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/NCT06025578</url>
    </required_header>
    <id_info>
      <org_study_id>IM027-1015</org_study_id>
      <secondary_id>2023-503699-25</secondary_id>
      <nct_id>NCT06025578</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary Fibrosis</brief_title>
    <official_title>A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary Fibrosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bristol-Myers Squibb</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Bristol-Myers Squibb</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278&#xD;
        in Participants with Progressive Pulmonary Fibrosis.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 18, 2023</start_date>
    <completion_date type="Anticipated">December 27, 2027</completion_date>
    <primary_completion_date type="Anticipated">December 27, 2027</primary_completion_date>
    <phase>Phase 3</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>Absolute change from baseline in forced vital capacity (FVC) measured in mL</measure>
      <time_frame>At Week 52</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Disease progression</measure>
      <time_frame>Up to approximately 4 years</time_frame>
      <description>Disease progression will be measured by the time to first disease progression event in at least 1 of the following parameters:&#xD;
  Absolute percent predicted forced vital capacity (ppFVC) decline of ≥ 10% from baseline&#xD;
  Acute exacerbation of pulmonary fibrosis&#xD;
  Lung fibrosis-related hospitalization&#xD;
  All-cause mortality</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in Living with Pulmonary Fibrosis Questionnaire (L-PF) cough domain score</measure>
      <time_frame>At Week 52 and up to approximately 4 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in L-PF dyspnea domain score</measure>
      <time_frame>At Week 52 and up to approximately 4 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in walking distance measured in 6-minute walk test (6MWT)</measure>
      <time_frame>At Week 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to the first occurrence of any of the components of the composite endpoint: time to first acute exacerbation of pulmonary fibrosis, first Lung fibrosis-related hospitalization, or all-cause mortality</measure>
      <time_frame>Up to approximately 4 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to absolute percent ppFVC decline of ≥ 10% from baseline</measure>
      <time_frame>Up to approximately 4 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to first acute exacerbation of pulmonary fibrosis</measure>
      <time_frame>Up to approximately 4 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to first lung fibrosis-related hospitalization</measure>
      <time_frame>Up to approximately 4 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to all-cause mortality</measure>
      <time_frame>Up to approximately 4 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in L-PF fatigue domain score</measure>
      <time_frame>At Week 52 and up to approximately 4 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in L-PF impact module score</measure>
      <time_frame>At Week 52 and up to approximately 4 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in cough numeric rating scale (NRS)</measure>
      <time_frame>At Week 52 and up to approximately 4 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) health utility index score</measure>
      <time_frame>At Week 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in EQ-5D-5L visual analog scale score</measure>
      <time_frame>At Week 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of decline from baseline in FVC (mL)</measure>
      <time_frame>At Week 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of decline in ppFVC from baseline</measure>
      <time_frame>At Week 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in ppFVC from baseline</measure>
      <time_frame>At Week 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants with absolute decline in ppFVC ≥10%</measure>
      <time_frame>At Week 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants with relative decline in ppFVC ≥10%</measure>
      <time_frame>At Week 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in single-breath diffusing capacity of the lung for carbon monoxide (DLCO SB) (corrected for hemoglobin) (mL/min/mm Hg)</measure>
      <time_frame>At Week 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in percent predicted single breath diffusing capacity of the lung for carbon monoxide (ppDLCO SB) (corrected for hemoglobin) from baseline</measure>
      <time_frame>At Week 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in quantitative lung fibrosis (QLF) score via high-resolution computed tomography (HRCT)</measure>
      <time_frame>At Week 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with Adverse Events (AEs)</measure>
