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/NCT06031415</url>
    </required_header>
    <id_info>
      <org_study_id>GS-US-666-6692</org_study_id>
      <nct_id>NCT06031415</nct_id>
    </id_info>
    <brief_title>Study of GS-0272 in Participants With Rheumatoid Arthritis or Systemic Lupus Erythematosus</brief_title>
    <acronym>MARASLE</acronym>
    <official_title>A Multicenter, Randomized, Placebo-Controlled Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of Multiple Ascending Subcutaneous Doses of GS-0272 in Adult Participants With Rheumatoid Arthritis or Systemic Lupus Erythematosus (MARASLE)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Gilead Sciences</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Gilead Sciences</source>
    <oversight_info>
      <has_dmc>No</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 goals of this clinical study are to learn more about the study drug, GS-0272, and its&#xD;
        safety and tolerability following multiple doses in participants with rheumatoid arthritis&#xD;
        (RA) and systemic lupus erythematosus (SLE).&#xD;
  &#xD;
        The primary objectives of this study are to assess the safety and tolerability of multiple&#xD;
        ascending subcutaneous (SC) doses of GS-0272 and to characterize the pharmacokinetics of&#xD;
        GS-0272 following multiple SC doses of GS-0272, in participants with RA or SLE.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">June 2025</completion_date>
    <primary_completion_date type="Anticipated">June 2025</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <intervention_model_description>Part A will have sequential cohorts. Part A and Part B will be in parallel.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Percentage of Participants Experiencing Adverse Events (AEs)</measure>
      <time_frame>First dose up to Week 12 plus 70 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of Participants Experiencing Serious Adverse Events (SAEs)</measure>
      <time_frame>First dose up to Week 12 plus 70 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of Participants With Laboratory Abnormalities</measure>
      <time_frame>First dose up to Week 12 plus 70 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Pharmacokinetics (PK) of GS-0272: AUCtau</measure>
      <time_frame>Day 1 predose through Day 197</time_frame>
      <description>AUCtau is defined as the area under the concentration versus time curve over the dosing interval.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>PK of GS-0272: Cmax</measure>
      <time_frame>Day 1 predose through Day 197</time_frame>
      <description>Cmax is defined the maximum observed plasma drug concentration.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>PK of GS-0272: Tmax</measure>
      <time_frame>Day 1 predose through Day 197</time_frame>
      <description>Tmax is defined as the time to maximum observed concentration.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Prevalence of Antidrug Antibodies (ADAs) for GS-0272</measure>
      <time_frame>Baseline (Day 1) through Day 197</time_frame>
      <description>Prevalence of ADAs will be measured as the proportion of participants who had at least one positive ADA sample (baseline or post-baseline) among all participants evaluable for ADA prevalence.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of ADAs for GS-0272</measure>
      <time_frame>Baseline (Day 1) through Day 197</time_frame>
      <description>ADA incidence will be measured as the proportion of participants who have treatment-emergent ADA sample (post-baseline) among all participants evaluable for ADA incidence.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">48</enrollment>
    <condition>Rheumatoid Arthritis</condition>
    <condition>Systemic Lupus Erythematosus</condition>
    <arm_group>
      <arm_group_label>Part A: Rheumatoid Arthritis (RA) Cohorts: GS-0272 or Placebo</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Part A will include participants with RA. Part A will have 3 cohorts. Each cohort in Part A will be randomized in a 3:1 ratio to receive either ascending doses of GS-0272 or placebo for 12 weeks.&#xD;
