding women.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>AnaptysBio Clinical Trial Inbox</last_name>
      <phone>858-362-2093</phone>
      <email>Clinicaltrialinfo@anaptysbio.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>AnaptysBio Investigative Site 10-112</name>
        <address>
          <city>Whittier</city>
          <state>California</state>
          <zip>90602</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>AnaptysBio Investigative Site 10-103</name>
        <address>
          <city>Aventura</city>
          <state>Florida</state>
          <zip>33180</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>AnaptysBio Investigative Site 10-122</name>
        <address>
          <city>Homestead</city>
          <state>Florida</state>
          <zip>33032</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>AnaptysBio Investigative Site 10-102</name>
        <address>
          <city>Miami</city>
          <state>Florida</state>
          <zip>33155</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>AnaptysBio Investigative Site 10-124</name>
        <address>
          <city>Plantation</city>
          <state>Florida</state>
          <zip>33324</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>AnaptysBio Investigative Site 10-101</name>
        <address>
          <city>Jackson</city>
          <state>Tennessee</state>
          <zip>38305</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>AnaptysBio Investigative Site 10-108</name>
        <address>
          <city>Mesquite</city>
          <state>Texas</state>
          <zip>75150</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>AnaptysBio Investigative Site 47-101</name>
        <address>
          <city>Mar del Plata</city>
          <state>Beunos Aires</state>
          <zip>7600</zip>
          <country>Argentina</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>AnaptysBio Investigative Site 47-104</name>
        <address>
          <city>Zárate</city>
          <state>Beunos Aires</state>
          <zip>2800</zip>
          <country>Argentina</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>AnaptysBio Investigative Site 47-102</name>
        <address>
          <city>Rosario</city>
          <state>Santa Fe</state>
          <zip>2000</zip>
          <country>Argentina</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>AnaptysBio Investigative Site 47-105</name>
        <address>
          <city>Rosario</city>
          <state>Santa Fe</state>
          <zip>2000</zip>
          <country>Argentina</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>AnaptysBio Investigative Site 47-103</name>
        <address>
          <city>San Miguel De Tucumán</city>
          <state>Tucuman</state>
          <zip>4000</zip>
          <country>Argentina</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>AnaptysBio Investigative Site 47-105</name>
        <address>
          <city>Cordoba</city>
          <zip>5016</zip>
          <country>Argentina</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>AnaptysBio Investigative Site 71-101</name>
        <address>
          <city>Tallinn</city>
          <zip>13419</zip>
          <country>Estonia</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>AnaptysBio Investigative Site 59-101</name>
        <address>
          <city>Tbilisi</city>
          <zip>0112</zip>
          <country>Georgia</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>AnaptysBio Investigative Site 59-105</name>
        <address>
          <city>Tbilisi</city>
          <zip>0131</zip>
          <country>Georgia</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>AnaptysBio Investigative Site 59-104</name>
        <address>
          <city>Tbilisi</city>
          <zip>0159</zip>
          <country>Georgia</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>AnaptysBio Investigative Site 59-106</name>
        <address>
          <city>Tbilisi</city>
          <zip>0159</zip>
          <country>Georgia</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>AnaptysBio Investigative Site 59-102</name>
        <address>
          <city>Tbilisi</city>
          <zip>0160</zip>
          <country>Georgia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Site 59-101</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>AnaptysBio Investigative Site 59-103</name>
        <address>
          <city>Tbilisi</city>
          <zip>0172</zip>
          <country>Georgia</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>AnaptysBio Investigative Site 28-103</name>
        <address>
          <city>Debrecen</city>
          <state>Hajdu-Bihar</state>
          <zip>4032</zip>
          <country>Hungary</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>AnaptysBio Investigative Site 28-104</name>
        <address>
          <city>Budapest</city>
          <zip>1036</zip>
          <country>Hungary</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>AnaptysBio Investigative Site 51-102</name>
        <address>
          <city>San Miguel</city>
          <state>Ciudad De Mexico</state>
