Psoriatic Plaque Clinical Trial
Official title:
An Observer Partially-blinded, Lesion-randomized, Intra-patient Controlled, 3-arm, Phase I Study to Assess Safety and Efficacy of Laser-assisted Topical Etanercept Administration in Patients With Mild to Moderate Plaque Psoriasis
The purpose of this study is to assess the feasibility and safety of topical administration
of etanercept via AFL micropores to psoriatic plaques in patients with mild to moderate
plaque-type psoriasis.
While a wide variety of therapeutic innovations to treat moderate-to-severe psoriasis
(accounting for around 30% of the cases) become available each year, there are few
innovations for topical therapies to treat mild/localized psoriasis (accounting for around
70% of the cases). Given that only about half of the patients respond adequately to the
current standard of care, the topical application of a fixed combination of calcipotriole
and betamethasone, there is a medical need for better topical therapies.
Etanercept has been used successfully to treat moderate-to-severe plaque-type psoriasis in
children and adults for more than a decade. Its standard route of application is through
subcutaneous injections. Different dosing regimens have been used: 1 x 50 mg or 2 x 50 mg
per week as well as 1 x 25 mg or 2 x 25 mg per week. Under these regimens, etanercept has a
well-established favorable long-term safety record, with injection site reactions (pain,
swelling) the most frequently reported side effects. However, rare but serious side effects
such as serious opportunistic infections resulting from immune system inhibition common to
anti-TNF agents limit its systemic use to these patients. For this reason, a localized
topical alternative route of administration would be desirable. However, the large molecular
size and chemical nature of etanercept prevent it from crossing the epidermal barrier. A CE
certified ablative fractional laser (AFL) device with Er:YAG source will be used to create
micropores in plaques to allow local delivery of etanercept directly into psoriatic plaques.
Monocentric, observer partially-blinded Phase I study.
In this study, three similar plaques on each patient will be prospectively identified by the
blinded observer and then randomized by an unblinded investigator by using the eCRF to one
of the three study treatments:
1. Standard of care (daily administration of Daivobet® by the patient),
2. Ablative fractional laser microporation + topical application of etanercept
3. Ablative fractional laser microporation alone.
Over the treatment period of 8 weeks, patients will return to the clinic twice weekly for
assessment of the three study plaques by the blinded observer, followed by administration of
the treatment of plaques assigned to AFL microporation with or without etanercept. Patients
will treat the remaining plaque with Daivobet® themselves on a daily basis.
Although no incompatibilities of AFL and etanercept are anticipated, because this is the
first time etanercept is administered topically via AFL micropores and using a AFL
microporation device, the study will be conducted in two stages: a Safety Stage consisting
of the first five patients and the Study Stage with thirty patients.
In the Safety Stage of the study, three different plaques of the first 5 patients will be
randomized and administered the respective treatments only once. Enrollment will be
suspended after the 5th patient has been enrolled to permit the data monitoring committee
(DMC) to review of the initial safety data from these first 5 patients to reassess risk.
Based on this review, the DMC will make one of three recommendations:
1. to continue the study as planned,
2. to continue the study with adjustments to study procedures, such as changes to laser
parameters, frequency of treatments or concentration of etanercept or,
3. in the event of extreme safety concerns, to terminate the study.
If option 1 is recommended, the study will resume with the Study Stage (Stage 2), in which
the initial 5 patients will once again begin treatment, with their plaques receiving the
same treatments to which they were previously randomized. Their treatment will continue for
8 weeks. Enrollment will also resume and continue until an additional 25 patients have been
enrolled. If the DMC recommends option 2, treatment and enrollment will resume as just
described after an adapted protocol has been submitted to and approved by the relevant
authorities. If the DMC recommends option 3, then the study will terminate.
The Study Stage will consist of 2 periods: screening period (up to 2 weeks prior to baseline
assessments and randomization) and treatment period (for the first 5 patients: initially 1
set of treatments, followed by suspension of treatment until after DMC review, then 8 weeks
of treatment; for the remaining 25 patients: 8 weeks of treatment depending on plaque
randomization, either daily Daivobet® or biweekly AFL with or without etanercept).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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