Status:
COMPLETED
Pilot Study of Ustekinumab for Subjects With Chronic Atopic Dermatitis
Lead Sponsor:
Rockefeller University
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
In psoriasis, epidermal hyperplasia is driven by underlying immune activation, whether as a direct response to IL-20 family cytokines that induces hyperplasia and inhibits keratinocyte terminal differ...
Eligibility Criteria
Inclusion
- Are male or female and ages 18-75.
- Have moderate to severe AD (as determined using the Objective SCORAD scale ≥15) and a history of therapeutic failure with at least two of the three different treatment categories as listed within the inclusion criteria.
- Patients must have tried and failed at least two of the three treatment categories of the following treatment modalities:
- Category 1 : Hydration plus topical steroids and/or antibiotics Category 2: Systemic Steroids and/or Phototherapy Category 3: Cyclosporine and/or Other Immunomodulators (Methotrexate, CellCept, Immuran, topical Calcineurin inhibitors)
- Patients who initially respond to cyclosporine but cannot sustain a response after the drug is discontinued will also be eligible.
- Patients that have contraindications to category 3 drugs will also be allowed to participate in the study.
- A washout period prior to screening will be required for the following medications:
- Cyclosporine/Oral Steroids/Imuran/Mycophenolate Mofetil/Other systemic immunosuppressants: 4 weeks
- Phototherapy/Moderate to High Potency Topical Corticosteroids: 2 weeks
- Women of childbearing potential must test negative for pregnancy and be using adequate birth control measures (e.g., Abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or have had a tubal ligation or a hysterectomy) during the study and for 6 months after receiving the last treatment. Likewise, men capable of fathering children must also use appropriate methods of birth control (e.g., abstinence, barrier methods with spermicide, or have had surgical sterilization such as vasectomy).
- Patients must be in general good health in the opinion of the investigator.
- Patients with stable chronic asthma, treated with inhaled corticosteroids, will be eligible.
- The screening laboratory tests must meet the following criteria:
- Hemoglobin \>9 g/dl WBC count \>3.5 x 109 cells/L Neutrophils \>1.5 x 109 cells/L Platelets \>100 x 109 cells/L AST/SGOT and ALT/SGPT levels must be within 2 times the upper limit of normal for the laboratory conducting the test. Alkaline phosphatase levels must be within 2 times the upper limit of normal for the laboratory conducting the test.
- Are PPD negative at the time of screening.
- The patients will be allowed to use topical therapy during the washout period. These will include emollients, and mild steroids (class 6 or 7), except on one target area that will be the site for the skin biopsies.
Exclusion
- Previous treatment with ustekinumab or other agent that specifically targets IL-12 or 23
- Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening, or are frequently in contact with individuals who carry active TB infection or a non-tubercular mycobacterial infection or an opportunistic infection
- Are HIV positive by history or POCT on the screening visit
- Have documented current active hepatitis B (surface antigen positive or asymptomatic chronic carriers) or hepatitis C infection (anti-HCV positive), by history and/or screening test
- Have a history of substance abuse (drug or alcohol) within the past year before screening
- Have any serious concomitant illness that could require the use of systemic corticosteroids or otherwise interfere with the patient's participation in the trial
- Pregnant women or women that are breast-feeding or plan to breast feed. Women of childbearing age who plan to get pregnant within 15 weeks of stopping study agent
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01806662
Start Date
March 1 2013
End Date
March 1 2015
Last Update
March 14 2018
Active Locations (1)
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1
Rockefeller University
New York, New York, United States, 10065