<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/NCT01732211</url>
  </required_header>
  <id_info>
    <org_study_id>A6261009</org_study_id>
    <nct_id>NCT01732211</nct_id>
  </id_info>
  <brief_title>A Phase 2, Safety, Tolerability, and Efficacy Study of PD 0360324 in Chronic Pulmonary Sarcoidosis</brief_title>
  <official_title>A PHASE 2 RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP, 20-WEEK SAFETY, TOLERABILITY, AND EFFICACY STUDY OF PD 0360324 IN ADULT SUBJECTS WITH CHRONIC PULMONARY SARCOIDOSIS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study proposes to evaluate the safety, tolerability, and efficacy of PD 0360324 in&#xD;
      subjects with chronic pulmonary sarcoidosis inadequately treated with standard of care&#xD;
      therapies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The trial was terminated prematurely on Mar 24, 2014 due to a business decision. The decision&#xD;
      to terminate the trial was not based on any clinical safety or efficacy concerns.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    See termination reason in detailed description.&#xD;
  </why_stopped>
  <start_date type="Actual">March 15, 2013</start_date>
  <completion_date type="Actual">September 23, 2013</completion_date>
  <primary_completion_date type="Actual">September 23, 2013</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>Basic Science</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline (Absolute) in % Predicted Forced Vital Capacity (FVC) Compared to Placebo at Week 16</measure>
    <time_frame>Baseline, Week 16</time_frame>
    <description>The percent predicted FVC was calculated by observed FVC/predicted FVC * 100. The predicted FVC values was calculated according to age, height, race and gender. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Chest X-ray Global Assessment Score (5-point )</measure>
    <time_frame>Baseline, Week 16</time_frame>
    <description>Digital copies of Chest x-rays performed during the study were graded according to a 5 point Likert scale: 1 = markedly worsened; 2 = worsened; 3 = unchanged; 4 = improved; and 5 = markedly improved. Baseline will be defined as the last available x-ray prior to first dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in FVC (Absolute ) Compared to Placebo at Weeks 2,4,8,12, 14, and 20</measure>
    <time_frame>Baseline, Weeks 2, 4, 8, 12, 14, and 20</time_frame>
    <description>FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was obtained from spirometry, performed before study treatment administration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Absolute in FVC (% Predicted) Compared to Placebo at Weeks 2,4,8,12,14, and 20</measure>
    <time_frame>Baseline, Weeks 2, 4, 8, 12, 14, and 20</time_frame>
    <description>The percent predicted FVC was calculated by observed FVC/predicted FVC * 100. The predicted FVC values was calculated according to age, height, race and gender. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 2,4,8,12,14, 16 and 20</measure>
    <time_frame>Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20</time_frame>
    <description>FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in % Predicted FEV1 at Weeks 2,4,8,12,14, 16 and 20</measure>
    <time_frame>Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20</time_frame>
    <description>The percent predicted FEV1 was calculated by observed FEV1/predicted FEV1 * 100. The predicted FEV1 values was calculated according to age, height, race and gender. FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Ratio of FEV1/FVC at Weeks 2,4,8,12,14, 16 and 20</measure>
    <time_frame>Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20</time_frame>
    <description>FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was obtained from spirometry, performed before study treatment administration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimated Treatment Effect Over Placebo in FVC Averaged Over 16 Weeks</measure>
    <time_frame>Baseline, Weeks 0, 2, 4, 8, 12, 14, 16</time_frame>
    <description>FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Through FVC was obtained from spirometry, performed before study treatment administration.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Pulmonary Sarcoidosis</condition>
  <arm_group>
    <arm_group_label>PD 0360324</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PD 0360324</intervention_name>
    <description>100 mg Q2W or 150 mg Q2W via intravenous infusion based on protocol determined dose escalation/de-escalation criteria; 12 weeks Active Therapy;</description>
    <arm_group_label>PD 0360324</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Normal Saline for injection</intervention_name>
    <description>normal saline Q2W via intravenous infusion for 12 weeks</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of biopsy-proved chronic pulmonary sarcoidosis either Stage 2 or Stage 3 for&#xD;
             at least 1 year;&#xD;
&#xD;
          -  Forced Vital Capacity (FVC) lung assessment of &gt;40% and &lt; or = to 80% predicted normal&#xD;
             values at screening;&#xD;
&#xD;
          -  age 21-75 years of age;&#xD;
&#xD;
          -  treatment with a stable (longer than 4 weeks) regimen of corticosteroids (between 10&#xD;
