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/NCT06015308</url>
    </required_header>
    <id_info>
      <org_study_id>SFY17915</org_study_id>
      <secondary_id>U1111-1280-8357</secondary_id>
      <nct_id>NCT06015308</nct_id>
    </id_info>
    <brief_title>A Study to Investigate Vaccine Responses in Subcutaneous Amlitelimab Treated Atopic Dermatitis Participants Aged 18 Years and Older Compared With Placebo</brief_title>
    <acronym>HYDRO</acronym>
    <official_title>A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Amlitelimab on Vaccine Antibody Responses in Adult Participants With Moderate to Severe Atopic Dermatitis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sanofi</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sanofi</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>
        This is a Phase 2, multicenter, randomized, double-blind placebo controlled, 2-arm study to&#xD;
        evaluate the effect of amlitelimab on vaccine antibody responses, and the safety of&#xD;
        amlitelimab concurrently administered with non-live vaccines in adult participants with&#xD;
        moderate-to-severe atopic dermatitis (AD).&#xD;
  &#xD;
        The purpose of this study is to compare the immune responses to concomitantly administered&#xD;
        Boostrix (tetanus, diphtheria, and acellular pertussis [Tdap]) and Pneumovax 23 (PPSV)&#xD;
        vaccines in adult participants with moderate-to-severe AD treated with amlitelimab versus&#xD;
        placebo. The study will evaluate the percentage of participants achieving a positive&#xD;
        anti-tetanus response at Week 16 (primary endpoint) and a positive anti-pneumococcal response&#xD;
        at Week 16 (primary endpoint).&#xD;
  &#xD;
        Study details include:&#xD;
  &#xD;
        The study duration will be up to 36 weeks (for participants not entering the LTS17367&#xD;
        [RIVER-AD]).&#xD;
  &#xD;
        The screening period will be 2 to 4 weeks. The treatment duration will be up to 16 weeks. The&#xD;
        post-treatment safety follow-up period will be16 weeks. The number of visits will be up to 7&#xD;
        (or 6 for those entering LTS17367 [RIVER-AD]).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study duration will be up to 36 weeks&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 4, 2023</start_date>
    <completion_date type="Anticipated">August 18, 2025</completion_date>
    <primary_completion_date type="Anticipated">April 28, 2025</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Percentage of participants with a positive tetanus response at Week 16</measure>
      <time_frame>Week 16</time_frame>
      <description>Positive tetanus response is defined as a ≥4-fold increase from pre-vaccination at baseline in anti-tetanus immunoglobulin G [IgG] titer for participants with a pre-vaccination tetanus antibody titers ≥0.1 IU/mL or a titer of ≥0.2 IU/mL for participants with pre-vaccination titers of &lt;0.1 IU/mL.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of participants with a positive pneumococcal vaccine response at Week 16</measure>
      <time_frame>Week 16</time_frame>
      <description>Positive pneumococcal vaccine response is defined as a ≥2-fold increase from baseline in anti-pneumococcal antibodies (APAb) against &gt;50% of the 23 serotypes.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants who experienced treatment-emergent adverse events (TEAE), including serious adverse events (SAE) and adverse events of special interest (AESI)</measure>
      <time_frame>Week 0 up to Week 32</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants with potentially clinically significant abnormalities (PCSA) for vital signs and clinical laboratory assessments</measure>
      <time_frame>Week 0 up to Week 32</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants discontinued from study treatment due to TEAEs</measure>
      <time_frame>Week 0 up to Week 32</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants with validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) of 0 (clear) or 1 (almost clear) and a reduction of ≥2 points from baseline at Week 16</measure>
      <time_frame>Week 16</time_frame>
      <description>The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants with a ≥75% reduction in EASI score (EASI-75) from baseline at Week 16</measure>
      <time_frame>Week 16</time_frame>
      <description>The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD using a 4-point scale; 0 (absent) to 3 (severe).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serum amlitelimab concentrations</measure>
      <time_frame>Week 0 up to Week 16</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of antidrug antibodies (ADAs) of amlitelimab</measure>
      <time_frame>Week 0 up to Week 16</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">166</enrollment>
    <condition>Dermatitis Atopic</condition>
    <arm_group>
      <arm_group_label>Amlitelimab</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive amlitelimab and vaccines as per protocol.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Participants will receive placebo matching amlitelimab and vaccines as per protocol.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Amlitelimab</intervention_name>
