Chronic Idiopathic UrticariaPhase 2/3EtanerceptCIUNCT01030120
Etanercept for the Treatment of Chronic Urticaria
A Phase 2/3 study testing etanercept in people with Chronic Idiopathic Urticaria, run by University of Utah at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of etanercept for patients with chronic idiopathic urticaria unresponsive to antihistamines. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Idiopathic Urticaria
- What is being tested?
- etanercept
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Oct 2012
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- History of CIU occurring at least biweekly for greater than 6 week
- Adult subjects between the ages of 18-70 years
- Failure to respond to systemic antihistaminic therapy
- Negative TB skin testing at baseline
- Subjects willing to comply with study requirements
- Negative urine pregnancy test at enrollment
- Voluntarily sign and date informed consent form
Who cannot join
- Current enrollment in any other investigational device or investigational drug trial(s), or receipt of any other investigational agent(s) within 28 days before baseline visit.
- Known hypersensitivity to Enbrel® (etanercept) or any of its components or known to have antibodies to etanercept.
- Latex sensitivity
- Prior or concurrent use of cyclophosphamide therapy
- Concurrent sulfasalazine therapy.
- Known HIV-positive status or known history of any other immuno-suppressing disease.
Show all 21Show fewer
- Any mycobacterial disease or high risk factors for tuberculosis (TB), such as family member with TB, positive purified protein derivative (PPD) or taking anti-tuberculosis medication
- Active or chronic infection within 4 weeks before screening visit, or between the screening and baseline visits.
- Severe comorbidities (diabetes mellitus requiring insulin; CHF of any severity or myocardial infarction or cerebrovascular accident or transient ischemic attack within 3 months of screening visit; unstable angina pectoris, uncontrolled hypertension (sitting systolic BP <80 mm Hg or > 160 or diastolic BP > 100 mm Hg), oxygen-dependent severe pulmonary disease, history of cancer within 5 years [other than resected cutaneous basal or squamous cell carcinoma of the skin or in situ cervical cancer])
- Exposure to hepatitis B or hepatitis C or to high risk factors for hepatitis B or C, such as intravenous drug use in patient.
- Systemic lupus erythematosus, history of multiple sclerosis, transverse myelitis, optic neuritis or seizure disorder.
- Use of a live vaccine 90 days prior to screening visit, or concurrent use of a live vaccine..
- Any condition or circumstances judged by the patient's investigator to render this clinical trial detrimental or otherwise unsuitable for the patient's participation.
- History of non-compliance with other therapies.
- Concurrent use of anakinra.
- Use of systemic immunosuppressive medication within 2 weeks of enrollment
- Use of dapsone, sulfapyridine, sulfasalazine, or colchicine within 2 weeks of enrollment
- Use of systemic corticosteroid within 2 weeks of enrollment
- For females of childbearing potential, a refusal to use an acceptable form of contraceptive including oral or patch birth control, injectable birth control, intrauterine device, surgical sterilization, condom, barrier, or spermicide, post-menopausal, or complete abstinence from sexual activity.
- For females, pregnancy, breast-feeding, or lactation
- Active or recent (within the previous month) infection by staphylococcus aureus
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Department of Dermatology
Salt Lake City, Utah, 84132
About this study
Official title: A 6 Week Randomized, Double Blind, Placebo-controlled Study With a 6 Week Open Label Extension to Assess the Efficacy of Etanercept in the Treatment of Chronic Idiopathic Urticaria
The purpose of this study is to evaluate the safety and efficacy of etanercept for patients with chronic idiopathic urticaria unresponsive to antihistamines.
Read the detailed description
Chronic urticaria is a common condition which can be debilitating, difficult to treat, and sometimes life-threatening. Approximately 15-25% of the population is affected by urticaria at least once in their lifetime, and chronic urticaria develops in more than 25% of these cases. Chronic urticaria is characterized by frequent, often daily, development of pruritic wheals of 6 weeks duration or longer. The average duration of chronic urticaria is 3-5 years in adults. In the majority of cases, an underlying trigger for the urticaria is not identified and these cases are referred to as idiopathic (CIU). These considerations have led to the hypothesis that CIU may have an autoimmune etiology.
