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Completed

NCT Number: NCT06790121

A Study to Investigate the Efficacy and Safety of Subcutaneous Lunsekimig (SAR443765) Compared With Placebo in Adult Participants With Moderate-to-severe Atopic Dermatitis

This is a parallel, Phase 2b, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of lunsekimig monotherapy in adult participants (aged 18 to 80 years, inclusive) with moderate-to-severe atopic dermatitis (AD).

This study explores the efficacy and safety of 3 subcutaneous (SC) dose regimens of lunsekimig in adult participants with moderate-to-severe AD who have a documented history, within 6 months prior to baseline, of an inadequate response to topical treatments or for whom topical therapies are not advised. The study consists of 6 arms: 3 parallel dosing regimens and matching placebo arms. Additionally, participants have the option of engaging in a dense pharmacokinetic/pharmodynamic (PK/PD) sampling subgroup.

The study duration will be up to approximately 36 weeks, including up to 4 weeks of screening, 24 weeks of treatment period and an 8-week safety follow-up period.

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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

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigational Site Number: 0203001, Prague, Czechia

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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 18 to 80 years of age, inclusive, at the time of signing the informed consent.
  • Diagnosis of Atopic Dermatitis (AD) as defined by the American Academy of Dermatology (AAD) clinical guidelines (2023) for 1 year or longer at baseline (Day 1)
  • Documented history within 6 months prior to Screening Visit, of either inadequate response or inadvisability of topical treatments
  • Eczema Area and Severity Index (EASI) score of 16 or higher (range, 0 to 72) at baseline (Day 1)
  • Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score of 3 or 4 at baseline visit (Day 1) (on the 0 to 4 vIGA-AD scale, a vIGA-AD score of 3 and 4 represents moderate and severe, respectively).
  • AD involvement of 10% or more of Body Surface Are (BSA) at baseline (Day 1)
  • Weekly average of daily Peak Pruritis-Numerical Rating (PP-NRS) score of ≥4 at baseline (Day 1)
  • Must have applied a stable dose of topical bland emollient (simple moisturizer, no additives [eg, urea]) at least once daily for a minimum of 5 out of 7 consecutive days before baseline (Day 1).

Exclusion criteria

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

  • Skin comorbidity that would adversely affect the ability to undertake AD assessments (eg, psoriasis, tinea corporis, and lupus erythematosus) according to the Investigator's judgment.
  • Known history of, or suspected, significant current immunosuppression

NOTE: 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

Lunsekimig

Drug

Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection

Other names: SAR443765

Placebo

Drug

Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection

Primary outcomes

  1. Percent change in Eczema Area and Severity Index (EASI) score from baseline to Week 24

    Time frame: From Baseline throughout the study, up to Week 24

    Eczema Area and Severity index is an Investigator-assessed validated tool used to measure the extent (area) and severity of atopic dermatitis (AD). Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.

Secondary outcomes

  1. Proportion of participants achieving EASI-75 at Week 24

    Time frame: From Baseline throughout the study, up to Week 24

    EASI 75 is defined by reduction of EASI score by ≥75% from baseline

  2. Proportion of participants with a Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score of 0 (clear) or 1 (almost clear) and a reduction from Baseline of ≥2 points at Week 24

    Time frame: From Baseline throughout the study, up to Week 24

    The Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score is a 5-point scale used to determine severity of AD and clinical response to treatment, ranging from 0 (clear) to 4 (severe).

  3. Proportion of participants with reduction (improvement) of ≥4 in the weekly average of daily Peak Pruritis-Numerical Rating Scale (PP-NRS) score from Baseline to Week 24

    Time frame: From Baseline throughout the study, up to Week 24

    The Peak Pruritis-Numerical Rating Scale (PP-NRS) is a validated single-item patient-reported outcome (PRO) to assess worst itch intensity on a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable".

  4. Absolute change from Baseline in EASI score at Week 24

    Time frame: From Baseline throughout the study, up to Week 24

    Eczema Area and Severity index is an Investigator-assessed validated tool used to measure the extent (area) and severity of atopic dermatitis (AD). Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.

  5. Percent change from Baseline in EASI score throughout the study

    Time frame: From Baseline throughout the study, up to Week 24

    Eczema Area and Severity index is an Investigator-assessed validated tool used to measure the extent (area) and severity of atopic dermatitis (AD). Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.

  6. Proportion of participants with a vIGA-AD score of 0 (clear) or 1 (almost clear) at Week 24

    Time frame: From Baseline throughout the study, up to Week 24

    The Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score is a 5-point scale used to determine severity of AD and clinical response to treatment, ranging from 0 (clear) to 4 (severe).

  7. Proportion of participants with a response of vIGA-AD 0 or 1 and a reduction from Baseline of ≥2 points throughout the study

    Time frame: From Baseline throughout the study, up to Week 24

    The Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score is a 5-point scale used to determine severity of AD and clinical response to treatment, ranging from 0 (clear) to 4 (severe).

  8. Percent change in the weekly average of daily PPNRS scores from Baseline to Week 24

    Time frame: From Baseline throughout tje study, up to Week 24

    The Peak Pruritis-Numerical Rating Scale (PP-NRS) is a validated single-item patient-reported outcome (PRO) to assess worst itch intensity on a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable".

  9. Percent change in the weekly average of daily sleep disturbance NRS score from Baseline to Week 24

    Time frame: From Baseline throughout the study, up to Week 24

    The Sleep Disturbance-Numerical Rating Scale (SD-NRS) is a validated single item 0-10 numerical rating scale assessing sleep disturbance associated with AD, with 0 being 'no sleep loss related to the symptoms of AD' and 10 being 'I did not sleep at all' due to the symptoms of AD.