      <description>Subcutaneous injection in abdomen, outer thigh, or upper arm</description>
      <arm_group_label>Amlitelimab</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Subcutaneous injection in abdomen, outer thigh, or upper arm</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Tdap vaccine</intervention_name>
      <description>Intramuscular (IM) injection into the deltoid muscle of the upper arm</description>
      <arm_group_label>Amlitelimab</arm_group_label>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>PPS vaccine</intervention_name>
      <description>Intramuscular or subcutaneous injection into the deltoid muscle of the upper arm</description>
      <arm_group_label>Amlitelimab</arm_group_label>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants must be 18 years of age (when signing informed consent form)&#xD;
  &#xD;
            -  Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology&#xD;
               Consensus Criteria)&#xD;
  &#xD;
            -  Documented history (within 6 months before screening) of either inadequate response or&#xD;
               inadvisability to topical treatments&#xD;
  &#xD;
            -  Validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) of 3 or&#xD;
               4 at baseline visit&#xD;
  &#xD;
            -  Eczema area and severity index (EASI) score of 12 or higher at baseline&#xD;
  &#xD;
            -  AD involvement of 10% or more of body surface area (BSA) at baseline&#xD;
  &#xD;
            -  Able and willing to comply with requested study visits and procedures&#xD;
  &#xD;
            -  Body weight ≥40 kg and ≤150 kg&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Skin co-morbidity that would adversely affect the ability to undertake AD assessments&#xD;
  &#xD;
            -  Receipt of any vaccine (expect influenza and COVID-19 vaccines) within 3 months prior&#xD;
               to screening&#xD;
  &#xD;
            -  Receipt of any pneumococcal vaccine within approximate timeframe of 5 years prior to&#xD;
               screening&#xD;
  &#xD;
            -  Prior receipt of two or more doses of Pneumovax 23 at any time&#xD;
  &#xD;
            -  Receipt of any tetanus-, diphtheria-, or pertussis-containing vaccine within&#xD;
               approximate timeframe of 5 years prior to screening&#xD;
  &#xD;
            -  Participants for whom administration of the pneumococcal vaccine provided in this&#xD;
               study is contraindicated or medically inadvisable, according to local label of the&#xD;
               vaccine&#xD;
  &#xD;
            -  Participants for whom administration of the tetanus, diphtheria, and pertussis vaccine&#xD;
               provided in this study is contraindicated or medically inadvisable, according to local&#xD;
               label of the vaccine&#xD;
  &#xD;
            -  Having received any of the specified therapy within the specified timeframe(s) prior&#xD;
               to the baseline visit&#xD;
  &#xD;
            -  Known history of or suspected significant current immunosuppression&#xD;
  &#xD;
            -  Any malignancies or history of malignancies prior to baseline (excluding in situ&#xD;
               excised and cured cervical carcinoma, non-melanoma skin cancer excised and cured &gt;3&#xD;
               years prior to baseline)&#xD;
  &#xD;
            -  History of solid organ or stem cell transplant&#xD;
  &#xD;
            -  Any active or chronic infection including helminthic infection requiring systemic&#xD;
               treatment within 2 weeks prior baseline&#xD;
  &#xD;
            -  Positive for human immunodeficiency virus (HIV), Hepatitis B or hepatitis C at&#xD;
               screening visit&#xD;
  &#xD;
            -  Participants with active tuberculosis (TB), latent TB, a history of incompletely&#xD;
               treated TB, suspected extrapulmonary TB infection, or who are at high risk of&#xD;
               contracting TB&#xD;
  &#xD;
          The above information is not intended to contain all considerations relevant to a potential&#xD;
          participation in a clinical trial.&#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>Clinical Sciences &amp; Operations</last_name>
      <role>Study Director</role>
      <affiliation>Sanofi</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Trial Transparency email recommended (Toll free for US &amp;amp; Canada)</last_name>
      <phone>800-633-1610</phone>
      <phone_ext>option 6</phone_ext>
      <email>Contact-US@sanofi.com</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 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>Dermatitis, Atopic</mesh_term>
      <mesh_term>Dermatitis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vaccines</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org</ipd_description>
    </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/NCT06015308
  org study id: SFY17915
  secondary id: U1111-1280-8357
  nct id: NCT06015308
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  This is a Phase 2, multicenter, randomized, double-blind placebo controlled, 2-arm study to
        evaluate the effect of amlitelimab on vaccine antibody responses, and the safety of
        amlitelimab concurrently administered with non-live vaccines in adult participants with
        moderate-to-severe atopic dermatitis (AD).
