<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01678092</url>
  </required_header>
  <id_info>
    <org_study_id>011394</org_study_id>
    <nct_id>NCT01678092</nct_id>
  </id_info>
  <brief_title>Single Center Study Using Omalizumab in Subjects With Atopic Dermatitis</brief_title>
  <acronym>OXAD</acronym>
  <official_title>Phase 1, Single Center Study Using Omalizumab in Subjects With Atopic Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A phase 1 single center study in which omalizumab is dosed normally (according to the product&#xD;
      insert) in subjects with atopic dermatitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Phase I randomized, double-blinded, placebo-controlled study of Omalizumab in subjects with&#xD;
      severe atopic dermatitis and food allergy. Subjects were to participate for 2 years. The&#xD;
      treatment period was a 24 week period during which subjects received Omalizumab either every&#xD;
      2 or 4 weeks subcutaneously (as per product insert guidelines). Subjects randomized to the&#xD;
      placebo group received sterile water every 2 or 4 weeks subcutaneously. Previous medications&#xD;
      were standardized at equivalent doses one month prior to the first dose. The monthly&#xD;
      laboratory assessment for each subject included a complete blood count (CBC), serum&#xD;
      chemistries (Chem7/AST/ALT), and IgE levels.&#xD;
&#xD;
      Safety: Adverse events and clinical status were actively monitored during study visits at&#xD;
      weeks 4, 8, 16, 20, 24, 28, 32, and 36 (up to 3 months after last study dose) the as well as&#xD;
      reviewed in daily diaries per NIH assessment guidelines. Assessments of platelet count (CBC),&#xD;
      liver function (LFTs), serum chemistry panel, and serum IgE were made on a monthly basis&#xD;
      during the treatment period (24 weeks). Serum pregnancy testing was performed at screening&#xD;
      only as part of the inclusion/exclusion criteria.&#xD;
&#xD;
      Efficacy: Efficacy parameters included a standardized SCORAD classification system,&#xD;
      Physician's Global Assessment (PGA) score and subject/care giver global assessment for&#xD;
      subjects at 24 weeks compared to baseline. An assessment for food allergy was made by skin&#xD;
      prick testing and RAST performed at baseline and during or after the last dose. Diaries were&#xD;
      also taken to assess use of concomitant medications and food allergy symptoms. In addition,&#xD;
      one of the secondary endpoints was to assess the durability of effect of Xolair once the&#xD;
      treatment was discontinued. This was achieved through follow-up visits 1, 2, 3, 6, 12, and 24&#xD;
      months after the last treatment dose. The investigators also assessed use of concomitant&#xD;
      medications and food allergies via daily diaries for each of these assessments.&#xD;
&#xD;
      Number of subjects planned: 20 (Omalizumab 10 and Placebo 10). Number of subjects analysed:&#xD;
      (Omalizumab 4 and Placebo 4).&#xD;
&#xD;
      Male or female aged 4-25 years. Diagnosis of severe atopic dermatitis (meeting SCORAD&#xD;
      criteria) with at least 6 months of documented symptoms. Also with concomitant food allergy&#xD;
      as determined by a positive skin prick testing.&#xD;
&#xD;
      Omalizumab was supplied as a sterile, white, preservative-free, lyophilized powder contained&#xD;
      in a single-use vial that is reconstituted with Sterile Water for Injection (SWFI), USP, and&#xD;
      administered as a subcutaneous (SC) injection. A Xolair vial contains 202.5 mg of Omalizumab,&#xD;
      145.5 mg sucrose, 2.8 mg L-histidine hydrochloride mono hydrate, 1.8 mg L-histidine and 0.5&#xD;
      mg polysorbate 20 and is designed to deliver 150 mg of Omalizumab, in 1.2 mL after&#xD;
      reconstitution with 1.4 mL SWFI, USP. Treatment dose was determined as outlined in the&#xD;
      product insert.&#xD;
&#xD;
      2 year study duration (24 Weeks treatment). The reference was placebo (sterile water) given&#xD;
      subcutaneously.&#xD;
&#xD;
      The primary efficacy variables were improvement of SCORAD, Physician's Global Assessment, and&#xD;
      Subject/Caregiver Global Assessment scores for subjects at 24 weeks compared to baseline.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2004</start_date>
  <completion_date type="Actual">December 2006</completion_date>
  <primary_completion_date type="Actual">December 2006</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <enrollment type="Actual">8</enrollment>
