AMLITELIMAB for Atopic dermatitis

Inclusion criteria

• {"criterion_text":"- Participant must be at least 12 years of age inclusive at the time of signing the informed consent."}
• {"criterion_text":"- Participated in an amlitelimab clinical trial for moderate to severe AD and received study treatment, adequately completed the assessments required for the treatment period. -- Have reached the rollover timepoint to LTS17367 at the last visit of the treatment period of their feederparent study SFY17915, INT18404, EFC17599, or EFC17600 --Participants in DRI17366 must only be enrolled from 1 of the following 3 groups: --- The first group: participants at Week 24 in the DRI17336 study who have not achieved an ≥ Eczema Area and Skin Severity Index (EASI)-75 and are Investigator Global Assessment (IGA) ≥ 2. --- The second group: participants entering LTS17367 between Week 28 and Week 52 of the feederparent study, due to loss of clinical response in the part 2 of the feederparent study. Timepoints for entering LTS17367 are Weeks 28, 32, 36, 40, 44, 48 or 52. For DRI17366 loss of clinical response is defined as the first instance of < EASI 50 during the second study period and where rescue therapy is no longer permitted. --- The third group: participants at Week 24 in DRI17366 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 -- Participated in DRI17366 completing the previous study safety follow up (week 68) and wish to re-initiate treatment with amlitelimab up to one year after the last visit"}
• {"criterion_text":"- Provide signed informed consent and able to comply with the requirements of the protocol"}
• {"criterion_text":"- Complied with the previous clinical trial protocol to the satisfaction of the investigator"}
• {"criterion_text":"- Body weight must be ≥25 kg"}

Exclusion criteria

• {"criterion_text":"- Developed a medical condition that would preclude participation as described in the section for permanent discontinuation of the feeder study or LTS17367 protocol"}
• {"criterion_text":"- Known history of or suspected current significant immunosuppression, including history of invasive opportunistic infections or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration"}
• {"criterion_text":"- History of solid organ or stem cell transplant"}
• {"criterion_text":"- Any malignancies or history of malignancies prior to baseline (except for non-melanoma skin cancer that has been excised and completely cured for more than 5 years prior to baseline)"}
• {"criterion_text":"- Participants positive for human immunodeficiency virus (HIV); participants with any of the following results at Screening (Visit 1) or at any point during the feeder study: presence of HBsAg with or without HBV DNA PCR test, or presence of anti-HBc Ab or presence of anti-HBs Ab with positive HBV DNA PCR test; positive HCVAb confirmed by positive HCV RNA"}
• {"criterion_text":"- History (within last 2 years prior to baseline) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator"}
• {"criterion_text":"- Participants with active TB, latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, non-TB mycobacterial infection, or who are at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to screening"}
• {"criterion_text":"- Participants with an determinate or a confirmed positive IGRA test are excluded from the study unless all of the following conditions are met: a) Have a history of prior documented completed chemoprophylaxis for latent TB infection (with a treatment regimen as per local guidelines), OR treated for active TB infection b) Have been in written form approved for participation in the present trial by a TB specialist who ruled out latent or active TB infection or other mycobacterial infection in the participant c) For whom review and approval from Sponsor have been granted are eligible"}
• {"criterion_text":"- Severe concomitant illness that would in the Investigator’s opinion inhibit the participant’s participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease"}
• {"criterion_text":"- Skin co-morbidity that would adversely affect the ability to undertake AD assessments (e.g., psoriasis, tinea corporis, lupus erythematosus) as per Investigator’s judgment"}
• {"criterion_text":"- Any medical condition which, in the opinion of the Investigator may present an unreasonable risk to the study participant as a result of his/her participation in this clinical study, may make particpant’s participation unreliable, or may interfere with study assessments"}
• {"criterion_text":"- In the Investigator’s opinion, medical conditions related to prior AD medications that have not healed/fully recovered for more than 2 weeks before screening visit, including, but not limited to, conjunctivitis, keratitis, eosinophilic conditions, arthralgia, herpes zoster, thrombosis"}

Primary endpoints

• {"endpoint_text":"- Percentage of participants who experienced treatment-emergent adverse event (TEAE)","definition_or_measurement_approach":"Measured as the percentage of participants who experienced a treatment-emergent adverse event (TEAE) during the study"}

