Efficacy and Safety Study of Omalizumab (Xolair®) to Treat Chronic Urticaria

Conditions

• Chronic Urticaria

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Omalizumab — BIOLOGICAL
  * Two injections will be administered the first two weeks * The following three injections will be administered every four weeks Consequently, we will administer 5 doses within 14 weeks
• Placebo — BIOLOGICAL
  * Two injections will be administered the first two weeks * The following three injections will be administered every four weeks Consequently, we will administer 5 doses within 14 weeks

Study Details

Chronic urticaria can be defined as the occurrence of widespread daily or almost daily wheals for at least 6 weeks, which may be accompanied by angioedema. While the wheals are transient, the resolution of angioedema is slower than wheals and could take up to 72 hours. The natural course of chronic urticaria is self-limited, with spontaneous remissions and occasional relapses. The investigators calculated a 0.6% (95% CI(Confidence Interval): 0.4-0.8) prevalence in a population study. It has a great impact on patients' quality of life. In a recent national survey on patients attending Allergy Department, chronic urticaria was the disease with greater impact on mental quality of life out of all allergic diseases. In spite of the high morbidity of this disease and the impact in quality of life, there is no available treatment. Last guidelines recommend initiating treatment with antihistamine and if there is no response to increase the dose off-label up to four-fold; systemic corticosteroids are also recommended in short tapering and if no response, the only treatment with clinical evidence to be employed is cyclosporine. As additional data, the treatment cost of this disease has been calculated in 2047$/year. In past years it has been employed the monoclonal humanized anti-Immunoglobulin IgE (iGE) antibody (Omalizumab) to treat moderate to severe asthma with good results. The rationale for this approach in chronic urticaria is that Omalizumab inhibits the binding of IgE to the high affinity IgE receptor (FceRI) which decreases the FceRI expression on the surface of mast cells and basophils so that immunoglobulin G cross linking of the alpha subunit and basophil degranulation is prevented.The hypothesis the investigators are working on is that monoclonal IgE antibody Omalizumab could be effective in controlling chronic urticaria symptoms in patients non respondent to conventional therapy. The investigators hypothesize that Omalizumab is able to revert the basophil or mast cell activation present in chronic urticaria.

Key Dates

Start date

Mar 31, 2012

Status verified

Apr 2017

Primary completion

Feb 29, 2016

Completion

Jun 30, 2017

Study Design

Enrollment

20 participants (actual)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Active Comparator: Omalizumab 300 mg
  * Subcutaneous route * 300 mg dose (independent from total IgE, weight or high)
• Placebo Comparator: Placebo
  * Saline serum * Subcutaneous route * 0.6 ml saline serum with same volume as an active treatment

Primary Outcome Measure

Symptom's control as measured by the UAS7 [ Time Frame: One year ]