MedPath

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

Phase 3
Recruiting
Conditions
Dermatitis Atopic
Interventions
Drug: Placebo
Registration Number
NCT06407934
Lead Sponsor
Sanofi
Brief 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 68 weeks including a 52-week randomized double-blind period, and a 16-week safety follow-up for participants not entering the LTS17367 (RIVER-AD).

The study duration will be up to 52 weeks for participants entering the LTS17367 \[RIVER-AD\] study at the Week 52 visit of EFC17600 (ESTUARY).

The total treatment duration will be up to 52 weeks. The total number of visits will be up to 15 visits (or 14 visits for those entering LTS17367 \[RIVER-AD\] study).

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
961
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Amlitelimab dose 1AmlitelimabSubcutaneous injection as per protocol
Amlitelimab dose 2AmlitelimabSubcutaneous injection as per protocol
PlaceboPlaceboSubcutaneous injection as per protocol
Primary Outcome Measures
NameTimeMethod
Proportion of participants who maintain treatment response at Week 48 of ESTUARY.Week 48

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.

Secondary Outcome Measures
NameTimeMethod
All participants: Serum amlitelimab concentrations measured at prespecified timepointsUp to Week 68
Responders from parent studies: Time to the first event of loss of EASI-100 among participants who were EASI-100 at baseline of ESTUARYUp to Week 48

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.

Responders from parent studies: Time to first rescue medication initiationUp to Week 48
Responders from parent studies: Proportion of participants who continue to be EASI-75 among the participants who met EASI-75 at baseline of ESTUARYUp to Week 48

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.

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 ESTUARYUp to Week 48

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).

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 ESTUARYUp to Week 48

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.

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 ESTUARYUp to Week 48

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.

Proportion of participants who maintain treatment response in ESTUARYUp to Week 44

Maintenance of treatment response is defined as having vIGA-AD 0 (clear) or 1 (almost clear) and/or 75% reduction in EASI compared to parent study baseline EASI. 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.

Responders from parent studies: Percent change in EASI from parent study baselineParent study baseline to Week 48

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.

Responders from parent studies: Proportion of participants with EASI-75Up to Week 48

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.

Responders from parent studies: Proportion of participants who continue to be EASI-50 among the participants who met EASI-50 at baseline of ESTUARYUp to Week 48

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.

Responders from parent studies: Proportion of participants with EASI-50Up to Week 48

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.

Responders from parent studies: Proportion of participants who continue to be EASI-90 among the participants who met EASI-90 at baseline of ESTUARYUp to Week 48

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.

Responders from parent studies: Proportion of participants with EASI-90Up to Week 48

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.

Responders from parent studies: Proportion of participants who continue to be EASI-100 among the participants who met EASI-100 at baseline of ESTUARYUp to Week 48

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.

Responders from parent studies: Proportion of participants with EASI-100Up to Week 48

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.

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 ESTUARYUp to Week 48

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.

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 ESTUARYUp to Week 48

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.

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 ESTUARYUp to Week 48

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.

Responders from parent studies: Proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear)Up to Week 48

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).

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)Up to Week 48

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).

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 ESTUARYUp to Week 48

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).

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 ESTUARYUp to Week 48

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).

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 ESTUARYUp to Week 48

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).

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 studyUp to Week 48

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).

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 studyUp to Week 48

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).

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 ESTUARYUp to Week 48

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.

Responders from parent studies: Proportion of participants with ≥ 4 points reduction in weekly average of daily PP-NRS from parent study baselineUp to Week 48

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.

Responders from parent studies: Percent change in weekly average of daily PP-NRS from parent study baselineParent study baseline to Week 48

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.

Responders from parent studies: Absolute change in weekly average of daily PP-NRS from parent study baselineParent study baseline to Week 48

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.

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 ESTUARYUp to Week 48

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.

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 ESTUARYUp to Week 48

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.

Responders from parent studies: Absolute change in weekly average of daily SD-NRS from parent study baselineParent study baseline to Week 48

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.

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 ESTUARYUp to Week 48

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.

Responders from parent studies: Proportion of participants with ≥3 points reduction in weekly average of daily SD-NRS from parent study baselineUp to Week 48

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.

Responders from parent studies: Proportion of participants with ≥ 4 points reduction in weekly average of daily SP-NRS from parent study baselineUp to Week 48

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.

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 baselineUp to Week 48

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.

Responders from parent studies: Absolute change in weekly average of daily SP-NRS from parent study baselineParent study baseline to Week 48

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.

Responders from parent studies: Proportion of participants who maintained SCORAD ≥ 8.7 among participants with reduction in SCORAD ≥ 8.7 at baseline of ESTUARYUp to Week 48

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).

Responders from parent studies: Percent change in SCORAD index from parent study baselineParent study baseline to Week 48

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).

Responders from parent studies: Absolute change in SCORAD index from parent study baselineParent study baseline to Week 48

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).

