UrticariaNCT02191072
Efficacy and Safety of Omalizumab in Patients With Severe Acute Urticaria
A study testing omalizumab in people with Urticaria, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Urticaria
- What is being tested?
- omalizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2014to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital
Taipei, Taipei, 100
Tsai Tsen-Fang, 886-972651561, tftsai@yahoo.com
About this study
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
Read the 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
- Being tested
- omalizumab
- Keywords
- urticaria,omalizumab
- Medical subject headings
- Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omalizumabDrug
Also called xolair
a recombinant DNA-derived humanized IgG1k monoclonal antibody that specifically binds to free human immunoglobulin E (IgE)
| Study group | Role | What they receive |
|---|---|---|
| omalizumab | Experimental | omalizumab 300mg subcutaneously once Receives: Drug: omalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in daily Urticaria Activity Score
Change in daily UAS from baseline to Day7 in the treatment period
Measured: 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
Measured: Day 1,3
Change from baseline in itch severity score
Measured: Day 0,1,3
Change from baseline in size of largest hive score
Measured: Day 0,1, 3
Proportion of patient could stop H1-antihistamine treatment
Measured: Day 0,3
Proportion of angioedema-free days
Measured: Day 3,4,5,6,7
The frequency and severity of treatment-emergent AEs and SAEs
Measured: 6 weeks follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionMay 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrticariaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tsai Tsen-Fang, Principal investigator, Department of Dermatology, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191072
- Sponsor's protocol ID
- 201404056MIPC
- Status last verified
- Jul 2014
- First submitted
- 9 Jul 2014
- Last updated
- 15 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Omalizumab in Patients With Severe Acute Urticaria
- ClinicalTrials.gov ID
- NCT02191072
- Acronym / sponsor ID
- 201404056MIPC
- Conditions
- Urticaria
- Keywords
- urticaria,omalizumab
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 15 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| omalizumab | Experimental | Drug: omalizumabomalizumab 300mg subcutaneously once |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| omalizumabAlso: xolaira recombinant DNA-derived humanized IgG1k monoclonal antibody that specifically binds to free human immunoglobulin E (IgE) | Drug | omalizumab |
Primary outcome
Change in daily Urticaria Activity Score
Time frame: D0,1,2,3,4,5,6,7and 1 hour
Change in daily UAS from baseline to Day7 in the treatment period
6 secondary outcomes
Proportion of patient with daily UAS=0 at Day 1, Day 3
Time frame: Day 1,3
Change from baseline in itch severity score
Time frame: Day 0,1,3
Change from baseline in size of largest hive score
Time frame: Day 0,1, 3
Proportion of patient could stop H1-antihistamine treatment
Time frame: Day 0,3
Proportion of angioedema-free days
Time frame: Day 3,4,5,6,7
The frequency and severity of treatment-emergent AEs and SAEs
Time frame: 6 weeks follow-up period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tsai Tsen-Fang principal investigator
Department of Dermatology, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing omalizumab in people with Urticaria, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hsien-Yi Chiu, MD (886-972654317, extra.owl0430@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in daily Urticaria Activity Score (time frame: D0,1,2,3,4,5,6,7and 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2014.