Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase 1, Single Center Study Using Omalizumab in Subjects With Atopic Dermatitis
Brief Summary: A phase 1 single center study in which omalizumab is dosed normally (according to the product insert) in subjects with atopic dermatitis.


Options:
A: Inclusion Criteria:

* ≥18 and ≤65 years of age at the time of consent.
* Patients with Atopic Dermatitis
* Pruritus visual analogue scale (VAS) ≥50 mm at the screening and baseline visit
* Eczema Area and Severity Index (EASI) ≥10 at the screening and baseline visit
* static Investigator's Global Assessment (sIGA) score ≥3 at the baseline visit

Exclusion Criteria:

* Serological evidence of hepatitis B virus or hepatitis C virus infection
* Known human immunodeficiency virus infection
* Ongoing treatment with specific or non-specific hyposensitization therapy for AD
* Treatment with mild or moderately potent topical corticosteroids (TCS) within 1 week prior to randomization
* History of infection including skin infection requiring treatment with oral or intravenous (IV) antibiotics, antivirals, or antifungals within 1 week prior to randomization.
* Evidence of tuberculosis (TB) infection as defined by a positive purified protein derivative (PPD) and/or positive interferon-gamma release assay.
* Pregnant or lactating women.
B: 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 -
C: Inclusion Criteria:

* Have a clinical diagnosis of atopic dermatitis (also known as atopic eczema) for at least 6 months prior to Day 1 that has been clinically stable for at least 1 month prior to Day 1 and is confirmed to be atopic dermatitis according to the criteria of Hanifin and Rajka.
* Have a PGA score of 2 (mild) or 3 (moderate) at Day 1.
* Have atopic dermatitis on the head (including face, but excluding hair bearing scalp), neck, trunk (excluding groin and genitals), or limbs including palms and soles covering at least 2% of total body surface area (BSA) and up to and including 20% of total BSA at Day 1. At least 2% of the total BSA will need to be on the head (including face, but excluding hair bearing scalp), neck, trunk (excluding groin and genitals), or limbs (excluding palms and soles).

Exclusion Criteria:

* Evidence of certain skin conditions/infections at baseline
* Currently have atopic dermatitis on groin, genitals, palm or soles
* Have certain laboratory abnormalities at baseline
* Females who are pregnant, breastfeeding, or are of childbearing potential not using highly effective contraception
D: The inclusion criteria included, but were not limited to, the following:

1. Chronic Atopic Dermatitis that had been present for at least 3 years
2. History of inadequate response to out-patient treatment with topical medications, or for whom topical treatments were otherwise inadvisable (e.g, because of important side effects or safety risks)
3. Willing and able to comply with all clinic visits and study-related procedures

The exclusion criteria included, but were not limited to, the following:

1. Prior treatment with dupilumab (REGN668/SAR231893)
2. Presence of certain laboratory abnormalities at the screening visit
3. Treatment with an investigational drug within 8 weeks of baseline visit
4. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
5. Certain other treatments and medical procedures undertaken within a particular time frame prior to the baseline visit
6. Known history of human immunodeficiency virus (HIV) infection
7. History of malignancy within 5 years before the baseline visit (with certain exceptions)
8. Planned surgical procedure during the length of the study
9. High risk of parasite infection
10. Any other medical or psychological condition that in the opinion of the investigator or the sponsor's medical monitor, would place the participants at risk, interfere with participation in the study or interfere with interpretation of study results
11. Pregnant or breast-feeding women

Answer: B