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The phase 4 study of the tacrolimus ointment 0.03% in Infant and toddler patients with Atopic dermatitis -Long-term study-

The phase 4 study of the tacrolimus ointment 0.03% in Infant and toddler patients with Atopic dermatitis

22

Age (mean): 13.8 months 6 - 11 months: 8 participants 12 - 17 months: 7 participants 18 - 23 months: 7 participants Sex: 14 male participants, 8 female participants Race: Asian (all) Height (mean): 74.77 cm Weight (mean): 9.20 kg Baseline EASI score (mean): 6.543 <=7: 18 participants >7: 4 participants Baseline vIGA score (mean) 2 (mild): 13 participants 3 (moderate): 9 participants

Enrolled in the study: 22 participants Received the study drug: 22 participants Completed the study: 21 participants Discontinued the study: 1 participant

Adverse events were reported in all 22 participants. Adverse events were moderate in 6 participants and mild in 22 participants. Of these, 2 treatment-related adverse events were application site irritation and impetigo, both of which were mild and resolved after appropriate treatment. No adverse events leading to death were reported. Serious adverse events were reported in 2 participants (Henoch-Schonlein purpura and pyrexia), both of which improved or resolved after appropriate treatment. An adverse event leading to temporary interruption of the study drug was reported in 1 participant (application site irritation), and adverse events leading to dose reduction were reported in 2 participants (impetigo and hand-foot-and-mouth disease), all resolved after appropriate treatment. Among the adverse events of special interests, skin irritation was reported in 1 participant, skin symptoms (such as erythema and blisters) suspected to be due to skin irritation were reported in 11 participants, and skin infections were reported in 14 participants. No participants showed clinically meaningful changes in hematological or blood biochemical test results.

Primary efficacy endpoints The mean (95% CI) percentage change in EASI at Week 4 was -77.80% (-90.59%, -65.01%). Because the upper limit of this 95%CI (-65.01%) was below the prespecified criterion, namely the estimated EASI percentage change in the hypothetical placebo group (-20%), the efficacy of the study drug in participants with AD aged >=6 months to <2 years was confirmed. Furthermore, the mean percentage change in EASI increased from baseline to -48.23% at Week 1 and -72.42% at Week 2, and thereafter ranged from -86.12% to -60.35% after Week 4. Based on the time-course of the mean percentage change in EASI, it was confirmed that the effect of the study drug was maintained throughout the study period (52 weeks). Other efficacy endpoints The proportion of participants achieving a 75% improvement in EASI from baseline was 33.3% at Week 1 and 66.7% at Week 2, indicating an increase from the early phase of treatment, and thereafter ranged from 57.1% to 81.0% after Week 4. The proportion of participants with a vIGA score of 0 or 1 increased over time, from 42.9% at Week 1 to 61.9% at Week 2, and thereafter ranged from 47.6% to 76.2% after Week 4. The mean BSA decreased over time from 13.5% at baseline to 8.6% at Week 1 and 4.0% at Week 2, and thereafter ranged from 2.7% to 5.2% after Week 4. The proportion of participants with a pruritus score of 0 or 1 was 27.3% at baseline, 47.6% at Week 2, and 66.7% at Week 4, and thereafter ranged from 42.9% to 52.4% after Week 12, remaining above baseline throughout the study period. The proportion of participants with an improvement of >=4 points from baseline in the total POEM score was 63.2% at Week 4 and remained above 50%, ranging from 50.0% to 66.7%, after Week 12. The mean change from baseline in the total DFI score was -0.4 at Week 4 and thereafter ranged from -1.1 to -0.7 after Week 12. The proportion of participants with an IDQOL dermatitis severity score of 0 or 1 was 4.5% at baseline and thereafter ranged from 42.9% to 66.7% after Week 4, remaining above baseline throughout the study period. In addition, the mean change from baseline in the total IDQOL quality-of-life index score was -1.4 at Week 4 and thereafter ranged from -1.4 to -1.0 after Week 12. Blood tacrolimus concentrations were below the limit of quantification (< 0.500 ng/mL) in all participants at all time points.

Tacrolimus ointment 0.03% was effective in patients with AD aged >=6 months to <2 years, and its efficacy was maintained during long-term treatment. In addition, no systemic drug accumulation was observed, and the safety profile was acceptable.

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2031230181

Nishiura Tomoyuki

Maruho Co.,Ltd. Kyoto R&D Center

93 chudoji Awatacho, Shimogyo-ku, Kyoto

ctinfo@mii.maruho.co.jp

- Clinical Trials Information

Maruho Co.,Ltd. Kyoto R&D Center

93 chudoji Awatacho, Shimogyo-ku, Kyoto

+81-75-325-3279

ctinfo@mii.maruho.co.jp

Complete

Aug. 01, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

Patients with mild or higher atopic dermatitis aged between 6 months and 2 years.

- medical history and/or concomitant disease of malignancy, serious allegies, allegy to tacrolimus or skin hypersensitivity to topical medicinal products.
- serious complication of any cardiac, hepatic, renal, pulmonary, hematological disorder etc, which is considered inappropriate to participate in the trial by investigators.

Both

Atopic dermatitis

Apply appropiriate amount of the tacrolimus ointment 0.03% once or twice daily to the affected area

EASI

+81-42-648-5551

July. 20, 2023

none