A Study to Evaluate the Treatment Response and Safety of Two Dose Regimens of Subcutaneous Amlitelimab Monotherapy Compared With Treatment Withdrawal in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis

Dermatitis Atopic Clinical Trial

— ESTUARY  

Official title:

A Phase 3, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group 48-week Extension Study to Evaluate the Treatment Response and Safety of Two Amlitelimab Dose Regimens Administered as Monotherapy by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06407934
• Other study ID #: EFC17600
• Secondary ID: U1111-1290-92152
• Status: Recruiting
• Phase: Phase 3
• Start date: May 8, 2024
• Est. completion date: January 5, 2027

Study information

• Verified date: May 2024
• Source: Sanofi
• Contact: Trial Transparency email recommended (Toll free for US & Canada)
• Phone: 800-633-1610
• Email: Contact-US[@]sanofi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multinational, multicenter, randomized, double-blind, placebo-controlled, parallel, Phase 3 study for treatment of participants aged 12 years and older diagnosed with moderate-to-severe atopic dermatitis (AD). The main objective of this study is to evaluate if those participants who received amlitelimab dose 1 in the parent studies (EFC17559 [COAST-1], EFC17560 [COAST 2], EFC17561 [SHORE]) and were responders can maintain their response either remaining at dose 1 or switching to dose 2 of amlitelimab compared to treatment withdrawal. Study details include: The study duration will be up to 64 weeks (for participants not entering the LTS17367 [RIVER-AD] study) including a 48-week randomized double-blind period, and a 16-week safety follow-up. The study duration will be up to 48 weeks for participants entering the LTS17367 [RIVER-AD] study at the Week 48 visit of EFC17600 (ESTUARY). The total treatment duration will be up to 48 weeks. The total number of visits will be up to 14 visits (or 13 visits for those entering LTS17367 [RIVER-AD] study).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 961
• Est. completion date: January 5, 2027
• Est. primary completion date: June 23, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Participants must be at least 12 years of age inclusive, at the time the informed consent is signed.
• Must have participated, received study treatment without permanent investigational medicinal product (IMP) discontinuation, and adequately completed the assessments required for the treatment period in one of the three 24-week parent studies EFC17559 (COAST-1), EFC17560 (COAST-2) or EFC17561 (SHORE) for moderate-to-severe AD.
• Able and willing to comply with requested study visit and procedures.
• Body weight must be = 25 kg. Exclusion Criteria:

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

• Developed a medical condition that would preclude participation as described in Permanent Discontinuation of EFC17559 (COAST-1)/EFC17560 (COAST-2)/EFC17561 (SHORE) clinical trial protocols.
• Having received any prohibited medication or procedure for AD that resulted in IMP discontinuation in the parent study EFC17559 (COAST-1), EFC17560 (COAST-2) or EFC17561 (SHORE).
• Participants who, during their participation in the parent study EFC17559 (COAST-1) /EFC17560 (COAST-2)/EFC17561 (SHORE), developed an adverse event (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.
• Participants who have had IMP permanently discontinued for any reason before or at the time of the planned first dose in the EFC17600 (ESTUARY) study.
• Conditions in the parent study EFC17559 (COAST-1)/EFC17560 (COAST-2)/EFC17561 (SHORE) that led to Investigator - or Sponsor-initiated withdrawal of participant from the study (eg, non-compliance, inability to complete study assessments, etc.).
• Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis Atopic
• Dermatitis, Atopic

Intervention

Drug:
• Amlitelimab
Pharmaceutical form: Injection solution Route of administration: Subcutaneous (SC) injection
• Placebo
Pharmaceutical form: Injection solution Route of administration: SC injection