Secondary endpoints

• {"endpoint_text":"- Percentage of participants who experienced treatment-emergent serious adverse events (SAEs)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Percentage of participants who experienced treatment-emergent adverse events of special interest (AESI)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Absolute change from DRI17366 baseline in EASI score at each LTS17367 visit in participants entering the study from DRI17366 Week 24","definition_or_measurement_approach":""}
• {"endpoint_text":"- Percent change from DRI17366 baseline in EASI score at each LTS17367 visit in participants entering the study from DRI17366 Week 24","definition_or_measurement_approach":""}
• {"endpoint_text":"- Proportion of participants with EASI50/EASI75/EASI90 from DRI17366 baseline at each LTS17367 visit in participants entering the study from DRI17366 Week 24","definition_or_measurement_approach":""}
• {"endpoint_text":"- Proportion of participants with a response of Validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) 0 or 1 at each LTS17367 visit in participants entering the study from DRI17366 Week 24","definition_or_measurement_approach":""}
• {"endpoint_text":"- Absolute change from feeder study baseline in EASI score in all participants entering the study [each LTS17367 visit]","definition_or_measurement_approach":""}
• {"endpoint_text":"- Percent change from feeder study baseline in EASI score in all participants entering the study [each LTS17367 visit]","definition_or_measurement_approach":""}
• {"endpoint_text":"- Proportion of participants with EASI50/ EASI75/EASI90 in all participants entering the study [each LTS17367 visit]","definition_or_measurement_approach":""}
• {"endpoint_text":"- Time to first EASI75/EASI90 in those participants who had not achieved it by the time of LTS17367 enrollment","definition_or_measurement_approach":""}
• {"endpoint_text":"- Serum amlitelimab concentration assessed at prespecified time points through the end of the study","definition_or_measurement_approach":"Measured by serum concentration assays at prespecified timepoints"}
• {"endpoint_text":"- Number of participants with anti drug antibodies (ADAs) of amlitelimab at specified timepoints","definition_or_measurement_approach":""}
• {"endpoint_text":"- Percentage of participants who experienced TEAE leading to treatment discontinuation","definition_or_measurement_approach":""}
• {"endpoint_text":"- Proportion of participants with vIGA-AD 0 or 1 with presence of only barely perceptible erythema (no induration/papulation, no lichenification, no oozing or crusting) at each LTS17367 visit","definition_or_measurement_approach":""}
• {"endpoint_text":"- Proportion of participants requiring topical treatment in all participants entering the study [each LTS17367 visit]","definition_or_measurement_approach":""}
• {"endpoint_text":"- Proportion of participants requiring rescue treatment [each LTS17367 visit]: all treatments in all participants entering the study","definition_or_measurement_approach":""}
• {"endpoint_text":"- Time from enrollment in LTS17367 to first loss of vIGA-AD 0 in those participants who were vIGA-AD 0 at LTS17367 rollover from EFC17600 (ESTUARY) and EFC17599 (AQUA)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Proportion of participants with vIGA-AD score 0/1 in all participants entering the study [each LTS17367 visit]","definition_or_measurement_approach":""}
• {"endpoint_text":"- Proportion of participants with vIGA-AD score 0 [each LTS17367 visit]","definition_or_measurement_approach":""}
• {"endpoint_text":"- Time to first vIGA-AD 0/1 after LTS17367 enrollment in those participants who had not achieved vIGA-AD 0/1 by the time of LTS17367 enrollment","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number of days on topical medication (per patient-year) in all participants entering the study","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change coming from feeder study baseline atopic dermatitis control tool (ADCT) in all participants entering the study [each LTS17367 visit]","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change from feeder study baseline in dermatology life quality index (DLQI/cDLQI) in all participants entering the study [each LTS17367 visit]","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change from feeder study baseline^ in patient oriented eczema measure (POEM) in all participants entering the study [each LTS17367 visit]","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change from feeder study baseline in BSA-AD [each LTS17367 visit]","definition_or_measurement_approach":""}
• {"endpoint_text":"- Time from enrollment in LTS17367 to first loss EASI75 in those participants who had reached EASI75 at LTS17367 rollover coming from EFC17600 (ESTUARY) and EFC17599 (AQUA)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Time from enrollment in LTS17367 to first loss of vIGA-AD 0/1 in those participants who were vIGA-AD 0/1 at LTS17367 rollover from EFC17600 (ESTUARY) and EFC17599 (AQUA)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Time from LTS17367 baseline to re-treatment with amlitelimab in those participants who were vIGA-AD 0/1 at LTS17367 rollover from EFC17600 (ESTUARY) and EFC17599 (AQUA).","definition_or_measurement_approach":""}
• {"endpoint_text":"- Time from last amlitelimab dose in feeder study to re-treatment with amlitelimab in those participants who were vIGA-AD 0/1 at LTS17367 rollover from EFC17600 (ESTUARY) and EFC17599 (AQUA).","definition_or_measurement_approach":""}

