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Long-Term Safety and Efficacy Evaluation of Amlitelimab in Adult Participants With Moderate to Severe Atopic Dermatitis

Primary Purpose

Dermatitis Atopic

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Amlitelimab
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:

  • Participant must be 18 years of age, inclusive, or older at the time of signing the informed consent.
  • Participated in KY1005-CT05 (DRI17366) for moderate to severe AD and received study treatment, adequately completed the assessments required for the treatment period. Participants must only be enrolled from 1 of the following 3 groups:

    • The first group: participants at Week 24 in the KY1005-CT05 (DRI17336) study who have not achieved an >= Eczema Area and Skin Severity Index (EASI)-75 and are Investigator Global Assessment (IGA) 2, 3 or 4.
    • The second group: participants entering the LTE between Week 28 and Week 52 of the parent study, due to loss of clinical response in the part 2 of the parent study. Loss of clinical response is defined as the first instance of < EASI-50 during the second study period.
    • The third group: participants at Week 24 in KY1005-CT05 (DRI17336) who have been re-randomized and who subsequently complete the study to Week 52, enter safety follow-up and experience worsening of their AD during safety follow-up or thereafter.
  • Provide signed informed consent and able to comply with the requirements of the protocol.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

  • Any participant who has received prohibited systemic therapies, as per KY1005-CT05 (DRI17366) clinical trial protocol, either during or after completion of KY1005-CT05 (DRI17366) will not be eligible for the long-term extension (LTE).
  • Participants who, during their participation in KY1005-CT05 (DRI17366), developed an adverse events (AE) or a serious adverse event (SAE) deemed related to amlitelimab, which in the opinion of the Investigator could indicate that continued treatment with amlitelimab may present an unreasonable risk for the participant.
  • Conditions in KY1005-CT05 (DRI17366), consistent with protocol-defined criteria for permanent IMP discontinuation, if deemed related to amlitelimab or led to Investigator or Sponsor-initiated withdrawal of participant from the study (e.g., non-compliance, inability to complete study assessments, etc.).
  • Developed a medical condition that would preclude participation as per KY1005-CT05 (DRI17366) clinical trial protocol.
  • Concurrent participation in any other clinical study, including non-interventional studies.
  • Only in those participants entering after completion of KY1005-CT05 (DRI17366) safety follow-up

    1. Newly diagnosed Tuberculosis (TB) or non-TB mycobacterial infections requiring treatment (including a positive QuantiFERON®-TB Gold blood test at the screening visit),
    2. Positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C antibody (HCV Ab) at the screening visit.
    3. Laboratory values at the Screening Visit:

    i) Serum creatinine > 1.6 mg/dL (141 micromol/L) in female patients and > 1.9 mg/dL (168 micromol/L) in male patients, ii) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.0 x upper limit of normal (ULN), iii) Serum total bilirubin >1.5 x ULN (except for subjects with Gilbert's syndrome, where total bilirubin must not exceed 3.0 mg/dL or 50 micromol/L), iv) In the Investigator's opinion, any additional clinically significant laboratory results from the clinical chemistry, haematology or urinalysis tests at the Screening visit.

    d) In the Investigator's opinion any significant abnormality on 12-lead ECG at the screening visit.

  • History of or known or suspected hypersensitivity to amlitelimab or the matching placebo formulation, or excipients used in the presentation of amlitelimab or placebo, or in preparation for administration. History of or known or suspected severe hypersensitivity reactions to other mAbs and/or their excipients.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sites / Locations

