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/NCT05963074</url>
    </required_header>
    <id_info>
      <org_study_id>54179060CLL2032</org_study_id>
      <secondary_id>2023-504044-34-00</secondary_id>
      <secondary_id>54179060CLL2032</secondary_id>
      <nct_id>NCT05963074</nct_id>
    </id_info>
    <brief_title>A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia</brief_title>
    <acronym>TAILOR</acronym>
    <official_title>Multicohort Study to Customize Ibrutinib Treatment Regimens for Patients With Previously Untreated Chronic Lymphocytic Leukemia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Janssen Research &amp; Development, LLC</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Pharmacyclics LLC.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Janssen Research &amp; Development, LLC</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 and safety of ibrutinib + venetoclax&#xD;
        (I+V) and ibrutinib monotherapy regimens in which dosing of ibrutinib is either proactively&#xD;
        reduced or reactively modified in response to adverse events (AEs).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 27, 2023</start_date>
    <completion_date type="Anticipated">November 22, 2028</completion_date>
    <primary_completion_date type="Anticipated">September 29, 2028</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Best Overall Response Rate (ORR)</measure>
      <time_frame>Up to 5 years</time_frame>
      <description>Best ORR is defined as the percentage of participants who achieve complete remission (CR), complete remission with an incomplete marrow recovery (CRi), nodular partial remission (nPR), or partial remission (PR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria as assessed by investigator.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Complete Response (CR) Rate</measure>
      <time_frame>Up to 5 years</time_frame>
      <description>CR rate is defined as the percentage of participants achieving a best overall response of CR or CRi per iwCLL 2018 criteria as assessed by investigator.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of Response (DOR)</measure>
      <time_frame>Up to 5 years</time_frame>
      <description>DOR is defined as the duration in days from the date of initial documentation of PR or better to the date of first documented evidence of PD or death.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression Free Survival (PFS)</measure>
      <time_frame>Up to 5 years</time_frame>
      <description>PFS by investigator assessment is defined as the duration from date of randomization to date of PD or death due to any cause, whichever occurs first.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Survival (OS)</measure>
      <time_frame>Up to 5 years</time_frame>
      <description>OS is defined as the time from date of randomization to date of death from any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cohorts 1a and 1b: Minimal Residual Disease (MRD) Negative Rate</measure>
      <time_frame>Up to 5 years</time_frame>
      <description>MRD-negative rate is defined as the percentage of participants who reach MRD-negative status (that is, less than [&lt;] 1 chronic lymphocytic leukemia (CLL) cell per 10,000 leukocytes or &lt;0.01 percentage [%]) in the peripheral blood.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Adverse Events (AEs)</measure>
      <time_frame>Up to 5 years</time_frame>
      <description>An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with AEs by Severity</measure>
      <time_frame>Up to 5 years</time_frame>
      <description>An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants with Rate of Discontinuation due to AEs</measure>
      <time_frame>Up to 5 years</time_frame>
      <description>Percentage of participants with rate of discontinuation due to AEs will be reported.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants with Dose Reduction due AEs</measure>
      <time_frame>Up to 5 years</time_frame>
      <description>Percentage of participants with dose reduction due AEs will be reported.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adherence Rates</measure>
      <time_frame>Up to 5 years</time_frame>
      <description>The adherence rate is defined as the percentage of total dose taken over the total dose prescribed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of Treatment</measure>
      <time_frame>Up to 5 years</time_frame>
      <description>Duration of treatment is defined as the time period in days between the date of first study treatment administration and date of last administration.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to Worsening as Measured by EuroQol 5 Dimension 5 Level Questionnaire (EQ-5D-5L)</measure>
      <time_frame>Up to 5 years</time_frame>
      <description>Time to worsening is defined as time interval (months) from randomization to first observation of deterioration. Time to worsening as measured by EQ-5D-5L will be reported.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to Worsening as Measured by European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC QLQ)-C30)</measure>
