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Efficacy and Safety of Omalizumab in Patients With Severe Acute Urticaria

Primary Purpose

Urticaria

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
omalizumab
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urticaria focused on measuring urticaria,omalizumab

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 20-75 years(2)Documented diagnosis of acute urticaria within 3 years
  • Documented diagnosis of acute urticaria within 3 years
  • Daily UAS at the beginning of study more than or equal to 4
  • At time of enrollment, the symptoms of this episode had persisted longer than 3 days even under oral/intravenous antihistamines with or without oral corticosteroid therapy

Exclusion Criteria:

  • Weight < 20 kg
  • Continuous use of suspected drugs that may induce acute urticaria
  • Pregnant woman
  • Evidence of parasitic infection defined as having the following three items:Risk factors for parasitic disease (living in an endemic area, chronic gastrointestinal (GI) symptoms, travel within the last 6 months to an endemic area and/or chronic immunosuppression) AND An absolute eosinophil count more than twice the upper limit of normal AND Evidence of parasitic colonization or infection on stool evaluation for ova and parasites. Note that stool ova and parasite evaluation will only be conducted in patients with both risk factors and an eosinophil count more than twice the upper limit of normal.
  • Atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or other skin disease associated with itch
  • Treatment with omalizumab within 12 months before screening
  • Treatment with any investigational agent within 30 days of screening
  • IV immunoglobulin G (IVIG), or plasmapheresis within 30 days prior to Day -14
  • Regular (daily/every other day) doxepin (oral) use within 6 weeks prior to Day -14
  • Patients with current malignancy, history of malignancy, or currently under work-up for suspected malignancy except non-melanoma skin cancer that has been treated or excised and is considered resolved
  • Hypersensitivity to omalizumab or any component of the formulation
  • History of anaphylactic shock
  • Presence of clinically significant cardiovascular, neurological, psychiatric, metabolic or other pathological conditions that could interfere with the interpretation of the study results and or compromise the safety of the patients
  • Medical examination or laboratory findings that suggest the possibility of decompensation of co-existing conditions for the duration of the study. Any items that are cause for uncertainty must be reviewed with the Medical Monitor
  • Inability to comply with study and follow-up procedures
  • Evidence of current drug or alcohol abuse

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

omalizumab

Arm Description

omalizumab 300mg subcutaneously once

Outcomes

Primary Outcome Measures

Change in daily Urticaria Activity Score
Change in daily UAS from baseline to Day7 in the treatment period

Secondary Outcome Measures

Proportion of patient with daily UAS=0 at Day 1, Day 3
Change from baseline in itch severity score
Change from baseline in size of largest hive score
Proportion of patient could stop H1-antihistamine treatment
Proportion of angioedema-free days
The frequency and severity of treatment-emergent AEs and SAEs

