Dupixent Special Drug Use Investigation for long term use (Pediatric Atopic Dermatitis)

Dupixent Special Drug Use Investigation for long term use (Pediatric Atopic Dermatitis) - Dupixent Special Drug Use Investigation for long term use (Pediatric Atopic Dermatitis)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000052375

Enrollment

Registered

2023-12-20

Start date

2024-01-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Pediatrics aged 6 months to <15 years who newly start receiving the treatment with Dupixent -Patients and/or the patient's legally acceptable representative who can provide informed consent and/or assent

Exclusion criteria

Exclusion criteria: -Subjects who are participating in or have been registered for clinical trials with therapeutic intervention to Dupixent

Design outcomes

Primary

Measure	Time frame
Safety:Incidence rates of adverse drug reactions, Safety specification items of Dupixent Effectiveness:Investigator's Global Assessment (IGA), Peak weekly pruritus numeric rating scale(Worst-itch-NRS), Worst-scratch/itch-NRS for children under 6 years old, Body Surface Area of involvement of atopic dermatitis (BSA), Eczema Area and Severity Index (EASI)	—

Countries

Japan

Contacts

Public ContactPublic contact for Drug use surveillance -

Sanofi K.K. Post-authorization regulatory studies, Medical Affairs

Sanofi_Medical@sanofi.com03-6301-3867

Outcome results