Efficacy and Safety of Omalizumab in Patients With Severe Acute Urticaria

NCT ID: NCT02191072

Last Updated: 2014-07-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-05-31

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.

Conditions

Urticaria

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

omalizumab

omalizumab 300mg subcutaneously once

Group Type: EXPERIMENTAL

omalizumab

Intervention Type: DRUG

a recombinant DNA-derived humanized IgG1k monoclonal antibody that specifically binds to free human immunoglobulin E (IgE)

Interventions

omalizumab

a recombinant DNA-derived humanized IgG1k monoclonal antibody that specifically binds to free human immunoglobulin E (IgE)

Intervention Type: DRUG

Other Intervention Names

xolair

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tsai Tsen-Fang

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, Taipei, Taiwan

Countries

Taiwan

Central Contacts

Hsien-Yi Chiu, MD

Role: CONTACT

extra.owl0430@yahoo.com.tw

886-972654317

Tsen-Fang Tasi, MD

Role: CONTACT

tftsai@yahoo.com

886-2-23562141

Facility Contacts

Tsai Tsen-Fang

Role: primary

tftsai@yahoo.com

886-972651561

Other Identifiers

201404056MIPC

Identifier Type: -

Identifier Source: org_study_id