Dermatitis atopic
Conditions
Interventions
Drug: Amlitelimab (SAR445229)
Pharmaceutical form: Injection solution, Route of administration: Subcutaneous
Drug: Placebo
Pharmaceutical form: Injection solution, Route of administration: Subcutane
Sponsors
Tanaka Tomoyuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participants must be at least 12 years of age inclusive (when signing informed consent form). - Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria). - Documented history prior to screening visit of inadequate response to a biologic AD medication or an oral JAK inhibitor (JAKi) therapy. - Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 3 or 4 at baseline visit. - Eczema Area and Severity Index (EASI) score of 16 or higher at baseline. - AD involvement of 10% or more of body surface area (BSA) at baseline. - Weekly average of daily Peak-Pruritus Numerical Rating Scale (PP-NRS) of >= 4 at baseline visit. - Able and willing to comply with requested study visits and procedures. - Body weight >= 25 kg
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: - Skin co-morbidity that would adversely affect the ability to undertake AD assessments - Known history of or suspected significant current immunosuppression. - Any malignancies or history of malignancies prior to baseline (with the exception of non-melanoma skin cancer excised and cured > 5 years prior to baseline). - History of solid organ or stem cell transplant. - Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to baseline. - Positive for human immunodeficiency virus, Hepatitis B or hepatitis C at screening visit. - Having active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB. - Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit. - In the Investigator's opinion, any clinically significant laboratory results or protocol specified laboratory abnormalities at screening. - History of hypersensitivity or allergy to any of the excipients or investigational medicinal product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. European Union (EU), EU reference countries, and Japan: Proportion of participants with vIGA-AD of 0 (clear) or 1 (almost clear) and a reduction from baseline of >= 2 points at Week 36 [Time Frame: Week 36] 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). 2. EU, EU reference countries, and Japan: Proportion of participants reaching 75% reduction from baseline in EASI score (EASI-75) at Week 36 [Time Frame: Week 36] 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. 3. United States (US) and US reference countries: Proportion of participants with vIGA-AD of 0 (clear) or 1 (almost clear) and a reduction from baseline of >= 2 points at Week 36 [Time Frame: Week 36] Refer to the primary outcome-1 for "vIGA-AD". | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of participants reaching EASI-75 at Week 36 (for US and US reference countries only) [Time Frame: Week (W) 36] Refer to the primary outcome-2 for "EASI". EASI-75 is 75% reduction from baseline in EASI score. 2. Proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear) with presence of only barely perceptible erythema (no induration/papulation, no lichenification, no oozing or crusting) [Time Frame: Baseline (Base) to W36] Refer to the primary outcome-1 for "vIGA-AD". 3. Proportion of participants with >= 4-point reduction in weekly average of daily PP-NRS from baseline in participants with baseline weekly average of daily PP-NRS >= 4 [Time Frame: Base to W36] 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. 4. Proportion of participants reaching EASI-75 [Time Frame: Base to W24] Refer to the primary outcome-2 for "EASI". EASI-75 is 75% reduction from baseline in EASI score. 5. Proportion of participants with vIGA-AD of 0 (clear) or 1 (almost clear) and a reduction from baseline of >= 2 points [Time Frame: Base to W24] Refer to the primary outcome-1 for "vIGA-AD". 6. Proportion of participants reaching EASI-90 [Time Frame: Base to W36] Refer to the primary outcome-2 for "EASI". EASI-90 is 90% reduction from baseline in EASI score. 7. Proportion of participants reaching EASI-100 [Time Frame: Base to W36] Refer to the primary outcome-2 for "EASI". EASI-100 is 100% reduction from baseline in EASI score. 8. Proportion of participants with PP-NRS 0 or 1 [Time Frame: Base to W36] Refer to the secondary outcome-3 for "PP-NRS". 9. Change in Dermatology Quality of Life Index (DLQI) from baseline in participants with age >= 16 years old [Time Frame: Base to W36] 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 i | — |
Countries
Canada, Chile, Japan, United Kingdom, United States
Contacts
Public ContactUnit Clinical
Sanofi K.K.
Outcome results
None listed