      <time_frame>Up to 28 days after last dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with Serious AEs (SAEs)</measure>
      <time_frame>Up to 28 days after last dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with AEs leading to early discontinuation of investigational medicinal product (IMP)</measure>
      <time_frame>Up to 28 days after last dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of treatment-emergent deaths</measure>
      <time_frame>Up to 28 days after last dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with clinical laboratory abnormalities</measure>
      <time_frame>Up to 28 days after last dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with electrocardiogram (ECG) abnormalities</measure>
      <time_frame>Up to 28 days after last dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with vital sign abnormalities</measure>
      <time_frame>Up to 28 days after last dose</time_frame>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">1092</enrollment>
    <condition>Progressive Pulmonary Fibrosis</condition>
    <arm_group>
      <arm_group_label>BMS-986278 Dose 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>BMS-986278 Dose 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>BMS-986278 Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>BMS-986278</intervention_name>
      <description>Specified dose on specified days</description>
      <arm_group_label>BMS-986278 Dose 1</arm_group_label>
      <arm_group_label>BMS-986278 Dose 2</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>BMS-986278 Placebo</intervention_name>
      <description>Specified dose on specified days</description>
      <arm_group_label>BMS-986278 Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of interstitial lung disease (ILD) with features consistent with progressive&#xD;
               ILD within 24 months prior to screening, and ≥ 10% extent of disease on screening&#xD;
               high-resolution computed tomography (HRCT)..&#xD;
  &#xD;
            -  If on pirfenidone or nintedanib, participants must have been on a stable dose for at&#xD;
               least 90 days prior to screening If not currently on pirfenidone or nintedanib,&#xD;
               participants must not have received either of these medications within 28 days prior&#xD;
               to screening.&#xD;
  &#xD;
            -  Mycophenolate mofetil (MMF), mycophenolic acid (MA), azathioprine (AZA), and&#xD;
               Tacrolimus are permitted provided that the participant is on a stable dose for at&#xD;
               least 90 days prior to screening. If not currently on MMF, MA, AZA, or tacrolimus,&#xD;
               participants must not have taken these medications within 28 days prior to screening.&#xD;
  &#xD;
            -  Traditional disease-modifying antirheumatic drug (DMARDs) (eg. Methotrexate,&#xD;
               leflunomide, sulfasalazine, or hydroxychloroquine), Biologic DMARDs (eg. TNF blockers&#xD;
               and IL-1 inhibitors) and Janus kinase inhibitors (JAK inhibitors) (eg. tofacitinib,&#xD;
               upadacitinib) are permitted provided that the participant is on a stable dose for at&#xD;
               least 90 days prior to screening.&#xD;
  &#xD;
            -  Systemic corticosteroids are permitted provided that the participant is on prednisone&#xD;
               ≤ 15 mg/day or equivalent for at least 70 days prior to Day 1.&#xD;
  &#xD;
            -  Women who are of childbearing potential must have a highly effective form of&#xD;
               contraception and must provide a negative urine/serum pregnancy test&#xD;
  &#xD;
            -  Men who are sexually active with women of childbearing potential agree to use male&#xD;
               barrier contraception&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Idiopathic pulmonary fibrosis with usual interstitial pneumonia (UIP) verification at&#xD;
               screening&#xD;
  &#xD;
            -  History of stroke or transient ischemic attack within 3 months prior to screening&#xD;
  &#xD;
            -  Significant cardiac disease within 6 months prior to screening per the investigator's&#xD;
               discretion&#xD;
  &#xD;
            -  Participants who have a current malignancy or a previous malignancy in the past 5&#xD;
               years prior to screening, except for those who have a documented history of cured&#xD;
               nonmetastatic squamous cell skin carcinoma, basal cell skin carcinoma, or cervical&#xD;
               carcinoma in situ.&#xD;
  &#xD;
          Note: Other protocol-defined inclusion/exclusion criteria apply&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Bristol-Myers Squibb</last_name>
      <role>Study Director</role>
      <affiliation>Bristol-Myers Squibb</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>BMS Study Connect Contact Center www.BMSStudyConnect.com</last_name>
      <phone>855-907-3286</phone>
