Etanercept for the Treatment of Chronic Urticaria

NCT01030120 | Withdrawn Phase 2 DMC

• 1 other identifier: 36414
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of etanercept for patients with chronic idiopathic urticaria unresponsive to antihistamines.

Conditions

Chronic Idiopathic Urticaria

Keywords

chronic idiopathic urticaria; etanercept

Outcome Measures

Primary Outcomes (1)

• 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

  12 weeks

Secondary Outcomes (1)

• Study the safety of etanercept in the treatment of CIU

  12 weeks

Study Arms (2)

etanercept

ACTIVE COMPARATOR

etanercept 50mg BIW

Drug: etanercept

placebo

PLACEBO COMPARATOR

matching placebo

Drug: placebo

Interventions

etanercept DRUG

etanercept 50mg BIW S.Q.

Also known as: enbrel

etanercept

placebo DRUG

placebo

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Department of Dermatology

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Chronic Urticaria

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Christopher Hull, MD

  University of Utah Department of Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 9, 2009
• First Posted: December 11, 2009
• Study Start: December 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: October 1, 2012
• Last Updated: June 2, 2015

Record last verified: 2015-05

Locations

US (1)