Incyte Announces Full Results From Phase 3 TRuE-V Program Evaluating Ruxolitinib Cream (Opzelura™) in Patients With Vitiligo
Incyte (Nasdaq:INCY) today announced the full 24-week results from its pivotal Phase 3 TRuE-V clinical trial program investigating ruxolitinib cream (Opzelura™), a topical JAK inhibitor, in adolescent and adult patients (age ≥12 years) with nonsegmental vitiligo. These data will be presented today as a late-breaking oral presentation (Abstract #D3T01.2A) at the European Academy of Dermatology and Venereology (EADV) 30th Congress, held virtually from September 29-October 2, 2021.
Building on the previously announced positive topline results from the TRuE-V program, findings from the Week 24 analysis showed treatment with 1.5% ruxolitinib cream twice daily (BID) resulted in greater improvement to vehicle for the primary and all key secondary endpoints in both the TRuE-V1 and TRuE-V2 studies. Results, which were consistent across both studies, showed:
- At Week 24, 29.9% of patients applying ruxolitinib cream achieved ≥75% improvement from baseline in the facial Vitiligo Area Scoring Index (F-VASI75), the primary endpoint.
- More than 51% of patients applying ruxolitinib cream achieved ≥50% improvement from baseline in F-VASI (F-VASI50), and more than 15% of patients applying ruxolitinib cream achieved ≥90% improvement from baseline in F-VASI (F-VASI90), key secondary endpoints.
- Additional key secondary endpoints were met, including a significantly greater proportion of patients achieving ≥50% improvement from baseline in total body Vitiligo Area Scoring Index (T-VASI50) and a Vitiligo Noticeability Scale (VNS) response with application of ruxolitinib cream compared to vehicle, and a significant improvement on percentage change from baseline in facial body surface area (F-BSA) with application of ruxolitinib cream compared to vehicle.
“We are pleased to share the full 24-week results from our pivotal Phase 3 TRuE-V program for the first time with the global dermatology community at EADV, which resulted in significant improvements in facial and total body repigmentation in vitiligo patients treated with ruxolitinib cream,” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & Autoimmunity, Incyte. “These positive results reinforce the potential for ruxolitinib cream as a meaningful treatment option for people suffering from vitiligo, and we look forward to working with regulators to bring the first approved medical treatment that directly addresses repigmentation to patients in the U.S. and Europe.”
The overall safety profile of ruxolitinib cream in vitiligo was consistent with previous study data. In the TRuE-V studies, patients using ruxolitinib cream did not report clinically significant application site reactions. Treatment-emergent adverse events were consistent with previous studies, with no serious treatment-related adverse events reported.
“The skin depigmentation associated with vitiligo can have a profound impact on a person’s life and patients are in need of additional treatment options,” said David Rosmarin, M.D., Vice Chair of Research and Education, Dermatology Department at Tufts Medical Center. “I am extremely encouraged about the potential of ruxolitinib cream, as evidenced by the clinically meaningful improvements in repigmentation shown in the pivotal trials, and the potential benefits it may bring for my patients.”
As previously disclosed, based on these findings Incyte expects to submit marketing applications for ruxolitinib cream for the treatment of adolescent and adult patients with vitiligo (age ≥12 years) to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) before the end of 2021. In September 2021, Opzelura™ (ruxolitinib) cream was approved by the FDA for the short-term and non-continuous 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.
Vitiligo is a chronic autoimmune disease characterized by depigmentation of skin that results from the loss of pigment-producing cells known as melanocytes. Over-activity of the JAK signaling pathway has been shown to drive inflammation involved in the pathogenesis and progression of vitiligo. It affects approximately 0.5% to 2.0% of the population globally1 and there are no U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA)-approved drug therapies for the treatment of vitiligo. It can occur at any age, although many patients with vitiligo will experience initial symptoms before the age of 202.
The TRuE-V clinical trial program includes two Phase 3 studies, TRuE-V1 (NCT04052425) and TRuE-V2 (NCT04057573), evaluating the safety and efficacy of ruxolitinib cream in patients with vitiligo.
The studies each enrolled approximately 300 patients (age ≥12 years) who have been diagnosed with non-segmental vitiligo and have depigmented areas including at least 0.5% of the body surface area (BSA) on the face, ≥0.5 facial Vitiligo Area Scoring Index [F-VASI] score, at least 3% BSA on nonfacial areas, ≥3 total body Vitiligo Area Scoring Index [T-VASI] score and total BSA involvement (facial and nonfacial) of up to 10%. Participants were randomized into two arms: 1.5% ruxolitinib cream twice daily (BID) and vehicle control for the 24-week double-blind period. Patients who successfully completed baseline and Week 24 assessments, including those that received vehicle control during the double-blind phase, were offered treatment extension with 1.5% ruxolitinib cream BID for an additional 28 weeks.
