atopic dermatitis
Conditions
Interventions
Drug: Dupilumab (SAR231893, Dupixent)
Pharmaceutical form: solution for injection, Route of administration: subcutaneous (SC)
Drug: Placebo
Pharmaceutical form: solution for injection, Route of admi
Sponsors
Tanaka Tomoyuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Japanese and >=6 months to = 3 at screening and baseline visits. - (Eczema Area and Severity Index) EASI >=16 at screening and baseline visits. - Baseline peak pruritus Numerical Rating Scale (NRS) average score for maximum itch intensity >=4 for participants >=12 to =4 for participants >=6 months to 10% at screening and baseline visits. - With documented recent history of inadequate response to topical AD medication(s). - Participant or parents/caregiver or legal guardians, must be able to understand and complete study-related questionnaires. - Body weight >=5 kg at baseline.
Exclusion criteria
Exclusion criteria: - Active chronic or acute infection within 2 weeks before the baseline visit or during the screening period. - Known or suspected immunodeficiency, including history of invasive opportunistic infections - Participants with active tuberculosis (TB) or non-tuberculous mycobacterial infection, or a history of incompletely treated TB. - Known history of human immunodeficiency virus (HIV)-1 and HIV-2 infection or HIV seropositivity at the screening - Participants with any of the following result at the screening: - - Positive (or indeterminate) Hepatitis B surface antigen (HBs Ag) or, - - Positive hepatitis B core antibody (HBc Ab) confirmed by positive hepatitis B virus (HBV) DNA or, - - Positive hepatitis C antibody (HCV Ab) confirmed by positive hepatitis C virus (HCV) RNA. - Presence of skin comorbidities that may interfere with study assessments - History of malignancy within 5 years before the baseline visit - History of systemic hypersensitivity or anaphylaxis to dupilumab or any other biologic therapy. - Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection. - Severe concomitant illness(es) - Participant with any other medical or psychological condition - Having used any of immunosuppressive/immunomodulating drugs and phototherapy within 4 weeks before the screening visit. - History of important side effects to medium potency TCS - Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit. - Either intravenous immunoglobulin therapy and/or plasmapheresis within 30 days prior to screening visit. - Planned or anticipated use of any prohibited medications and procedures during screening and study treatment period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with Eczema Area and Severity Index (EASI)-75 (>=75% improvement from baseline EASI) [Time frame for evaluation: At Week 16] The EASI is a composite index with scores ranging from 0 to 72.Higher scores indicates worse condition | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percent change in EASI score [Time frame for evaluation: From baseline to week 16] The EASI is a composite index with scores ranging from 0 to 72.Higher scores indicates worse condition 2. Percent change in weekly average of daily worst itch numerical rating scale (NRS) for participants aged >=6 years to =6 years old to =12 years to = 12 to =6 months to =6 years old to =50% improvement from baseline) [Time frame for evaluation: At Week 16] The EASI is a composite index with scores ranging from 0 to 72.Higher scores indicates worse condition 8. Proportion of participants with EASI-90 (>=90% improvement from baseline) [Time frame for evaluation: At Week 16] The EASI is a composite index with scores ranging from 0 to 72.Higher scores indicates worse condition 9. Change in percent body surface area (BSA) affected by atopic dermatitis (AD) [Time frame for evaluation: From baseline to week 16] BSA affected by atopic dermatitis will be assessed for each major section of the body (head, trunk, arms, and legs). 10. Change in Children's Dermatology Life Quality Index (CDLQI) (>=4 years) [Time frame for evaluation: From baseline to week 16] The CDLQI is a validated questionnaire designed to measure the impact of skin disease on the Quality of Life. The higher the score, the greater the impact is on the quality of life 11. Change in Infants' Dermatitis Quality of Life Index (IDQOL) (=12 years to = 12 to =6 years to =6 years old to =6 months to =6 years old to <12 years old range from 1 to 10 in which 1 indicates no itching while 10 indicate worst itching possible 16. Incidence of Adverse Event [Time frame for evaluation: From baseline to week 16] Incidence of Treatment-Emergent Adverse Events (TEAEs), SAEs, and AESIs 17. Incidence of Skin-infection TEAE [Time frame for evaluation: From baseline to week 16] Incidence of skin-infection TEAEs (excluding herpetic infections) 18. Incidence of Adverse Event during open-label extension [Time frame for evaluation: week 16 to week 17 | — |
Contacts
Public ContactUnit Clinical
Sanofi K.K.
Outcome results
None listed