  Dosing will begin in Cohort 1. Cohorts 2 and 3 will be initiated upon review of blinded safety data from the preceding cohort.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Part B: Systemic Lupus Erythematosus (SLE) Cohort: GS-0272 or Placebo</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Part B will include participants with SLE. Part B will have only 1 cohort (Cohort 4). Participants in Cohort 4 will be randomized in a 3:1 ratio to receive either GS-0272 or placebo for 12 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>GS-0272</intervention_name>
      <description>Administered subcutaneously</description>
      <arm_group_label>Part A: Rheumatoid Arthritis (RA) Cohorts: GS-0272 or Placebo</arm_group_label>
      <arm_group_label>Part B: Systemic Lupus Erythematosus (SLE) Cohort: GS-0272 or Placebo</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Administered subcutaneously</description>
      <arm_group_label>Part A: Rheumatoid Arthritis (RA) Cohorts: GS-0272 or Placebo</arm_group_label>
      <arm_group_label>Part B: Systemic Lupus Erythematosus (SLE) Cohort: GS-0272 or Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Key Inclusion Criteria:&#xD;
  &#xD;
          Part A (Rheumatoid Arthritis (RA) Cohorts)-Specific Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of RA at least 3 months prior to screening fulfilling the 2010 American&#xD;
               College of Rheumatology (ACR)/European League Against Rheumatism (EULAR)&#xD;
               classification criteria.&#xD;
  &#xD;
            -  Ongoing treatment with 1 or 2 conventional synthetic disease-modifying antirheumatic&#xD;
               drugs (csDMARDs) for at least 12 weeks prior to the first dose of study drug, with a&#xD;
               stable dose for at least 4 weeks prior to the first dose of study drug, as follows:&#xD;
  &#xD;
            -  Individuals must not be on a biologic disease-modifying antirheumatic drugs&#xD;
               (bDMARD)/targeted synthetic disease-modifying antirheumatic drug (tsDMARD) at Day 1 or&#xD;
               during the study and must discontinue b/tsDMARD use for at least 4 weeks (with the&#xD;
               exception of rituximab, which must be discontinued for at least 16 weeks) prior to the&#xD;
               first dose of study drug.&#xD;
  &#xD;
          Part B (Systemic Lupus Erythematosus (SLE) Cohort)-Specific Inclusion Criteria:&#xD;
  &#xD;
            -  Fulfill EULAR/ACR 2019 classification criteria for SLE at least 24 weeks prior to the&#xD;
               first dose of study drug.&#xD;
  &#xD;
            -  Individuals using protocol-permitted nonbiologic immunosuppressive/immunomodulatory&#xD;
               agents (antimalarials, methotrexate (MTX), azathioprine, cyclosporine, leflunomide,&#xD;
               minocycline, mycophenolate mofetil, mycophenolic acid, dapsone, and oral [not topical]&#xD;
               tacrolimus) for the treatment of SLE must maintain stable dose(s) for at least 4 weeks&#xD;
               prior to the first dose of study drug and through the end of study.&#xD;
  &#xD;
          Key Exclusion Criteria:&#xD;
  &#xD;
            -  Meet any of the protocol-specified infection criteria (hepatitis C, Hepatitis B, HIV,&#xD;
               tuberculosis, others).&#xD;
  &#xD;
            -  Highly active SLE (including but not limited to lupus nephritis, neuropsychiatric SLE,&#xD;
               and/or vasculitis) that could put the individual at risk per investigator's judgment.&#xD;
  &#xD;
            -  Exposure to cyclophosphamide or any biologic lupus therapy within 8 weeks prior to the&#xD;
               first dose of study drug.&#xD;
  &#xD;
          Note: Other protocol defined Inclusion/Exclusion criteria may apply.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gilead Study Director</last_name>
      <role>Study Director</role>
      <affiliation>Gilead Sciences</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Gilead Clinical Study Information Center</last_name>
      <phone>1-833-445-3230 (GILEAD-0)</phone>
      <email>GileadClinicalTrials@gilead.com</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 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>Arthritis</mesh_term>
      <mesh_term>Arthritis, Rheumatoid</mesh_term>
      <mesh_term>Lupus Erythematosus, Systemic</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06031415
  org study id: GS-US-666-6692
  nct id: NCT06031415
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The goals of this clinical study are to learn more about the study drug, GS-0272, and its
        safety and tolerability following multiple doses in participants with rheumatoid arthritis
        (RA) and systemic lupus erythematosus (SLE).
