Phase III Study of JTE-052 Ointment in Pediatric Patients with Atopic Dermatitis

Phase III Clinical Study of JTE-052 Ointment - Randomized Controlled and Long-Term Extension Study of JTE-052 Ointment in Japanese Pediatric Patients with Atopic Dermatitis -

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224005

Enrollment

120

Registered

2018-08-14

Start date

2018-09-10

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

investigational material(s) Generic name etc : JTE-052A INN of investigational material : delgocitinib Therapeutic category code : 269 Other agents for epidermis Dosage and Administration for Investig

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients diagnosed with mild, moderate or severe AD Modified Eczema Area and Severity Index(mEASI) >=5

Exclusion criteria

Exclusion criteria: Active infection at the prospective application site History of tuberculosis Hepatitis B/C virus carriers or history of hepatitis B/C virus infection History or presence of malignant tumor Use of topical corticosteroids (classified as strongest or very strong drugs) within 28 days before baseline Use of topical corticosteroids (classified as strong, medium or weak drugs) or tacrolimus hydrate ointment within 7 days before baseline

Design outcomes

Primary

Measure	Time frame
efficacy Percent change in mEASI	—

Secondary

Measure	Time frame
efficacy Eczema Area and Severity Index (EASI) Investigator's Global Assessment (IGA) Face and Neck IGA Pruritus score Percent body surface area (%BSA) affected by eczema with inflammation Time (in days) to dropout due to worsened target disease	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026