  • Medical Research Center of Miami II, Inc-Site Number:8401019Recruiting
  • Alliance Clinical Research - Tampa-Site Number:8401013Recruiting
  • Aeroallergy Research Laboratories Of Savannah Inc-Site Number:8401004Recruiting
  • CONTINENTAL CLINICAL RESEARCH-Site Number:8401011Recruiting
  • Revival Research Corporation - Michigan - ClinEdge - PPDS-Site Number:8401012Recruiting
  • Vital Prospects Clinical Research Institute, P.C.-Site Number:8401005Recruiting
  • International Clinical Research-Tennessee LLC-Site Number:8401008Recruiting
  • Investigational Site Number :0363002Recruiting
  • Investigational Site Number :0363003Recruiting
  • Investigational Site Number :0363001Recruiting
  • Investigational Site Number :1002004Recruiting
  • Investigational Site Number :1002005
  • Investigational Site Number :1002003Recruiting
  • Investigational Site Number :1002006Recruiting
  • Investigational Site Number :1002002Recruiting
  • Investigational Site Number :1241106Recruiting
  • Investigational Site Number :1241108Recruiting
  • Investigational Site Number :1241107Recruiting
  • Investigational Site Number :1241101Recruiting
  • Investigational Site Number :2762203Recruiting
  • Investigational Site Number :2762202Recruiting
  • Investigational Site Number :2762207Recruiting
  • Investigational Site Number :2762208Recruiting
  • Investigational Site Number :2762201Recruiting
  • Investigational Site Number :3482303Recruiting
  • Investigational Site Number :3482305Recruiting
  • Investigational Site Number :3482306Recruiting
  • Investigational Site Number :3923114Recruiting
  • Investigational Site Number :3923101Recruiting
  • Investigational Site Number :3923108Recruiting
  • Investigational Site Number :3923113Recruiting
  • Investigational Site Number :3923110Recruiting
  • Investigational Site Number :3923106Recruiting
  • Investigational Site Number :3923112Recruiting
  • Investigational Site Number :3923115Recruiting
  • Investigational Site Number :3923104Recruiting
  • Investigational Site Number :3923107Recruiting
  • Investigational Site Number :3923105Recruiting
  • Investigational Site Number :3923109Recruiting
  • Investigational Site Number :3923102Recruiting
  • Investigational Site Number :6162414Recruiting
  • Investigational Site Number :6162418Recruiting
  • Investigational Site Number :6162417Recruiting
  • Investigational Site Number :6162415Recruiting
  • Investigational Site Number :6162416Recruiting
  • Investigational Site Number :6162406Recruiting
  • Investigational Site Number :6162407Recruiting
  • Investigational Site Number :6162412Recruiting
  • Investigational Site Number :6162411Recruiting
  • Investigational Site Number :6162413Recruiting
  • Investigational Site Number :6162401Recruiting
  • Investigational Site Number :6162419Recruiting
  • Investigational Site Number :6162403Recruiting
  • Investigational Site Number :6162402Recruiting
  • Investigational Site Number :6162404Recruiting
  • Investigational Site Number :6162405Recruiting
  • Investigational Site Number :6162410Recruiting
  • Investigational Site Number :6162408Recruiting
  • Investigational Site Number :6162409Recruiting
  • Investigational Site Number :7242504Recruiting
  • Investigational Site Number :7242503Recruiting
  • Investigational Site Number :7242505Recruiting
  • Investigational Site Number :7242501Recruiting
  • Investigational Site Number :1583201Recruiting
  • Investigational Site Number :1583202Recruiting
  • Investigational Site Number :1583203Recruiting
  • Investigational Site Number :8262603Recruiting
  • Investigational Site Number :8262601Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Amlitelimab

Arm Description

Subcutaneous injection as per protocol.

Outcomes

Primary Outcome Measures

Percentage of participants who experienced treatment-emergent adverse event (TEAE) from baseline during the study
Percentage of participants who experienced TEAE from baseline during the study.

