Efficacy and Safety of CRTH2 Antagonist AZD1981 in Chronic Idiopathic Urticaria (CIU) Antihistamines

Chronic Idiopathic Urticaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02031679
• Other study ID #: NA_00089252
• Status: Recruiting
• Phase: Phase 2
• First received: January 7, 2014
• Last updated: January 24, 2014
• Start date: January 2014
• Est. completion date: January 2015

Study information

• Verified date: January 2014
• Source: Johns Hopkins University
• Contact: Kelly Devine
• Phone: 410-550-2200
• Email: kdevine1[@]jhmi.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

We are recruiting for a chronic hives study. This research is being done to test whether an investigational drug called AZD1981 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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, 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 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Idiopathic Urticaria
• Urticaria

Intervention

Drug:
• AZD1981
AZD1981 is an oral, potent, selective, reversible antagonist of CRTh2 (Chemoattractant Receptor Homologous Molecule expressed on Th2 cells).
• Placebo
Sugar pill manufactured to mimic AZD1981 10 mg tablet

Locations

Country	Name	City	State
United States	Johns Hopkins Asthma and Allergy Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in circulating leukocyte population numbers that are targeted by CRTh2 inhibition such as blood basophils, eosinophil and lymphocyte counts		21-28 days	No
Other	The proportion of patients who achieve at least 50% improvement/decrease from baseline in UAS7		21-28 days	No
Other	Pruritus-free and hive-free days (based on diary) during treatment period.		21-28 days	No
Primary	The change in diary-based clinical symptoms as measured by the Urticaria Activity Score 7 (UAS7)	The UAS score, which is the sum of pruritus and hives, will be used to calculate the UAS7. The UAS7 is a sum of the daily average (average of a.m. and p.m.) for 7 days	21-28 Days	No
Secondary	The number of participants with adverse events	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.	8 weeks	Yes
Secondary	The ability of AZD1981 to inhibit PGD2-induced Eosinophil shape		21-28 days	No
Secondary	The quality of life benefit provided by treatment of refractory CIU with AZD1981 in CIU as assessed by a sleep interference scale and Dermatology Life Quality Index (DLQI)		21-28 days	No