Primary and secondary endpoints met in both TRuE-AD1 and TRuE-AD2 trials for ruxolitinib cream to treat atopic dermatitis.- Incyte

Incyte announced that the second randomized, vehicle-controlled, pivotal Phase III study from the TRuE-AD clinical trial program has met its primary endpoint . Building on the previously-reported positive topline results from TRuE-AD2, the results of TRuE-AD1 also show that significantly more patients treated with ruxolitinib cream 0.75% or 1.5% achieved Investigator’s Global Assessment Treatment Success (IGA-TS) – defined as an IGA score of 0 (clear) or 1 (almost clear) with at least a two-point improvement from baseline at Week 8 – than patients treated with vehicle control (non-medicated cream). The overall efficacy and safety profile of ruxolitinib cream was consistent with previous data, and no new safety signals were observed. The TRuE-AD1 and TRuE-AD2 trials both evaluated the safety and efficacy of ruxolitinib cream in adolescent and adult patients (age greater than 12 years) with mild-to-moderate atopic dermatitis (AD). The long-term safety portion of both studies will continue as planned. Additionally, data from both studies will be further analyzed and submitted for publication and presentation at an upcoming scientific meeting. Key Findings from TRuE-AD1 and TRuE-AD2 : Almost 1,250 patients (aged greater than 12 years) diagnosed with AD for at least two years and who are candidates for topical therapy were enrolled in the identically-designed TRuE-AD1 and TRuE-AD2 trials. Patients with an Investigator’s Global Assessment (IGA) score of 2 to 3, and with AD on 3% to 20% of their Body Surface Area (BSA) (excluding scalp) were randomized 2:2:1 into one of three treatment arms for eight weeks, including: ruxolitinib cream 0.75% administered twice daily (BID); ruxolitinib cream 1.5% BID; and vehicle (non-medicated cream).The primary endpoint of both TRuE-AD1 and TRuE-AD2 was IGA-TS at week 8. Secondary endpoints in both trials included the proportion of participants who achieved a greater than 75% improvement in Eczema Area and Severity Index (EASI75) score at week 8 and the proportion of participants with a greater than 4-point improvement in Itch Numerical Rating Scale (NRS4) score at week 8. Key efficacy results include: TRuE-AD1 : 50.0% of patients treated with ruxolitinib cream 0.75% BID and 53.8% of patients treated with ruxolitinib cream 1.5% BID achieved IGA-TS, compared to 15.1% treated with vehicle control (p < 0.0001 and p < 0.0001, respectively). 56.0% of patients treated with ruxolitinib cream 0.75% BID and 62.1% of patients treated with ruxolitinib cream 1.5% BID achieved at least a 75% improvement in their EASI score from baseline, compared to 24.6% treated with vehicle control (p < 0.0001 and p < 0.0001, respectively). TRuE-AD2 : 39.0% of patients treated with ruxolitinib cream 0.75% BID and 51.3% of patients treated with ruxolitinib cream 1.5% BID achieved IGA-TS, compared to 7.6% treated with vehicle control (p < 0.0001 and p < 0.0001, respectively). 51.5% of patients treated with ruxolitinib cream 0.75% BID and 61.8% of patients treated with ruxolitinib cream 1.5% BID achieved at least a 75% improvement in their EASI score from baseline, compared to 14.4% treated with vehicle control (p < 0.0001 and p < 0.0001, respectively). In addition, a statistically-significant difference in itch reduction as measured by the NRS4 was observed for both dose strengths compared to vehicle control in both TRuE-AD1 and TRuE-AD2. In both TRuE-AD1 and TRuE-AD2 after 8 weeks of treatment, the overall rate of treatment emergent adverse events was comparable between the ruxolitinib cream 0.75% BID, ruxolitinib cream 1.5% BID and vehicle control groups (29.4%, 26.3% and 33.6%, respectively). The rate of serious adverse events was 0.8% and 0.6% for ruxolitinib cream 0.75% BID and 1.5% BID, respectively, and 0.8% for vehicle control. Long-term safety is currently being evaluated in the 44-week extension period of both studies. About TRuE-A : The TRuE-AD clinical trial program consists of two randomized, double-blind, dose-ranging, vehicle-controlled Phase III studies, TRuE-AD1 (NCT03745638) and TRuE-AD2 (NCT03745651), evaluating the safety and efficacy of ruxolitinib cream compared to vehicle (non-medicated cream) in patients with atopic dermatitis (AD). Both studies enrolled more than 600 patients (age greater than 12 years) diagnosed with AD for at least two years and who were candidates for topical therapy. Patients with an Investigator’s Global Assessment (IGA) score of 2 to 3, and with AD on 3% to 20% of their Body Surface Area (BSA) (excluding scalp) were randomized 2:2:1 into one of three treatment arms for eight weeks, including: ruxolitinib cream 0.75% administered twice daily (BID); ruxolitinib cream 1.5% BID; and vehicle (non-medicated cream). Participants who successfully completed an assessment at Week 8 were offered participation in the 44-week long-term safety treatment extension period with ruxolitinib cream 0.75% or 1.5% BID. The primary endpoint of the TRuE-AD studies was the proportion of participants achieving an Investigator’s Global Assessment Treatment Success (IGA-TS), defined as an IGA score of 0 (clear) or 1 (almost clear) with at least a 2-point improvement from baseline at Week 8. Other key secondary endpoints include: the proportion of patients achieving at least a 75% improvement from baseline in the Eczema Area and Severity Index (EASI75) score – another measurement of the extent and severity of AD, and the proportion of participants with at least a four-point improvement in the itch numerical rating scale (NRS). The studies have also been tracking the frequency, duration and severity of adverse events associated with the use of ruxolitinib cream.