Secondary Outcome Measures

Percentage of participants who experienced treatment-emergent SAEs from baseline during the study
Percentage of participants who experienced treatment-emergent SAEs from baseline during the study.
Percentage of participants who experienced treatment-emergent adverse events of special interest (AESI) from baseline during study
Percentage of participants who experienced treatment-emergent AESI from baseline during study.
Absolute change from KY1005-CT05 (DRI17366) baseline in Eczema Area and Skin Severity Index (EASI) score at each visit in participants entering the study from KY1005-CT05 (DRI17366) Week 24
EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.
Percent change from KY1005-CT05 (DRI17366) baseline in EASI score at each visit in participants entering the study from KY1005-CT05 (DRI17366) Week 24
EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.
Proportion of participants with EASI75/EASI90/EASI100 from KY1005-CT05 (DRI17366) baseline at each visit in participants entering the study from KY1005-CT05 (DRI17366) Week 24
EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD. EASI75: >= 75% reduction in score from baseline; EASI90: >= 90% reduction in score from baseline; EASI100: >= 100% reduction in score from baseline.
Proportion of participants with a response of investigator global assessment (IGA) 0 or 1and a reduction from baseline of >= 2 points at each visit in participants entering the study from KY1005-CT05 (DRI17366) Week 24
The IGA is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.
Absolute change from LTE baseline in EASI score at pre-specified timepoints in all participants entering the study
EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.
Percent change from LTE baseline in EASI score at pre-specified timepoints in all participants entering the study
EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.
Proportion of participants with EASI50/ EASI75/EASI90/EASI100 at pre-specified timepoints in all participants entering the study
EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD. EASI50: >= 50% reduction in score from baseline; EASI75: >= 75% reduction in score from baseline; EASI90: >= 90% reduction in score from baseline; EASI100: >= 100% reduction in score from baseline.
Time to first EASI75/EASI90/EASI100 in those participants who had not achieved it by the time of LTE entry in all participants entering the study
EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD. EASI75: >= 75% reduction in score from baseline; EASI90: >= 90% reduction in score from baseline; EASI100: >= 100% reduction in score from baseline.
Time to first remission after LTE enrolment (achieving IGA 0/1) in those participants who had not achieved IGA 0/1 by the time of LTE entry in all participants entering the study
The IGA is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.
Proportion of participants with IGA score 0/1 at each visit in all participants entering the study
The IGA is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.
Proportion of participants with low disease activity state (e.g., IGA <= 2) at each visit in all participants entering the study
The IGA is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.
Proportion of participants requiring rescue treatment at each visit: all treatments in all participants entering the study
Proportion of participants requiring rescue treatment at each visit: all treatments in all participants entering the study.
Proportion of participants requiring rescue treatment at each visit: topical treatments in all participants entering the study
Proportion of participants requiring rescue treatment at each visit: topical treatments in all participants entering the study.
Proportion of participants requiring rescue treatment at each visit: systematic treatments in all participants entering the study
Proportion of participants requiring rescue treatment at each visit: systematic treatments in all participants entering the study.
Number of days on topical medication (per patient-year) in all participants entering the study
Number of days on topical medication (per patient-year) in all participants entering the study.
Change from LTE baseline to prespecified time points through the end of the study: atopic dermatitis control tool (ADCT) in all participants entering the study
ADCT is a six-item patient self-administered instrument designed and validated to assess atopic dermatitis (AD) control. The score ranges from 0-24 with higher scores indicate worsening disease control.
Change from LTE baseline to prespecified time points through the end of the study: dermatology life quality index (DLQI) in all participants entering the study
The DLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in adult patients. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.
Change from LTE baseline to prespecified time points through the end of the study: patient oriented eczema measure (POEM) in all participants entering the study
The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a scale ranging from 0 to 4 (0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, 4 = all days). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). Higher scores indicated more severe disease and poor quality of life.
Serum amlitelimab concentration assessed at prespecified time points through the end of the study
Serum amlitelimab concentration assessed at prespecified time points through the end of the study.
Anti-amlitelimab antibody titre in participants with positive response
Anti-amlitelimab antibody titre in participants with positive response.
Number of participants with positive anti-drug antibody response
Number of participants with positive anti-drug antibody response.

Full Information

First Posted
August 5, 2022
Last Updated
August 4, 2023
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT05492578
Brief Title
Long-Term Safety and Efficacy Evaluation of Amlitelimab in Adult Participants With Moderate to Severe Atopic Dermatitis
Official Title
A Long-term Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Subcutaneous Amlitelimab in Adult Participants With Moderate to Severe Atopic Dermatitis Who Participated in KY1005-CT05 (DRI17366)
Study Type
Interventional

2. Study Status

Record Verification Date
August 4, 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 22, 2022 (Actual)
Primary Completion Date
October 29, 2027 (Anticipated)
Study Completion Date
October 29, 2027 (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 single group, Phase 2, long-term extension study for treatment. The purpose of this study is to characterize the safety and efficacy of amlitelimab in treated adult participants with moderate to severe AD who have previously been enrolled in study KY1005-CT05 (DRI17366). Visits during the on-treatment period will be at Week 0, 1, 2, 4 and every 4 weeks (Q4W) thereafter. If remote or telephone visits are considered appropriate for participants instead of clinic visits at the timepoints indicated in the schedule of activities (SoA), home visits (e.g., home nurses, etc) will be required for administration of investigational medicinal product (IMP) and assessment of vital signs. This decision is at the discretion of the investigator.

