Single Center Study Using Omalizumab in Subjects With Atopic Dermatitis

NCT01678092

NOT RECRUITING

A phase 1 single center study in which omalizumab is dosed normally (according to the product insert) in subjects with atopic dermatitis.

Phase 1, Single Center Study Using Omalizumab in Subjects With Atopic Dermatitis

Ages Eligible for Study: 4 Years to 25 Years

Sexes Eligible for Study: All

Accepts Healthy Volunteers: No

Inclusion Criteria:

Subjects will be considered for inclusion in this study based on meeting all of the following criteria: 1. Male or female, aged 4 to 25 years with weight at study entry of greater than 15 kg 2. Subjects with AD involving greater than 10% of total body surface area (BSA) 3. Subjects with AD PGA score of severe at study entry 4. Subject with SCORAD score defined as severe at study entry 5. IgE level at study entry between 50 IU/mL and 3000 IU/mL 6. Subjects with documented food allergy as determined by a positive skin prick test to the specific allergen extract, defined as a wheal of at least 0.5 the diameter of the histamine produced wheal and at least 3 mm larger than the diameter of the negative control, associated with exacerbation of atopic dermatitis 7. Men and women of reproductive potential who document use of adequate contraception during the study and for 3 months after the conclusion of treatment with study drug/placebo 8. Historical documentation of atopic dermatitis on one occasion in the patient's medical record. The patient should have 6 months or more of atopic dermatitis symptoms. 9. Women of childbearing potential who have a negative pregnancy test (urine or serum) at the time of study entry -

Exclusion Criteria:

Subjects will be ineligible for this study based on any one of the following criteria: 1. With a chronic or acute disease that might interfere with the evaluation of Xolair therapy 2. Pregnancy or lactation 3. Current or prior malignancies (excluding non-melanoma skin carcinoma or carcinoma in situ of the cervix that has been adequately treated) 4. History of infection with human immunodeficiency virus (HSC-1), hepatitis B virus (HBV), or hepatitis C virus (HCV); or Hepatitis A virus (HAV) 5. Infections that require intravenous antibiotic therapy 6. Significant organ dysfunction, including cardiac, renal, liver, CNS, pulmonary, vascular, gastrointestinal, endocrine, or metabolic 7. Treatment with a humanized or chimeric antibody therapy within 4 weeks prior to study entry 8. Treatment with any investigational drugs or therapies within 2 weeks prior to study entry 9. Any use of oral, systemic corticosteroids within 2 weeks prior to study entry 10. Any use of topical agents for eczema or anti-pruritic agents 1 week prior to study entry. 11. Treatment with antihistamines within 4 days of the first skin test screen. 12. History of allergen immunotherapy within one year of the study start -

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