             and 30 mg of prednisone) for at least 3 months prior to Screening; (other&#xD;
             anti-inflammatory drugs may be permitted as defined by the study protocol)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of any other pulmonary (lung) disease than sarcoidosis (ex, asthma requiring&#xD;
             maintenance treatment, chronic obstructive pulmonary disease (COPD));&#xD;
&#xD;
          -  Pulmonary hypertension, significant lung fibrosis, any chronic infection (eg, TB,&#xD;
             HIV);&#xD;
&#xD;
          -  treatment with other biologic anti-inflammatory/immuno-modulatory drugs;&#xD;
&#xD;
          -  active smokers;&#xD;
&#xD;
          -  class 3 or 4 congestive heart failure;&#xD;
&#xD;
          -  cancer, or history of cancer within past 5 years;&#xD;
&#xD;
          -  history of ischemic heart disease, heart attack, stroke, any heart muscle disease;&#xD;
&#xD;
          -  liver disease;&#xD;
&#xD;
          -  history of alcohol or drug abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mount Sinai School Of Medicine/Mount Sinai Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Arts Building</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Barrett Cancer Center at UC Health</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iinterstitial Lung Disease &amp; Sarcoidosis Clinic</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45267</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6261009&amp;StudyName=A%20Phase%202%2C%20Safety%2C%20Tolerability%2C%20and%20Efficacy%20Study%20of%20PD%200360324%20in%20Chronic%20Pulmonary%20Sarcoidosis</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>November 19, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <results_first_submitted>January 17, 2017</results_first_submitted>
  <results_first_submitted_qc>December 16, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">January 6, 2020</results_first_posted>
  <disposition_first_submitted>October 30, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>October 30, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">November 26, 2015</disposition_first_posted>
  <last_update_submitted>December 16, 2019</last_update_submitted>
  <last_update_submitted_qc>December 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Phase 2</keyword>
  <keyword>Randomized</keyword>
  <keyword>Double Blind</keyword>
  <keyword>Placebo Controlled</keyword>
  <keyword>Parallel</keyword>
  <keyword>20 Week Safety</keyword>
  <keyword>Tolerability</keyword>
  <keyword>and Efficacy Study</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcoidosis, Pulmonary</mesh_term>
    <mesh_term>Sarcoidosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
    <ipd_url>https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests</ipd_url>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>In Part A, approximately 22 subjects were to be enrolled to receive PD 0360324 100 mg once every 2 weeks (Q2W)/150 mg Q2W. In Part B, approximately 66 subjects were planned to be enrolled to receive PD 0360324 (either 100 or 150 mg Q2W defined in Part A) B.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>PD 0360324 100 mg Q2W / 150 mg Q2W</title>
          <description>PD-0360324 100 milligram (mg) was administered as intravenous infusion on Day 1 of every 2 weeks for Week 0 and Week 2. PD-0360324 150 mg was administered as intravenous infusion on Day 1 of every 2 weeks for Weeks 4, 6, 8, 10, and 12.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>PD 0360324 100 mg Q2W / 150 mg Q2W</title>
          <description>PD-0360324 100 milligram (mg) was administered as intravenous infusion on Day 1 of every 2 weeks for Week 0 and Week 2. PD-0360324 150 mg was administered as intravenous infusion on Day 1 of every 2 weeks for Weeks 4, 6, 8, 10, and 12.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58" spread="NA">Standard deviation cannot be calculated for a sample size of 1.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline (Absolute) in % Predicted Forced Vital Capacity (FVC) Compared to Placebo at Week 16</title>
        <description>The percent predicted FVC was calculated by observed FVC/predicted FVC * 100. The predicted FVC values was calculated according to age, height, race and gender. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.</description>
        <time_frame>Baseline, Week 16</time_frame>
        <population>No subjects were analyzed due to early termination of the study and the small enrollment number.</population>
        <group_list>
          <group group_id="O1">
            <title>PD 0360324 100 mg Q2W / 150 mg Q2W</title>
            <description>PD-0360324 100 milligram (mg) was administered as intravenous infusion on Day 1 of every 2 weeks for Week 0 and Week 2. PD-0360324 150 mg was administered as intravenous infusion on Day 1 of every 2 weeks for Weeks 4, 6, 8, 10, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline (Absolute) in % Predicted Forced Vital Capacity (FVC) Compared to Placebo at Week 16</title>
          <description>The percent predicted FVC was calculated by observed FVC/predicted FVC * 100. The predicted FVC values was calculated according to age, height, race and gender. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.</description>