Responders from parent studies: Change in percent Body Surface Area (BSA) affected by AD from parent study baselineParent study baseline to Week 48
Responders from parent studies: Proportion of participants who maintained POEM ≥4 among the participants with reduction in POEM ≥4 at baseline of ESTUARYUp to Week 48

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.

Responders from parent studies: Change in POEM from parent study baselineParent study baseline to Week 48

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.

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 ≥6Up to Week 48

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.

Responders from parent studies: Change in CDLQI in participants with age ≥12 to <16 years oldParent study baseline to Week 48

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.

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 baselineParent study baseline to Week 48

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.

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 baselineUp to Week 48

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.

Responders from parent studies: Proportion of participants with HADS-D <8 among the participants who had HADS-D ≥8 at parent study baselineUp to Week 48

The Hospital Anxiety Depression Scale-Depression (HADS) ranges 0-21 with higher score indicating a poorer state.

Responders from parent studies: Proportion of participants with HADS-A <8 among the participants who had HADS-A ≥8 at parent study baselineUp to Week 48

The Hospital Anxiety Depression Scale-Anxiety (HADS-A) ranges 0-21 with higher score indicating a poorer state.

Responders from parent studies: Proportion of participants requiring rescue medication during the study up to Week 48 of ESTUARYUp to Week 48
Non-responders from parent studies: Percent change in EASI from parent study baselineParent study baseline to Week 48

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.

Non-responders from parent studies: Proportion of participants with EASI-75Up to Week 48

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.

Non-responders from parent studies: Proportion of participants who continue to be EASI-50 among the participants who met EASI-50 at baseline of ESTUARYUp to Week 48

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.

Non-responders from parent studies: Proportion of participants with EASI-50Up to Week 48

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.

Non-responders from parent studies: Proportion of participants with EASI-90Up to Week 48

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.

Non-responders from parent studies: Proportion of participants with EASI-100Up to Week 48

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.

Non-responders from parent studies: Proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear)Up to Week 48

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).

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)Up to Week 48

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).

Non-responders from parent studies: Proportion of participants with ≥ 4 points reduction in weekly average of daily PP-NRS from parent study baselineUp to Week 48

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.

Non-responders from parent studies: Percent change in weekly average of daily PP-NRS from parent study baselineParent study baseline to Week 48

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.

Non-responders from parent studies: Absolute change in weekly average of daily PP-NRS from parent study baselineParent study baseline to Week 48

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.

Non-responders from parent studies: Absolute change in weekly average of daily SD-NRS from parent study baselineParent study baseline to Week 48

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.

Non-responders from parent studies: Proportion of participants with ≥3 points reduction in weekly average of daily SD-NRS from parent study baselineUp to Week 48

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.

Non-responders from parent studies: Proportion of participants with ≥ 4 points reduction in weekly average of daily SP-NRS from parent study baseline [Up to Week 48

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.

Non-responders from parent studies: Absolute change in weekly average of daily SP-NRS from parent study baselineParent study baseline to Week 48

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.

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 baselineUp to Week 48

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.

Non-responders from parent studies: Change in CDLQI in participants with age ≥12 to <16 years oldParent study baseline to Week 48

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.

Non-responders from parent studies: Change in DLQI in participants with age ≥16 years among the participants with DLQI ≥4 at parent study baselineParent study baseline to Week 48

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.

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 baselineUp to Week 48

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.

Non-responders from parent studies: Proportion of participants with HADS-D <8 among the participants who had HADS-D ≥8 at parent study baselineUp to Week 48

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.

Non-responders from parent studies: Proportion of participants with HADS-A <8 among the participants who had HADS-A ≥8 at parent study baselineUp to Week 48

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.

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 68
All participants: Incidence of antidrug antibodies (ADAs) of amlitelimabUp to Week 68

Trial Locations

Locations (304)

Cahaba Dermatology & Skin Health Center- Site Number : 8401066

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Birmingham, Alabama, United States

Center for Dermatology and Plastic Surgery- Site Number : 8401119

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Scottsdale, Arizona, United States

Scottsdale Clinical Trials- Site Number : 8401149

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Scottsdale, Arizona, United States

Eclipse Clinical Research- Site Number : 8401158

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Tucson, Arizona, United States

Johnson Dermatology- Site Number : 8401076

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Fort Smith, Arkansas, United States

Encino Research Center- Site Number : 8401042

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Encino, California, United States

First OC Dermatology- Site Number : 8401025

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Fountain Valley, California, United States

Center for Dermatology Clinical Research- Site Number : 8401018

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Fremont, California, United States

Marvel Clinical Research- Site Number : 8401102

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Huntington Beach, California, United States

Sunwise Clinical Research- Site Number : 8401022

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Lafayette, California, United States

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Cahaba Dermatology & Skin Health Center- Site Number : 8401066
🇺🇸Birmingham, Alabama, United States

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