The primary endpoint of both studies in the TRuE-V program is the proportion of patients achieving F-VASI75, defined as at least a 75% improvement from baseline in the F-VASI score at Week 24. Key secondary endpoints include: the percentage change from baseline in facial BSA (F-BSA) at Week 24, the proportion of patients achieving F-VASI50 (at least 50% improvement from baseline in the F-VASI), F-VASI90 (at least 90% improvement from baseline in the F-VASI) and T-VASI50 (at least 50% improvement from baseline in the T-VASI) at Week 24, the proportion of patients achieving F-VASI75, F-VASI90, T-VASI50 and T-VASI75 (at least 75% improvement from baseline in the T-VASI) at Week 52 and the proportion of patients achieving a Vitiligo Noticeability Scale (VNS) score of 4 (a lot less noticeable) or 5 (no longer noticeable) at Week 24. The studies also track the frequency, duration and severity of adverse events associated with the use of ruxolitinib cream.
About Opzelura™ (ruxolitinib) Cream
Opzelura, a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, is the first and only topical JAK inhibitor approved for use in the United States 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.
Additionally, ruxolitinib cream is in Phase 3 development for the treatment of adolescents and adults with vitiligo in the TRuE-V clinical program. Results from this Phase 3 program were recently announced.
Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States as Opzelura.
Opzelura is a trademark of Incyte.
IMPORTANT SAFETY INFORMATION
OPZELURA cream is for use on the skin only. Do not use OPZELURA cream, in your eyes, mouth or vagina.
OPZELURA may cause serious side effects, including:
Serious Infections: OPZELURA cream 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.
OPZELURA 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.
Increased risk of death from all causes, including sudden cardiac death, has happened in people taking JAK inhibitors by mouth.
Cancer and immune system problems: OPZELURA may increase your risk of certain cancers by changing the way your immune system works. Some people have had lymphoma and other cancers while taking JAK inhibitors by mouth, especially if they are a current or past smoker. Some people have had skin cancers while taking OPZELURA. Your healthcare provider will regularly check your skin during your treatment with OPZELURA.
There is an increased risk of major cardiovascular events such as heart attack, stroke or cardiac death in people with cardiovascular risk factors and who are current or past smokers while using JAK inhibitors to treat inflammatory conditions.
Blood clots: 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.
Low blood cell counts: 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.
Cholesterol increases: Cholesterol increase has happened in people when ruxolitinib is taken by mouth. Tell your healthcare provider if you have high cholesterol or triglycerides.
Before starting OPZELURA, tell your healthcare provider if you:
- have an infection, are being treated for one, or have an infection that keeps coming back
- have diabetes, chronic lung disease, HIV, or a weak immune system
- have or had TB, or have been in close contact with someone with TB
- have had shingles (herpes zoster) or hepatitis B or C
- live, have lived in, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections. These infections may happen or become more severe if you use OPZELURA. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common.
think you have an infection or have symptoms of an infection such as:
- fever, sweating, or chills
- muscle aches
- cough or shortness of breath
- blood in your phlegm
- weight loss
- warm, red, or painful skin or sores on your body
- diarrhea or stomach pain
- burning when you urinate or urinating more often than usual
- feeling very tired
- have ever had any type of cancer, or are a current or past smoker
- have had blood clots in the veins of your legs or lungs in the past
- have high cholesterol or triglycerides
- have or have had low white or red blood cell counts
- are pregnant or plan to become pregnant. It is not known if OPZELURA will harm your unborn baby. There is a pregnancy exposure registry for individuals who use OPZELURA during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. If you become exposed to OPZELURA during pregnancy, you and your healthcare provider should report exposure to Incyte Corporation at 1-855-463-3463.
- are breastfeeding or plan to breastfeed. It is not known if OPZELURA passes into your breast milk. Do not breastfeed during treatment with OPZELURA and for about 4 weeks after the last dose.
After starting OPZELURA:
- Call your healthcare provider right away if you have any symptoms of an infection. OPZELURA can make you more likely to get infections or make worse any infections that you have.
Get emergency help right away if you have any symptoms of a heart attack or stroke while using OPZELURA, including:
- discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
- severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
- pain or discomfort in your arms, back, neck, jaw, or stomach
- shortness of breath with or without chest discomfort
- breaking out in a cold sweat
- nausea or vomiting
- feeling lightheaded
- weakness in one part or on one side of your body
- slurred speech
- Tell your healthcare provider right away if you have any signs and symptoms of blood clots during treatment with OPZELURA, including: swelling, pain or tenderness in one or both legs, sudden, unexplained chest or upper back pain, or shortness of breath or difficulty breathing.
