{"id":769065,"date":"2023-07-11T16:54:29","date_gmt":"2023-07-11T20:54:29","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/incyte-announces-positive-topline-results-from-phase-3-trial-evaluating-ruxolitinib-cream-opzelura-in-children-with-atopic-dermatitis\/"},"modified":"2023-07-11T16:54:29","modified_gmt":"2023-07-11T20:54:29","slug":"incyte-announces-positive-topline-results-from-phase-3-trial-evaluating-ruxolitinib-cream-opzelura-in-children-with-atopic-dermatitis","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/incyte-announces-positive-topline-results-from-phase-3-trial-evaluating-ruxolitinib-cream-opzelura-in-children-with-atopic-dermatitis\/","title":{"rendered":"Incyte Announces Positive Topline Results from Phase 3 Trial Evaluating Ruxolitinib Cream (Opzelura\u00ae) in Children with Atopic Dermatitis"},"content":{"rendered":"

<\/p>\n

Incyte Announces Positive Topline Results from Phase 3 Trial Evaluating Ruxolitinib Cream (Opzelura\u00ae<\/sup>) in Children with Atopic Dermatitis<\/b><\/p>\n

Phase 3 TruE-AD3 Study met its primary endpoint<\/i><\/b><\/p>\n

WILMINGTON, Del.–(BUSINESS WIRE<\/a>)–
\nIncyte (Nasdaq:INCY) today announced positive topline results from its randomized, vehicle-controlled, pivotal Phase 3 TRuE-AD3 study evaluating the safety and efficacy of ruxolitinib cream (Opzelura\u00ae<\/sup>) in children (age \u22652 to <12 years) with atopic dermatitis (AD).<\/p>\n

\nThe study met its primary endpoint and showed significantly more patients treated with ruxolitinib cream 0.75% and 1.5% achieved Investigator\u2019s Global Assessment Treatment Success (IGA-TS) than patients treated with vehicle control (non-medicated cream). Investigator\u2019s Global Assessment Treatment Success (IGA-TS) is defined as an IGA score of 0 (clear) or 1 (almost clear) with at least a two-point improvement from baseline at Week 8. The overall 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.<\/p>\n

\n“AD is a chronic, immune-mediated skin condition that affects about 13% of all children in the U.S. It can cause disruptive symptoms like redness, dry skin and intense itch, which can detrimentally impact quality of life and be difficult to manage for both the child and their caregivers,” said Jim Lee, M.D., Group Vice President, Inflammation & AutoImmunity, Incyte. “We have already seen the benefit that ruxolitinib cream can have among adult and adolescent patients with atopic dermatitis in the TRuE-AD1 and TRuE-AD2 studies, and this new positive data reinforces the potential of ruxolitinib cream to offer children a much-needed effective, non-steroidal topical therapy. We look forward to discussing these data with regulatory agencies to determine next steps.”<\/p>\n

\nData from TRuE-AD3 will be submitted for presentation at an upcoming scientific meeting.<\/p>\n

\nAD \u2013 the most common type of eczema \u2013 is a chronic skin disease, which in the U.S. affects an estimated 2-3 million patients ages 2-11 and more than 21 million people 12 years and older1,2<\/sup>. It is characterized by inflammation and itch. Signs and symptoms include irritated and itchy skin that can cause red lesions that may ooze and crust. People with AD are also more susceptible to bacterial, viral and fungal infections3<\/sup>.<\/p>\n

About TRuE-AD3
\n
<\/b>TRuE-AD3 (NCT04921969) is a randomized, double-blind, vehicle-controlled Phase 3 study evaluating the safety and efficacy of ruxolitinib cream compared to vehicle (non-medicated cream) in children with atopic dermatitis (AD). The study enrolled over 300 patients (age \u22652 to <12 years) diagnosed with AD for at least 3 months and who were candidates for topical therapy.<\/p>\n

\nPatients with an Investigator\u2019s Global Assessment (IGA) score of 2 to 3 (a measure of disease severity), and with AD on 3% to 20% of their Body Surface Area (BSA; excluding scalp) were randomized 2:2:1 to receive ruxolitinib cream 0.75% administered twice daily (BID); ruxolitinib cream 1.5% BID; or vehicle (non-medicated cream) BID. Participants who successfully completed an efficacy assessment at Week 8 were offered participation in the 44-week long-term safety treatment extension period with their same treatment group (ruxolitinib cream 0.75% or 1.5% BID). Participants initially randomized to vehicle cream were re-randomized (1:1) in a blinded manner to one of the active treatment group.<\/p>\n

