NCT01713725

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2012

Longer than P75 for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 25, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

October 24, 2017

Status Verified

April 1, 2017

Enrollment Period

3.9 years

First QC Date

October 22, 2012

Last Update Submit

October 23, 2017

Conditions

Chronic Urticaria

Keywords

Chronic urticariaChronic spontaneous urticariaAutoimmune and non autoimmune urticariaUAS7

Outcome Measures

Primary Outcomes (1)

  • Symptom's control as measured by the UAS7

    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 Outcomes (2)

  • Use of Medication

    One year

  • Quality of life score (CU-Q2oL)

    One year

Other Outcomes (2)

  • Treatments drops off

    One year

  • Days off

    One year

Study Arms (2)

Omalizumab 300 mg

ACTIVE COMPARATOR

* Subcutaneous route * 300 mg dose (independent from total IgE, weight or high)

Biological: OmalizumabBiological: Placebo

Placebo

PLACEBO COMPARATOR

* Saline serum * Subcutaneous route * 0.6 ml saline serum with same volume as an active treatment

Biological: OmalizumabBiological: Placebo

Interventions

OmalizumabBIOLOGICAL

* 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

Also known as: Xolair
Omalizumab 300 mgPlacebo
PlaceboBIOLOGICAL

* 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

Also known as: Saline serum
Omalizumab 300 mgPlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 other condition that do not allow to accomplish the clinical trial requisites as use of drugs, alcohol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital Santiago Apostol

Vitoria-Gasteiz, Alava, 01004, Spain

Location

Clinica Universitaria de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital de Basurto

Bilbao, Vizvaya, 48013, Spain

Location

Hospital Clinic

Barcelona, 08036, Spain

Location

Related Publications (6)

  • Ferrer M, Gamboa P, Sanz ML, Goikoetxea MJ, Cabrera-Freitag P, Javaloyes G, Berroa F, Kaplan AP. Omalizumab is effective in nonautoimmune urticaria. J Allergy Clin Immunol. 2011 May;127(5):1300-2. doi: 10.1016/j.jaci.2010.12.1085. Epub 2011 Feb 11. No abstract available.

    PMID: 21315432BACKGROUND

  • Gaig P, Olona M, Munoz Lejarazu D, Caballero MT, Dominguez FJ, Echechipia S, Garcia Abujeta JL, Gonzalo MA, Lleonart R, Martinez Cocera C, Rodriguez A, Ferrer M. Epidemiology of urticaria in Spain. J Investig Allergol Clin Immunol. 2004;14(3):214-20.

    PMID: 15552715BACKGROUND

  • Ferrer M. Epidemiology, healthcare, resources, use and clinical features of different types of urticaria. Alergologica 2005. J Investig Allergol Clin Immunol. 2009;19 Suppl 2:21-6.

    PMID: 19530414BACKGROUND

  • Mathias SD, Crosby RD, Zazzali JL, Maurer M, Saini SS. Evaluating the minimally important difference of the urticaria activity score and other measures of disease activity in patients with chronic idiopathic urticaria. Ann Allergy Asthma Immunol. 2012 Jan;108(1):20-24. doi: 10.1016/j.anai.2011.09.008. Epub 2011 Nov 2.

    PMID: 22192960BACKGROUND

  • Saini S, Rosen KE, Hsieh HJ, Wong DA, Conner E, Kaplan A, Spector S, Maurer M. A randomized, placebo-controlled, dose-ranging study of single-dose omalizumab in patients with H1-antihistamine-refractory chronic idiopathic urticaria. J Allergy Clin Immunol. 2011 Sep;128(3):567-73.e1. doi: 10.1016/j.jaci.2011.06.010. Epub 2011 Jul 18.

    PMID: 21762974BACKGROUND

  • Valero A, Herdman M, Bartra J, Ferrer M, Jauregui I, Davila I, del Cuvillo A, Montoro J, Mullol J, Sastre J, Canonica GW, Baiardini I. Adaptation and validation of the Spanish version of the Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL). J Investig Allergol Clin Immunol. 2008;18(6):426-32.

    PMID: 19123433BACKGROUND

MeSH Terms

Conditions

Chronic Urticaria

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

UrticariaSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Anti-IdiotypicAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalSerum GlobulinsGlobulins

Study Officials

  • Marta Ferrer, MD, PhD

    Clinica Universitaria, Universidad de Navarra

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2012

First Posted

October 25, 2012

Study Start

March 1, 2012

Primary Completion

February 1, 2016

Study Completion

June 1, 2017

Last Updated

October 24, 2017

Record last verified: 2017-04

Locations

ES(4)