      <time_frame>Up to 5 years</time_frame>
      <description>Time to worsening is defined as time interval from randomization to first observation of deterioration. Time to worsening as measured by EORTC QLQ-C30 will be reported.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to Worsening as Measured by EORTC QLQ-CLL17</measure>
      <time_frame>Up to 5 years</time_frame>
      <description>Time to worsening is defined as time interval from randomization to first observation of deterioration. Time to worsening as measured by EORTC QLQ-CLL17 will be reported.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to Worsening as Measured by Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score</measure>
      <time_frame>Up to 5 years</time_frame>
      <description>Time to Worsening is defined as time interval (months) from randomization to first observation of deterioration. Time to worsening as measured by FACIT-fatigue total score will be reported.</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">320</enrollment>
    <condition>Leukemia, Lymphocytic, Chronic, B-Cell</condition>
    <condition>Small Lymphocytic Lymphoma</condition>
    <arm_group>
      <arm_group_label>Cohort 1a: Ibrutinib Lead-in+Fixed Duration Ibrutinib+Venetoclax</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive ibrutinib 420 milligrams (mg) capsule every day (QD) for a lead-in of 3 cycles (1 cycle = 28 days). From Cycle 4, venetoclax 400 mg tablet dose ramp-up (from 20 to 400 mg over 5 weeks) will begin, and venetoclax 400 mg QD will be administered with ibrutinib 420 mg QD, orally for 12 cycles through Cycle 15.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 1b: Ibrutinib Lead-in+Fixed Duration Ibrutinib+Venetoclax</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive ibrutinib 420 mg capsule QD for a lead-in of 3 cycles (1 cycle = 28 days). From Cycle 4, venetoclax 400 mg tablet dose ramp-up (from 20 to 400 mg over 5 weeks) will begin and ibrutinib dose will be reduced to 280 mg and will be administered QD, venetoclax 400 mg tablets QD will be administered with ibrutinib 280 mg for 12 cycles through Cycle 15.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 2a: Continuous Ibrutinib Monotherapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive ibrutinib 420 mg QD (or last tolerated dose) until disease progression (PD) or unacceptable toxicity.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 2b: Continuous Ibrutinib Monotherapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive ibrutinib 420 mg QD for 3 cycles. Ibrutinib 280 mg QD (or last tolerated dose) will begin at cycle 4 and continue until disease progression or unacceptable toxicity.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ibrutinib</intervention_name>
      <description>Ibrutinib capsules will be administered orally.</description>
      <arm_group_label>Cohort 1a: Ibrutinib Lead-in+Fixed Duration Ibrutinib+Venetoclax</arm_group_label>
      <arm_group_label>Cohort 1b: Ibrutinib Lead-in+Fixed Duration Ibrutinib+Venetoclax</arm_group_label>
      <arm_group_label>Cohort 2a: Continuous Ibrutinib Monotherapy</arm_group_label>
      <arm_group_label>Cohort 2b: Continuous Ibrutinib Monotherapy</arm_group_label>
      <other_name>JNJ-54179060, IMBRUVICA</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Venetoclax</intervention_name>
      <description>Venetoclax tablets will be administered orally.</description>
      <arm_group_label>Cohort 1a: Ibrutinib Lead-in+Fixed Duration Ibrutinib+Venetoclax</arm_group_label>
      <arm_group_label>Cohort 1b: Ibrutinib Lead-in+Fixed Duration Ibrutinib+Venetoclax</arm_group_label>
      <other_name>VENCLEXTA, VENCLYXTO</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of chronic lymphocytic leukemia/ small lymphocytic lymphoma (CLL/SLL) as per&#xD;
               International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 diagnostic&#xD;
               criteria&#xD;
  &#xD;
            -  For ibruinib + venetocIax (I+V) cohorts: eastern cooperative oncology group (ECOG)&#xD;
               performance status of 0-1. For ibrutinib monotherapy cohorts: ECOG performance status&#xD;
               of 0-2&#xD;
  &#xD;
            -  Measurable nodal disease by computed tomography (CT), defined as at least 1 lymph node&#xD;
               greater than and equal to (&gt;=) 1.5 centimeters (cm) in longest diameter&#xD;
  &#xD;
            -  A participant using oral contraceptives must use an additional contraceptive method&#xD;
  &#xD;
            -  A participant must agree not to be pregnant, breastfeeding, or planning to become&#xD;
               pregnant while enrolled in this study or within 3 months after the last dose of study&#xD;
               treatment&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura, such&#xD;
               as those participants with a declining hemoglobin level or platelet count secondary to&#xD;