Locations

Country	Name	City	State
United States	Florida International Research Center Site Number : 8401091	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants who maintain clinical response at Week 48 of ESTUARY.	Maintenance of clinical response is defined as having validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) 0 (clear) or 1 (almost clear) and/or 75% reduction in Eczema Area and Severity Index (EASI) compared to parent study baseline EASI (EASI-75). 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). The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.	Week 48
Secondary	Responders from parent studies: Proportion of participants who continue to be EASI-75 among the participants who met EASI-75 at baseline of ESTUARY	The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score.	Up to Week 48
Secondary	Responders from parent studies: Proportion of participants who continue to be vIGA-AD 0 (clear) or 1 (almost clear) among participants who met vIGA-AD 0 (clear) or 1 (almost clear) at baseline of ESTUARY	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).	Up to Week 48
Secondary	Responders from parent studies: Proportion of participants who continue to be vIGA-AD 0 or 1 with presence of only barely perceptible erythema among those who are vIGA-AD 0 or 1 with presence of only barely perceptible erythema at baseline of ESTUARY	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), 1 (almost clear) to 4 (severe). Barely perceptible erythema with no induration/papulation, no lichenification, no oozing or crusting.	Up to Week 48
Secondary	Responders from parent studies: Proportion of participants who maintained weekly average of daily PP-NRS reduction of =4 among the participants with weekly average of daily PP-NRS reduction of = 4 at baseline of ESTUARY	The Peak Pruritus-Numerical Rating Scale (PP-NRS) is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.	Up to Week 48
Secondary	Responders from parent studies: Percent change in EASI from parent study baseline	The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.	Parent study baseline to Week 48
Secondary	Responders from parent studies: Proportion of participants with EASI-75	The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score.	Up to Week 48
Secondary	Responders from parent studies: Proportion of participants who continue to be EASI-50 among the participants who met EASI-50 at baseline of ESTUARY	The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-50 is 50% reduction from baseline in EASI score.	Up to Week 48
Secondary	Responders from parent studies: Proportion of participants with EASI-50	The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-50 is 50% reduction from baseline in EASI score.	Up to Week 48
Secondary	Responders from parent studies: Proportion of participants who continue to be EASI-90 among the participants who met EASI-90 at baseline of ESTUARY	The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-90 is 90% reduction from baseline in EASI score.	Up to Week 48
Secondary	Responders from parent studies: Proportion of participants with EASI-90	The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-90 is 90% reduction from baseline in EASI score.	Up to Week 48
Secondary	Responders from parent studies: Proportion of participants who continue to be EASI-100 among the participants who met EASI-100 at baseline of ESTUARY	The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-100 is 100% reduction from baseline in EASI score.	Up to Week 48
Secondary	Responders from parent studies: Proportion of participants with EASI-100	The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-100 is 100% reduction from baseline in EASI score.	Up to Week 48
Secondary	Responders from parent studies: Time to the first event of loss of EASI-75 response among the participants who were EASI-75 responders at baseline of ESTUARY	The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score.	Up to Week 48
Secondary	Responders from parent studies: Time to the first event of loss of EASI-50 response among the participants who were EASI-50 responders at baseline of ESTUARY	The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-50 is 50% reduction from baseline in EASI score.	Up to Week 48
Secondary	Responders from parent studies: Time to the first event of loss of EASI-90 response among the participants who were EASI-90 responders at baseline of ESTUARY	The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-90 is 90% reduction from baseline in EASI score.	Up to Week 48
Secondary	Responders from parent studies: Time to the first event of loss of EASI-100 among participants who were EASI-100 at baseline of ESTUARY	The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-100 is 100% reduction from baseline in EASI score.	Up to Week 48
Secondary	Responders from parent studies: Proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear)	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).	Up to Week 48
Secondary	Responders from parent studies: Proportion of participants who are vIGA-AD 0 (clear) or 1 (almost clear) with presence of only barely perceptible erythema (no induration/papulation, no lichenification, no oozing or crusting)	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).	Up to Week 48
Secondary	Responders from parent studies: Time to first event of vIGA-AD =3 (moderate or severe) among those participants who were vIGA-AD 0 (clear) or 1 (almost clear) at baseline of ESTUARY	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).	Up to Week 48
Secondary	Responders from parent studies: Time to first event of vIGA-AD =3 (moderate or severe) among those participants who were vIGA-AD 0 (clear) at baseline of ESTUARY	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).	Up to Week 48
Secondary	Responders from parent studies: Proportion of participants who have an increase of =2 points in vIGA-AD from ESTUARY baseline among the participants who were vIGA-AD 0 (clear) or 1 (almost clear) at baseline of ESTUARY	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).	Up to Week 48
Secondary	Responders from parent studies: Proportion of participants who have an increase of =2 points in vIGA-AD from ESTUARY baseline among the participants who were vIGA-AD 3 (moderate) at baseline of parent study	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).	Up to Week 48
Secondary	Responders from parent studies: Proportion of participants who have an increase of =2 points in vIGA-AD from ESTUARY baseline among the participants who were vIGA-AD 4 (severe) at baseline of parent study	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).	Up to Week 48
