Pilot Study of Ustekinumab for Subjects With Chronic Atopic Dermatitis

Part of paid clinical trials in New York, New York.

Sponsor
Rockefeller University
Study ID
NCT01806662
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Ustekinumab — DRUG
    Injection of monoclonal antibody against the p40 subunit of IL-12/23
  • Placebo — OTHER
    Injection of placebo

Study Details

Atopic dermatitis (AD) is a chronic disease associated with intense itching, which affects most aspects of everyday life in the majority of patients. Acute inflammation and extensor/facial involvement is common in infants, whereas chronic inflammation increases in prevalence with age, as do localization to flexures. AD has a complex background characterized by immune activation, increased epidermal thickness in chronic diseased skin, and defective barrier function. In normal, healthy skin, the outer layer of the epidermis, the stratum corneum is made up flattened dead cells called corneocytes held together by a mixture of lipids and proteins. The stratum corneum and, in particular, the lipid layer are vital in providing a natural barrier function that locks water inside the skin and keeps allergens and irritants out. In people with AD, the barrier function is defective, which leads to dry skin. As the skin dries out, it cracks allowing allergens and irritants to penetrate. Mild AD can be controlled with emollients and topical medications. However, moderate to severe AD is extremely difficult to control and requires systemic treatment that is often unsatisfactory due to impracticality and lack of effectiveness. Only three therapeutic options exist for moderate to severe AD, including: 1) oral steroids 2) cyclosporine A (CsA), that is not widely used in the US as it is not FDA approved for AD and 3) ultraviolet phototherapy. Oral steroids and CsA treatments have major side effects and UV radiation therapy is highly inconvenient for patients. Several biologic medications, such as TNF-alpha inhibitors, are effective, convenient, and relatively safe therapies for psoriasis, but have thus far not shown efficacy in AD. Ustekinumab is a unique biologic medication that may specifically target AD. The investigators study will determine whether there is a reversal of the skin thickness and the immune pathways involved in the disease during treatment with Ustekinumab and what specific immune cells are involved. The investigators are also interested to understand how the clinical reversal of the disease will correlate with tissue reversal of the disease.

Key Dates

Start date
Mar 31, 2013
Status verified
Feb 2018
Primary completion
Mar 31, 2015
Completion
Mar 31, 2015

Study Design

Enrollment
32 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm (Ustekinumab first, Then Placebo)
    Since there is a crossover design, each patient will be in the treatment arm for 16 weeks of the study.
  • Placebo Comparator: Placebo Arm (Placebo first, Then Ustekinumab)
    Since there is a crossover design, each patient will be in the placebo arm for 16 weeks of the study. If a patient begins in the placebo arm, they will switch over to the treatment arm at week 16.

Primary Outcome Measure

Proportion of SCORAD-50 Response at Week 16. [ Time Frame: Week 16 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Rockefeller UniversityNew YorkNew York10065-

Find similar trials in New York, NY

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Rockefeller University· New York, NY

Related Studies