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

October 23, 2017 updated by: Clinica Universidad de Navarra, Universidad de Navarra

Multicenter, Double- Blinded, Placebo- Controlled, Randomized, Cross-over (2x2) Clinical Trial, to Assess Efficacy and Safety of a New Indication for Omalizumab (Xolair®, Novartis) in Autoimmune and no Autoimmune Chronic Urticaria.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of the present study is to demonstrate with an adequate methodology the efficacy and safety of Omalizumab for a new indication that is chronic autoimmune and no autoimmune urticaria. For that purpose, The investigators will perform a Multicenter double- blinded, placebo- controlled, randomized cross-over (2x2) trial. The investigators will include 20 patients including both female and male adults non respondent to antihistamines at supra therapeutic dose. Efficacy will be evaluated through the Urticaria Activity Score 7 (UAS7), Chronic Urticaria Quality of Life validated questionnaire, patients' symptoms card and use of medication. Dropouts in each treatment group will be also evaluated. The investigators will also record leave days because of urticaria and Emergency Department visits, as well as adverse reactions during treatment.

The present study would allow to offer to the Health System an evidence to evaluate the convenience or not to approve the use of Omalizumab for the new indication of chronic urticaria treatment. It is important to take into account that in the present study the investigators will include both autoimmune and non-autoimmune urticaria, since the efficacy could differ between both urticaria types. In the same way, the Health Authorities (AEMPS) would have independent additional information obtained through adequate methodology in the case that a new indication is requested. The investigators also want to stress that in the near future the company that manufactures this antibody could ask for a new indication for chronic urticaria.

A third outcome expected is to offer information on the lasting effect of the drug that is symptoms' free weeks after the dose. This information would be provided from the washing period data and from those patients who were allocated of placebo after the active drug arm. This would give much needed information on the best dosing scheduling protocol.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clínic
    • Alava
      • Vitoria, Alava, Spain, 01004
        • Hospital Santiago Apostol
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Clinica Universitaria de Navarra
    • Vizvaya
      • Bilbao, Vizvaya, Spain, 48013
        • Hospital de Basurto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult female and male patients
  • Diagnosis of chronic autoimmune or non autoimmune urticaria
  • The investigators defined chronic urticarial 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.
  • No response to therapeutic doses of antihistamines
  • The investigators define therapeutic doses of antihistamines the maximal dose included in the drug labeling
  • Written informed consent.

Exclusion Criteria:

  • Urticaria vasculitis or any kind of physical urticaria
  • Total IgE value above 700 UI/l
  • Pruritus related to dermatitis or other skin condition
  • Any systemic disease that do not allow to follow up or interpretation data
  • Omalizumab treatment within the previous 12 months
  • Treatment with corticosteroids or immunosuppressive drugs within the previous 4 weeks
  • Any exclusion criteria included in the drug labeling
  • Any other condition that do not allow to accomplish the clinical trial requisites as use of drugs, alcohol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Omalizumab 300 mg
  • Subcutaneous route
  • 300 mg dose (independent from total IgE, weight or high)
Biological: Omalizumab
  • 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
Other Names:
  • Xolair
Biological: Placebo
  • 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
Other Names:
  • Saline serum
Placebo Comparator: Placebo
  • Saline serum
  • Subcutaneous route
  • 0.6 ml saline serum with same volume as an active treatment
Biological: Omalizumab
  • 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
Other Names:
  • Xolair
Biological: Placebo
  • 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
Other Names:
  • Saline serum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom's control as measured by the UAS7
Time Frame: One year
The Urticaria Activity Score 7 measures number the weekly average of hives and pruritus measured twice a day. It scores from 0 to 42
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of Medication
Time Frame: One year
Two antihistamines and corticosteroids are allowed as rescue medication that would be recorded by the patient.
One year
Quality of life score (CU-Q2oL)
Time Frame: One year
Specific QOL score for chronic urticaria.It includes 23 items categorized under the following scales: limits looks, swelling/eating, functioning, sleep, mental status, and itching/embarrassment.
One year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatments drops off
Time Frame: One year
Number of patients that abandon the study due to lack of control of the disease
One year
Days off
Time Frame: One year
Days off from work due to chronic urticaria symptoms
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Collaborators

Hospital Clinic of Barcelona
Complejo Hospitalario de Navarra
Hospital Universitari Joan XXIII de Tarragona.
Hospital Vall d'Hebron
Hospital Universitario Central de Asturias
Hospital Clínico Universitario Lozano Blesa
Gregorio Marañón Hospital

Investigators

  • Principal Investigator: Marta Ferrer, MD, PhD, Clinica Universitaria, Universidad de Navarra

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2012

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

October 22, 2012

First Submitted That Met QC Criteria

October 24, 2012

First Posted (Estimate)

October 25, 2012

Study Record Updates

Last Update Posted (Actual)

October 24, 2017

Last Update Submitted That Met QC Criteria

October 23, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CUN-OMAL-CU-2010
  • 2010-024113-31 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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