CIU is a major affliction causing serious disability to a degree equal to that experienced by sufferers from coronary artery disease. Antihistamines are the most common therapy used. However, most cases of CIU are resistant to combinations of antihistamines and other therapies. In addition, patients are often intolerant to the side effects of antihistamines including sedation and cognitive dysfunction. The treatment of CIU patients can be frustrating. For those who do not respond to typical treatments, other therapies are needed. In many patients, immunosuppressant medications are required but this can lead to adverse effects such as renal dysfunction, liver function abnormalities, and anemia. A safer and more efficacious therapy is clearly needed for CIU.
A few preclinical investigations have demonstrated an upregulation of TNF-alpha in patients with CIU. This is in contrast to acute urticaria where TNF-alpha does not appear to play as important of a role in the inflammatory response . This may explain why patients with CIU do not typically respond to usual therapies for acute urticaria. It has been suggested that CIU is an immediate hypersensitivity phenomenon appearing immediately after exposure to an antigen, but the presence of a delayed inflammatory phase is nevertheless observed in this pathology. Soluble factors play a role in this delayed inflammatory phase. Cytokines, including TNF-alpha, are important mediators the pathogenesis of this delayed response. Studies have demonstrated a similar immune profile as that found in patients with rheumatoid arthritis. In one study, cytokines were evaluated in lesional and non-lesional skin of patients with acute urticaria, CIU, delayed pressure urticaria, and cold urticaria. This study demonstrated upregulation of TNF-alpha on endothelial cells and perivascular cells in the dermis. Additionally, TNF-alpha was expressed throughout the epidermis in lesional and non-lesional skin of CIU patients, but not controls. These preclinical investigations support the use of targeted therapy of TNF-alpha in patients with CIU. Therapies directed at modulating the effects of TNF-alpha, including etanercept, may provide effective and safe long-term treatment for patients not responding to anti-histamines alone.
HYPOTHESIS: We hypothesize that the blockage of TNF with etanercept could be a useful and safe therapy for patients with CIU.
OBJECTIVES:
Primary Objective: To determine the efficacy of etanercept on the clinical features of CIU. A positive response to treatment (a % change from baseline of urticaria activity scores
Secondary Objective: Study the safety of etanercept in the treatment of CIU
- Conditions
- Chronic Idiopathic Urticaria
- Being tested
- etanercept, placebo
- Keywords
- chronic idiopathic urticaria, etanercept
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etanerceptDrug
Also called enbrel
etanercept 50mg BIW S.Q.
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| etanercept | Active comparator | etanercept 50mg BIW Receives: Drug: etanercept |
| placebo | Placebo comparator | matching placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the efficacy of etanercept on the clinical features of CIU. A positive response to treatment (a % change from baseline of urticaria activity scores
Measured: 12 weeks
Secondary outcomes (1)
Study the safety of etanercept in the treatment of CIU
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2009 (estimated)
- Study startDec 2010
- Primary completionJul 2012 (estimated)
- Study completionOct 2012 (estimated)
Why it stopped: Unable to complete agreement with sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Idiopathic UrticariaStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Investigators
- Christopher Hull, MD, Principal investigator, University of Utah Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01030120
- Sponsor's protocol ID
- 36414
- Acronym
- EtanerceptCIU
- Status last verified
- May 2015
- First submitted
- 9 Dec 2009
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6 Week Randomized, Double Blind, Placebo-controlled Study With a 6 Week Open Label Extension to Assess the Efficacy of Etanercept in the Treatment of Chronic Idiopathic Urticaria
- ClinicalTrials.gov ID
- NCT01030120
- Acronym / sponsor ID
- EtanerceptCIU / 36414
- Conditions
- Chronic Idiopathic Urticaria
- Keywords
- chronic idiopathic urticaria, etanercept
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to complete agreement with sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 11 Dec 2009 (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.
The purpose of this study is to evaluate the safety and efficacy of etanercept for patients with chronic idiopathic urticaria unresponsive to antihistamines.
Detailed description
Chronic urticaria is a common condition which can be debilitating, difficult to treat, and sometimes life-threatening. Approximately 15-25% of the population is affected by urticaria at least once in their lifetime, and chronic urticaria develops in more than 25% of these cases. Chronic urticaria is characterized by frequent, often daily, development of pruritic wheals of 6 weeks duration or longer. The average duration of chronic urticaria is 3-5 years in adults. In the majority of cases, an underlying trigger for the urticaria is not identified and these cases are referred to as idiopathic (CIU). These considerations have led to the hypothesis that CIU may have an autoimmune etiology.