          <population>No subjects were analyzed due to early termination of the study and the small enrollment number.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Chest X-ray Global Assessment Score (5-point )</title>
        <description>Digital copies of Chest x-rays performed during the study were graded according to a 5 point Likert scale: 1 = markedly worsened; 2 = worsened; 3 = unchanged; 4 = improved; and 5 = markedly improved. Baseline will be defined as the last available x-ray prior to first dose.</description>
        <time_frame>Baseline, Week 16</time_frame>
        <population>No subjects were analyzed due to early termination of the study and the small enrollment number.</population>
        <group_list>
          <group group_id="O1">
            <title>PD 0360324 100 mg Q2W / 150 mg Q2W</title>
            <description>PD-0360324 100 milligram (mg) was administered as intravenous infusion on Day 1 of every 2 weeks for Week 0 and Week 2. PD-0360324 150 mg was administered as intravenous infusion on Day 1 of every 2 weeks for Weeks 4, 6, 8, 10, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Chest X-ray Global Assessment Score (5-point )</title>
          <description>Digital copies of Chest x-rays performed during the study were graded according to a 5 point Likert scale: 1 = markedly worsened; 2 = worsened; 3 = unchanged; 4 = improved; and 5 = markedly improved. Baseline will be defined as the last available x-ray prior to first dose.</description>
          <population>No subjects were analyzed due to early termination of the study and the small enrollment number.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in FVC (Absolute ) Compared to Placebo at Weeks 2,4,8,12, 14, and 20</title>
        <description>FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was obtained from spirometry, performed before study treatment administration.</description>
        <time_frame>Baseline, Weeks 2, 4, 8, 12, 14, and 20</time_frame>
        <population>No subjects were analyzed due to early termination of the study and the small enrollment number.</population>
        <group_list>
          <group group_id="O1">
            <title>PD 0360324 100 mg Q2W / 150 mg Q2W</title>
            <description>PD-0360324 100 milligram (mg) was administered as intravenous infusion on Day 1 of every 2 weeks for Week 0 and Week 2. PD-0360324 150 mg was administered as intravenous infusion on Day 1 of every 2 weeks for Weeks 4, 6, 8, 10, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in FVC (Absolute ) Compared to Placebo at Weeks 2,4,8,12, 14, and 20</title>
          <description>FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was obtained from spirometry, performed before study treatment administration.</description>
          <population>No subjects were analyzed due to early termination of the study and the small enrollment number.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Absolute in FVC (% Predicted) Compared to Placebo at Weeks 2,4,8,12,14, and 20</title>
        <description>The percent predicted FVC was calculated by observed FVC/predicted FVC * 100. The predicted FVC values was calculated according to age, height, race and gender. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.</description>
        <time_frame>Baseline, Weeks 2, 4, 8, 12, 14, and 20</time_frame>
        <population>No subjects were analyzed due to early termination of the study and the small enrollment number.</population>
        <group_list>
          <group group_id="O1">
            <title>PD 0360324 100 mg Q2W / 150 mg Q2W</title>
            <description>PD-0360324 100 milligram (mg) was administered as intravenous infusion on Day 1 of every 2 weeks for Week 0 and Week 2. PD-0360324 150 mg was administered as intravenous infusion on Day 1 of every 2 weeks for Weeks 4, 6, 8, 10, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Absolute in FVC (% Predicted) Compared to Placebo at Weeks 2,4,8,12,14, and 20</title>
          <description>The percent predicted FVC was calculated by observed FVC/predicted FVC * 100. The predicted FVC values was calculated according to age, height, race and gender. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.</description>
          <population>No subjects were analyzed due to early termination of the study and the small enrollment number.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 2,4,8,12,14, 16 and 20</title>
        <description>FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration.</description>
        <time_frame>Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20</time_frame>
        <population>No subjects were analyzed due to early termination of the study and the small enrollment number.</population>
        <group_list>
          <group group_id="O1">
            <title>PD 0360324 100 mg Q2W / 150 mg Q2W</title>
            <description>PD-0360324 100 milligram (mg) was administered as intravenous infusion on Day 1 of every 2 weeks for Week 0 and Week 2. PD-0360324 150 mg was administered as intravenous infusion on Day 1 of every 2 weeks for Weeks 4, 6, 8, 10, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 2,4,8,12,14, 16 and 20</title>
          <description>FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration.</description>
