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Phase 3 Clinical Study of JTE-061 Cream - 52-week Long-term Study in Patients with Atopic Dermatitis -

Phase 3 Clinical Study of JTE-061 Cream - 52-week Long-term Study in Patients with Atopic Dermatitis -

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2031210256
Enrollment
270
Registered
2021-08-18
Start date
2021-09-21
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

Sponsors

Nemoto Takanori
Lead Sponsor
Torii Pharmaceutical Co.,LTD
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Japanese patients aged >= 12 years at informed consent who can visit the study site as an outpatient 2. Patients with clinical diagnosis of AD according to the criteria of the Japanese Dermatological Association prior to or at informed consent 3. Patients whose IGA score, EASI score, and %BSA affected meet the criteria specified in the study protocol

Exclusion criteria

Exclusion criteria: 1. Patients with a history of or current significant dermatologic or inflammatory condition that, in the investigator's opinion, would make it difficult to interpret data or assessments during the study 2. Patients with a history of or current acute active bacterial, fungal, or viral (e.g., herpes simplex, herpes zoster, and varicella) skin infection within 1 week prior to Week 0 3. Patients who have used any prohibited therapy specified in the study protocol within the indicated period before Week 0 4. Patients with serious concomitant disease(s) 5. Patients with a history of or current cancer within 5 years prior to screening visit

Design outcomes

Primary

MeasureTime frame
Adverse events and adverse drug reactions Change from Baseline and clinically significant abnormalities in laboratory test results Change from Baseline and clinically significant abnormalities in vital signs

Contacts

Public Contactclinical trials information

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