Sweden

Earliest CTIS Part Ii Submission Date

24-09-2024

Latest Decision Or Authorization Date

19-12-2024

Processing Time Days

86

Number Of Participants

1

Denmark

Earliest CTIS Part Ii Submission Date

15-01-2025

Latest Decision Or Authorization Date

21-01-2025

Processing Time Days

6

Number Of Participants

5

Netherlands

Earliest CTIS Part Ii Submission Date

23-01-2025

Latest Decision Or Authorization Date

02-02-2025

Processing Time Days

10

Number Of Participants

1

France

Earliest CTIS Part Ii Submission Date

24-09-2024

Latest Decision Or Authorization Date

03-12-2024

Processing Time Days

70

Number Of Participants

24

Bulgaria

Earliest CTIS Part Ii Submission Date

05-12-2023

Latest Decision Or Authorization Date

19-02-2024

Processing Time Days

76

Number Of Participants

71

Greece

Earliest CTIS Part Ii Submission Date

21-01-2025

Latest Decision Or Authorization Date

28-01-2025

Processing Time Days

7

Number Of Participants

9

Spain

Earliest CTIS Part Ii Submission Date

05-12-2023

Latest Decision Or Authorization Date

08-01-2024

Processing Time Days

34

Number Of Participants

33

Hungary

Earliest CTIS Part Ii Submission Date

05-12-2023

Latest Decision Or Authorization Date

09-01-2024

Processing Time Days

35

Number Of Participants

4

Poland

Earliest CTIS Part Ii Submission Date

05-12-2023

Latest Decision Or Authorization Date

10-01-2024

Processing Time Days

36

Number Of Participants

147

Portugal

Earliest CTIS Part Ii Submission Date

07-11-2024

Latest Decision Or Authorization Date

10-12-2024

Processing Time Days

33

Number Of Participants

5

Italy

Earliest CTIS Part Ii Submission Date

12-12-2024

Latest Decision Or Authorization Date

03-02-2025

Processing Time Days

53

Number Of Participants

18

Germany

Earliest CTIS Part Ii Submission Date

05-12-2023

Latest Decision Or Authorization Date

09-01-2024

Processing Time Days

35

Number Of Participants

64

Czechia

Earliest CTIS Part Ii Submission Date

05-12-2023

Latest Decision Or Authorization Date

09-01-2024

Processing Time Days

35

Number Of Participants

75

Primary sponsor

Full Name

Sanofi-Aventis Recherche & Developpement

Organisation Type

Pharmaceutical company

Country Of Registered Address

France

Contract research organisations

Name

Icon Clinical Research Limited

Responsibilities

sponsorDuties codes: [1,7]

Name

Pharmaceutical Product Development LLC

Responsibilities

sponsorDuties codes: [4]

Name

PPD Global Central Labs (S) Pte Ltd / PPD International Holdings LLC / Ppd Laboratories (Suzhou) Co. Ltd.

Responsibilities

operations/central lab roles (sponsorDuties codes: [4])

Name

Azenta US Inc. / Azenta Germany GmbH

Responsibilities

Laboratory sample storage

Name

ESMS Global Limited

Responsibilities

Centralized 24-Hour Emergency System: eSMS

Third parties

• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: [1]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Laboratory sample storage","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"Centralized 24-Hour Emergency System: eSMS","organisation_type":"Pharmaceutical company"}
• {"country":"Portugal","full_name":"Evidenze Portugal Unipessoal Lda.","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
• {"country":"Greece","full_name":"Bioiatriki Private Medical Polyclinic S.A.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Italy","full_name":"Depo-pack S.r.l.","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Laboratory sample storage","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Signant Health Management Limited","duties_or_roles":"sponsorDuties codes: [7]","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Mapi Research Trust","duties_or_roles":"sponsorDuties codes: [7]","organisation_type":"Pharmaceutical company"}
• {"country":"Singapore","full_name":"PPD Global Central Labs (S) Pte Ltd","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
• {"country":"Poland","full_name":"Centrala Farmaceutyczna Cefarm S.A.","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"PPD International Holdings LLC","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
• {"country":"Hungary","full_name":"PetMobile Kft.","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Non-Pharmaceutical company"}
• {"country":"China","full_name":"Ppd Laboratories (Suzhou) Co. Ltd.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
• {"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
• {"country":"Spain","full_name":"Ashfield Iberia S.L","duties_or_roles":"Home Health Care / Nursing","organisation_type":"Industry"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: [7]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Rules Based Medicine Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United Kingdom","full_name":"Ashfield Healthcare Limited","duties_or_roles":"Home Health Care / Nursing","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}