  
        The purpose of this study is to compare the immune responses to concomitantly administered
        Boostrix (tetanus, diphtheria, and acellular pertussis [Tdap]) and Pneumovax 23 (PPSV)
        vaccines in adult participants with moderate-to-severe AD treated with amlitelimab versus
        placebo. The study will evaluate the percentage of participants achieving a positive
        anti-tetanus response at Week 16 (primary endpoint) and a positive anti-pneumococcal response
        at Week 16 (primary endpoint).
  
        Study details include:
  
        The study duration will be up to 36 weeks (for participants not entering the LTS17367
        [RIVER-AD]).
  
        The screening period will be 2 to 4 weeks. The treatment duration will be up to 16 weeks. The
        post-treatment safety follow-up period will be16 weeks. The number of visits will be up to 7
        (or 6 for those entering LTS17367 [RIVER-AD]).
  The study duration will be up to 36 weeks
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Investigator)
  measure: Percentage of participants with a positive tetanus response at Week 16
  time frame: Week 16
  description: Positive tetanus response is defined as a ≥4-fold increase from pre-vaccination at baseline in anti-tetanus immunoglobulin G [IgG] titer for participants with a pre-vaccination tetanus antibody titers ≥0.1 IU/mL or a titer of ≥0.2 IU/mL for participants with pre-vaccination titers of <0.1 IU/mL.
  measure: Percentage of participants with a positive pneumococcal vaccine response at Week 16
  time frame: Week 16
  description: Positive pneumococcal vaccine response is defined as a ≥2-fold increase from baseline in anti-pneumococcal antibodies (APAb) against >50% of the 23 serotypes.
  measure: Percentage of participants who experienced treatment-emergent adverse events (TEAE), including serious adverse events (SAE) and adverse events of special interest (AESI)
  time frame: Week 0 up to Week 32
  measure: Percentage of participants with potentially clinically significant abnormalities (PCSA) for vital signs and clinical laboratory assessments
  time frame: Week 0 up to Week 32
  measure: Percentage of participants discontinued from study treatment due to TEAEs
  time frame: Week 0 up to Week 32
  measure: Proportion of participants with validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) of 0 (clear) or 1 (almost clear) and a reduction of ≥2 points from baseline at Week 16
  time frame: Week 16
  description: The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).
  measure: Proportion of participants with a ≥75% reduction in EASI score (EASI-75) from baseline at Week 16
  time frame: Week 16
  description: The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD using a 4-point scale; 0 (absent) to 3 (severe).
  measure: Serum amlitelimab concentrations
  time frame: Week 0 up to Week 16
  measure: Incidence of antidrug antibodies (ADAs) of amlitelimab
  time frame: Week 0 up to Week 16
  arm group label: Amlitelimab
  arm group type: Experimental
  description: Participants will receive amlitelimab and vaccines as per protocol.
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Participants will receive placebo matching amlitelimab and vaccines as per protocol.
  intervention type: Drug
  intervention name: Amlitelimab
  description: Subcutaneous injection in abdomen, outer thigh, or upper arm
  arm group label: Amlitelimab
  intervention type: Drug
  intervention name: Placebo
  description: Subcutaneous injection in abdomen, outer thigh, or upper arm
  arm group label: Placebo
  intervention type: Biological
  intervention name: Tdap vaccine
  description: Intramuscular (IM) injection into the deltoid muscle of the upper arm
  arm group label: Amlitelimab
  arm group label: Placebo
  intervention type: Biological
  intervention name: PPS vaccine
  description: Intramuscular or subcutaneous injection into the deltoid muscle of the upper arm
  arm group label: Amlitelimab
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Clinical Sciences & Operations
  role: Study Director
  affiliation: Sanofi
  last name: Trial Transparency email recommended (Toll free for US &amp; Canada)
  phone: 800-633-1610
  phone ext: option 6
  email: Contact-US@sanofi.com
  responsible party type: Sponsor
  mesh term: Dermatitis, Atopic
  mesh term: Dermatitis
  mesh term: Vaccines
  sharing ipd: Yes
  ipd description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org