CIU is a major affliction causing serious disability to a degree equal to that experienced by sufferers from coronary artery disease. Antihistamines are the most common therapy used. However, most cases of CIU are resistant to combinations of antihistamines and other therapies. In addition, patients are often intolerant to the side effects of antihistamines including sedation and cognitive dysfunction. The treatment of CIU patients can be frustrating. For those who do not respond to typical treatments, other therapies are needed. In many patients, immunosuppressant medications are required but this can lead to adverse effects such as renal dysfunction, liver function abnormalities, and anemia. A safer and more efficacious therapy is clearly needed for CIU.
A few preclinical investigations have demonstrated an upregulation of TNF-alpha in patients with CIU. This is in contrast to acute urticaria where TNF-alpha does not appear to play as important of a role in the inflammatory response . This may explain why patients with CIU do not typically respond to usual therapies for acute urticaria. It has been suggested that CIU is an immediate hypersensitivity phenomenon appearing immediately after exposure to an antigen, but the presence of a delayed inflammatory phase is nevertheless observed in this pathology. Soluble factors play a role in this delayed inflammatory phase. Cytokines, including TNF-alpha, are important mediators the pathogenesis of this delayed response. Studies have demonstrated a similar immune profile as that found in patients with rheumatoid arthritis. In one study, cytokines were evaluated in lesional and non-lesional skin of patients with acute urticaria, CIU, delayed pressure urticaria, and cold urticaria. This study demonstrated upregulation of TNF-alpha on endothelial cells and perivascular cells in the dermis. Additionally, TNF-alpha was expressed throughout the epidermis in lesional and non-lesional skin of CIU patients, but not controls. These preclinical investigations support the use of targeted therapy of TNF-alpha in patients with CIU. Therapies directed at modulating the effects of TNF-alpha, including etanercept, may provide effective and safe long-term treatment for patients not responding to anti-histamines alone.
HYPOTHESIS: We hypothesize that the blockage of TNF with etanercept could be a useful and safe therapy for patients with CIU.
OBJECTIVES:
Primary Objective: To determine the efficacy of etanercept on the clinical features of CIU. A positive response to treatment (a % change from baseline of urticaria activity scores
Secondary Objective: Study the safety of etanercept in the treatment of CIU
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| etanercept | Active comparator | Drug: etanerceptetanercept 50mg BIW |
| placebo | Placebo comparator | Drug: placebomatching placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- History of CIU occurring at least biweekly for greater than 6 week
- Adult subjects between the ages of 18-70 years
- Failure to respond to systemic antihistaminic therapy
- Negative TB skin testing at baseline
- Subjects willing to comply with study requirements
Key exclusion criteria (21 listed)
- Current enrollment in any other investigational device or investigational drug trial(s), or receipt of any other investigational agent(s) within 28 days before baseline visit.
- Known hypersensitivity to Enbrel® (etanercept) or any of its components or known to have antibodies to etanercept.
- Latex sensitivity
- Prior or concurrent use of cyclophosphamide therapy
- Concurrent sulfasalazine therapy.
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 |
|---|---|---|
| etanerceptAlso: enbreletanercept 50mg BIW S.Q. | Drug | etanercept |
| placeboplacebo | Drug | placebo |
Primary outcome
To determine the efficacy of etanercept on the clinical features of CIU. A positive response to treatment (a % change from baseline of urticaria activity scores
Time frame: 12 weeks
1 secondary outcome
Study the safety of etanercept in the treatment of CIU
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
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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.
Christopher Hull, MD principal investigator
University of Utah Department of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing etanercept in people with Chronic Idiopathic Urticaria, run by University of Utah at 1 site in United States.
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 7 inclusion and 21 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: withdrawn, as of the sponsor's last update on 2 Jun 2015. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the efficacy of etanercept on the clinical features of CIU. A positive response to treatment (a % change from baseline of urticaria activity scores (time frame: 12 weeks). 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 2 Jun 2015.