Dermatitis atopic
Conditions
Sponsors
Obara Kentaro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participants must be 12 years of age (when signing informed consent form) - Diagnosis of atopic dermatitis (AD) for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria) - Documented history (within 6 months before screening) of inadequate response to topical treatments, and/or inadequate response to systemic therapies (within 12 months before screening) - Validated Investigator Global Assessment scale 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 Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) of 0 (clear) or 1 (almost clear) and a reduction from baseline of >=2 points at Week 24 [Time Frame: Week 24] 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 Eczema Area and Severity Index (EASI) score (EASI-75) at Week 24 [Time Frame: Week 24] 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 24 [Time Frame: Week 24] Refer to the primary outcome-1 for "vIGA-AD". | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of participants reaching EASI-75 at Week 24 (for US and US reference countries only) [Time Frame: Week 24] 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) and a reduction from baseline of >=2 points [Time Frame: Baseline to Week 24] Refer to the primary outcome-1 for "vIGA-AD". 3. Proportion of participants with >=4-point reduction in weekly average of daily Peak Pruritus-Numerical Rating Scale (PP-NRS) from baseline in participants with baseline weekly average of daily PP-NRS >=4 [Time Frame: Baseline to Week 24] 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: Baseline to Week 20] 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: Baseline to Week 20] Refer to the primary outcome-1 for "vIGA-AD". 6. Proportion of participants with vIGA-AD 0 (clear) [Time frame: Week 24] 7. Proportion of participants reaching EASI-90 [Time Frame: Baseline to Week 24] Refer to the primary outcome-2 for "EASI". EASI-90 is 90% reduction from baseline in EASI score. 8. Proportion of participants reaching EASI-100 [Time Frame: Baseline to Week 24] Refer to the primary outcome-2 for "EASI". EASI-100 is 100% reduction from baseline in EASI score. 9. Proportion of participants with PP-NRS 0 or 1 [Time frame: Baseline to Week 24] 10. Change in Dermatology Quality of Life (QoL) Index (DLQI) from baseline in participants with age >=16 years old [Time Frame: Baseline to Week 24] The DLQI is a va | — |
Countries
Argentina, Brazil, Bulgaria, Canada, Chile, China, Czechia, France, Germany, Italy, Japan, Spain, Turkey, United States
Contacts
Public ContactUnit Clinical
Sanofi K.K.
Outcome results
None listed