Trial Search Results

Single Center Study Using Omalizumab in Subjects With Atopic Dermatitis

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

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Intervention(s):

  • Biological: omalizumab

Phase:

Phase 1

Eligibility


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 -

Ages Eligible for Study

4 Years - 25 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305