Role of Immunoglobulin E (IgE) Bearing Cells in Chronic Idiopathic Urticaria (CIU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03111628
Recruitment Status : Recruiting
First Posted : April 13, 2017
Last Update Posted : October 9, 2018
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
This is a Phase IV, single-site study that will examine blood cells or tissue obtained from CIU patients receiving open-label treatment with omalizumab at the current FDA-approved dose of 300 mg/month for 12 weeks in addition to standard therapy with anti-histamines. Results from the 3 Phase III studies in CIU patients provide evidence that a meaningful change in symptoms is apparent at 1-2 wks. The Minimal Important Difference (MID) is achieved by 70% of patients by 2 wks on multiple background drugs for hives. The goal is to identity the IgE bearing cell type associated with clinical symptom change.

Condition or disease Intervention/treatment Phase
Urticaria Chronic Drug: Omalizumab Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Active therapy
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Role of Immunoglobulin E (IgE) Bearing Cells in Chronic Idiopathic Urticaria
Actual Study Start Date : October 6, 2017
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives
Drug Information available for: Omalizumab

Arm Intervention/treatment
Omalizumab 300mg every month for 3 doses
Drug: Omalizumab
omalizumab 300 mg every 4 weeks by subcutaneous injection
Other Name: Xolair

Primary Outcome Measures :
  1. Clinical symptoms by the UAS 7 [ Time Frame: From first injection to time of meaningful change ( maximum of 12 Weeks) ]
    The time to meaningful change in diary-based clinical symptoms as measured by the Urticaria Activity Score from baseline (Wk -7 to Day -1) to the date at which an MID (5 point change in weekly UAS 7) or achievement of > 50% reduction in daily symptom score for 3 days if in the first week. The UAS score, which is the sum of pruritus and hives, will be used to calculate the UAS7. The UAS7 score obtained 1 week prior to randomization will be used as the baseline.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female, ages 18-65
  • Females must be surgically sterile or postmenopausal or using a highly effective form of birth control throughout the duration of the study.
  • Females must have a negative urine pregnancy test at screening and other visits specified in this protocol unless documented to have a hysterectomy or be postmenopausal.
  • Clinical history of CIU at the time of screening, as defined by pruritus and hives for > 3 days in a 7-day period for > 6 consecutive weeks despite treatment with H1 antihistamine.
  • CIU diagnosis > 3 months (by history)
  • No underlying etiology clearly defined for urticaria (main manifestation cannot be physical urticaria).
  • Non-diary based UAS scores ≥ 2 at either the screening visit (Week -3), at the run-in visit (Week -2), or on Day 1.
  • Compliance with study procedures during run-in period (e.g., completion of the study diary).

Exclusion Criteria:

  • Pregnant females, Recent history of drug or alcohol abuse (within 3 years prior to screening visit).Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
  • Use of any investigational drugs within 30 days of screening.
  • Active atopic dermatitis or other skin disease associated with pruritus during the time of the study, which require treatment with topical corticosteroids.
  • Clinically relevant major systemic disease (making interpretation of the study results difficult) including a history of anaphylaxis.
  • Inability to comply with study and follow-up procedures
  • Patients may not use oral or systemic steroids during the study or within 4 weeks prior to enrollment.
  • Patients may not take H2 antihistamines and leukotriene receptor antagonists within 7 days before screening, during the screening, run-in, or treatment phases. The exception will be if they are already on these medications for the treatment of Gastro-Esophageal Reflux Disease (GERD), asthma or allergic rhinitis.
  • Any clinically relevant abnormal findings in clinical chemistry, hematology, urinalysis, physical examination, pulse, blood pressure at baseline, which, in the opinion of the investigator, could put the patient at risk because of his/her participation in the study.
  • Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or may compromise the quality of the data obtained from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03111628

Contact: Kelly Devine, RN 410-550-2129

United States, Maryland
Johns Hopkins Asthma and Allergy Center Recruiting
Baltimore, Maryland, United States, 21224
Principal Investigator: Sarbjit S Saini, M.D.         
Sponsors and Collaborators
Johns Hopkins University
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Sarbjit Saini, MD Johns Hopkins University

Responsible Party: Johns Hopkins University Identifier: NCT03111628     History of Changes
Other Study ID Numbers: IRB00105590
R01AI116658 ( U.S. NIH Grant/Contract )
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents