Bioequivalence study of JTE-052

Phase III Clinical Study of JTE-052 new drug product - Bioequivalence study between new drug product and JTE-052 ointment in patients with atopic dermatitis -

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031230713

Enrollment

234

Registered

2024-03-15

Start date

2024-04-22

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

Twice daily topical application of JTE-052 new drug product or JTE-052 ointment 0.5%

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with moderate or severe atopic dermatitis 2. Modified Eczema Area and Severity Index (mEASI) = >10

Exclusion criteria

Exclusion criteria: 1. Patients with active infection at the study drug application site 2. Use of topical corticosteroids (strongest or very strong) within 28 days before an initiation of study drug (Week 0) 3. Use of topical corticosteroids (strong, medium or weak) within 7 days before an initiation of study drug (Week 0)

Design outcomes

Primary

Measure	Time frame
Percent change in mEASI score from Week 0 at the final evaluation (the end of treatment [EOT])	—

Contacts

Public Contactinformation clinical trials

Shionogi & Co.,Ltd.

clinicaltrials-info@shionogi.co.jp+81-3-6635-3505

Outcome results

None listed

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