- Tell your healthcare provider right away if you develop or have worsening of any symptoms of low blood cell counts, such as: unusual bleeding, bruising, tiredness, shortness of breath or fever.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of OPZELURA include: pain or swelling in your nose or throat (nasopharyngitis), diarrhea, bronchitis, ear infection, increase in a type of white blood cell (eosinophil) count, hives, inflamed hair pores (folliculitis), swelling of the tonsils (tonsillitis), and runny nose (rhinorrhea).
These are not all of the possible side effects of OPZELURA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Incyte Corporation at 1-855-463-3463.
About Incyte Dermatology
Incyte’s science-first approach and expertise in immunology has formed the foundation of the company. In Dermatology, the Company’s research and development efforts are focused on leveraging our knowledge of the JAK-STAT pathway to identify and develop topical and oral therapies with the potential to modulate immune pathways driving uncontrolled inflammation and help restore normal immune function.
Currently, Incyte is exploring the potential of JAK inhibition for a number of immune-mediated dermatologic conditions with a high unmet medical need, including vitiligo and hidradenitis suppurativa. To learn more, visit the Dermatology section of Incyte.com.
Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.
Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding Incyte’s TRuE-V clinical program, whether and when ruxolitinib cream might be approved to treat patients with vitiligo , the potential for success of such treatment, Incyte’s expectations with respect to submitting marketing applications for ruxolitinib cream for the treatment of adolescent and adult patients with vitiligo to regulators and Incyte’s Dermatology program generally, contain predictions, estimates and other forward-looking statements.
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; the effects of the COVID-19 pandemic and measures to address the pandemic on the Company’s clinical trials, supply chain, other third-party providers and development and discovery operations; determinations made by the FDA, EMA and other regulatory authorities; the efficacy or safety of the Company’s products; the acceptance of the Company’s products in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission, including its annual report and its quarterly report on Form 10-Q for the quarter ended June 30, 2021. The Company disclaims any intent or obligation to update these forward-looking statements.
1 Kruger C. A review of the worldwide prevalence of vitiligo in children/adolescents and adults. Int J Dermatol. 2012;51(10):1206-1212.
2 Rodrigues M. New Discoveries in the pathogenesis and classification of vitiligo. J Am Acad Dermatol. 2017; 77:1-13.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
+1 302 498 6171
+1 302 274 4324
+1 302 274 4773
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
The Spotlight on Iceland’s Capital City Shines Even Brighter With the Arrival of The Reykjavik EDITION21.10.2021 18:30:00 EEST | Press release
A flourishing culinary hotspot with cool cafés, a rollicking nightlife and an epic music scene, the spotlight is shining brightly on Iceland’s hip capital city and, with typical finesse, the arrival of The Reykjavik EDITION further cements EDITION Hotels' uncanny ability to land in just the right place at the right time. “Reykjavik is a really cool, young city -perfect for our brand,” says Ian Schrager, the visionary pioneer of the boutique hotel concept, PUBLIC and EDITION creator. “We think this is Reykjavik’s time and we’re right here at the very heart of it and at the perfect time.” This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211021005764/en/ The Reykjavik EDITION (Photo: Business Wire) Opening in preview on November 9th, 2021, The Reykjavik EDITION will set a new standard as the city’s first truly luxury hotel experience, combining the best of the Icelandic capital with the personal, intimate and individual experienc
MediaTek Selected to Power Vewd for Automotive Platform21.10.2021 17:41:00 EEST | Press release
Vewd, the leading provider of OTT software solutions, today announced that MediaTek’s Autus I20 (MT2712) chipset was selected as the first reference platform to power Vewd for Automotive, a white-labeled, cloud-managed content aggregation and monetization solution for in-vehicle infotainment equipment providers and car manufacturers. MediaTek’s customer base, streaming ecosystem partnerships, and strong technical capabilities make it the strongest supplier to meet the needs of car manufacturers. Together, Vewd and MediaTek will target Strategy Analytics’ estimated 70 million connected cars on the road by 2025. Vewd for Automotive solves key rear-seat content challenges facing manufacturers through a turnkey solution ready for deployment. For manufacturers, content in the car represents an increasing consumer demand, along with the demand for connectivity that provides additional after-sale branding and revenue opportunities. By partnering with content providers, manufacturers can enabl
Biognosys to Present Major Scientific and Technological Advances at the ASMS 2021 Mass Spectrometry Conference21.10.2021 17:00:00 EEST | Press release
