Clinical Trial: Study of Apremilast in Atopic or Contact Dermatitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: The objective of this study is to evaluate the efficacy of apremilast in patients with recalcitrant atopic or contact dermatitis.

Detailed Summary:

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.

Sponsor: Tufts Medical Center

Current Primary Outcome: Number of Patients Achieving an Improvement (Decrease) in IGA (Investigator Global Assessment) by Two or More Points [ Time Frame: 12 weeks ]

Improvement in IGA (Investigator Global Assessment) by two or more points on a five point scale, with 0 being no disease activity and 5 being maximum disease activity, at week 12


Original Primary Outcome: To evaluate the clinical efficacy of apremilast, when taken for 12 weeks, in subjects with recalcitrant contact or atopic dermatitis. [ Time Frame: 12 weeks ]

Current Secondary Outcome:

  • Number of Patients Achieving 75% Reduction in Eczema Area and Severity Index (EASI) Score at Week 12 in Reference to Week 0 [ Time Frame: 12 weeks ]
    EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, edema, lichenification, and excoriations/erosions are scored on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 to 6. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.
  • Number of Patients Achieving 50% Reduction in Eczema Area and Severity Index (EASI) Score at Week 12 in Reference to Week 0 [ Time Frame: 12 weeks ]
    EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, edema, lichenification, and excoriations/erosions are scored on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 to 6. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.


Original Secondary Outcome:

  • To evaluate the safety of apremilast (20 mg PO, twice per day [BID] for 12 weeks) in subjects with recalcitrant contact or atopic dermatitis [ Time Frame: 12 weeks ]
  • To evaluate the change in Biomarkers in serum at Week 12 in reference to Week 0 (Baseline visit) in subjects with contact or atopic dermatitis taking apremilast [ Time Frame: 12 weeks ]
  • To determine the time to relapse in the Follow-up phase [ Time Frame: 4 weeks ]
  • To determine the effect of apremilast on quality-of-life [ Time Frame: 12 weeks ]


Information By: Tufts Medical Center

Dates:
Date Received: June 30, 2009
Date Started: June 2009
Date Completion:
Last Updated: November 23, 2010
Last Verified: November 2010