Single Center Study Using Omalizumab in Subjects With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1

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

Detailed description: 
      A Phase I randomized, double-blinded, placebo-controlled study of Omalizumab in subjects with
      severe atopic dermatitis and food allergy. Subjects were to participate for 2 years. The
      treatment period was a 24 week period during which subjects received Omalizumab either every
      2 or 4 weeks subcutaneously (as per product insert guidelines). Subjects randomized to the
      placebo group received sterile water every 2 or 4 weeks subcutaneously. Previous medications
      were standardized at equivalent doses one month prior to the first dose. The monthly
      laboratory assessment for each subject included a complete blood count (CBC), serum
      chemistries (Chem7/AST/ALT), and IgE levels.

      Safety: Adverse events and clinical status were actively monitored during study visits at
      weeks 4, 8, 16, 20, 24, 28, 32, and 36 (up to 3 months after last study dose) the as well as
      reviewed in daily diaries per NIH assessment guidelines. Assessments of platelet count (CBC),
      liver function (LFTs), serum chemistry panel, and serum IgE were made on a monthly basis
      during the treatment period (24 weeks). Serum pregnancy testing was performed at screening
      only as part of the inclusion/exclusion criteria.

      Efficacy: Efficacy parameters included a standardized SCORAD classification system,
      Physician's Global Assessment (PGA) score and subject/care giver global assessment for
      subjects at 24 weeks compared to baseline. An assessment for food allergy was made by skin
      prick testing and RAST performed at baseline and during or after the last dose. Diaries were
      also taken to assess use of concomitant medications and food allergy symptoms. In addition,
      one of the secondary endpoints was to assess the durability of effect of Xolair once the
      treatment was discontinued. This was achieved through follow-up visits 1, 2, 3, 6, 12, and 24
      months after the last treatment dose. The investigators also assessed use of concomitant
      medications and food allergies via daily diaries for each of these assessments.

      Number of subjects planned: 20 (Omalizumab 10 and Placebo 10). Number of subjects analysed:
      (Omalizumab 4 and Placebo 4).

      Male or female aged 4-25 years. Diagnosis of severe atopic dermatitis (meeting SCORAD
      criteria) with at least 6 months of documented symptoms. Also with concomitant food allergy
      as determined by a positive skin prick testing.

      Omalizumab was supplied as a sterile, white, preservative-free, lyophilized powder contained
      in a single-use vial that is reconstituted with Sterile Water for Injection (SWFI), USP, and
      administered as a subcutaneous (SC) injection. A Xolair vial contains 202.5 mg of Omalizumab,
      145.5 mg sucrose, 2.8 mg L-histidine hydrochloride mono hydrate, 1.8 mg L-histidine and 0.5
      mg polysorbate 20 and is designed to deliver 150 mg of Omalizumab, in 1.2 mL after
      reconstitution with 1.4 mL SWFI, USP. Treatment dose was determined as outlined in the
      product insert.

      2 year study duration (24 Weeks treatment). The reference was placebo (sterile water) given
      subcutaneously.

      The primary efficacy variables were improvement of SCORAD, Physician's Global Assessment, and
      Subject/Caregiver Global Assessment scores for subjects at 24 weeks compared to baseline.
    

Intervention name(s): omalizumab
Intervention type(s): Biological
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment