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Phase 3 Clinical Study of JTE-061 Cream - Randomized Vehicle-controlled Study (Double-blind Period) and Extension Study (Extension Period) in Pediatric Patients with Atopic Dermatitis -

Phase 3 Clinical Study of JTE-061 Cream - Randomized Vehicle-controlled Study (Double-blind Period) and Extension Study (Extension Period) in Pediatric 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

Complete

July. 25, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

1. Japanese patients aged between 2 and 11 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

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

Both

Atopic Dermatitis

<Double-blind Period>
Once daily topical application of thin layer of JTE-061 cream 0.5% or vehicle cream to all affected areas (except the hairy scalp)
<Extension Period>
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

July. 06, 2023

No

none