Trial record 2 of 5 for:    Open Studies | "Histamine Antagonists"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Johns Hopkins University
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Sarbjit Saini, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT02031679
First received: January 7, 2014
Last updated: January 24, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Chronic Idiopathic Urticaria
Drug: AZD1981
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • The change in diary-based clinical symptoms as measured by the Urticaria Activity Score 7 (UAS7) [ Time Frame: 21-28 Days ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • The number of participants with adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    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.

  • The ability of AZD1981 to inhibit PGD2-induced Eosinophil shape [ Time Frame: 21-28 days ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: 21-28 days ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change in circulating leukocyte population numbers that are targeted by CRTh2 inhibition such as blood basophils, eosinophil and lymphocyte counts [ Time Frame: 21-28 days ] [ Designated as safety issue: No ]
  • The proportion of patients who achieve at least 50% improvement/decrease from baseline in UAS7 [ Time Frame: 21-28 days ] [ Designated as safety issue: No ]
  • Pruritus-free and hive-free days (based on diary) during treatment period. [ Time Frame: 21-28 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: January 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Drug: AZD1981
AZD1981 is an oral, potent, selective, reversible antagonist of CRTh2 (Chemoattractant Receptor Homologous Molecule expressed on Th2 cells).
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.

Drug: Placebo
Sugar pill manufactured to mimic AZD1981 10 mg tablet

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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, 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02031679

Contacts
Contact: Kelly Devine 410-550-2200 kdevine1@jhmi.edu
Contact: Eric Oliver, MD 410-550-2300 eolive15@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Asthma and Allergy Center Recruiting
Baltimore, Maryland, United States, 21224-6821
Contact: Kelly Devine, RN    410-550-2200    kdevine1@jhmi.edu   
Contact: Eric Oiver, MD    410-550-2300    eolive15@jhmi.edu   
Principal Investigator: Sarbjit S Saini, MD         
Sub-Investigator: Eric T Oliver, MD         
Sponsors and Collaborators
Johns Hopkins University
AstraZeneca
Investigators
Principal Investigator: Sarbjit S Saini, MD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Sarbjit Saini, Associate Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02031679     History of Changes
Other Study ID Numbers: NA_00089252
Study First Received: January 7, 2014
Last Updated: January 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:
Chronic Idiopathic Urticaria

Additional relevant MeSH terms:
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Histamine Antagonists
Histamine H1 Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 14, 2014