A Study to Investigate the Efficacy and Safety of Subcutaneous Lunsekimig (SAR443765) Compared With Placebo in Adult Participants With Moderate-to-severe Atopic Dermatitis
- Registration Number
- NCT06790121
- Lead Sponsor
- Sanofi
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 144
- 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).
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo arm B Placebo Participants will receive subcutaneous injection of matching placebo. Placebo arm D Placebo Participants will receive subcutaneous injection of matching placebo. Placebo arm F Placebo Participants will receive subcutaneous injection of matching placebo. Lunsekimig arm A Lunsekimig Participants will receive subcutaneous injection of lunsekimig dosing regimen A. Lunsekimig arm C Lunsekimig Participants will receive subcutaneous injection of lunsekimig dosing regimen C. Lunsekimig arm E Lunsekimig Participants will receive subcutaneous injection of lunsekimig dosing regimen E.
- Primary Outcome Measures
Name Time Method Percent change in Eczema Area and Severity Index (EASI) score from baseline to Week 24 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 Outcome Measures
Name Time Method Proportion of participants achieving EASI-75 at Week 24 From Baseline throughout the study, up to Week 24 EASI 75 is defined by reduction of EASI score by ≥75% from baseline
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 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).
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 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".
Absolute change from Baseline in EASI score at Week 24 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.
Percent change from Baseline in EASI score throughout the study 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.
Number of participants with treatment-emergent adverse events (TEAEs), including local reactions, adverse events of special interest (AESIs), and serious adverse events (SAEs) From Baseline throughout the study, up to Week 32 Proportion of participants with a vIGA-AD score of 0 (clear) or 1 (almost clear) at Week 24 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).
Proportion of participants with a response of vIGA-AD 0 or 1 and a reduction from Baseline of ≥2 points throughout the study 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).
Percent change in the weekly average of daily PPNRS scores from Baseline to Week 24 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".
Percent change in the weekly average of daily sleep disturbance NRS score from Baseline to Week 24 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.
Percent change in the weekly average of daily skin pain NRS score from Baseline to Week 24 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.
Change in percent Body Surface Area (BSA) affected by Atopic Dermatitis from Baseline to Week 24. 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.
Proportion of participants achieving EASI-50 at Week 24 From Baseline throughout the study, up to Week 24 EASI-50 is defined by reduction of EASI score by ≥50% from baseline.
Proportion of participants achieving EASI-90 at Week 24 From Baseline throughout the study, up to Week 24 EASI-90 is defined by reduction of EASI score by ≥90% from baseline.
Proportion of participants with improvement (reduction) of ≥4 points in the weekly average of daily PP NRS scores from Baseline throughout the study 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".
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 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.
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 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.
Percent change in Scoring of Atopic Dermatitis (SCORAD) Index from Baseline to Week 24 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).
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 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.
Percent change in Dermatology Life Quality Index (DLQI) score from Baseline to Week 24 and throughout the study 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.
Percent change in Patient Oriented Eczema Measure (POEM) score from Baseline to Week 24 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.
Percent change in Hospital Anxiety and Depression Scale (HADS) from Baseline to Week 24 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.
Incidence of Antidrug antibody (ADA) against lunsekimig up to end of study From Baseline throughout the study, up to Week 32 Serum concentrations of lunsekimig throughout the study From Baseline throughout the study, up to Week 32 Serum concentrations of lunsekimig in the pharmacokinetic/pharmacodynamics (PK/PD) subgroup throughout the study From Baseline throughout the study, up to Week 32
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Trial Locations
- Locations (16)
T. Joseph Raoof MD Inc-Site Number: 8400004
🇺🇸Encino, California, United States
Clinical Trials Research Institute-Site Number: 8400003
🇺🇸Thousand Oaks, California, United States
Investigational Site Number: 3920005
🇯🇵Asahikawa-shi, Japan
Investigational Site Number: 3920006
🇯🇵Nerima-ku, Japan
Investigational Site Number: 3920007
🇯🇵Yokohama-shi, Japan
Driven Research LLC-Site Number: 8400020
🇺🇸Coral Gables, Florida, United States
Southern Indiana Clinical Trials-Site Number: 8400024
🇺🇸New Albany, Indiana, United States
Health Concepts-Site Number: 8400025
🇺🇸Rapid City, South Dakota, United States
Skin Cancer and Dermatology Institute-Site Number: 8400011
🇺🇸Reno, Nevada, United States
Red River Research Partners-Site Number: 8400008
🇺🇸Fargo, North Dakota, United States
Skin Care Research-Site Number: 8400013
🇺🇸Boca Raton, Florida, United States
Indiana Clinical Trials Center, P.C.-Site Number: 8400018
🇺🇸Plainfield, Indiana, United States
Investigational Site Number: 3920008
🇯🇵Tachikawa-shi, Japan
Clinical Trials Management LLC-Site Number: 8400010
🇺🇸Covington, Louisiana, United States
Medisearch LLC-Site Number: 8400017
🇺🇸Saint Joseph, Missouri, United States
DermResearch-Site Number: 8400014
🇺🇸Austin, Texas, United States