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Phase III Clinical Study of JTE-052 new drug product - Bioequivalence study between new drug product and JTE-052 ointment in patients with atopic dermatitis -

Bioequivalence study of JTE-052

251

Of the 251 subjects treated with the investigational product, a total of 6 subjects, consisting of 4 subjects in the JTE-052 new drug product group and 2 subjects in the JTE-052 ointment 0.5% group, were excluded from the PPS, and a total of 245 subjects, consisting of 121 subjects in the JTE-052 new drug product group and 124 subjects in the JTE-052 ointment 0.5% group, were included in the PPS. 186 of the 245 subjects (75.9%) were male, and the mean age in the 245 subjects was 33.6 years. The baseline value of mEASI score was 14.519 in the JTE-052 new drug product group and 14.100 in the JTE-052 ointment 0.5% group.

251 subjects were randomly assigned to each group. A total of 251 subjects treated the investigational product, consisting of 125 in the JTE-052 new drug product group and 126 subjects in the JTE-052 ointment 0.5% group. After initiation of study treatment, the study was discontinued in 6 subjects in the JTE-052 new drug product group and no subjects in the JTE-052 ointment 0.5% group. The study treatment was completed in 119 subjects in the JTE-052 new drug product group and 126 subjects in the JTE-052 ointment 0.5% group.

No deaths, other serious adverse events or adverse events leading to study treatment discontinuation were observed. Adverse events occurred in 34 subjects (27.2%) in the JTE-052 new drug product group and 30 subjects (23.8%) in the JTE-052 ointment 0.5% group. There was no adverse event that was assessed as severe. Adverse drug reactions occurred in 6 subjects (4.8%) in the JTE-052 new drug product group and in 5 subjects (4.0%) in the JTE-052 ointment 0.5% group. Adverse drug reactions that occurred in >=2 subjects were application site dryness in 2 subjects (1.6%) in the JTE-052 new drug product group, and application site folliculitis in 2 subjects (1.6%) in the JTE-052 ointment 0.5% group.

The percent change in mEASI score at the EOT in the PPS was -53.04% (95% CI: -59.12%, -46.97%) in the JTE-052 new drug product group and -55.97% (95% CI: -61.97%, -49.97%) in the JTE-052 ointment 0.5% group. The intergroup difference was 2.93% (95% CI: -5.62%, 11.48%). Therefore, JTE-052 new drug product and JTE-052 ointment 0.5% were determined to be equivalent.

JTE-052 new drug product or JTE-052 ointment 0.5% was applied twice daily for 4 weeks to patients with atopic dermatitis to verify the bioequivalence of the two formulation based on clinical evaluations. As a result, JTE-052 new drug product and JTE-052 ointment 0.5% were bioequivalent.

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2031230713

Mitsui Hironori

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

May. 01, 2024

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

1. Patients diagnosed with moderate or severe atopic dermatitis
2. Modified Eczema Area and Severity Index (mEASI) = >10

1. Patients with active infection at the study drug application site
2. Use of topical corticosteroids (strongest or very strong) within 28 days before an initiation of study drug (Week 0)
3. Use of topical corticosteroids (strong, medium or weak) within 7 days before an initiation of study drug (Week 0)

Both

atopic dermatitis

Twice daily topical application of JTE-052 new drug product or JTE-052 ointment 0.5%

Percent change in mEASI score from Week 0 at the final evaluation (the end of treatment [EOT])

+81-42-648-5551

April. 11, 2024

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