Secondary	Responders from parent studies: Proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear) and/or EASI-75 among the participants who were vIGA-AD 0 (clear) or 1 (almost clear) and/or EASI-75 at baseline of ESTUARY	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). The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score.	Up to Week 48
Secondary	Responders from parent studies: Proportion of participants with = 4 points reduction in weekly average of daily PP-NRS from parent study baseline	The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.	Up to Week 48
Secondary	Responders from parent studies: Percent change in weekly average of daily PP-NRS from parent study baseline	The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.	Parent study baseline to Week 48
Secondary	Responders from parent studies: Absolute change in weekly average of daily PP-NRS from parent study baseline	The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.	Parent study baseline to Week 48
Secondary	Responders from parent studies: Proportion of participants who maintained PP-NRS 0 or 1 among the participants who were PP-NRS 0 or 1 at baseline of ESTUARY	The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.	Up to Week 48
Secondary	Responders from parent studies: Proportion of participants who maintained vIGA-AD 0 or 1 and/or EASI-75 and weekly average of daily (WAD) PP-NRS reduction >4 among those who were vIGA-AD 0 or 1 and/or EASI-75 and WAD PP-NRS reduction >4 at BL of ESTUARY	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), 1 (almost clear) to 4 (severe). The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score. The Peak Pruritus-Numerical Rating Scale (PP-NRS) is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable. BL=baseline.	Up to Week 48
Secondary	Responders from parent studies: Absolute change in weekly average of daily SD-NRS from parent study baseline	The Sleep Disturbance-Numerical Rating Scale (SD-NRS) is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD with 0 = no sleep loss and 10 = did not sleep at all.	Parent study baseline to Week 48
Secondary	Responders from parent studies: Proportion of participants who maintained weekly average of daily SD-NRS reduction of = 3 among the participants with weekly average of daily SD-NRS reduction of =3 at baseline of ESTUARY	The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD with 0 = no sleep loss and 10 = did not sleep at all.	Up to Week 48
Secondary	Responders from parent studies: Proportion of participants with =3 points reduction in weekly average of daily SD-NRS from parent study baseline	The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD with 0 = no sleep loss and 10 = did not sleep at all.	Up to Week 48
Secondary	Responders from parent studies: Proportion of participants with = 4 points reduction in weekly average of daily SP-NRS from parent study baseline	The Skin Pain-Numerical Rating Scale (SP-NRS) is a single item 0-10 numeric rating scale assessing skin pain associated with AD with 0 = no pain and 10 = worst possible pain imaginable.	Up to Week 48
Secondary	Responders from parent studies: Proportion of participants who maintained weekly average of daily SP-NRS reduction of = 4 among the participants with weekly average of daily SP-NRS reduction of =4 at ESTUARY baseline	The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD with 0 = no pain and 10 = worst possible pain imaginable.	Up to Week 48
Secondary	Responders from parent studies: Absolute change in weekly average of daily SP-NRS from parent study baseline	The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD with 0 = no pain and 10 = worst possible pain imaginable.	Parent study baseline to Week 48
Secondary	Responders from parent studies: Proportion of participants who maintained SCORAD = 8.7 among participants with reduction in SCORAD = 8.7 at baseline of ESTUARY	The Scoring Atopic Dermatitis (SCORAD) index is a clinical tool to evaluate the extent and severity of AD. Total score ranges from 0 (absent disease) to 103 (severe disease).	Up to Week 48
Secondary	Responders from parent studies: Percent change in SCORAD index from parent study baseline	The SCORAD index is a clinical tool to evaluate the extent and severity of AD. Total score ranges from 0 (absent disease) to 103 (severe disease).	Parent study baseline to Week 48
Secondary	Responders from parent studies: Absolute change in SCORAD index from parent study baseline	The SCORAD index is a clinical tool to evaluate the extent and severity of AD. Total score ranges from 0 (absent disease) to 103 (severe disease).	Parent study baseline to Week 48
Secondary	Responders from parent studies: Change in percent Body Surface Area (BSA) affected by AD from parent study baseline		Parent study baseline to Week 48
Secondary	Responders from parent studies: Proportion of participants who maintained POEM =4 among the participants with reduction in POEM =4 at baseline of ESTUARY	The Patient Oriented Eczema Measure (POEM) is a 7-item self-assessment questionnaire that assesses disease symptoms on a 5-point scale; 0 (no days) to 4 (every day in the last week). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (very severe). Higher scores indicated more severe disease and poor quality of life.	Up to Week 48
Secondary	Responders from parent studies: Change in POEM from parent study baseline	The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a 5-point scale; 0 (no days) to 4 (every day in the last week). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (very severe). Higher scores indicated more severe disease and poor quality of life.	Parent study baseline to Week 48
Secondary	Responders from parent studies: Proportion of participants with a reduction in Children's Dermatology Life Quality Index (CDLQI) =6 among participants aged =12 to <16 years old and with CDLQI baseline =6	The CDLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in children aged 4-<16 years. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.	Up to Week 48
Secondary	Responders from parent studies: Change in CDLQI in participants with age =12 to <16 years old	The CDLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in children aged 4-<16 years. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.	Parent study baseline to Week 48
Secondary	Responders from parent studies: Change in Dermatology Life Quality Index (DLQI) in participants with age =16 years among the participants with DLQI =4 at parent study baseline	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.	Parent study baseline to Week 48
