- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02031679
Efficacy and Safety of Chemoattractant Receptor-homologous Molecule Expressed on T Helper Type 2 (CRTh2) Antagonist AZD1981 in Chronic Idiopathic Urticaria (CIU) Antihistamines
A Phase IIa, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of the CRTh2 Antagonist AZD1981 in Patients With Chronic Idiopathic Urticaria (CIU) Who Are Refractory to H1 Antihistamines
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21224-6821
- Johns Hopkins Asthma and Allergy Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AZD1981
AZD1981 for oral administration will be available in tablet form. AZD1981 tablets will be provided in 10 mg strengths. The drug will be self-administered by the subject. Subjects will take 4 tablets in the morning, 4 tablets in the afternoon, and 4 tablets in the evening. The tablets should be swallowed whole with a glass of water. |
AZD1981 is an oral, potent, selective, reversible antagonist of CRTh2 (Chemoattractant Receptor Homologous Molecule expressed on Th2 cells).
Other Names:
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Placebo Comparator: Placebo
The placebo will be available in tablet form. The placebo contains the same ingredients as the AZD1981 with the exception of the active compound. The placebo will be self-administered by the subject. Subjects will take 4 tablets in the morning, 4 tablets in the afternoon, and 4 tablets in the evening. The tablets should be swallowed whole with a glass of water. |
Sugar pill manufactured to mimic AZD1981 10 mg tablet
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Change in Diary-based Clinical Symptoms as Measured by the Urticaria Activity Score 7 (UAS7)
Time Frame: 7 Days
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The UAS score, which is the sum of pruritus and hives, will be used to calculate the UAS7.
UAS is a validated measure of Chronic Spontaneous Urticaria (CSU) disease activity which scores the intensity of pruritus (0-3, with 0 = no itch and 3 is severe itch) and number of hives (0-3 0 means no hives and 3 means greater than 50 hives) with a maximum value of 6 for a given day.
The UAS7 is the sum of the daily average UAS scores (average of a.m. and p.m.) for 7 days with a minimum score of 0 and a maximum value of 42.
The UAS7 is a sum of the daily average (average of a.m. and p.m.) for 7 days.
The baseline score was established during the second placebo therapy week and compared to the final week of the 4 week active treatment period.
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7 Days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Number of Participants With Adverse Events
Time Frame: 8 weeks
|
The safety of AZD1981 will be assessed using the following outcome measures: incidence and severity of treatment-emergent adverse events and serious adverse events, clinical laboratory measures, and vital signs.
In particular we will measure CBC's with differential at baseline and week 4 and liver function tests every 2 weeks based on past trial experience of dose-related toxicity.
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8 weeks
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The Ability of AZD1981 to Inhibit Prostaglandin D2 (PGD2)-Induced Eosinophil Shape
Time Frame: Baseline, End of treatment, end of washout
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The measure of Eosinophil shape change was assessed by cell scatter characteristics using a flow cytometer.
Cellular scatter was established with buffer and then several doses of PGD2 stimulation.
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Baseline, End of treatment, end of washout
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sarbjit S Saini, MD, Johns Hopkins University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NA_00089252
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Idiopathic Urticaria
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United BioPharmaNot yet recruiting
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J. Uriach and CompanyTerminated
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Johns Hopkins UniversityNational Institute of Allergy and Infectious Diseases (NIAID)CompletedUrticaria ChronicUnited States
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University Hospital Inselspital, BerneNovartis; University of Bern; Adverse Drug Reactions, Advice and Consulting ADR-ACCompletedChronic Idiopathic Urticaria | Chronic Urticaria | Chronic Spontaneous UrticariaSwitzerland
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Jonathan A. Bernstein, MDCompletedChronic Idiopathic UrticariaUnited States
-
University of ZurichUnknownChronic Idiopathic UrticariaSwitzerland
-
University of UtahWithdrawnChronic Idiopathic UrticariaUnited States
-
UCB PharmaCompleted
-
Lotus PharmaceuticalUnknownUrticaria | Chronic Idiopathic UrticariaTaiwan
-
J. Uriach and CompanyTerminated
Clinical Trials on AZD1981
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AstraZenecaCompletedModerate to Severe COPDSweden, Bulgaria, Poland, Denmark, Slovakia
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AstraZenecaCompleted
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AstraZenecaCompleted
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AstraZenecaCompletedHealthy | Postmenopausal | Surgically Sterile WomenSweden
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AstraZenecaCompleted