Incyte Announces that the TRuE-AD2 Pivotal Trial of Ruxolitinib Cream Met its Primary Endpoint in Patients with Atopic Dermatitis
The study, part of the TRuE-AD clinical trial program, met its primary endpoint. Significantly more patients treated with ruxolitinib cream 0.75% and 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 is consistent with previous data, and no new safety signals were observed. The long-term safety portion of the study will continue as planned.
"This positive topline result reinforces the potential of ruxolitinib cream, if approved, to offer AD patients a much-needed effective, non-steroidal therapy," said
Data from TRuE-AD2 will be submitted for presentation at an upcoming scientific meeting.
AD is a common chronic disease characterized by inflammation of the skin. At least 11 million people in
TRuE-AD2 (NCT03745651) is an
Patients with an Investigator’s Global Assessment (IGA) score of 2 to 3 (a measure of disease severity), and with AD involving between 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 TRuE-AD2 is 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 two-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 (EASI) score – another measurement of disease extent and severity – or EASI75, and the proportion of participants with at least a four-point improvement in the itch numerical rating scale (NRS). The study is also tracking the frequency, duration and severity of adverse events associated with the use of ruxolitinib cream.
For more information about the study, please visit http://clinicaltrials.gov/ct2/show/NCT03745651.
The TRuE-AD clinical trial program is evaluating ruxolitinib cream in patients with atopic dermatitis (AD) and includes two Phase 3 studies: TRuE-AD1 (NCT03745638) and TRuE-AD2 (NCT03745651). The TRuE-AD1 trial is ongoing with initial results expected in the first quarter of 2020. For more information about TRuE-AD1, please visit http://clinicaltrials.gov/ct2/show/NCT03745638.
About Ruxolitinib Cream
Ruxolitinib cream is a proprietary formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib that has been designed for topical application. Ruxolitinib cream is currently in Phase 3 development for the treatment of patients with mild to moderate atopic dermatitis (TRuE-AD) and for the treatment of adolescents and adults with vitiligo (TRuE-V).
Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the potential of ruxolitinib cream to become a first line treatment for patients with atopic dermatitis, the planned submission of the TRuE-AD data to the U.S.
These forward-looking statements are based on the Company’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the
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