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A Study to Investigate Vaccine Responses in Subcutaneous Amlitelimab Treated Atopic Dermatitis Participants Aged 18 Years and Older Compared With Placebo (HYDRO)

Primary Purpose

Dermatitis Atopic

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Amlitelimab
Placebo
Tdap vaccine
PPS vaccine
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatitis Atopic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants must be 18 years of age (when signing informed consent form) Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria) Documented history (within 6 months before screening) of either inadequate response or inadvisability to topical treatments Validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) of 3 or 4 at baseline visit Eczema area and severity index (EASI) score of 12 or higher at baseline AD involvement of 10% or more of body surface area (BSA) at baseline Able and willing to comply with requested study visits and procedures Body weight ≥40 kg and ≤150 kg Exclusion Criteria: Skin co-morbidity that would adversely affect the ability to undertake AD assessments Receipt of any vaccine (expect influenza and COVID-19 vaccines) within 3 months prior to screening Receipt of any pneumococcal vaccine within approximate timeframe of 5 years prior to screening Prior receipt of two or more doses of Pneumovax 23 at any time Receipt of any tetanus-, diphtheria-, or pertussis-containing vaccine within approximate timeframe of 5 years prior to screening Participants for whom administration of the pneumococcal vaccine provided in this study is contraindicated or medically inadvisable, according to local label of the vaccine Participants for whom administration of the tetanus, diphtheria, and pertussis vaccine provided in this study is contraindicated or medically inadvisable, according to local label of the vaccine Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit Known history of or suspected significant current immunosuppression Any malignancies or history of malignancies prior to baseline (excluding in situ excised and cured cervical carcinoma, non-melanoma skin cancer excised and cured >3 years prior to baseline) History of solid organ or stem cell transplant Any active or chronic infection including helminthic infection requiring systemic treatment within 2 weeks prior baseline Positive for human immunodeficiency virus (HIV), Hepatitis B or hepatitis C at screening visit Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Amlitelimab

    Placebo

    Arm Description

    Participants will receive amlitelimab and vaccines as per protocol.

    Participants will receive placebo matching amlitelimab and vaccines as per protocol.

    Outcomes

    Primary Outcome Measures

    Percentage of participants with a positive tetanus response at Week 16
    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.
    Percentage of participants with a positive pneumococcal vaccine response at Week 16
    Positive pneumococcal vaccine response is defined as a ≥2-fold increase from baseline in anti-pneumococcal antibodies (APAb) against >50% of the 23 serotypes.

    Secondary Outcome Measures

    Percentage of participants who experienced treatment-emergent adverse events (TEAE), including serious adverse events (SAE) and adverse events of special interest (AESI)
    Percentage of participants with potentially clinically significant abnormalities (PCSA) for vital signs and clinical laboratory assessments
    Percentage of participants discontinued from study treatment due to TEAEs
    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
    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).
    Proportion of participants with a ≥75% reduction in EASI score (EASI-75) from baseline at Week 16
    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).
    Serum amlitelimab concentrations
    Incidence of antidrug antibodies (ADAs) of amlitelimab

    Full Information

    First Posted
    August 23, 2023
    Last Updated
    September 13, 2023
    Sponsor
    Sanofi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06015308
    Brief Title
    A Study to Investigate Vaccine Responses in Subcutaneous Amlitelimab Treated Atopic Dermatitis Participants Aged 18 Years and Older Compared With Placebo
    Acronym
    HYDRO
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 4, 2023 (Anticipated)
    Primary Completion Date
    April 28, 2025 (Anticipated)
    Study Completion Date
    August 18, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sanofi

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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]).
    Detailed Description
    The study duration will be up to 36 weeks

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dermatitis Atopic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    166 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Amlitelimab
    Arm Type
    Experimental
    Arm Description
    Participants will receive amlitelimab and vaccines as per protocol.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Participants will receive placebo matching amlitelimab and vaccines as per protocol.
    Intervention Type
    Drug
    Intervention Name(s)
    Amlitelimab
    Intervention Description
    Subcutaneous injection in abdomen, outer thigh, or upper arm
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Subcutaneous injection in abdomen, outer thigh, or upper arm
    Intervention Type
    Biological
    Intervention Name(s)
    Tdap vaccine
    Intervention Description
    Intramuscular (IM) injection into the deltoid muscle of the upper arm
    Intervention Type
    Biological
    Intervention Name(s)
    PPS vaccine
    Intervention Description
    Intramuscular or subcutaneous injection into the deltoid muscle of the upper arm
    Primary Outcome Measure Information:
    Title
    Percentage of participants with a positive tetanus response at 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.
    Time Frame
    Week 16
    Title
    Percentage of participants with a positive pneumococcal vaccine response at 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.
    Time Frame
    Week 16
    Secondary Outcome Measure Information:
    Title
    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
    Title
    Percentage of participants with potentially clinically significant abnormalities (PCSA) for vital signs and clinical laboratory assessments
    Time Frame
    Week 0 up to Week 32
    Title
    Percentage of participants discontinued from study treatment due to TEAEs
    Time Frame
    Week 0 up to Week 32
    Title
    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
    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).
    Time Frame
    Week 16
    Title
    Proportion of participants with a ≥75% reduction in EASI score (EASI-75) from baseline at 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).
    Time Frame
    Week 16
    Title
    Serum amlitelimab concentrations
    Time Frame
    Week 0 up to Week 16
    Title
    Incidence of antidrug antibodies (ADAs) of amlitelimab
    Time Frame
    Week 0 up to Week 16

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participants must be 18 years of age (when signing informed consent form) Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria) Documented history (within 6 months before screening) of either inadequate response or inadvisability to topical treatments Validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) of 3 or 4 at baseline visit Eczema area and severity index (EASI) score of 12 or higher at baseline AD involvement of 10% or more of body surface area (BSA) at baseline Able and willing to comply with requested study visits and procedures Body weight ≥40 kg and ≤150 kg Exclusion Criteria: Skin co-morbidity that would adversely affect the ability to undertake AD assessments Receipt of any vaccine (expect influenza and COVID-19 vaccines) within 3 months prior to screening Receipt of any pneumococcal vaccine within approximate timeframe of 5 years prior to screening Prior receipt of two or more doses of Pneumovax 23 at any time Receipt of any tetanus-, diphtheria-, or pertussis-containing vaccine within approximate timeframe of 5 years prior to screening Participants for whom administration of the pneumococcal vaccine provided in this study is contraindicated or medically inadvisable, according to local label of the vaccine Participants for whom administration of the tetanus, diphtheria, and pertussis vaccine provided in this study is contraindicated or medically inadvisable, according to local label of the vaccine Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit Known history of or suspected significant current immunosuppression Any malignancies or history of malignancies prior to baseline (excluding in situ excised and cured cervical carcinoma, non-melanoma skin cancer excised and cured >3 years prior to baseline) History of solid organ or stem cell transplant Any active or chronic infection including helminthic infection requiring systemic treatment within 2 weeks prior baseline Positive for human immunodeficiency virus (HIV), Hepatitis B or hepatitis C at screening visit Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Trial Transparency email recommended (Toll free for US &amp; Canada)
    Phone
    800-633-1610
    Ext
    option 6
    Email
    Contact-US@sanofi.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Clinical Sciences & Operations
    Organizational Affiliation
    Sanofi
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan 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

    Learn more about this trial

    A Study to Investigate Vaccine Responses in Subcutaneous Amlitelimab Treated Atopic Dermatitis Participants Aged 18 Years and Older Compared With Placebo

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