Aug. 18, 2021 |
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April. 26, 2024 |
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jRCT2031210256 |
Phase 3 Clinical Study of JTE-061 Cream - 52-week Long-term Study in Patients with Atopic Dermatitis - |
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Phase 3 Clinical Study of JTE-061 Cream - 52-week Long-term Study in Patients with Atopic Dermatitis - |
June. 07, 2023 |
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291 |
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No notable findings were identified in demographics (age, sex, etc.) or baseline characteristics (IGA score, etc.). |
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A total of 291 subjects received the investigational product. Of these, 237 subjects completed the study. |
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Treatment with JTE-061 cream was generally safe in patients with AD. |
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The IGA treatment success rate increased over time until Week 24, and an increasing trend was observed thereafter. The EASI-75 response rate increased over time until Week 24 remained at a similar level thereafter. |
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When JTE-061 cream 1% was administered once daily for 52 weeks to patients with AD, the plasma concentration of JTE-061 was low, and treatment with JTE-061 was generally safe. In addition, the efficacy of JTE-061 cream 1% in the treatment of AD was maintained up to 52 weeks after initiation of treatment. |
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No |
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https://jrct.niph.go.jp/latest-detail/jRCT2031210256 |
Nemoto Takanori |
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Japan Tobacco Inc. |
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3-4-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan |
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+81-120-404-611 |
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clinicaltrials-info-r@jt.com |
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information clinical trials |
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Japan Tobacco Inc. |
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3-4-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan |
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+81-120-404-611 |
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clinicaltrials-info-r@jt.com |
Complete |
Oct. 06, 2021 |
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Sept. 21, 2021 | ||
270 | ||
Interventional |
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single arm study |
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open(masking not used) |
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uncontrolled control |
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single assignment |
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treatment purpose |
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1. Japanese patients aged >= 12 years at informed consent who can visit the study site as an outpatient |
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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 |
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12age old over | ||
No limit | ||
Both |
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Atopic Dermatitis |
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Once daily topical application of thin layer of JTE-061 cream 1% to all affected areas (except the hairy scalp) |
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Adverse events and adverse drug reactions |
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Japan Tobacco Inc. |
Torii Pharmaceutical Co.,LTD | |
Applicable |
Sugiura Clinic Institutional Review Board | |
4-4-16-301, Hon-cho, Kawaguchi-shi, Saitama | |
+81-42-648-5551 |
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sugiura-irb@eps.co.jp | |
Approval | |
none |