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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Amlitelimab
Arm Type
Experimental
Arm Description
Subcutaneous injection as per protocol.
Intervention Type
Drug
Intervention Name(s)
Amlitelimab
Intervention Description
Solution for injection Subcutaneous
Primary Outcome Measure Information:
Title
Percentage of participants who experienced treatment-emergent adverse event (TEAE) from baseline during the study
Description
Percentage of participants who experienced TEAE from baseline during the study.
Time Frame
Baseline to Week 120
Secondary Outcome Measure Information:
Title
Percentage of participants who experienced treatment-emergent SAEs from baseline during the study
Description
Percentage of participants who experienced treatment-emergent SAEs from baseline during the study.
Time Frame
Baseline to Week 120
Title
Percentage of participants who experienced treatment-emergent adverse events of special interest (AESI) from baseline during study
Description
Percentage of participants who experienced treatment-emergent AESI from baseline during study.
Time Frame
Baseline to Week 120
Title
Absolute change from KY1005-CT05 (DRI17366) baseline in Eczema Area and Skin Severity Index (EASI) score at each visit in participants entering the study from KY1005-CT05 (DRI17366) Week 24
Description
EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.
Time Frame
DRI17366 Baseline to Week 104
Title
Percent change from KY1005-CT05 (DRI17366) baseline in EASI score at each visit in participants entering the study from KY1005-CT05 (DRI17366) Week 24
Description
EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.
Time Frame
DRI17366 Baseline to Week 104
Title
Proportion of participants with EASI75/EASI90/EASI100 from KY1005-CT05 (DRI17366) baseline at each visit in participants entering the study from KY1005-CT05 (DRI17366) Week 24
Description
EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD. EASI75: >= 75% reduction in score from baseline; EASI90: >= 90% reduction in score from baseline; EASI100: >= 100% reduction in score from baseline.
Time Frame
DRI17366 Baseline to Week 104
Title
Proportion of participants with a response of investigator global assessment (IGA) 0 or 1and a reduction from baseline of >= 2 points at each visit in participants entering the study from KY1005-CT05 (DRI17366) Week 24
Description
The IGA is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.
Time Frame
Baseline to Week 104
Title
Absolute change from LTE baseline in EASI score at pre-specified timepoints in all participants entering the study
Description
EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.
Time Frame
Baseline to Week 104
Title
Percent change from LTE baseline in EASI score at pre-specified timepoints in all participants entering the study
Description
EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.
Time Frame
Baseline to Week 104
Title
Proportion of participants with EASI50/ EASI75/EASI90/EASI100 at pre-specified timepoints in all participants entering the study
Description
EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD. EASI50: >= 50% reduction in score from baseline; EASI75: >= 75% reduction in score from baseline; EASI90: >= 90% reduction in score from baseline; EASI100: >= 100% reduction in score from baseline.
Time Frame
Baseline to Week 104
Title
Time to first EASI75/EASI90/EASI100 in those participants who had not achieved it by the time of LTE entry in all participants entering the study
Description
EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD. EASI75: >= 75% reduction in score from baseline; EASI90: >= 90% reduction in score from baseline; EASI100: >= 100% reduction in score from baseline.
Time Frame
Baseline to Week 104
Title
Time to first remission after LTE enrolment (achieving IGA 0/1) in those participants who had not achieved IGA 0/1 by the time of LTE entry in all participants entering the study
Description
The IGA is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.
Time Frame
Baseline to Week 104
Title
Proportion of participants with IGA score 0/1 at each visit in all participants entering the study
Description
The IGA is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.
Time Frame
Baseline to Week 104
Title
Proportion of participants with low disease activity state (e.g., IGA <= 2) at each visit in all participants entering the study
Description
The IGA is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.
Time Frame
Baseline to Week 104
Title
Proportion of participants requiring rescue treatment at each visit: all treatments in all participants entering the study
Description
Proportion of participants requiring rescue treatment at each visit: all treatments in all participants entering the study.
Time Frame
Baseline to Week 120
Title
Proportion of participants requiring rescue treatment at each visit: topical treatments in all participants entering the study
Description
Proportion of participants requiring rescue treatment at each visit: topical treatments in all participants entering the study.
Time Frame
Baseline to Week 120
Title
Proportion of participants requiring rescue treatment at each visit: systematic treatments in all participants entering the study
Description
Proportion of participants requiring rescue treatment at each visit: systematic treatments in all participants entering the study.
Time Frame
Baseline to Week 120
Title
Number of days on topical medication (per patient-year) in all participants entering the study
Description
Number of days on topical medication (per patient-year) in all participants entering the study.
Time Frame
Baseline to Week 120
Title
Change from LTE baseline to prespecified time points through the end of the study: atopic dermatitis control tool (ADCT) in all participants entering the study
Description
ADCT is a six-item patient self-administered instrument designed and validated to assess atopic dermatitis (AD) control. The score ranges from 0-24 with higher scores indicate worsening disease control.
Time Frame
Baseline to Week 104
Title
Change from LTE baseline to prespecified time points through the end of the study: dermatology life quality index (DLQI) in all participants entering the study
Description
The DLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in adult patients. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.
Time Frame
Baseline to Week 104
Title
Change from LTE baseline to prespecified time points through the end of the study: patient oriented eczema measure (POEM) in all participants entering the study
Description
The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a scale ranging from 0 to 4 (0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, 4 = all days). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). Higher scores indicated more severe disease and poor quality of life.
Time Frame
Baseline to Week 104
Title
Serum amlitelimab concentration assessed at prespecified time points through the end of the study
Description
Serum amlitelimab concentration assessed at prespecified time points through the end of the study.
Time Frame
Baseline to Week 104
Title
Anti-amlitelimab antibody titre in participants with positive response
Description
Anti-amlitelimab antibody titre in participants with positive response.
Time Frame
Baseline to Week 120
Title
Number of participants with positive anti-drug antibody response
Description
Number of participants with positive anti-drug antibody response.
Time Frame
Baseline to Week 120