Biognosys, a leading inventor and developer of mass spectrometry-based proteomics solutions, today announced they will be presenting major scientific and technological advances on their proprietary proteomics research services, software, and kits at the American Society for Mass Spectrometry (ASMS) Annual Conference from October 31st to November 4th in Philadelphia (USA). Biognosys will present a record number of 3 oral presentations, 10 scientific posters, 2 poster collaborations, 1 workshop panel, and 2 Spectronaut™ breakfast seminars. In addition, their team of scientific experts will be present at booth #224 to answer questions and demo software. Further demo sessions will be offered at the Bruker Daltonics booth #719. Collectively, this presence demonstrates Biognosys’ significant contributions to transforming life science and clinical research with next-generation proteomics, particularly in the areas of plasma proteomics, immunopeptidomics, and proteomics data analysis. Lukas Re
SHV Energy Implements Global Remote LPG Tank Monitoring With Sigfox Netherlands’ 0G Network and Reduces Carbon Emissions21.10.2021 17:00:00 EEST | Press release
SHV Energy and Sigfox are rolling out a global LPG tank level monitoring solution. The implementation has started in France, Belgium and Germany and is already generating lower carbon emissions and improved customer satisfaction. Over the next three years, 50,000 units will be rolled out worldwide. Sigfox’s IoT (Internet of Things) asset monitoring capability enables SHV Energy to reduce the cost of tank level monitoring, while increasing efficiency and productivity. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211021005065/en/ SHV Energy LPG tank (Photo: Sigfox) SHV Energy, a leading global distributor of off-grid energy such as LPG, LNG, biofuels and renewables, with 30 million customers in 25 countries and 16,700 employees, selected to work with Sigfox, a world’s leading IoT communication service provider and 0G network pioneer. SHV Energy set-up a Telemetry Centre of Excellence and used Sigfox’ solutions and partner At
SSZN Selects Newsight's NSI1000 Chip for Its Advanced Industry 4.0 Production Line Sensors21.10.2021 16:50:00 EEST | Press release
Newsight Imaging Ltd., an innovative semiconductor company developing machine vision sensors, spectral vision chips and systems, announces a commercial agreement with SSZN. SSZN is a leader in developing smart industry 4.0 solutions for supporting automated production line supervision. Newsight will provide SSZN with the NSI1000 - its new and advanced sensor chip. The deal follows a successful design-win where SSZN conducted an evaluation using the NSI1000 chip, closely supported by Newsight's engineering teams in Israel and Shenzhen. The first order of 100,000 chips will be supplied in the upcoming months. The NSI1000 CMOS Image sensor chip, launched by Newsight last year, consists of 32 lines of 1024 pixels and it supports multiple modes, such as multi-triangulation for state-of-the-art accuracy and fast operation on production line inspection. The sensor implements Newsight's enhanced Time of Flight (eTOF™) technology for advanced, long-range, and high-resolution 3D depth image capt
Esper and Lenovo Collaborate on Android Device Deployment in Enterprises21.10.2021 16:05:00 EEST | Press release
DevOps for Devices leader Esper and Lenovo™ are teaming up to place Esper software on key models of Lenovo Android tablets and other intelligent business devices. This collaboration allows enterprises that manage large fleets of devices to focus on their critical line-of-business applications, leaving the device infrastructure and management tasks to Lenovo and Esper’s joint solution. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211021005372/en/ Lenovo K10 Tablet (Photo: Business Wire) As the fastest-growing tablet maker (YoY) last quarter1, Lenovo’s expertise in smarter device design, engineering and user experiences combines with Esper’s modern, DevOps-powered device infrastructure software that lets organizations of every size and segment (e.g. healthcare, retail, hospitality), easily set up, manage, better secure, and maintain large fleets of devices on their journey to digital transformation. “With proprietary feature
Finalist Teams Selected in $10M ANA Avatar XPRIZE Competition21.10.2021 16:00:00 EEST | Press release
XPRIZE, the world’s leader in designing and operating incentive competitions to solve humanity’s grand challenges, announced today that 15 teams from 8 countries are advancing to the finals round of the $10M ANA Avatar XPRIZE competition. Sponsored by All Nippon Airways (ANA), Japan’s largest airline, the Avatar XPRIZE is a four-year global competition focused on the development of an avatar system that will deploy a human’s senses, actions, and presence to a remote location in real time, leading to a more connected world. In the future, avatars could help provide critical care and deploy immediate responses in emergency situations, or offer opportunities for exploration and new ways of collaboration, stretching the boundaries of what is possible and maximizing the impact of skill and knowledge sharing. These avatars must demonstrate the ability to execute tasks across a variety of real-world scenarios and convey a sense of presence for both the operator and the recipient in those inte
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom