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Phase 3 Clinical Study of JTE-061 Cream - Randomized Vehicle-controlled Study (Double-blind Period) and Extension Study (Extension Period) in Pediatric Patients with Atopic Dermatitis -

Phase 3 Clinical Study of JTE-061 Cream - Randomized Vehicle-controlled Study (Double-blind Period) and Extension Study (Extension Period) in Pediatric Patients with Atopic Dermatitis -

162

<Double-blind Period> There was no notable differences between the treatment groups (107 subjects in the 0.5% cream group, 55 subjects in the vehicle cream group) in the subject demographics (age, sex, etc.) or baseline characteristics (IGA score, EASI score, etc.) in the double-blind period. 82 of 162 subjects (50.6%) in total (the 0.5% cream group and the vehicle cream group combined) were male. The mean age was 7.0 years in 162 subjects in total. In both treatment groups, approximately 60% of subjects had a baseline IGA score of 3 (moderate). The baseline value of EASI score was 10.898 in the 0.5% cream group and 10.668 in the vehicle cream group. <Overall Study Period (Double-blind period and Extension Period)> The subject demographics (age, sex, etc.) and baseline characteristics (IGA score, EASI score, etc.) in both treatment groups (107 subjects in the 0.5% - 0.5% group, 47 subjects in the vehicle - 0.5% group) in the overall study period were comparable to those in the double-blind period. 79 of 154 subjects (51.3%) in total (the 0.5% - 0.5% group and the vehicle - 0.5% group combined) were male. The mean age was 7.1 years in 154 subjects in total. In both treatment groups, approximately 60% of subjects had a baseline IGA score of 3 (moderate). The baseline value of EASI score was 10.898 in the 0.5% - 0.5% group and 10.515 in the vehicle - 0.5% group.

162 subjects were randomly assigned to each group. A total of 162 subjects received the investigational product, consisting of 107 subjects in the 0.5% cream group and 55 subjects in the vehicle cream group. After initiation of study treatment in the double-blind period, the study was discontinued in 3 subjects in the 0.5% cream group and 8 subjects in the vehicle cream group. In the double-blind period, the study treatment was completed in 102 subjects in the 0.5% cream group and 30 subjects in the vehicle cream group. All subjects who completed study treatment in the double-blind period proceeded to the extension period. During the period from the assessments at Week 4 to the assessments at Week 8, 2 subjects in the 0.5% cream group and 17 subjects in the vehicle cream group switched to the extension period because of worsening of AD that made it difficult to continue the double-blind period. Therefore, a total of 151 subjects (104 in the 0.5% cream group and 47 in the vehicle cream group) entered the extension period. In the extension period, the study was discontinued after the start of treatment with JTE-061 cream 0.5% in 8 subjects (5 treated with 0.5% - 0.5% and 3 treated with vehicle - 0.5%). A total of 143 subjects (99 treated with 0.5% - 0.5% and 44 treated with vehicle - 0.5% ) completed up to 60 weeks of study treatment including the double-blind period.

<Double-blind Period> No deaths or other serious adverse events occurred. Adverse events leading to study treatment discontinuation occurred in 2 subjects (1.9%) in the 0.5% cream group and 8 subjects (14.5%) in the vehicle cream group. Adverse drug reactions leading to study treatment discontinuation were 1 event of dermatitis atopic in 1 subject each in the 0.5% cream group and the vehicle cream group. Adverse events occurred in 78 subjects (72.9%) in the 0.5% cream group and 41 subjects (74.5%) in the vehicle cream group. There was no adverse event that was assessed as severe. Adverse drug reactions occurred in 7 subjects (6.5%) in the 0.5% cream group and 2 subjects (3.6%) in the vehicle cream group. The adverse drug reaction that occurred in >= 2% of subjects in the 0.5% cream group was application site folliculitis in 3 subjects (2.8%). The adverse drug reaction that occurred in >= 2% of subjects in the vehicle cream group was dermatitis atopic in 2 subjects (3.6%). <Overall Study Period (Double-blind period and Extension Period)> No deaths occurred. The other serious adverse event of tibia fracture occurred in 1 subject (0.6%) in JTE-061 total, but causal relationship with the investigational product was ruled out. Adverse events leading to study treatment discontinuation occurred in 4 subjects (2.6%) in JTE-061 total. Adverse drug reactions leading to study treatment discontinuation were 2 events of dermatitis atopic in 2 subjects (1.3%) in JTE-061 total. Adverse events occurred in 150 subjects (97.4%) in JTE-061 total. An adverse event that was assessed as severe of liver function test increased occurred in 1 subject (0.6%) in JTE-061 total, but causal relationship with the investigational product was ruled out. Adverse drug reactions occurred in 22 subjects (14.3%) in JTE-061 total. Adverse drug reactions that occurred in >= 2% of subjects in JTE-061 total were application site folliculitis in 7 subjects (4.5%), acne in 6 subjects (3.9%), and application site acne and dermatitis atopic in 4 subjects (2.6%) each.

<Double-blind Period> The proportion of subjects with >= 75% improvement in EASI score from Baseline (EASI-75 response rate) at Week 8, the primary endpoint, was 52.59% in the 0.5% cream group and 12.60% in the vehicle cream group, with the difference between the 2 groups (0.5% cream group - vehicle cream group) of 40.0% (95% CI: 26.3% to 53.7%). The EASI-75 response rate at Week 8 was significantly higher in the 0.5% cream group than in the vehicle cream group (p < 0.0001, 2-sided alpha of 5%), demonstrating the superiority of the 0.5% cream over the vehicle cream. The least-squares mean percent change in EASI score from Baseline at Week 8, a key secondary endpoint, was -68.28% in the 0.5% cream group and -23.01% in the vehicle cream group. The difference between the 2 groups was -45.27% (95% CI: -59.48% to -31.06%). An improvement in EASI score was noted in the 0.5% cream group, and the mean percent change in EASI score from Baseline at Week 8 was greater in the 0.5% cream group than in the vehicle cream group. The Proportion of subjects who achieve an IGA score of clear (0) or almost clear (1) with a minimum 2-grade improvement from Baseline (IGA treatment success rate) at Week 8, a key secondary endpoint, was 26.2% in the 0.5% cream group and 1.8% in the vehicle cream group, with the difference between the 2 groups of 24.4% (95% CI: 13.2% to 34.0%). The IGA treatment success rate at Week 8 was higher in the 0.5% cream group than in the vehicle cream group. <Overall Study Period (Double-blind period and Extension Period)> Improvements in EASI score, IGA score, %BSA affected, POEM score, and pruritus score were noted after the start of JTE-061 cream 0.5% administration and were sustained through Week 60.

In the 8-week double-blind treatment in pediatric patients with AD, the EASI-75 response rate at Week 8 was significantly higher in the 0.5% cream group than in the vehicle cream group, demonstrating the superiority of the 0.5% cream over the vehicle cream. In the 60-week treatment (across double-blind and extension periods), the plasma concentration of JTE-061 was low, and JTE-061 cream 0.5% was generally safe and well tolerated. The efficacy of JTE-061 cream 0.5% was shown to be sustained through Week 60.

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2031230139

Yamane Satoshi

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

July. 25, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

1. Japanese patients aged between 2 and 11 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

<Double-blind Period>
Once daily topical application of thin layer of JTE-061 cream 0.5% or vehicle cream to all affected areas (except the hairy scalp)
<Extension Period>
Once daily topical application of thin layer of JTE-061 cream 0.5% to all affected areas (except the hairy scalp)

Proportion of subjects with >= 75% improvement in EASI score from Baseline at Week 8

+81-42-648-5551

July. 06, 2023

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