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant must be 18 years of age, inclusive, or older at the time of signing the informed consent. Participated in KY1005-CT05 (DRI17366) for moderate to severe AD and received study treatment, adequately completed the assessments required for the treatment period. Participants must only be enrolled from 1 of the following 3 groups: The first group: participants at Week 24 in the KY1005-CT05 (DRI17336) study who have not achieved an >= Eczema Area and Skin Severity Index (EASI)-75 and are Investigator Global Assessment (IGA) 2, 3 or 4. The second group: participants entering the LTE between Week 28 and Week 52 of the parent study, due to loss of clinical response in the part 2 of the parent study. Loss of clinical response is defined as the first instance of < EASI-50 during the second study period. The third group: participants at Week 24 in KY1005-CT05 (DRI17336) who have been re-randomized and who subsequently complete the study to Week 52, enter safety follow-up and experience worsening of their AD during safety follow-up or thereafter. Provide signed informed consent and able to comply with the requirements of the protocol. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: Any participant who has received prohibited systemic therapies, as per KY1005-CT05 (DRI17366) clinical trial protocol, either during or after completion of KY1005-CT05 (DRI17366) will not be eligible for the long-term extension (LTE). Participants who, during their participation in KY1005-CT05 (DRI17366), developed an adverse events (AE) or a serious adverse event (SAE) deemed related to amlitelimab, which in the opinion of the Investigator could indicate that continued treatment with amlitelimab may present an unreasonable risk for the participant. Conditions in KY1005-CT05 (DRI17366), consistent with protocol-defined criteria for permanent IMP discontinuation, if deemed related to amlitelimab or led to Investigator or Sponsor-initiated withdrawal of participant from the study (e.g., non-compliance, inability to complete study assessments, etc.). Developed a medical condition that would preclude participation as per KY1005-CT05 (DRI17366) clinical trial protocol. Concurrent participation in any other clinical study, including non-interventional studies. Only in those participants entering after completion of KY1005-CT05 (DRI17366) safety follow-up Newly diagnosed Tuberculosis (TB) or non-TB mycobacterial infections requiring treatment (including a positive QuantiFERON®-TB Gold blood test at the screening visit), Positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C antibody (HCV Ab) at the screening visit. Laboratory values at the Screening Visit: i) Serum creatinine > 1.6 mg/dL (141 micromol/L) in female patients and > 1.9 mg/dL (168 micromol/L) in male patients, ii) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.0 x upper limit of normal (ULN), iii) Serum total bilirubin >1.5 x ULN (except for subjects with Gilbert's syndrome, where total bilirubin must not exceed 3.0 mg/dL or 50 micromol/L), iv) In the Investigator's opinion, any additional clinically significant laboratory results from the clinical chemistry, haematology or urinalysis tests at the Screening visit. d) In the Investigator's opinion any significant abnormality on 12-lead ECG at the screening visit. History of or known or suspected hypersensitivity to amlitelimab or the matching placebo formulation, or excipients used in the presentation of amlitelimab or placebo, or in preparation for administration. History of or known or suspected severe hypersensitivity reactions to other mAbs and/or their excipients. The above information is not intended to contain all considerations relevant to a patient's 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 number for US & Canada)
Phone
800-633-1610
Ext
option 6
Email
Contact-US@sanofi.com
Facility Information:
Facility Name
Medical Research Center of Miami II, Inc-Site Number:8401019
City
Miami
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Individual Site Status
Recruiting
Facility Name
Alliance Clinical Research - Tampa-Site Number:8401013
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Individual Site Status
Recruiting
Facility Name
Aeroallergy Research Laboratories Of Savannah Inc-Site Number:8401004
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Individual Site Status
Recruiting
Facility Name
CONTINENTAL CLINICAL RESEARCH-Site Number:8401011
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21212
Country
United States
Individual Site Status
Recruiting
Facility Name
Revival Research Corporation - Michigan - ClinEdge - PPDS-Site Number:8401012
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084-3536
Country
United States
Individual Site Status
Recruiting
Facility Name
Vital Prospects Clinical Research Institute, P.C.-Site Number:8401005
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Individual Site Status
Recruiting
Facility Name
International Clinical Research-Tennessee LLC-Site Number:8401008
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130-2450
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0363002
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0363003
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0363001
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1002004
City
Pleven
ZIP/Postal Code
5803
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1002005
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :1002003
City
Sofia
ZIP/Postal Code
1463
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1002006
City
Sofia
ZIP/Postal Code
1529
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1002002
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1241106