  <condition>Atopic Dermatitis</condition>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>omalizumab</intervention_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects will be considered for inclusion in this study based on meeting all of the&#xD;
        following criteria:&#xD;
&#xD;
          1. Male or female, aged 4 to 25 years with weight at study entry of greater than 15 kg&#xD;
&#xD;
          2. Subjects with AD involving greater than 10% of total body surface area (BSA)&#xD;
&#xD;
          3. Subjects with AD PGA score of severe at study entry&#xD;
&#xD;
          4. Subject with SCORAD score defined as severe at study entry&#xD;
&#xD;
          5. IgE level at study entry between 50 IU/mL and 3000 IU/mL&#xD;
&#xD;
          6. Subjects with documented food allergy as determined by a positive skin prick test to&#xD;
             the specific allergen extract, defined as a wheal of at least 0.5 the diameter of the&#xD;
             histamine produced wheal and at least 3 mm larger than the diameter of the negative&#xD;
             control, associated with exacerbation of atopic dermatitis&#xD;
&#xD;
          7. Men and women of reproductive potential who document use of adequate contraception&#xD;
             during the study and for 3 months after the conclusion of treatment with study&#xD;
             drug/placebo&#xD;
&#xD;
          8. Historical documentation of atopic dermatitis on one occasion in the patient's medical&#xD;
             record. The patient should have 6 months or more of atopic dermatitis symptoms.&#xD;
&#xD;
          9. Women of childbearing potential who have a negative pregnancy test (urine or serum) at&#xD;
             the time of study entry -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects will be ineligible for this study based on any one of the following criteria:&#xD;
&#xD;
          1. With a chronic or acute disease that might interfere with the evaluation of Xolair&#xD;
             therapy&#xD;
&#xD;
          2. Pregnancy or lactation&#xD;
&#xD;
          3. Current or prior malignancies (excluding non-melanoma skin carcinoma or carcinoma in&#xD;
             situ of the cervix that has been adequately treated)&#xD;
&#xD;
          4. History of infection with human immunodeficiency virus (HSC-1), hepatitis B virus&#xD;
             (HBV), or hepatitis C virus (HCV); or Hepatitis A virus (HAV)&#xD;
&#xD;
          5. Infections that require intravenous antibiotic therapy&#xD;
&#xD;
          6. Significant organ dysfunction, including cardiac, renal, liver, CNS, pulmonary,&#xD;
             vascular, gastrointestinal, endocrine, or metabolic&#xD;
&#xD;
          7. Treatment with a humanized or chimeric antibody therapy within 4 weeks prior to study&#xD;
             entry&#xD;
&#xD;
          8. Treatment with any investigational drugs or therapies within 2 weeks prior to study&#xD;
             entry&#xD;
&#xD;
          9. Any use of oral, systemic corticosteroids within 2 weeks prior to study entry&#xD;
&#xD;
         10. Any use of topical agents for eczema or anti-pruritic agents 1 week prior to study&#xD;
             entry.&#xD;
&#xD;
         11. Treatment with antihistamines within 4 days of the first skin test screen.&#xD;
&#xD;
         12. History of allergen immunotherapy within one year of the study start -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kari Nadeau, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University School of Medicine</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>November 24, 2015</last_update_submitted>
  <last_update_submitted_qc>November 24, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 26, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Kari Christine Nadeau</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Eczema</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Omalizumab</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01678092
org study id: 011394
nct id: NCT01678092
lead sponsor: 
has dmc: Yes
A phase 1 single center study in which omalizumab is dosed normally (according to the product
      insert) in subjects with atopic dermatitis.
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.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
intervention type: Biological
intervention name: omalizumab
criteria: 
gender: All
minimum age: 4 Years
maximum age: 25 Years
healthy volunteers: No
last name: Kari Nadeau, MD, PhD
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Kari Christine Nadeau
investigator title: Principle Investigator
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
mesh term: Omalizumab