JRCT ID: jRCT2031210256
Registered date:18/08/2021
Phase 3 Clinical Study of JTE-061 Cream - 52-week Long-term Study in Patients with Atopic Dermatitis -
Basic Information
Recruitment status | Not Recruiting |
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Health condition(s) or Problem(s) studied | Atopic Dermatitis |
Date of first enrollment | 21/09/2021 |
Target sample size | 270 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Once daily topical application of thin layer of JTE-061 cream 1% to all affected areas (except the hairy scalp) |
Outcome(s)
Primary Outcome | 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 |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 12age old |
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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 |
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Secondary Sponsor | Torii Pharmaceutical Co.,LTD |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | clinical trials information |
Address | 3-4-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan Tokyo Japan 103-0023 |
Telephone | +81-120-404-611 |
clinicaltrials-info-r@jt.com | |
Affiliation | Japan Tobacco Inc. |
Scientific contact | |
Name | Takanori Nemoto |
Address | 3-4-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan Tokyo Japan 103-0023 |
Telephone | +81-120-404-611 |
clinicaltrials-info-r@jt.com | |
Affiliation | Japan Tobacco Inc. |