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1241108
City
Niagara Falls
State/Province
Ontario
ZIP/Postal Code
L2H 1H5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1241107
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1241101
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 1E6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2762203
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2762202
City
Blankenfelde-Mahlow
ZIP/Postal Code
15827
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2762207
City
Gera
ZIP/Postal Code
07548
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2762208
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2762201
City
Münster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3482303
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3482305
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3482306
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3923114
City
Obihiro-Shi
State/Province
Hokkaido
ZIP/Postal Code
080-0013
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3923101
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0063
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3923108
City
Kagoshima-Shi
State/Province
Kagoshima
ZIP/Postal Code
890-0063
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3923113
City
Yokohama-Shi
State/Province
Kanagawa
ZIP/Postal Code
221-0825
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3923110
City
Sakai-shi
State/Province
Osaka
ZIP/Postal Code
593-8324
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3923106
City
Shimotsuga-gun
State/Province
Tochigi
ZIP/Postal Code
321-0293
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3923112
City
Adachi-Ku
State/Province
Tokyo
ZIP/Postal Code
120-0034
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3923115
City
Chuo-Ku
State/Province
Tokyo
ZIP/Postal Code
103-0028
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3923104
City
Edogawa-Ku
State/Province
Tokyo
ZIP/Postal Code
133-0052
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3923107
City
Minato-Ku
State/Province
Tokyo
ZIP/Postal Code
108-0014
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3923105
City
Setagaya-Ku
State/Province
Tokyo
ZIP/Postal Code
158-0097
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3923109
City
Habikino-shi
ZIP/Postal Code
583-8588
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3923102
City
Kyoto-shi
ZIP/Postal Code
602-8566
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6162414
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
50-381
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6162418
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
51-318
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6162417
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
51-685
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6162415
City
Lódz
State/Province
Lódzkie
ZIP/Postal Code
90-127
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6162416
City
Lódz
State/Province
Lódzkie
ZIP/Postal Code
90-436
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6162406
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-559
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6162407
City
Kraków
State/Province
Malopolskie
ZIP/Postal Code
30-727
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6162412
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
00-874
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6162411
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
01-142
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6162413
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-672
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6162401
City
Rzeszow
State/Province
Podkarpackie
ZIP/Postal Code
35-055
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6162419
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-879
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6162403
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-214
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6162402
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-382
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6162404
City
Gdynia
State/Province
Pomorskie
ZIP/Postal Code
81-537
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6162405
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-040
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6162410
City
Szczecin
State/Province
Zachodniopomorskie
ZIP/Postal Code
71-500
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6162408
City
Krakow
ZIP/Postal Code
30-033
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6162409
City
Krakow
ZIP/Postal Code
31-011
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7242504
City
Pontevedra
State/Province
Galicia [Galicia]
ZIP/Postal Code
36071
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7242503
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7242505
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7242501
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1583201
City
Kaohsiung Hsien
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1583202
City
Taichung
ZIP/Postal Code
402
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1583203
City
Tao Yuan County
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :8262603
City
London
State/Province
London, City Of
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :8262601
City
London
State/Province
London, City Of
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Individual Site Status
Recruiting

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

Long-Term Safety and Efficacy Evaluation of Amlitelimab in Adult Participants With Moderate to Severe Atopic Dermatitis

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