Efficacy and Safety of Chemoattractant Receptor-homologous Molecule Expressed on T Helper Type 2 (CRTh2) Antagonist AZD1981 in Chronic Idiopathic Urticaria (CIU) Antihistamines
Condition: Chronic Idiopathic Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Intervention: AZD1981; Placebo
Intervention description: AZD1981 is an oral, potent, selective, reversible antagonist of CRTh2 (Chemoattractant Receptor Homologous Molecule expressed on Th2 cells).; Sugar pill manufactured to mimic AZD1981 10 mg tablet
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Chronic Idiopathic Urticaria

Summary:

      The investigators are recruiting for a chronic hives study. This research is being done to
      test whether an investigational drug called AstraZeneca drug (AZD)1981 may be helpful for
      treating people with Chronic Idiopathic Urticaria who continue to have symptoms despite
      taking antihistamines. The word "investigational" means that AZD1981 is not approved for
      marketing by the Food and Drug Administration (FDA). The FDA is allowing the use of AZD1981
      in this study.

      People with chronic hives lasting for at least 6 months and without a known cause may join.
      The study involves 6 visits over 8 weeks. Approximately 48 participants expected to take part
      in this study at the Johns Hopkins Asthma and Allergy Clinic. All participants will be
      treated with the study medication and/or placebo for 8 weeks.

      The results of this trial may have a benefit others with Chronic Idiopathic Urticaria who
      don't respond well to antihistamines by generating experience and data to support the design
      of a larger, multicenter trial investigating the efficacy of AZD1981 in treating
      antihistamine refractory CIU.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

          -  Must meet the criteria for Chronic Idiopathic Urticaria (CIU) as defined by itching
             and hives for >3 days per week for over 6 weeks with no clear cause

          -  CIU symptoms must have started at least 6 months prior to starting the study

          -  Must have moderate to severe CIU, using a standardized survey, despite taking
             antihistamines

        Exclusion Criteria

          -  Pregnant females or females who plan to become pregnant during the study

          -  Drug or alcohol abuse within the past 3 years

          -  Use of any investigational drug with 30 days of the start of the study

          -  Eczema or other skin conditions associated with itching (besides hives)

          -  Inability to comply with follow-up procedures

          -  Use of the following therapies in the past 30 days: hydroxychloroquine, sulfasalazine,
             dapsone, methotrexate, cyclophosphamide, Intravenous Immunoglobulin (IVIG),
             plasmapheresis, cyclosporine, oral or systemic steroids, or other monoclonal antibody
             therapies

          -  Use of doxepin within the past 2 weeks

          -  Use of either H2 antihistamines and leukotriene receptor antagonists within 7 days
             before starting the study (unless already on these medications for Gastroesophageal
             Reflux Disease (GERD), asthma or allergic rhinitis)

          -  Inability to take diphenhydramine (Benadryl)

          -  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 or interfere with ability to comply with study procedures.