Phase 3 TruE-AD3 Study met its primary
endpoint
Incyte (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®) in children (age ≥2 to <12 years) with atopic
dermatitis (AD).
The study met its primary endpoint and showed significantly more
patients treated with ruxolitinib cream 0.75% and 1.5% achieved
Investigator’s Global Assessment Treatment Success (IGA-TS) than
patients treated with vehicle control (non-medicated cream).
Investigator’s 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.
"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."
Data from TRuE-AD3 will be submitted for presentation at an
upcoming scientific meeting.
AD – the most common type of eczema – 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. 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.
About TRuE-AD3 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 ≥2 to <12 years) diagnosed
with AD for at least 3 months and who were candidates for topical
therapy.
Patients with an Investigator’s 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.
The primary endpoint of TRuE-AD3 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. 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
disease extent and severity – 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.
For more information about the study, please visit
https://clinicaltrials.gov/ct2/show/NCT04921969.
About Opzelura® (ruxolitinib) Cream 1.5% Opzelura, a
novel cream formulation of Incyte’s 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.
In 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.
Incyte has worldwide rights for the development and
commercialization of ruxolitinib cream, marketed in the United
States and Europe as Opzelura.
Opzelura and the Opzelura logo are registered trademarks of
Incyte.
IMPORTANT SAFETY INFORMATION
OPZELURA is for use on the skin only. Do not use OPZELURA in
your eyes, mouth, or vagina.
OPZELURA may cause serious side effects, including:
Serious Infections: 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.
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 due to any reason (all causes):
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.
Cancer and immune system problems: 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.
Increased risk of major cardiovascular events: 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.
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. 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.
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 had an
infection that does not go away or keeps coming back
- have diabetes, chronic lung disease, HIV, or a weak immune
system
- have TB or have been in close contact with someone with TB
- have had shingles (herpes zoster)
- have or have had 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 a heart attack, other heart problems, or a stroke
- 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 in people treated
for atopic dermatitis include: common cold (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).
The most common side effects of OPZELURA in people treated
for nonsegmental vitiligo include: acne at the application
site, itching at the application site, common cold
(nasopharyngitis), headache, urinary tract infection, redness at
the application site, and fever.
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.
Please see the Full Prescribing Information, including Boxed
Warning, and Medication Guide for OPZELURA.
INDICATIONS AND USAGE
OPZELURA is a prescription medicine used on the skin (topical)
for:
- short-term and non-continuous chronic treatment of mild to
moderate eczema (atopic dermatitis) in non-immunocompromised adults
and children 12 years of age and older whose disease is not well
controlled with topical prescription therapies or when those
therapies are not recommended
- the treatment of a type of vitiligo called nonsegmental
vitiligo in adults and children 12 years of age and older
The use of OPZELURA along with therapeutic biologics, other JAK
inhibitors, or strong immunosuppressants such as azathioprine or
cyclosporine is not recommended. It is not known if OPZELURA is
safe and effective in children less than 12 years of age with
atopic dermatitis or nonsegmental vitiligo.
About Incyte Dermatology Incyte’s science-first approach
and expertise in immunology has formed the foundation of the
company. Today, we are building on this legacy as we discover and
develop innovative dermatology treatments to bring solutions to
patients in need.
Our research and development efforts in dermatology are
initially focused on leveraging our knowledge of the JAK-STAT
pathway. We are exploring the potential of JAK inhibition for a
number of immune-mediated dermatologic conditions with a high unmet
medical need, including atopic dermatitis, vitiligo, hidradenitis
suppurativa, lichen planus, lichen sclerosus and prurigo
nodularis.
To learn more, visit the Dermatology section of Incyte.com.
About Incyte 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.
Forward-Looking Statements Except for the historical
information set forth herein, the matters set forth in this press
release, including statements regarding the TRuE-AD3 trial and the
potential for Opzelura to become a treatment option for children
with AD, contain predictions, estimates and other forward-looking
statements.
These forward-looking statements are based on Incyte’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 U.S. FDA and other regulatory
authorities outside of the United States; the efficacy or safety of
Incyte and its partners’ products; the acceptance of Incyte and its
partners’ products in the marketplace; market competition; sales,
marketing, manufacturing and distribution requirements; and other
risks detailed from time to time in Incyte’s reports filed with the
Securities and Exchange Commission, including its annual report for
the year ended December 31, 2022. Incyte disclaims any intent or
obligation to update these forward-looking statements.
1 U.S. Census Bureau (2020). 2020 Decennial Census. Retrieved
from
https://data.census.gov/cedsci/table?q=Populations%20and%20People&tid=DECENNIALPL2020.P1
[data.census.gov]. 2 Data on file. 3 Boguniewicz M, et al. Ann
Allergy Asthma Immunol. 2018;120(1):10-22.
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Media Catalina Loveman +1 302 498 6171
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Investors Greg Shertzer +1 302 498 4779
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