      <email>Clinical.Trials@bms.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>First line of the email MUST contain the NCT# and Site #.</last_name>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Stanford Hospital and Clinics</name>
        <address>
          <city>Stanford</city>
          <state>California</state>
          <zip>94305</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Rishi Raj, Site 0352</last_name>
        <phone>650-736-8083</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>University Hospitals Cleveland Medical Center</name>
        <address>
          <city>Cleveland</city>
          <state>Ohio</state>
          <zip>44106</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Maroun Matta, Site 0186</last_name>
        <phone>216-844-8447</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Local Institution - 0110</name>
        <address>
          <city>Aarhus</city>
          <state>Region Midtjylland</state>
          <zip>8200</zip>
          <country>Denmark</country>
        </address>
      </facility>
      <contact>
        <last_name>Site 0110</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Local Institution - 0258</name>
        <address>
          <city>Mainz</city>
          <zip>55131</zip>
          <country>Germany</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Local Institution - 0306</name>
        <address>
          <city>Jongno-gu</city>
          <state>Seoul</state>
          <zip>03080</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <contact>
        <last_name>Site 0306</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Local Institution - 0164</name>
        <address>
          <city>Braga</city>
          <zip>4710-243</zip>
          <country>Portugal</country>
        </address>
      </facility>
      <contact>
        <last_name>Site 0164</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Local Institution - 0179</name>
        <address>
          <city>Porto</city>
          <zip>4200-319</zip>
          <country>Portugal</country>
        </address>
      </facility>
      <contact>
        <last_name>Site 0179</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Local Institution - 0178</name>
        <address>
          <city>Santander</city>
          <state>CB</state>
          <zip>39010</zip>
          <country>Spain</country>
        </address>
      </facility>
      <contact>
        <last_name>Site 0178</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Denmark</country>
      <country>Germany</country>
      <country>Korea, Republic of</country>
      <country>Portugal</country>
      <country>Spain</country>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm</url>
      <description>FDA Safety Alerts and Recalls</description>
    </link>
    <link>
      <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
      <description>Investigator Inquiry Form</description>
    </link>
    <link>
      <url>https://www.bmsstudyconnect.com/s/US/English/USenHome</url>
      <description>BMS Clinical Trial Patient Recruiting</description>
    </link>
    <link>
      <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
      <description>BMS Clinical Trial Information</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 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 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>BMS-986278</keyword>
    <keyword>LPA1 antagonist</keyword>
    <keyword>Pulmonary fibrosis</keyword>
    <keyword>Interstitial lung disease</keyword>
    <keyword>Rheumatoid Arthritis</keyword>
    <keyword>Connective Tissue Disorders</keyword>
    <keyword>Sarcoidosis</keyword>
    <keyword>Scleroderma</keyword>
    <keyword>Fibrosis</keyword>
    <keyword>Antifibrotic therapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pulmonary Fibrosis</mesh_term>
      <mesh_term>Fibrosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>See plan description</ipd_time_frame>
      <ipd_access_criteria>See plan description</ipd_access_criteria>
      <ipd_url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html</ipd_url>
    </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/NCT06025578
  org study id: IM027-1015
  secondary id: 2023-503699-25
  nct id: NCT06025578
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278
        in Participants with Progressive Pulmonary Fibrosis.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Absolute change from baseline in forced vital capacity (FVC) measured in mL
  time frame: At Week 52
  measure: Disease progression
  time frame: Up to approximately 4 years
  description: Disease progression will be measured by the time to first disease progression event in at least 1 of the following parameters:
  Absolute percent predicted forced vital capacity (ppFVC) decline of ≥ 10% from baseline
  Acute exacerbation of pulmonary fibrosis
  Lung fibrosis-related hospitalization
  All-cause mortality
  measure: Change from baseline in Living with Pulmonary Fibrosis Questionnaire (L-PF) cough domain score
  time frame: At Week 52 and up to approximately 4 years
