Primary and secondary endpoints met in both
TRuE-AD1 and TRuE-AD2
Incyte (Nasdaq:INCY) today announced that the second randomized,
vehicle-controlled, pivotal Phase 3 study from the TRuE-AD clinical
trial program has met its primary endpoint.
Building on the previously-reported positive topline results
from TRuE-AD2, the results of TRuE-AD1 also show that significantly
more patients treated with ruxolitinib cream 0.75% or 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 was
consistent with previous data, and no new safety signals were
observed.
The TRuE-AD1 and TRuE-AD2 trials both evaluated the safety and
efficacy of ruxolitinib cream in adolescent and adult patients (age
≥ 12 years) with mild-to-moderate atopic dermatitis (AD). The
long-term safety portion of both studies will continue as planned.
Additionally, data from both studies will be further analyzed and
submitted for publication and presentation at an upcoming
scientific meeting.
“The successful outcomes of both the TRuE-AD1 and TRuE-AD2
studies confirm the potential of ruxolitinib cream as an important,
non-steroidal treatment option for the millions of patients
suffering from AD,” said Jim Lee, M.D., Group Vice President,
Inflammation & AutoImmunity, Incyte. “We look forward to
working with regulators as we seek approval of ruxolitinib cream as
the first topical formulation of a JAK inhibitor for patients with
AD.”
Key Findings from TRuE-AD1 and TRuE-AD2
Almost 1,250 patients (age ≥ 12 years) diagnosed with AD for at
least two years and who are candidates for topical therapy were
enrolled in the identically-designed TRuE-AD1 and TRuE-AD2 trials.
Patients with an Investigator’s Global Assessment (IGA) score of 2
to 3, and with AD on 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).
The primary endpoint of both TRuE-AD1 and TRuE-AD2 was IGA-TS at
week 8. Secondary endpoints in both trials included the proportion
of participants who achieved a ≥75% improvement in Eczema Area and
Severity Index (EASI75) score at week 8 and the proportion of
participants with a ≥ 4-point improvement in Itch Numerical Rating
Scale (NRS4) score at week 8. Key efficacy results include:
TRuE-AD1
- 50.0% of patients treated with ruxolitinib cream 0.75% BID and
53.8% of patients treated with ruxolitinib cream 1.5% BID achieved
IGA-TS, compared to 15.1% treated with vehicle control (p <
0.0001 and p < 0.0001, respectively).
- 56.0% of patients treated with ruxolitinib cream 0.75% BID and
62.1% of patients treated with ruxolitinib cream 1.5% BID achieved
at least a 75% improvement in their EASI score from baseline,
compared to 24.6% treated with vehicle control (p < 0.0001 and p
< 0.0001, respectively).
TRuE-AD2
- 39.0% of patients treated with ruxolitinib cream 0.75% BID and
51.3% of patients treated with ruxolitinib cream 1.5% BID achieved
IGA-TS, compared to 7.6% treated with vehicle control (p <
0.0001 and p < 0.0001, respectively).
- 51.5% of patients treated with ruxolitinib cream 0.75% BID and
61.8% of patients treated with ruxolitinib cream 1.5% BID achieved
at least a 75% improvement in their EASI score from baseline,
compared to 14.4% treated with vehicle control (p < 0.0001 and p
< 0.0001, respectively).
In addition, a statistically-significant difference in itch
reduction as measured by the NRS4 was observed for both dose
strengths compared to vehicle control in both TRuE-AD1 and
TRuE-AD2.
In both TRuE-AD1 and TRuE-AD2 after 8 weeks of treatment, the
overall rate of treatment emergent adverse events was comparable
between the ruxolitinib cream 0.75% BID, ruxolitinib cream 1.5% BID
and vehicle control groups (29.4%, 26.3% and 33.6%, respectively).
The rate of serious adverse events was 0.8% and 0.6% for
ruxolitinib cream 0.75% BID and 1.5% BID, respectively, and 0.8%
for vehicle control. Long-term safety is currently being evaluated
in the 44-week extension period of both studies.
About Atopic Dermatitis
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% 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 consists of two randomized,
double-blind, dose-ranging, vehicle-controlled Phase 3 studies,
TRuE-AD1 (NCT03745638) and TRuE-AD2 (NCT03745651), evaluating the
safety and efficacy of ruxolitinib cream compared to vehicle
(non-medicated cream) in patients with atopic dermatitis (AD). Both
studies enrolled more than 600 patients (age ≥ 12 years) diagnosed
with AD for at least two years and who were candidates for topical
therapy.
Patients with an Investigator’s Global Assessment (IGA) score of
2 to 3, and with AD on 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 the TRuE-AD studies was 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. Other key 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 the extent and severity of AD, and the proportion of
participants with at least a four-point improvement in the itch
numerical rating scale (NRS). The studies have also been tracking
the frequency, duration and severity of adverse events associated
with the use of ruxolitinib cream.
For more information about the TRuE-AD studies, please visit
http://clinicaltrials.gov/ct2/show/NCT03745638 and
http://clinicaltrials.gov/ct2/show/NCT03745651.
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). Incyte has worldwide rights for
the development and commercialization of ruxolitinib cream.
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 presentation of data from the Company’s ongoing
clinical development program for ruxolitinib cream, whether and
when the Company will file an NDA for ruxolitinib cream, and
whether ruxolitinib cream will be approved for use in the U.S. or
elsewhere, 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; determinations made by the FDA; the Company’s dependence on
its relationships with its collaboration partners; the efficacy or
safety of the Company’s products and the products of the Company’s
collaboration partners; the acceptance of the Company’s products
and the products of the Company’s collaboration partners in the
marketplace; market competition; sales, marketing, manufacturing
and distribution requirements; greater than expected expenses;
expenses relating to litigation or strategic activities; and other
risks detailed from time to time in the Company’s reports filed
with the Securities and Exchange Commission, including its Form
10-K for the year ended December 31, 2019. The Company disclaims
any intent or obligation to update these forward-looking
statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20200219005204/en/
Media Catalina Loveman +1 302 498 6171
cloveman@incyte.comm
Investors Michael Booth, DPhil +1 302 498 5914
mbooth@incyte.com
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