               autoimmune destruction within the 4 weeks prior to first dose of study treatment, or&#xD;
               the need for prednisone greater than (&gt;) 20 milligrams (mg) daily (or corticosteroid&#xD;
               equivalent) to treat or control the autoimmune disease&#xD;
  &#xD;
            -  Known bleeding disorders (example, von Willebrand's disease or hemophilia)&#xD;
  &#xD;
            -  Stroke or intracranial hemorrhage within 6 months prior to enrollment&#xD;
  &#xD;
            -  Known or suspected Richter's transformation or central nervous system (CNS)&#xD;
               involvement&#xD;
  &#xD;
            -  Currently active, clinically significant cardiovascular disease, such as uncontrolled&#xD;
               arrhythmia or Class II, III, or IV congestive heart failure as defined by the New York&#xD;
               Heart Association Functional Classification&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Janssen Research &amp; Development, LLC Clinical Trial</last_name>
      <role>Study Director</role>
      <affiliation>Janssen Research &amp; Development, LLC</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Study Contact</last_name>
      <phone>844-434-4210</phone>
      <email>Participate-In-This-Study@its.jnj.com</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Leukemia</mesh_term>
      <mesh_term>Leukemia, Lymphoid</mesh_term>
      <mesh_term>Leukemia, Lymphocytic, Chronic, B-Cell</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Venetoclax</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The data sharing policy of the Janssen Pharmaceutical Companies of Johnson &amp; Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu</ipd_description>
      <ipd_url>https://www.janssen.com/clinical-trials/transparency</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/NCT05963074
  org study id: 54179060CLL2032
  secondary id: 2023-504044-34-00
  secondary id: 54179060CLL2032
  nct id: NCT05963074
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this study is to evaluate the efficacy and safety of ibrutinib + venetoclax
        (I+V) and ibrutinib monotherapy regimens in which dosing of ibrutinib is either proactively
        reduced or reactively modified in response to adverse events (AEs).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Best Overall Response Rate (ORR)
  time frame: Up to 5 years
  description: Best ORR is defined as the percentage of participants who achieve complete remission (CR), complete remission with an incomplete marrow recovery (CRi), nodular partial remission (nPR), or partial remission (PR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria as assessed by investigator.
  measure: Complete Response (CR) Rate
  time frame: Up to 5 years
  description: CR rate is defined as the percentage of participants achieving a best overall response of CR or CRi per iwCLL 2018 criteria as assessed by investigator.
  measure: Duration of Response (DOR)
  time frame: Up to 5 years
  description: DOR is defined as the duration in days from the date of initial documentation of PR or better to the date of first documented evidence of PD or death.
  measure: Progression Free Survival (PFS)
  time frame: Up to 5 years
  description: PFS by investigator assessment is defined as the duration from date of randomization to date of PD or death due to any cause, whichever occurs first.
  measure: Overall Survival (OS)
  time frame: Up to 5 years
  description: OS is defined as the time from date of randomization to date of death from any cause.
  measure: Cohorts 1a and 1b: Minimal Residual Disease (MRD) Negative Rate
  time frame: Up to 5 years
  description: MRD-negative rate is defined as the percentage of participants who reach MRD-negative status (that is, less than [<] 1 chronic lymphocytic leukemia (CLL) cell per 10,000 leukocytes or <0.01 percentage [%]) in the peripheral blood.
  measure: Number of Participants with Adverse Events (AEs)
  time frame: Up to 5 years
  description: An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
  measure: Number of Participants with AEs by Severity
  time frame: Up to 5 years
  description: An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
  measure: Percentage of Participants with Rate of Discontinuation due to AEs
  time frame: Up to 5 years
  description: Percentage of participants with rate of discontinuation due to AEs will be reported.
  measure: Percentage of Participants with Dose Reduction due AEs
  time frame: Up to 5 years
  description: Percentage of participants with dose reduction due AEs will be reported.
  measure: Adherence Rates
  time frame: Up to 5 years
  description: The adherence rate is defined as the percentage of total dose taken over the total dose prescribed.
  measure: Duration of Treatment
  time frame: Up to 5 years
  description: Duration of treatment is defined as the time period in days between the date of first study treatment administration and date of last administration.