Full Information

First Posted
July 9, 2014
Last Updated
July 14, 2014
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02191072
Brief Title
Efficacy and Safety of Omalizumab in Patients With Severe Acute Urticaria
Official Title
Efficacy and Safety of Omalizumab in Patients With Severe Acute Urticaria
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
May 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Efficacy of omalizumab in chronic spontaneous urticaria had been demonstrated in phase II and phase III studies. Clinical symptoms and signs had been significantly reduced with omalizumab as doses of 150 mg and 300 mg at 4-week intervals in patients with chronic spontaneous urticaria who remained symptomatic despite antihistamine treatment. Omalizumab had an onset of effect within a week after initiation. Thus, the investigators hypothesize that omalizumab will be effective in the treatment of severe acute urticaria as add on therapy with a fast onset of action. Objective:To investigate the efficacy and safety of omalizumab in the treatment of severe acute urticaria Study design: This prospective, interventional, single-arm open label study will recruit patients with severe acute urticaria from emergency departments, hospitalized and outpatient departments. The included patients will receive a single subcutaneous dose of 300mg omalizumab therapy. The efficacy of omalizumab will be evaluated by physical examination and assessed by Urticaria Activity Score (UAS) at baseline, 1 hour, Day 1, Day3, Day 7, and 6 weeks after omalizumab therapy. The frequency and severity of treatment-emergent adverse events will also be evaluated
Detailed Description
Acute urticaria is defined as hives that persist less than 6 weeks. Some patients with acute urticaria may progressed and need urgent management at urgent care clinics and emergency rooms. Nonsedating H1-antihistamines represent the mainstay and corticosteroids and various immunosuppressive therapies are being used in severely affected patients, or for those patients who experience a poor response to antihistamines. However, even though already treated by antihistamines, the symptoms still last longer than 3 days in more than 34% of the patients. Efficacy of omalizumab in chronic spontaneous urticaria had been demonstrated in phase II and phase III studies. Clinical symptoms and signs had been significantly reduced with omalizumab as doses of 150 mg and 300 mg at 4-week intervals in patients with chronic spontaneous urticaria who remained symptomatic despite antihistamine treatment. Omalizumab had an onset of effect within a week after initiation. Thus, the investigators hypothesize that omalizumab will be effective in the treatment of severe acute urticaria as add on therapy with a fast onset of action. Objective:To investigate the efficacy and safety of omalizumab in the treatment of severe acute urticaria Study design: This prospective, interventional, single-arm open label study will recruit patients with severe acute urticaria from emergency departments, hospitalized and outpatient departments. The included patients will receive a single subcutaneous dose of 300mg omalizumab therapy. The efficacy of omalizumab will be evaluated by physical examination and assessed by Urticaria Activity Score (UAS) at baseline, 1 hour, Day 1, Day3, Day 7, and 6 weeks after omalizumab therapy. The frequency and severity of treatment-emergent adverse events will also be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urticaria
Keywords
urticaria,omalizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
omalizumab
Arm Type
Experimental
Arm Description
omalizumab 300mg subcutaneously once
Intervention Type
Drug
Intervention Name(s)
omalizumab
Other Intervention Name(s)
xolair
Intervention Description
a recombinant DNA-derived humanized IgG1k monoclonal antibody that specifically binds to free human immunoglobulin E (IgE)
Primary Outcome Measure Information:
Title
Change in daily Urticaria Activity Score
Description
Change in daily UAS from baseline to Day7 in the treatment period
Time Frame
D0,1,2,3,4,5,6,7and 1 hour
Secondary Outcome Measure Information:
Title
Proportion of patient with daily UAS=0 at Day 1, Day 3
Time Frame
Day 1,3
Title
Change from baseline in itch severity score
Time Frame
Day 0,1,3
Title
Change from baseline in size of largest hive score
Time Frame
Day 0,1, 3
Title
Proportion of patient could stop H1-antihistamine treatment
Time Frame
Day 0,3
Title
Proportion of angioedema-free days
Time Frame
Day 3,4,5,6,7
Title
The frequency and severity of treatment-emergent AEs and SAEs
Time Frame
6 weeks follow-up period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 20-75 years(2)Documented diagnosis of acute urticaria within 3 years Documented diagnosis of acute urticaria within 3 years Daily UAS at the beginning of study more than or equal to 4 At time of enrollment, the symptoms of this episode had persisted longer than 3 days even under oral/intravenous antihistamines with or without oral corticosteroid therapy Exclusion Criteria: Weight < 20 kg Continuous use of suspected drugs that may induce acute urticaria Pregnant woman Evidence of parasitic infection defined as having the following three items:Risk factors for parasitic disease (living in an endemic area, chronic gastrointestinal (GI) symptoms, travel within the last 6 months to an endemic area and/or chronic immunosuppression) AND An absolute eosinophil count more than twice the upper limit of normal AND Evidence of parasitic colonization or infection on stool evaluation for ova and parasites. Note that stool ova and parasite evaluation will only be conducted in patients with both risk factors and an eosinophil count more than twice the upper limit of normal. Atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or other skin disease associated with itch Treatment with omalizumab within 12 months before screening Treatment with any investigational agent within 30 days of screening IV immunoglobulin G (IVIG), or plasmapheresis within 30 days prior to Day -14 Regular (daily/every other day) doxepin (oral) use within 6 weeks prior to Day -14 Patients with current malignancy, history of malignancy, or currently under work-up for suspected malignancy except non-melanoma skin cancer that has been treated or excised and is considered resolved Hypersensitivity to omalizumab or any component of the formulation History of anaphylactic shock Presence of clinically significant cardiovascular, neurological, psychiatric, metabolic or other pathological conditions that could interfere with the interpretation of the study results and or compromise the safety of the patients Medical examination or laboratory findings that suggest the possibility of decompensation of co-existing conditions for the duration of the study. Any items that are cause for uncertainty must be reviewed with the Medical Monitor Inability to comply with study and follow-up procedures Evidence of current drug or alcohol abuse
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hsien-Yi Chiu, MD
Phone
886-972654317
Email
extra.owl0430@yahoo.com.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Tsen-Fang Tasi, MD
Phone
886-2-23562141
Email
tftsai@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tsai Tsen-Fang
Organizational Affiliation
Department of Dermatology, National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tsai Tsen-Fang
Phone
886-972651561
Email
tftsai@yahoo.com

12. IPD Sharing Statement

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Efficacy and Safety of Omalizumab in Patients With Severe Acute Urticaria

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