          <zip>11850</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>AnaptysBio Investigative Site 51-106</name>
        <address>
          <city>Mexico City</city>
          <zip>11650</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>AnaptysBio Investigative Site 73-101</name>
        <address>
          <city>Chisinau</city>
          <state>Kishinev</state>
          <zip>29</zip>
          <country>Moldova, Republic of</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>AnaptysBio Investigative Site 72-103</name>
        <address>
          <city>Cayma</city>
          <state>Arequipa</state>
          <zip>4001</zip>
          <country>Peru</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>AnaptysBio Investigative Site 72-103</name>
        <address>
          <city>Bella Vista</city>
          <state>Callao</state>
          <zip>Callao 2</zip>
          <country>Peru</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>AnaptysBio Investigative Site 72-102</name>
        <address>
          <city>San Isidro</city>
          <state>Lima</state>
          <zip>Lima 27</zip>
          <country>Peru</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>AnaptysBio Investigative Site 30-107</name>
        <address>
          <city>Warsaw</city>
          <state>Mazowieckie</state>
          <zip>02-118</zip>
          <country>Poland</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>AnaptysBio Investigative Site 30-112</name>
        <address>
          <city>Poznań</city>
          <state>Wielkopolskie</state>
          <zip>60693</zip>
          <country>Poland</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>AnaptysBio Investigative Site 30-102</name>
        <address>
          <city>Bytom</city>
          <state>Woj.Slaskie</state>
          <zip>41-902</zip>
          <country>Poland</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>AnaptysBio Investigative Site 67-101</name>
        <address>
          <city>Košice</city>
          <zip>4011</zip>
          <country>Slovakia</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location_countries>
      <country>Argentina</country>
      <country>Estonia</country>
      <country>Georgia</country>
      <country>Hungary</country>
      <country>Mexico</country>
      <country>Moldova, Republic of</country>
      <country>Peru</country>
      <country>Poland</country>
      <country>Slovakia</country>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>PD-1 Agonist</keyword>
    <keyword>ANB030</keyword>
    <keyword>Renoir</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Arthritis</mesh_term>
      <mesh_term>Arthritis, Rheumatoid</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06041269
  org study id: ANB030-203
  nct id: NCT06041269
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  Renoir Study: This study will evaluate the safety, tolerability, and efficacy of ANB 030 in
        subjects with moderate to severe Rheumatoid Arthritis (RA)
  This study is a Phase 2 global, Randomized, Double-Blind, Placebo-Controlled Study to
        Evaluate the Efficacy and Safety of Rosnilimab as an add on therapy in Subjects with Moderate
        to Severe Rheumatoid Arthritis.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Mean change from Baseline in 28-Joint Disease Activity Score based on CRP (DAS28-CRP) at Week 12
  time frame: Baseline to Week 12
  description: The DAS28-CRP is a validated composite assessment that assesses RA disease activity based on tender and swollen joint counts of 28 joints
  measure: American College of Rheumatology 20%, Improvement Criteria (ACR20) response rate at Week 12
  time frame: Baseline to Week 12
  measure: American College of Rheumatology 50% and 70% Improvement Criteria (ACR50 and ACR70) response rates at Week 12
  time frame: Baseline to Week 12
  arm group label: ANB030 SC Dose 1
  arm group type: Experimental
  description: This arm will receive treatment SC
  arm group label: ANB030 SC Dose 2
  arm group type: Experimental
  description: This arm will receive treatment SC
  arm group label: ANB030 SC Dose 3
  arm group type: Experimental
  description: This arm will receive treatment SC
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: This arm will receive Placebo
  intervention type: Drug
  intervention name: ANB030
  description: PD-1 agonist antibody
  arm group label: ANB030 SC Dose 1
  arm group label: ANB030 SC Dose 2
  arm group label: ANB030 SC Dose 3
  other name: Rosnilimab
  intervention type: Drug
  intervention name: Placebo
  description: Placebo
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: AnaptysBio Clinical Trial Inbox
  phone: 858-362-2093
  email: Clinicaltrialinfo@anaptysbio.com
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  country: Argentina
  country: Estonia
  country: Georgia
  country: Hungary
  country: Mexico
  country: Moldova, Republic of
  country: Peru
  country: Poland
  country: Slovakia
  country: United States
  responsible party type: Sponsor
  mesh term: Arthritis
  mesh term: Arthritis, Rheumatoid
  sharing ipd: Yes