  
        The primary objectives of this study are to assess the safety and tolerability of multiple
        ascending subcutaneous (SC) doses of GS-0272 and to characterize the pharmacokinetics of
        GS-0272 following multiple SC doses of GS-0272, in participants with RA or SLE.
  allocation: Randomized
  intervention model: Sequential Assignment
  intervention model description: Part A will have sequential cohorts. Part A and Part B will be in parallel.
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Percentage of Participants Experiencing Adverse Events (AEs)
  time frame: First dose up to Week 12 plus 70 days
  measure: Percentage of Participants Experiencing Serious Adverse Events (SAEs)
  time frame: First dose up to Week 12 plus 70 days
  measure: Percentage of Participants With Laboratory Abnormalities
  time frame: First dose up to Week 12 plus 70 days
  measure: Pharmacokinetics (PK) of GS-0272: AUCtau
  time frame: Day 1 predose through Day 197
  description: AUCtau is defined as the area under the concentration versus time curve over the dosing interval.
  measure: PK of GS-0272: Cmax
  time frame: Day 1 predose through Day 197
  description: Cmax is defined the maximum observed plasma drug concentration.
  measure: PK of GS-0272: Tmax
  time frame: Day 1 predose through Day 197
  description: Tmax is defined as the time to maximum observed concentration.
  measure: Prevalence of Antidrug Antibodies (ADAs) for GS-0272
  time frame: Baseline (Day 1) through Day 197
  description: Prevalence of ADAs will be measured as the proportion of participants who had at least one positive ADA sample (baseline or post-baseline) among all participants evaluable for ADA prevalence.
  measure: Incidence of ADAs for GS-0272
  time frame: Baseline (Day 1) through Day 197
  description: ADA incidence will be measured as the proportion of participants who have treatment-emergent ADA sample (post-baseline) among all participants evaluable for ADA incidence.
  arm group label: Part A: Rheumatoid Arthritis (RA) Cohorts: GS-0272 or Placebo
  arm group type: Experimental
  description: Part A will include participants with RA. Part A will have 3 cohorts. Each cohort in Part A will be randomized in a 3:1 ratio to receive either ascending doses of GS-0272 or placebo for 12 weeks.
  Dosing will begin in Cohort 1. Cohorts 2 and 3 will be initiated upon review of blinded safety data from the preceding cohort.
  arm group label: Part B: Systemic Lupus Erythematosus (SLE) Cohort: GS-0272 or Placebo
  arm group type: Experimental
  description: Part B will include participants with SLE. Part B will have only 1 cohort (Cohort 4). Participants in Cohort 4 will be randomized in a 3:1 ratio to receive either GS-0272 or placebo for 12 weeks.
  intervention type: Drug
  intervention name: GS-0272
  description: Administered subcutaneously
  arm group label: Part A: Rheumatoid Arthritis (RA) Cohorts: GS-0272 or Placebo
  arm group label: Part B: Systemic Lupus Erythematosus (SLE) Cohort: GS-0272 or Placebo
  intervention type: Drug
  intervention name: Placebo
  description: Administered subcutaneously
  arm group label: Part A: Rheumatoid Arthritis (RA) Cohorts: GS-0272 or Placebo
  arm group label: Part B: Systemic Lupus Erythematosus (SLE) Cohort: GS-0272 or Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Gilead Study Director
  role: Study Director
  affiliation: Gilead Sciences
  last name: Gilead Clinical Study Information Center
  phone: 1-833-445-3230 (GILEAD-0)
  email: GileadClinicalTrials@gilead.com
  responsible party type: Sponsor
  mesh term: Arthritis
  mesh term: Arthritis, Rheumatoid
  mesh term: Lupus Erythematosus, Systemic
  sharing ipd: No