          <population>No subjects were analyzed due to early termination of the study and the small enrollment number.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in % Predicted FEV1 at Weeks 2,4,8,12,14, 16 and 20</title>
        <description>The percent predicted FEV1 was calculated by observed FEV1/predicted FEV1 * 100. The predicted FEV1 values was calculated according to age, height, race and gender. FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.</description>
        <time_frame>Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20</time_frame>
        <population>No subjects were analyzed due to early termination of the study and the small enrollment number.</population>
        <group_list>
          <group group_id="O1">
            <title>PD 0360324 100 mg Q2W / 150 mg Q2W</title>
            <description>PD-0360324 100 milligram (mg) was administered as intravenous infusion on Day 1 of every 2 weeks for Week 0 and Week 2. PD-0360324 150 mg was administered as intravenous infusion on Day 1 of every 2 weeks for Weeks 4, 6, 8, 10, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in % Predicted FEV1 at Weeks 2,4,8,12,14, 16 and 20</title>
          <description>The percent predicted FEV1 was calculated by observed FEV1/predicted FEV1 * 100. The predicted FEV1 values was calculated according to age, height, race and gender. FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.</description>
          <population>No subjects were analyzed due to early termination of the study and the small enrollment number.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Ratio of FEV1/FVC at Weeks 2,4,8,12,14, 16 and 20</title>
        <description>FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was obtained from spirometry, performed before study treatment administration.</description>
        <time_frame>Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20</time_frame>
        <population>No subjects were analyzed due to early termination of the study and the small enrollment number.</population>
        <group_list>
          <group group_id="O1">
            <title>PD 0360324 100 mg Q2W / 150 mg Q2W</title>
            <description>PD-0360324 100 milligram (mg) was administered as intravenous infusion on Day 1 of every 2 weeks for Week 0 and Week 2. PD-0360324 150 mg was administered as intravenous infusion on Day 1 of every 2 weeks for Weeks 4, 6, 8, 10, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Ratio of FEV1/FVC at Weeks 2,4,8,12,14, 16 and 20</title>
          <description>FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was obtained from spirometry, performed before study treatment administration.</description>
          <population>No subjects were analyzed due to early termination of the study and the small enrollment number.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Estimated Treatment Effect Over Placebo in FVC Averaged Over 16 Weeks</title>
        <description>FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Through FVC was obtained from spirometry, performed before study treatment administration.</description>
        <time_frame>Baseline, Weeks 0, 2, 4, 8, 12, 14, 16</time_frame>
        <population>No subjects were analyzed due to early termination of the study and the small enrollment number.</population>
        <group_list>
          <group group_id="O1">
            <title>PD 0360324 100 mg Q2W / 150 mg Q2W</title>
            <description>PD-0360324 100 milligram (mg) was administered as intravenous infusion on Day 1 of every 2 weeks for Week 0 and Week 2. PD-0360324 150 mg was administered as intravenous infusion on Day 1 of every 2 weeks for Weeks 4, 6, 8, 10, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Estimated Treatment Effect Over Placebo in FVC Averaged Over 16 Weeks</title>
          <description>FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Through FVC was obtained from spirometry, performed before study treatment administration.</description>
          <population>No subjects were analyzed due to early termination of the study and the small enrollment number.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>PD 0360324 100 mg Q2W / 150 mg Q2W</title>
          <description>PD-0360324 100 milligram (mg) was administered as intravenous infusion on Day 1 of every 2 weeks for Week 0 and Week 2. PD-0360324 150 mg was administered as intravenous infusion on Day 1 of every 2 weeks for Weeks 4, 6, 8, 10, and 12.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 17.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Due to early termination of the study and the small enrollment number, analysis of primary and secondary pharmacodynamic endpoints could not be performed.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Pfizer ClinicalTrials.gov Call Center</name_or_title>
      <organization>Pfizer, Inc.</organization>
      <phone>1-800-718-1021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01732211
org study id: A6261009
nct id: NCT01732211
lead sponsor: 
has dmc: Yes
The study proposes to evaluate the safety, tolerability, and efficacy of PD 0360324 in
      subjects with chronic pulmonary sarcoidosis inadequately treated with standard of care
      therapies.