  measure: Change from baseline in L-PF dyspnea domain score
  time frame: At Week 52 and up to approximately 4 years
  measure: Change from baseline in walking distance measured in 6-minute walk test (6MWT)
  time frame: At Week 52
  measure: Time to the first occurrence of any of the components of the composite endpoint: time to first acute exacerbation of pulmonary fibrosis, first Lung fibrosis-related hospitalization, or all-cause mortality
  time frame: Up to approximately 4 years
  measure: Time to absolute percent ppFVC decline of ≥ 10% from baseline
  time frame: Up to approximately 4 years
  measure: Time to first acute exacerbation of pulmonary fibrosis
  time frame: Up to approximately 4 years
  measure: Time to first lung fibrosis-related hospitalization
  time frame: Up to approximately 4 years
  measure: Time to all-cause mortality
  time frame: Up to approximately 4 years
  measure: Change from baseline in L-PF fatigue domain score
  time frame: At Week 52 and up to approximately 4 years
  measure: Change from baseline in L-PF impact module score
  time frame: At Week 52 and up to approximately 4 years
  measure: Change from baseline in cough numeric rating scale (NRS)
  time frame: At Week 52 and up to approximately 4 years
  measure: Change from baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) health utility index score
  time frame: At Week 52
  measure: Change from baseline in EQ-5D-5L visual analog scale score
  time frame: At Week 52
  measure: Rate of decline from baseline in FVC (mL)
  time frame: At Week 52
  measure: Rate of decline in ppFVC from baseline
  time frame: At Week 52
  measure: Change in ppFVC from baseline
  time frame: At Week 52
  measure: Proportion of participants with absolute decline in ppFVC ≥10%
  time frame: At Week 52
  measure: Proportion of participants with relative decline in ppFVC ≥10%
  time frame: At Week 52
  measure: Change from baseline in single-breath diffusing capacity of the lung for carbon monoxide (DLCO SB) (corrected for hemoglobin) (mL/min/mm Hg)
  time frame: At Week 52
  measure: Change in percent predicted single breath diffusing capacity of the lung for carbon monoxide (ppDLCO SB) (corrected for hemoglobin) from baseline
  time frame: At Week 52
  measure: Change from baseline in quantitative lung fibrosis (QLF) score via high-resolution computed tomography (HRCT)
  time frame: At Week 52
  measure: Number of participants with Adverse Events (AEs)
  time frame: Up to 28 days after last dose
  measure: Number of participants with Serious AEs (SAEs)
  time frame: Up to 28 days after last dose
  measure: Number of participants with AEs leading to early discontinuation of investigational medicinal product (IMP)
  time frame: Up to 28 days after last dose
  measure: Number of treatment-emergent deaths
  time frame: Up to 28 days after last dose
  measure: Number of participants with clinical laboratory abnormalities
  time frame: Up to 28 days after last dose
  measure: Number of participants with electrocardiogram (ECG) abnormalities
  time frame: Up to 28 days after last dose
  measure: Number of participants with vital sign abnormalities
  time frame: Up to 28 days after last dose
  arm group label: BMS-986278 Dose 1
  arm group type: Experimental
  arm group label: BMS-986278 Dose 2
  arm group type: Experimental
  arm group label: BMS-986278 Placebo
  arm group type: Placebo Comparator
  intervention type: Drug
  intervention name: BMS-986278
  description: Specified dose on specified days
  arm group label: BMS-986278 Dose 1
  arm group label: BMS-986278 Dose 2
  intervention type: Drug
  intervention name: BMS-986278 Placebo
  description: Specified dose on specified days
  arm group label: BMS-986278 Placebo
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Bristol-Myers Squibb
  role: Study Director
  affiliation: Bristol-Myers Squibb
  last name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  phone: 855-907-3286
  email: Clinical.Trials@bms.com
  last name: First line of the email MUST contain the NCT# and Site #.
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  country: Denmark
  country: Germany
  country: Korea, Republic of
  country: Portugal
  country: Spain
  country: United States
  url: https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
  description: FDA Safety Alerts and Recalls
  url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
  description: Investigator Inquiry Form
  url: https://www.bmsstudyconnect.com/s/US/English/USenHome
  description: BMS Clinical Trial Patient Recruiting
  url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
  description: BMS Clinical Trial Information
  responsible party type: Sponsor
  mesh term: Pulmonary Fibrosis
  mesh term: Fibrosis
  sharing ipd: Yes
  ipd description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: See plan description
  ipd access criteria: See plan description
  ipd url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html