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

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

Yamane Satoshi

Shionogi & Co.,Ltd.

3-4-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan

clinicaltrials-info@shionogi.co.jp

clinical trials information

Shionogi & Co.,Ltd.

3-4-1, Nihonbashi-Honcho , Chuo-ku, Tokyo, Japan

+81-3-6635-3505

clinicaltrials-info@shionogi.co.jp

Not Recruiting

July. 03, 2025

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1. Japanese patients aged 3 months to < 24 months 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

1. Patients with a current significant skin or inflammatory condition that, in the opinion of the investigator or subinvestigator, 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 or current cancer

Both

Atopic Dermatitis

Once daily topical application of thin layer of JTE-061 cream 0.5% to all affected areas (except the hairy scalp)

Proportion of subjects with >= 75% improvement in EASI score from Baseline at Week 8

+81-42-648-5551

June. 12, 2025

No

none