Efficacy and Safety of Omalizumab in Patients With Severe Acute Urticaria

NCT02191072 | Unknown

• 1 other identifier: 201404056MIPC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Urticaria

Keywords

urticaria,omalizumab

Outcome Measures

Primary Outcomes (1)

• Change in daily Urticaria Activity Score

  Change in daily UAS from baseline to Day7 in the treatment period

  D0,1,2,3,4,5,6,7and 1 hour

Secondary Outcomes (6)

• Proportion of patient with daily UAS=0 at Day 1, Day 3

  Day 1,3

• Change from baseline in itch severity score

  Day 0,1,3

• Change from baseline in size of largest hive score

  Day 0,1, 3

• Proportion of patient could stop H1-antihistamine treatment

  Day 0,3

• Proportion of angioedema-free days

  Day 3,4,5,6,7

Study Arms (1)

omalizumab

EXPERIMENTAL

omalizumab 300mg subcutaneously once

Drug: omalizumab

Interventions

omalizumab DRUG

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

Also known as: xolair

omalizumab

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Urticaria

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Tsai Tsen-Fang

  Department of Dermatology, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsien-Yi Chiu, MD

CONTACT

886-972654317; extra.owl0430@yahoo.com.tw

Tsen-Fang Tasi, MD

CONTACT

886-2-23562141; tftsai@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2014
• First Posted: July 15, 2014
• Study Start: July 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: July 15, 2014

Record last verified: 2014-07

Locations

TW (1)