The trial was terminated prematurely on Mar 24, 2014 due to a business decision. The decision
      to terminate the trial was not based on any clinical safety or efficacy concerns.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Triple (Participant, Care Provider, Investigator)
measure: Change From Baseline (Absolute) in % Predicted Forced Vital Capacity (FVC) Compared to Placebo at Week 16
time frame: Baseline, Week 16
description: The percent predicted FVC was calculated by observed FVC/predicted FVC * 100. The predicted FVC values was calculated according to age, height, race and gender. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
measure: Change From Baseline in Chest X-ray Global Assessment Score (5-point )
time frame: Baseline, Week 16
description: Digital copies of Chest x-rays performed during the study were graded according to a 5 point Likert scale: 1 = markedly worsened; 2 = worsened; 3 = unchanged; 4 = improved; and 5 = markedly improved. Baseline will be defined as the last available x-ray prior to first dose.
measure: Change From Baseline in FVC (Absolute ) Compared to Placebo at Weeks 2,4,8,12, 14, and 20
time frame: Baseline, Weeks 2, 4, 8, 12, 14, and 20
description: FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was obtained from spirometry, performed before study treatment administration.
measure: Change From Baseline Absolute in FVC (% Predicted) Compared to Placebo at Weeks 2,4,8,12,14, and 20
time frame: Baseline, Weeks 2, 4, 8, 12, 14, and 20
description: The percent predicted FVC was calculated by observed FVC/predicted FVC * 100. The predicted FVC values was calculated according to age, height, race and gender. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
measure: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 2,4,8,12,14, 16 and 20
time frame: Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20
description: FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration.
measure: Change From Baseline in % Predicted FEV1 at Weeks 2,4,8,12,14, 16 and 20
time frame: Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20
description: The percent predicted FEV1 was calculated by observed FEV1/predicted FEV1 * 100. The predicted FEV1 values was calculated according to age, height, race and gender. FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.
measure: Change From Baseline in Ratio of FEV1/FVC at Weeks 2,4,8,12,14, 16 and 20
time frame: Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20
description: FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was obtained from spirometry, performed before study treatment administration.
measure: Estimated Treatment Effect Over Placebo in FVC Averaged Over 16 Weeks
time frame: Baseline, Weeks 0, 2, 4, 8, 12, 14, 16
description: FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Through FVC was obtained from spirometry, performed before study treatment administration.
arm group label: PD 0360324
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Biological
intervention name: PD 0360324
description: 100 mg Q2W or 150 mg Q2W via intravenous infusion based on protocol determined dose escalation/de-escalation criteria; 12 weeks Active Therapy;
arm group label: PD 0360324
intervention type: Other
intervention name: Normal Saline for injection
description: normal saline Q2W via intravenous infusion for 12 weeks
arm group label: Placebo
criteria: 
gender: All
minimum age: 21 Years
maximum age: 75 Years
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6261009&StudyName=A%20Phase%202%2C%20Safety%2C%20Tolerability%2C%20and%20Efficacy%20Study%20of%20PD%200360324%20in%20Chronic%20Pulmonary%20Sarcoidosis
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Sarcoidosis, Pulmonary
mesh term: Sarcoidosis
sharing ipd: Yes
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
ipd url: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Due to early termination of the study and the small enrollment number, analysis of primary and secondary pharmacodynamic endpoints could not be performed.
point of contact: 