Incyte Announces First Patient Treated in Phase 3 Clinical Trial Program for Ruxolitinib Cream in Atopic Dermatitis
- Category: Small Molecules
- Published on Friday, 21 December 2018 14:46
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WILMINGTON, DE, USA I December 20, 2018 I Incyte (Nasdaq:INCY) today announced that the first patient has been treated in the Phase 3 TRuE-AD clinical trial program evaluating the long-term safety and efficacy of ruxolitinib cream as monotherapy for adolescent and adult patients (age ≥ 12 years) with atopic dermatitis (AD) who are candidates for topical therapy.
“With the initiation of the Phase 3 program, for ruxolitinib cream, we are moving closer to our goal of providing a safe and effective alternative treatment for adolescent and adult patients living with this chronic, burdensome disease.”
“Atopic dermatitis can have a serious impact on patients’ overall health and quality of life and, unfortunately, the long-term use of prescription topical corticosteroids can lead to significant side effects, underscoring the medical need for new topical therapies to treat this chronic skin disease,” said Steven Stein, M.D., Chief Medical Officer, Incyte. “With the initiation of the Phase 3 program, for ruxolitinib cream, we are moving closer to our goal of providing a safe and effective alternative treatment for adolescent and adult patients living with this chronic, burdensome disease.”
AD is a common chronic disease characterized by inflammation of the skin. At least 11 million people in the United States have been diagnosed with and are being treated for AD. The majority of these patients have a mild or moderate form of the disease and approximately 80 percent are adults or adolescents. Signs and symptoms of AD include irritated and itchy skin that can cause red lesions that may ooze and crust. Patients with AD are also more susceptible to bacterial, viral and fungal infections.
About TRuE- AD
The TRuE-AD clinical trial program includes two Phase 3 studies (NCT03745638 and NCT03745651) evaluating the safety and efficacy of ruxolitinib cream in patients with atopic dermatitis (AD).
The studies will each enroll approximately 600 patients (age ≥ 12 years) who have been diagnosed with AD for at least two years, who have an Investigator’s Global Assessment (IGA) score of 2 to 3, a Body Surface Area (BSA) involvement (excluding scalp) of 3% to 20% and who are candidates for topical therapy. Participants will be randomized 2:2:1 into one of three treatment arms.
The primary endpoint of the TRuE-AD studies 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 2-point improvement from baseline at Week 8. Key secondary endpoints include: the proportion of patients achieving at least a 75 percent improvement from baseline in the Eczema Area and Severity Index (EASI) score – a measurement of the extent and severity of AD – or EASI75, and the proportion of participants with at least a four-point improvement in the itch numerical rating scale (NRS). The studies will also track the frequency, duration and severity of adverse events associated with the use of ruxolitinib cream.
Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit the Company’s website at www.incyte.com.