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EUCRISA Clinical Studies (crisaborole)

14 CLINICAL STUDIES

Two multicenter, randomized, double-blind, parallel-group, vehicle-controlled trials (Trials 1 and 2) treated a total of 1522 subjects 2 to 79 years of age (86.3% of subjects were 2 to 17 years of age) with a 5% to 95% treatable BSA. At baseline, 38.5% of the subjects had an Investigator's Static Global Assessment [ISGA] score of 2 (mild), and 61.5% had an ISGA score of 3 (moderate), in the overall assessment of atopic dermatitis (erythema, induration/papulation, and oozing/crusting) on a severity scale of 0 to 4.

In both trials, subjects were randomized 2:1 to receive EUCRISA or vehicle applied twice daily for 28 days. The primary efficacy endpoint was the proportion of subjects at Day 29 who achieved success, defined as an ISGA grade of Clear (score of 0) or Almost Clear (score of 1) with a 2-grade or greater improvement from baseline, comparing EUCRISA-treated subjects to vehicle-treated subjects.

Efficacy results from the two trials are summarized in Table 2.

Table 2: Primary Efficacy Outcomes in Subjects with Mild to Moderate Atopic Dermatitis at Day 29
Trial 1Trial 2
EUCRISA
(N=503)
Vehicle
(N=256)
EUCRISA
(N=513)
Vehicle
(N=250)
*
Defined as an ISGA score of Clear (0) or Almost Clear (1) with a 2-grade or greater improvement from baseline.
Success in ISGA*32.8%25.4%31.4%18.0%

The success rates over time are presented in Figure 1.

*
Success is defined as an ISGA score of Clear (0) or Almost Clear (1) with a 2-grade or greater improvement from baseline.
Figure 1: Success in ISGA* Over Time in Subjects with Mild to Moderate Atopic Dermatitis
Trial 1Trial 2
Figure 1Figure 1
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