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OpenTrials
Active, Not Recruiting

NCT Number: NCT06407934

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

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 primary objective of ESTUARY is to assess the maintenance of treatment response on continued Q12W dosing 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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Dermatitis Atopic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site Number : 0320021, Berazategui, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 Exclusion Criteria or 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.

Treatment and study plan

Amlitelimab

Drug

Pharmaceutical form: Injection solution

Route of administration: Subcutaneous (SC) injection

Other names: SAR445229

Placebo

Drug

Pharmaceutical form: Injection solution

Route of administration: SC injection

Primary outcomes

  1. US and US reference countries: Proportion of participants who are responders AND maintained vIGA-AD ≤2 without experiencing relapse among participants who were responders at baseline of ESTUARY

    Time frame: Week 24

    Clinical response is defined as having vIGA-AD 0 or 1. Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^. The validated Investigator Global Assessment scale for atopic dermatitis (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 Eczema Area and Severity Index (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 symbol ^ represents "based on parent study baseline".

  2. EU, EU Reference Countries, and Japan: Proportion of participants who maintain treatment response in ESTUARY without experiencing relapse

    Time frame: Week 48

    Maintenance of clinical response is defined as having vIGA-AD 0 or 1 OR EASI-75^ OR vIGA-AD 0 or 1 and EASI-75^.

    Relapse is defined as having vIGA-AD ≥3 or loss of 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. EASI-75 is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

Secondary outcomes

  1. Proportion of participants who continue to be EASI-75^ among the participants who met EASI-75^ at baseline of ESTUARY

    Time frame: Up 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. The symbol ^ represents "based on parent study baseline".

  2. Proportion of participants who continue to be vIGA-AD 0 or 1 among participants who met vIGA-AD 0 or 1 at baseline of ESTUARY

    Time frame: 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).

  3. Proportion of participants who continue to be vIGA-AD 0 or 1 with presence of only barely perceptible erythema among the participants who were vIGA-AD 0 or 1 with presence of only barely perceptible erythema at baseline of ESTUARY

    Time frame: 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). Only barely perceptible erythema = no induration/papulation, no lichenification, no oozing or crusting.

  4. 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

    Time frame: Up 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. The symbol ^ represents "based on parent study baseline".

  5. Proportion of participants who maintain treatment response without experiencing relapse

    Time frame: Up to Week 48

    Maintenance of treatment response is defined as having vIGA-AD 0 or 1 OR EASI-75^ OR vIGA-AD 0 or 1 and EASI-75^.

    Relapse is defined as having vIGA-AD ≥3 or loss of 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.

  6. Percent change in EASI from parent study baseline

    Time frame: Parent 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.

  7. Proportion of participants who maintained EASI-75^ without experiencing relapse among the participants who met EASI-75^ at baseline of ESTUARY

    Time frame: Up to Week 48

    Relapse is defined as having vIGA-AD ≥3 or loss of 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. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

  8. Proportion of participants with EASI-75^

    Time frame: Up 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. The symbol ^ represents "based on parent study baseline".

  9. Proportion of participants who continue to be EASI-90^ among the participants who met EASI-90^ at baseline of ESTUARY

    Time frame: Up 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. The symbol ^ represents "based on parent study baseline".

  10. Proportion of participants with EASI-90^

    Time frame: Up 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. The symbol ^ represents "based on parent study baseline".

  11. Time to the first event of vIGA-AD ≥3 or loss of EASI-75^ among the participants who were vIGA-AD 0 or EASI-75^ at baseline of ESTUARY

    Time frame: 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).

    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 symbol ^ represents "based on parent study baseline".

  12. Proportion of participants with vIGA-AD 0 or 1

    Time frame: 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).

  13. Proportion of participants who are vIGA-AD 0 or 1 with presence of only barely perceptible erythema (no induration/papulation, no lichenification, no oozing or crusting)

    Time frame: 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).

  14. EU, EU Reference Countries, and Japan: Time to first event of vIGA-AD ≥3 or loss of EASI^75 among those participants who were vIGA-AD 0 or 1 at baseline of ESTUARY

    Time frame: 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).

    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 symbol ^ represents "based on parent study baseline".

  15. EU, EU Reference Countries, and Japan: Time to first event of vIGA-AD ≥3 or loss of EASI^75 among those participants who were vIGA-AD 0 at baseline of ESTUARY

    Time frame: 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).

    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 symbol ^ represents "based on parent study baseline".

