Phase 3 Clinical Study of JTE-061 Cream - Randomized Vehicle-controlled Study (Part 1) and Extension Study (Part 2) in Patients with Atopic Dermatitis -

JRCT ID: jRCT2031210255

Registered date:18/08/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Atopic Dermatitis
• Date of first enrollment: 08/09/2021
• Target sample size: 210
• Study type: Interventional

Intervention(s)

<Part 1>
Once daily topical application of thin layer of JTE-061 cream 1% or vehicle cream to all affected areas (except the hairy scalp)
<Part 2>
Once daily topical application of thin layer of JTE-061 cream 1% to all affected areas (except the hairy scalp)

Outcome(s)

• Primary Outcome: Proportion of subjects who achieve a IGA score of clear (0) or almost clear (1) with a minimum 2-grade improvement from Baseline at Week 8

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Nemoto Takanori
• Secondary Sponsor: Torii Pharmaceutical Co.,LTD