Single Center Study Using Omalizumab in Subjects With Atopic Dermatitis

NCT01678092 | Completed Phase 1 DMC

• 1 other identifier: 011394
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atopic Dermatitis

Interventions

omalizumab BIOLOGICAL

Eligibility Criteria

• Age: 4 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 -

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94022, United States

Location

Related Publications (1)

• Iyengar SR, Hoyte EG, Loza A, Bonaccorso S, Chiang D, Umetsu DT, Nadeau KC. Immunologic effects of omalizumab in children with severe refractory atopic dermatitis: a randomized, placebo-controlled clinical trial. Int Arch Allergy Immunol. 2013;162(1):89-93. doi: 10.1159/000350486. Epub 2013 Jun 27.

  PMID: 23816920 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Kari Nadeau, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: August 30, 2012
• First Posted: September 3, 2012
• Study Start: May 1, 2004
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: November 26, 2015

Record last verified: 2015-11

Locations

US (1)