  16. Proportion of participants with weekly average of daily PP-NRS reduction of ≥4^

    Time frame: Parent 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. The symbol ^ represents "based on parent study baseline".

  17. Proportion of participants who maintain PP-NRS ≤4 among participants who were PP-NRS ≤4 at baseline of ESTUARY

    Time frame: Up 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.

  18. EU, EU Reference Countries, and Japan: Proportion of participants who maintain reduction in POEM ≥4^ among the participants with reduction in POEM ≥4^ at baseline of ESTUARY

    Time frame: Up 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. The symbol ^ represents "based on parent study baseline".

  19. EU, EU Reference Countries, and Japan: Proportion of participants with a reduction in CDLQI ≥6^ among participants aged ≥12 to <16 years old and with reduction in CDLQI ≥6^ at baseline of ESTUARY

    Time frame: Up to Week 48

    The Children's Dermatology Quality of Life Index (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. The symbol ^ represents "based on parent study baseline".

  20. EU, EU Reference Countries, and Japan: Proportion of participants with ≥ 4 reduction in DLQI ≥4^ among the participants aged ≥16 years old and with reduction in DLQI ≥4^ at baseline of ESTUARY

    Time frame: Up 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.

  21. 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)

    Time frame: Up to week 68

  22. Pharmacokinetic: Serum amlitelimab concentrations

    Time frame: Up to Week 68

  23. Incidence of antidrug antibodies (ADAs) of amlitelimab

    Time frame: Up to Week 68

  24. Pharmacokinetic: maximum plasma concentration (Cmax)

    Time frame: Up to Week 68

  25. Pharmacokinetic: AUC4W and AUC12W

    Time frame: Up to Week 4 and 12

    Cumulative area under the serum concentration curve over 4 weeks (AUC4W). Cumulative area under the serum concentration curve over 12 weeks (AUC12W).

  26. Proportion of participants who are EASI-75^ among participants who had EASI-75^ at baseline of ESTUARY and did not relapse by Week 12

    Time frame: Up to Week 48

    Relapse is defined as having vIGA-AD ≥3 or loss of 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. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

  27. Time to first recapture of EASI-75^ among participants who had EASI-75^ at baseline of ESTUARY and subsequently relapsed

    Time frame: Up to Week 48

    Relapse is defined as having vIGA-AD ≥3 or loss of 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. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

  28. Proportion of participants who recapture EASI-75^ by visit among the participants who had EASI-75^ at baseline of ESTUARY and subsequently relapsed

    Time frame: Up to Week 48

    Relapse is defined as having vIGA-AD ≥3 or loss of 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. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

  29. Proportion of participants who are EASI 90^ AND who maintain EASI-75^ without experiencing relapse among participants who had EASI-90^ at baseline of ESTUARY

    Time frame: Up to Week 48

    Relapse is defined as having vIGA-AD ≥3 or loss of 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. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

  30. Proportion of participants who are EASI 90^ without experiencing relapse among participants who had EASI-90^ at baseline of ESTUARY

    Time frame: Up to Week 48

    Relapse is defined as having vIGA-AD ≥3 or loss of 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. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

  31. Proportion of participants who are EASI-90^ among participants who had EASI-90^ at baseline of ESTUARY and did not relapse by Week 12.

    Time frame: Up to Week 48

    Relapse is defined as having vIGA-AD ≥3 or loss of 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. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

  32. Proportion of participants who are vIGA-AD 0 or 1 AND who maintain vIGA-AD ≤2 without experiencing relapse among participants who had vIGA-AD 0 or 1 at baseline of ESTUARY

    Time frame: Up to Week 48

    Relapse is defined as having vIGA-AD ≥3 or loss of 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. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

  33. Proportion of participants who maintain vIGA-AD response within 1 point of baseline without experiencing relapse among participants who had vIGA-AD 0 or 1 at baseline of ESTUARY

    Time frame: Up to Week 48

    Relapse is defined as having vIGA-AD ≥3 or loss of 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. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

  34. Proportion of participants who maintain vIGA-AD 0 or 1 without experiencing relapse among participants who had vIGA-AD 0 or 1 at baseline of ESTUARY

    Time frame: Up to Week 48

    Relapse is defined as having vIGA-AD ≥3 or loss of 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. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

  35. Proportion of participants who are vIGA-AD 0 or 1 without experiencing relapse among participants who had vIGA-AD 0 or 1 at baseline of ESTUARY

    Time frame: Up to Week 48

    Relapse is defined as having vIGA-AD ≥3 or loss of 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. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

  36. Time to first recapture of vIGA-AD 0 or 1 among participants who had vIGA-AD 0 or 1 at baseline of ESTUARY and subsequently relapsed

    Time frame: 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).