Secondary	Responders from parent studies: Proportion of participants with = 4 points reduction in DLQI from parent study baseline among the participants with DLQI =4 at parent study baseline	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.	Up to Week 48
Secondary	Responders from parent studies: Proportion of participants with HADS-D <8 among the participants who had HADS-D =8 at parent study baseline	The Hospital Anxiety Depression Scale-Depression (HADS) ranges 0-21 with higher score indicating a poorer state.	Up to Week 48
Secondary	Responders from parent studies: Proportion of participants with HADS-A <8 among the participants who had HADS-A =8 at parent study baseline	The Hospital Anxiety Depression Scale-Anxiety (HADS-A) ranges 0-21 with higher score indicating a poorer state.	Up to Week 48
Secondary	Responders from parent studies: Proportion of participants requiring rescue medication during the study up to Week 48 of ESTUARY		Up to Week 48
Secondary	Responders from parent studies: Time to first rescue medication initiation		Up to Week 48
Secondary	Non-responders from parent studies: Percent change in EASI from parent study baseline	The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.	Parent study baseline to Week 48
Secondary	Non-responders from parent studies: Proportion of participants with EASI-75	The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score.	Up to Week 48
Secondary	Non-responders from parent studies: Proportion of participants who continue to be EASI-50 among the participants who met EASI-50 at baseline of ESTUARY	The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-50 is 50% reduction from baseline in EASI score.	Up to Week 48
Secondary	Non-responders from parent studies: Proportion of participants with EASI-50	The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-50 is 50% reduction from baseline in EASI score.	Up to Week 48
Secondary	Non-responders from parent studies: Proportion of participants with EASI-90	The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-90 is 90% reduction from baseline in EASI score.	Up to Week 48
Secondary	Non-responders from parent studies: Proportion of participants with EASI-100	The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-100 is 100% reduction from baseline in EASI score.	Up to Week 48
Secondary	Non-responders from parent studies: Proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear)	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).	Up to Week 48
Secondary	Non-responders from parent studies: Proportion of participants who are vIGA-AD 0 (clear) or 1 (almost clear) with presence of only barely perceptible erythema (no induration/papulation, no lichenification, no oozing or crusting)	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).	Up to Week 48
Secondary	Non-responders from parent studies: Proportion of participants with = 4 points reduction in weekly average of daily PP-NRS from parent study baseline	The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.	Up to Week 48
Secondary	Non-responders from parent studies: Percent change in weekly average of daily PP-NRS from parent study baseline	The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.	Parent study baseline to Week 48
Secondary	Non-responders from parent studies: Absolute change in weekly average of daily PP-NRS from parent study baseline	The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.	Parent study baseline to Week 48
Secondary	Non-responders from parent studies: Absolute change in weekly average of daily SD-NRS from parent study baseline	The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD with 0 = no sleep loss and 10 = did not sleep at all.	Parent study baseline to Week 48
Secondary	Non-responders from parent studies: Proportion of participants with =3 points reduction in weekly average of daily SD-NRS from parent study baseline	The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD with 0 = no sleep loss and 10 = did not sleep at all.	Up to Week 48
Secondary	Non-responders from parent studies: Proportion of participants with = 4 points reduction in weekly average of daily SP-NRS from parent study baseline [	The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD with 0 = no pain and 10 = worst possible pain imaginable.	Up to Week 48
Secondary	Non-responders from parent studies: Absolute change in weekly average of daily SP-NRS from parent study baseline	The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD with 0 = no pain and 10 = worst possible pain imaginable.	Parent study baseline to Week 48
Secondary	Non-responders from parent studies: Proportion of participants with a reduction in CDLQI =6 among participants aged =12 to <16 years old and with CDLQI =6 at parent study baseline	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.	Up to Week 48
Secondary	Non-responders from parent studies: Change in CDLQI in participants with age =12 to <16 years old	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.	Parent study baseline to Week 48
Secondary	Non-responders from parent studies: Change in DLQI in participants with age =16 years among the participants with DLQI =4 at parent study baseline	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.	Parent study baseline to Week 48
Secondary	Non-responders from parent studies: Proportion of participants with = 4 points reduction in DLQI from parent study baseline among the participants with DLQI =4 at parent study baseline	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.	Up to Week 48
Secondary	Non-responders from parent studies: Proportion of participants with HADS-D <8 among the participants who had HADS-D =8 at parent study baseline	The HADS is 14-item questionnaire with two subscales: anxiety & depression. Each subscale (anxiety & depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.	Up to Week 48
Secondary	Non-responders from parent studies: Proportion of participants with HADS-A <8 among the participants who had HADS-A =8 at parent study baseline	The HADS is 14-item questionnaire with two subscales: anxiety & depression. Each subscale (anxiety & depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.	Up to Week 48
Secondary	All participants: Percentage of participants who experienced Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and/or Treatment-Emergent Adverse Events of Special Interest (AESI)		Up to week 64
Secondary	All participants: Serum amlitelimab concentrations measured at prespecified timepoints		Up to Week 64
Secondary	All participants: Incidence of antidrug antibodies (ADAs) of amlitelimab		Up to Week 64