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

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

291

No notable findings were identified in demographics (age, sex, etc.) or baseline characteristics (IGA score, etc.).

A total of 291 subjects received the investigational product. Of these, 237 subjects completed the study.

Treatment with JTE-061 cream was generally safe in patients with AD.

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.

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.

No

https://jrct.niph.go.jp/latest-detail/jRCT2031210256

Nemoto Takanori

Japan Tobacco Inc.

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

clinicaltrials-info-r@jt.com

information clinical trials

Japan Tobacco Inc.

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

+81-120-404-611

clinicaltrials-info-r@jt.com

Complete

Oct. 06, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

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

Once daily topical application of thin layer of JTE-061 cream 1% to all affected areas (except the hairy scalp)

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

+81-42-648-5551

Aug. 05, 2021

none