  37. Proportion of participants who recapture vIGA-AD 0 or 1 among participants who had vIGA-AD 0 or 1 at baseline of ESTUARY and subsequently relapsed

    Time frame: 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).

  38. Proportion of participants who are vIGA-AD 0 or 1 among participants who had vIGA-AD 0 or 1 at baseline of ESTUARY and did not relapse by Week 12

    Time frame: Up to Week 48

    Relapse is defined as having vIGA-AD ≥3 or loss of 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. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

  39. Proportion of participants who are vIGA-AD 0 or 1 with only barely perceptible erythema AND who maintain vIGA-AD ≤2 without experiencing relapse among participants who had vIGA-AD 0 or 1 with only barely perceptible erythema at baseline of ESTUARY

    Time frame: Up to Week 48

    Relapse is defined as having vIGA-AD ≥3 or loss of 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. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

    Only barely perceptible erythema = no induration/papulation, no lichenification, no oozing or crusting.

  40. Proportion of participants who are vIGA-AD 0 or 1 with presence of only barely perceptible erythema among participants who had vIGA-AD 0 or 1 with presence of only barely perceptible erythema at baseline of ESTUARY and did not relapse by Week 12

    Time frame: Up to Week 48

    Relapse is defined as having vIGA-AD ≥3 or loss of 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. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

    Only barely perceptible erythema = no induration/papulation, no lichenification, no oozing or crusting.

  41. Proportion of participants who maintain weekly average of daily PP-NRS reduction of ≥4^ without experiencing relapse among participants with weekly average of daily PP NRS reduction of ≥4^ at baseline of ESTUARY

    Time frame: Up to Week 48

    Relapse is defined as having vIGA-AD ≥3 or loss of 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. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

  42. Proportion of participants who maintain PP NRS ≤4 without experiencing relapse among participants who had PP-NRS ≤4 at baseline of ESTUARY

    Time frame: Up to Week 48

    Relapse is defined as having vIGA-AD ≥3 or loss of 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. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

  43. Proportion of participants who achieve PP-NRS reduction of ≥4

    Time frame: Up 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.

  44. Proportion of participants who achieve PP-NRS ≤4

    Time frame: Up 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.

  45. Duration of maintained response without relapse

    Time frame: Up to Week 48

    Maintenance of clinical response is defined as having vIGA-AD 0 or 1 OR EASI-75^ OR vIGA-AD 0 or 1 and EASI-75^.

    Relapse is defined as having vIGA-AD ≥3 or loss of 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. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline".

  46. Percent change in Head & Neck EASI sub-score from the parent study baseline among participants with Head & Neck EASI sub-score >0 at baseline of the parent study

    Time frame: From parent study baseline to Week 48

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Four body areas are considered separately: Head & Neck, Trunk including genital area, Upper extremities and Lower extremities including the buttocks. Head & Neck sub-score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.

  47. Proportion of participants Head & Neck EASI sub-score EASI-75^ among participants with Head & Neck EASI sub-score >0 at baseline of the parent study

    Time frame: From parent study baseline to Week 48

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Four body areas are considered separately: Head & Neck, Trunk including genital area, Upper extremities and Lower extremities including the buttocks. Head & Neck sub-score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.

    Head & Neck EASI sub-score EASI-75 is 75% reduction from baseline in Head & Neck EASI sub-score. The symbol ^ represents "based on parent study baseline"

  48. Proportion of participants with Head & Neck EASI sub-score EASI-90^ among participants with Head & Neck EASI sub-score >0 at baseline of parent study

    Time frame: From parent study baseline to Week 48

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Four body areas are considered separately: Head & Neck, Trunk including genital area, Upper extremities and Lower extremities including the buttocks. Head & Neck sub-score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.

    Head & Neck EASI sub-score EASI-90 is 90% reduction from baseline in Head & Neck EASI sub-score. The symbol ^ represents "based on parent study baseline"

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A Phase 3, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group 52-week Extension Study to Evaluate the Treatment Response and Safety of Two Amlitelimab Dose Regimens Administered by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis

Acronym: ESTUARY

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 9, 2024
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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