Single Center Study Using Omalizumab in Subjects With Atopic Dermatitis

Completed · Phase 1

Conditions studied: Atopic Dermatitis

In brief

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

Key facts

Study ID

NCT01678092

Run by

Stanford University

People needed

8

Starts

2004-05-01

Expected to finish

2006-12-01

Last updated by the study team

2015-11-26

Who can join

Age: 4 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects will be considered for inclusion in this study based on meeting all of the following criteria:
• Male or female, aged 4 to 25 years with weight at study entry of greater than 15 kg
• Subjects with AD involving greater than 10% of total body surface area (BSA)
• Subjects with AD PGA score of severe at study entry
• Subject with SCORAD score defined as severe at study entry
• IgE level at study entry between 50 IU/mL and 3000 IU/mL
• 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
• 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
• 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.
• Women of childbearing potential who have a negative pregnancy test (urine or serum) at the time of study entry -

You may not qualify if…

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

Where it is running

• Stanford University School of Medicine — Stanford, California, United States

Full record on ClinicalTrials.gov

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