\nThe primary endpoint of TRuE-AD3 is the proportion of participants achieving an Investigator\u2019s 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. Secondary endpoints include: the proportion of patients achieving at least a 75% improvement from baseline in the Eczema Area and Severity Index (EASI75) score \u2013 another measurement of disease extent and severity \u2013 and the proportion of participants with at least a 4-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.<\/p>\n

\nFor more information about the study, please visit https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04921969<\/a>.<\/p>\n

About Opzelura\u00ae<\/sup> (ruxolitinib) Cream 1.5%
\n
<\/b>Opzelura, a novel cream formulation of Incyte\u2019s selective JAK1\/JAK2 inhibitor ruxolitinib, approved by the U.S. Food & Drug Administration for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older, is the first and only treatment for repigmentation approved for use in the United States. Opzelura is also approved in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended.<\/p>\n

\nIn Europe, Opzelura (ruxolitinib) cream 15mg\/g is approved for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.<\/p>\n

\nIncyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States and Europe as Opzelura.<\/p>\n

\nOpzelura and the Opzelura logo are registered trademarks of Incyte.<\/p>\n

IMPORTANT SAFETY INFORMATION<\/b><\/p>\n

\nOPZELURA is for use on the skin only. Do not use OPZELURA in your eyes, mouth, or vagina.<\/p>\n

OPZELURA may cause serious side effects, including:<\/b><\/p>\n

Serious Infections: <\/b>OPZELURA contains ruxolitinib. Ruxolitinib belongs to a class of medicines called Janus kinase (JAK) inhibitors. JAK inhibitors are medicines that affect your immune system. JAK inhibitors can lower the ability of your immune system to fight infections. Some people have had serious infections while taking JAK inhibitors by mouth, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have been hospitalized or died from these infections. Some people have had serious infections of their lungs while taking OPZELURA. Your healthcare provider should watch you closely for signs and symptoms of TB during treatment with OPZELURA.<\/p>\n

\nOPZELURA should not be used in people with an active, serious infection, including localized infections. You should not start using OPZELURA if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster) while using OPZELURA.<\/p>\n

Increased risk of death due to any reason (all causes): <\/b>Increased risk of death has happened in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking a medicine in the class of medicines called JAK inhibitors by mouth.<\/p>\n

Cancer and immune system problems: <\/b>OPZELURA may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers have happened in people taking a medicine in the class of medicines called JAK inhibitors by mouth. People taking JAK inhibitors by mouth have a higher risk of certain cancers including lymphoma and lung cancer, especially if they are a current or past smoker. Some people have had skin cancers while using OPZELURA. Your healthcare provider will regularly check your skin during your treatment with OPZELURA. Limit the amount of time you spend in the sunlight. Wear protective clothing when you are in the sun and use a broad-spectrum sunscreen.<\/p>\n

Increased risk of major cardiovascular events: <\/b>Increased risk of major cardiovascular events such as heart attack, stroke, or death have happened in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and taking a medicine in the class of medicines called JAK inhibitors by mouth, especially in current or past smokers.<\/p>\n

Blood clots: <\/b>Blood clots in the veins of your legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE) can happen in some people taking OPZELURA. This may be life-threatening. Blood clots in the vein of the legs (deep vein thrombosis, DVT) and lungs (pulmonary embolism, PE) have happened more often in people who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking a medicine in the class of medicines called JAK inhibitors by mouth.<\/p>\n

Low blood cell counts: <\/b>OPZELURA may cause low platelet counts (thrombocytopenia), low red blood cell counts (anemia), and low white blood cell counts (neutropenia). If needed, your healthcare provider will do a blood test to check your blood cell counts during your treatment with OPZELURA and may stop your treatment if signs or symptoms of low blood cell counts happen.<\/p>\n

Cholesterol increases: <\/b>Cholesterol increase has happened in people when ruxolitinib is taken by mouth. Tell your healthcare provider if you have high cholesterol or triglycerides.<\/p>\n

Before starting OPZELURA, tell your healthcare provider if you:<\/b><\/p>\n