  measure: Time to Worsening as Measured by EuroQol 5 Dimension 5 Level Questionnaire (EQ-5D-5L)
  time frame: Up to 5 years
  description: Time to worsening is defined as time interval (months) from randomization to first observation of deterioration. Time to worsening as measured by EQ-5D-5L will be reported.
  measure: Time to Worsening as Measured by European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC QLQ)-C30)
  time frame: Up to 5 years
  description: Time to worsening is defined as time interval from randomization to first observation of deterioration. Time to worsening as measured by EORTC QLQ-C30 will be reported.
  measure: Time to Worsening as Measured by EORTC QLQ-CLL17
  time frame: Up to 5 years
  description: Time to worsening is defined as time interval from randomization to first observation of deterioration. Time to worsening as measured by EORTC QLQ-CLL17 will be reported.
  measure: Time to Worsening as Measured by Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score
  time frame: Up to 5 years
  description: Time to Worsening is defined as time interval (months) from randomization to first observation of deterioration. Time to worsening as measured by FACIT-fatigue total score will be reported.
  arm group label: Cohort 1a: Ibrutinib Lead-in+Fixed Duration Ibrutinib+Venetoclax
  arm group type: Experimental
  description: Participants will receive ibrutinib 420 milligrams (mg) capsule every day (QD) for a lead-in of 3 cycles (1 cycle = 28 days). From Cycle 4, venetoclax 400 mg tablet dose ramp-up (from 20 to 400 mg over 5 weeks) will begin, and venetoclax 400 mg QD will be administered with ibrutinib 420 mg QD, orally for 12 cycles through Cycle 15.
  arm group label: Cohort 1b: Ibrutinib Lead-in+Fixed Duration Ibrutinib+Venetoclax
  arm group type: Experimental
  description: Participants will receive ibrutinib 420 mg capsule QD for a lead-in of 3 cycles (1 cycle = 28 days). From Cycle 4, venetoclax 400 mg tablet dose ramp-up (from 20 to 400 mg over 5 weeks) will begin and ibrutinib dose will be reduced to 280 mg and will be administered QD, venetoclax 400 mg tablets QD will be administered with ibrutinib 280 mg for 12 cycles through Cycle 15.
  arm group label: Cohort 2a: Continuous Ibrutinib Monotherapy
  arm group type: Experimental
  description: Participants will receive ibrutinib 420 mg QD (or last tolerated dose) until disease progression (PD) or unacceptable toxicity.
  arm group label: Cohort 2b: Continuous Ibrutinib Monotherapy
  arm group type: Experimental
  description: Participants will receive ibrutinib 420 mg QD for 3 cycles. Ibrutinib 280 mg QD (or last tolerated dose) will begin at cycle 4 and continue until disease progression or unacceptable toxicity.
  intervention type: Drug
  intervention name: Ibrutinib
  description: Ibrutinib capsules will be administered orally.
  arm group label: Cohort 1a: Ibrutinib Lead-in+Fixed Duration Ibrutinib+Venetoclax
  arm group label: Cohort 1b: Ibrutinib Lead-in+Fixed Duration Ibrutinib+Venetoclax
  arm group label: Cohort 2a: Continuous Ibrutinib Monotherapy
  arm group label: Cohort 2b: Continuous Ibrutinib Monotherapy
  other name: JNJ-54179060, IMBRUVICA
  intervention type: Drug
  intervention name: Venetoclax
  description: Venetoclax tablets will be administered orally.
  arm group label: Cohort 1a: Ibrutinib Lead-in+Fixed Duration Ibrutinib+Venetoclax
  arm group label: Cohort 1b: Ibrutinib Lead-in+Fixed Duration Ibrutinib+Venetoclax
  other name: VENCLEXTA, VENCLYXTO
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Janssen Research & Development, LLC Clinical Trial
  role: Study Director
  affiliation: Janssen Research & Development, LLC
  last name: Study Contact
  phone: 844-434-4210
  email: Participate-In-This-Study@its.jnj.com
  responsible party type: Sponsor
  mesh term: Leukemia
  mesh term: Leukemia, Lymphoid
  mesh term: Leukemia, Lymphocytic, Chronic, B-Cell
  mesh term: Venetoclax
  sharing ipd: Yes
  ipd description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
  ipd url: https://www.janssen.com/clinical-trials/transparency