Efficacy and Safety of CRTH2 Antagonist AZD1981 in Chronic Idiopathic Urticaria (CIU) Antihistamines
| Status: | Completed |
|---|---|
| Conditions: | Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/2/2016 |
| Start Date: | January 2014 |
| End Date: | January 2015 |
| Contact: | Kelly Devine |
| Email: | kdevine1@jhmi.edu |
| Phone: | 410-550-2200 |
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
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.
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.
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.
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