  10. Percent change in the weekly average of daily skin pain NRS score from Baseline to Week 24

    Time frame: From Baseline throughout the study, up to Week 24

    The Skin Pain-NRS is a whole number scale ranging from 0 to 10 with a 24-hour recall period, with 0 = no pain and 10 = worst possible pain imaginable. The threshold for determining clinically meaningful change is ≥ 4-point change in the weekly average SP-NRS.

  11. Change in percent Body Surface Area (BSA) affected by Atopic Dermatitis from Baseline to Week 24.

    Time frame: From Baseline throughout the study, up to Week 24

    The BSA affected by AD will be assessed in 4 body regions: head/neck, trunk (including the genitals), upper extremities, and lower extremities (including the buttocks). Each body region should be evaluated from 0 to 100%. The percentage of the affected area will be multiplied by the proportion of that body region to the whole body.

  12. Proportion of participants achieving EASI-50 at Week 24

    Time frame: From Baseline throughout the study, up to Week 24

    EASI-50 is defined by reduction of EASI score by ≥50% from baseline.

  13. Proportion of participants achieving EASI-90 at Week 24

    Time frame: From Baseline throughout the study, up to Week 24

    EASI-90 is defined by reduction of EASI score by ≥90% from baseline.

  14. Proportion of participants with improvement (reduction) of ≥4 points in the weekly average of daily PP NRS scores from Baseline throughout the study

    Time frame: From Baseline throughout the study, up to Week 24

    The Peak Pruritis-Numerical Rating Scale (PP-NRS) is a validated single-item patient-reported outcome (PRO) to assess worst itch intensity on a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable".

  15. Proportion of participants with improvement (reduction) of ≥4 points in the weekly average of daily SD-NRS scores from Baseline to Week 24, in participants with a baseline weekly average of daily SD-NRS scores of ≥4 points

    Time frame: From Baseline throughout the study, up to Week 24

    The Sleep Disturbance-Numerical Rating Scale (SD-NRS) is a validated single item 0-10 numerical rating scale assessing sleep disturbance associated with AD, with 0 being 'no sleep loss related to the symptoms of AD' and 10 being 'I did not sleep at all' due to the symptoms of AD.

  16. Proportion of participants with improvement (reduction) of ≥4 points in the weekly average of daily Skin Pain NRS scores from Baseline to Week 24, in participants with a baseline weekly average of daily Skin Pain NRS scores of ≥4 points

    Time frame: From Baseline throughout the study, up to Week 24

    The Skin Pain--Numerical Rating Scale (SP-NRS) is a whole number scale ranging from 0 to 10 with a 24-hour recall period, with 0 = no pain and 10 = worst possible pain imaginable. The threshold for determining clinically meaningful change is ≥ 4-point change in the weekly average SP-NRS.

  17. Percent change in Scoring of Atopic Dermatitis (SCORAD) Index from Baseline to Week 24

    Time frame: From Baseline throughout the study, up to Week 24

    The Scoring of Atopic Dermatitis (SCORAD) Index is a validated clinical tool that was developed to standardize the evaluation of the extent and severity of AD. Total score ranges from 0 (absent disease) to 103 (severe disease).

  18. Proportion of participants with an improvement of ≥4 points in Dermatology Life Quality Index (DLQI) score from Baseline to Week 24 and throughout the study

    Time frame: From Baseline throughout the study, up to Week 24

    The Dermatology Life Quality Index (DLQI) is a 10-item dermatology specific health-related quality of life (HRQoL) questionnaire. The total score is correlated to the detrimental effect of AD on QoL and ranges from 0 to 30, with a higher score indicating a poorer QoL.

  19. Percent change in Dermatology Life Quality Index (DLQI) score from Baseline to Week 24 and throughout the study

    Time frame: From Baseline throughout the study, up to Week 24

    The Dermatology Life Quality Index (DLQI) is a 10-item dermatology specific health-related quality of life (HRQoL) questionnaire. The total score is correlated to the detrimental effect of AD on QoL and ranges from 0 to 30, with a higher score indicating a poorer QoL.

  20. Percent change in Patient Oriented Eczema Measure (POEM) score from Baseline to Week 24

    Time frame: From Baseline throughout the study, up to Week 24,

    The Scoring of Atopic Dermatitis (SCORAD) Index is a validated clinical tool that was developed to standardise the evaluation of the extent and severity of AD.

  21. Percent change in Hospital Anxiety and Depression Scale (HADS) from Baseline to Week 24

    Time frame: From Baseline throughout the study, up to to Week 24

    The Hospital Anxiety and Depression Scale (HADS) is a 14-item patient-reported outcome (PRO) questionnaire used to assess states of anxiety and depression over the past week with two subscales. Each subscale (anxiety & depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.

  22. Incidence of Antidrug antibody (ADA) against lunsekimig up to end of study

    Time frame: From Baseline throughout the study, up to Week 32

  23. Serum concentrations of lunsekimig throughout the study

    Time frame: From Baseline throughout the study, up to Week 32

  24. Serum concentrations of lunsekimig in the pharmacokinetic/pharmacodynamics (PK/PD) subgroup throughout the study

    Time frame: From Baseline throughout the study, up to Week 32

  25. Number of participants with treatment-emergent adverse events (TEAEs), including local reactions, adverse events of special interest (AESIs), and serious adverse events (SAEs)

    Time frame: From Baseline throughout the study, up to Week 32

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of 3 Subcutaneous Dose Regimens of Lunsekimig (SAR443765) in Adult Participants With Moderate-to-severe Atopic Dermatitis

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2025
Registry last updated
Apr 21, 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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