Atopic Dermatitis Clinical Trial
Official title:
A Phase 2, Open-label, Investigator-Initiated Study to Evaluate the Safety and Efficacy of Apremilast in Subjects With Recalcitrant Contact or Atopic Dermatitis
The objective of this study is to evaluate the efficacy of apremilast in patients with recalcitrant atopic or contact dermatitis.
Atopic Dermatitis (AD) is a chronic, inflammatory skin disease characterized by dry, red,
and itchy patches that can become thickened and lichenified with time. Contact Dermatitis,
or Allergic Contact Dermatitis (ACD), is an eczematous reaction in response to an
environmental allergen.
The etiology of Atopic Dermatitis (AD) and Allergic Contact Dermatitis (ACD) has not been
completely elucidated, and new understandings of underlying mechanisms have expanded and
focused treatment regimens and paradigms.
Atopic Dermatitis (AD) is thought to be mediated by Th2 type T cells elaborating a number of
cytokines which are blocked in vitro by apremilast. The chronic Atopic Dermatitis (AD)
pathway may involve a change to Th1 cytokines. Genetic factors do not contribute as much to
the course of Allergic Contact Dermatitis (ACD) as in Atopic Dermatitis (AD). Rather,
Allergic Contact Dermatitis (ACD) is a type IV, T-cell mediated, delayed-hypersensitivity
reaction that can be self-limited. Similar to Atopic Dermatitis (AD), a number of
pro-inflammatory cytokines are involved in recruiting T cells preferentially to the skin:
Th1 cytokines, Th2 cytokines, CD8 cytokines, and T-regulatory cytokines. These pathways in
Allergic Contact Dermatitis (ACD) are activated by IFN-γ, driven by TNF-α, and as above,
apremilast has been shown to block these cytokines in vitro.
Current treatments for Atopic Dermatitis (AD) and Allergic Contact Dermatitis (ACD) include
skin care, trigger avoidance (especially in the case of ACD), topical corticosteroids,
steroid sparing treatments, antihistamines, topical and systemic antibiotics, and
ultraviolet light. For more recalcitrant Atopic Dermatitis (AD) and Allergic Contact
Dermatitis (ACD)cases, several immunosuppressive treatments exist.
Subjects with recalcitrant Atopic Dermatitis (AD) or Allergic Contact Dermatitis (ACD)have
exhausted conventional systemic treatment options because they do not respond to
conventional systemic therapy or cannot use these agents due to side effects or cumulative
toxicity.
There is an urgent need to evaluate new therapeutic options in recalcitrant Atopic
Dermatitis (AD) and Allergic Contact Dermatitis (ACD). Very few of the available drugs for
recalcitrant Atopic Dermatitis (AD) and Allergic Contact Dermatitis (ACD) have reasonable
efficacy and safety profiles in this condition, are easily available, or easy to administer.
A new treatment strategy is needed for the treatment of recalcitrant contact or atopic
dermatitis that would increase efficacy, minimize toxicity for both short and long-term
treatment, and be easy to administer. The availability of alternative drug treatment(s)
offering safe and effective short and long-term management would significantly benefit
subjects with recalcitrant contact or atopic dermatitis.
This study uses a novel oral agent (apremilast) that modulates multiple anti-inflammatory
pathways through targeted phosphodiesterase type IV (PDE4) inhibition decreased expression
of dermatitis. Apremilast has pharmacodynamic properties with a potential therapeutic
benefit for treating inflammatory autoimmune disorders that involve elevated serum cytokine
levels, including Atopic Dermatitis (AD) and Allergic Contact Dermatitis (ACD).
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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