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Omalizumab in Chronic Spontaneous Urticaria Patients Non Responding to Initial Standard antihistaminE Treatment

NCT ID: NCT02550106

Last Updated: 2020-02-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-22

Study Completion Date

2016-01-11

Brief Summary

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Evaluate the proportion of patients with an urticaria control test \[UCT\] score of greater than or equal to 12 at Week 12.

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Detailed Description

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Conditions

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CHRONIC SPONTANEOUS URTICARIA

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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OMALIZUMAB

sub cutaneous injections of 300 mg every 4 weeks until Week 8.

Group Type EXPERIMENTAL

OMALIZUMAB

Intervention Type DRUG

sub cutaneous injections of 300 mg every 4 weeks until Week 8.

Interventions

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OMALIZUMAB

sub cutaneous injections of 300 mg every 4 weeks until Week 8.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female patients aged between 18 and 75 years.
* Diagnosis of CSU for ≥ 6 months and an inadequate response to nsH1 antihistamines at the time of the request, as defined by the following:
* The presence of itch and hives for \> 6 consecutive weeks at any time prior to enrollment, despite current use of H1 antihistamine therapy during this time period.
* Weekly UAS7 score (range 0 to 42) 16 and UCT score (range 0 to 16) \< 8 prior to enrollment (Day 1)
* Current use of an H1 antihistamine for CSU on the day of the initial visit and Day
* Informed consent

Exclusion Criteria

* Treatment with an investigational agent within 30 days before enrollment.
* Routine (daily or every other day during 5 or more consecutive days) doses of the following medications within 30 days prior to Day -7: systemic or cutaneous (topical) corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide.
* Intravenous (i.v.) immunoglobulin G or plasmapheresis within 30 days prior to Day -7
* Regular (daily/every other day) doxepin (oral) use within 14 days prior to Day -7.
* Any H2 antihistamine use within 7 days prior to Day -7.
* Any leukotriene receptor antagonist (LTRA) (montelukast or zafirlukast) within 7 days prior to Day 7.
* Concomitant use of cyclosporine or any other immunosuppressive agent.
* Hypersensitivity to omalizumab or any component of the formulation.
* History of anaphylactic shock.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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CLAIRE BERNIER TAUGOURDEAU

Role: PRINCIPAL_INVESTIGATOR

HOPITAL HOTEL DIEU - NANTES CEDEX 1

PASCAL JOLY

Role: PRINCIPAL_INVESTIGATOR

HOPITAL CHARLES NICOLLE - ROUEN CEDEX

LUDOVIC MARTIN

Role: PRINCIPAL_INVESTIGATOR

HOTEL DIEU - ANGERS CEDEX 9

GERARD GUILLET

Role: PRINCIPAL_INVESTIGATOR

CHR LA MILETRIE - POITIERS CEDEX

PATRICE PLANTIN

Role: PRINCIPAL_INVESTIGATOR

CHI DE CORNOUAILLE - QUIMPER CEDEX

ALAIN DUPUY

Role: PRINCIPAL_INVESTIGATOR

HOPITAL PONTCHAILLOU - RENNES CEDEX 9

EVELYNE COLLET

Role: PRINCIPAL_INVESTIGATOR

CHU SITE DU BOCAGE - DIJON CEDEX

ANNICK BARBAUD

Role: PRINCIPAL_INVESTIGATOR

HOPITAUX DE BRABOIS - VANDOEUVRE LES NANCY CEDEX

ZIAD REGUIAI

Role: PRINCIPAL_INVESTIGATOR

HOPITAL ROBERT DEBRE - REIMS CEDEX

FABIEN PELLETIER

Role: PRINCIPAL_INVESTIGATOR

HOPITAL JEAN MINJOZ - BESANCON CEDEX

DELPHINE STAUMONT SALLE

Role: PRINCIPAL_INVESTIGATOR

HOPITAL CLAUDE HURIEZ- LILLE CEDEX

JULIETTE JEGOU

Role: PRINCIPAL_INVESTIGATOR

CH DE CHALONS EN CHAMPAGNE - CHALONS EN CHAMPAGNE CEDEX

EMMANUELLE AMSLER

Role: PRINCIPAL_INVESTIGATOR

HOPITAL TENON - PARIS CEDEX 20

OLIVIER CHOSIDOW

Role: PRINCIPAL_INVESTIGATOR

HOPITAL HENRI MONDOR - CRETEIL

VINCENT DESCAMPS

Role: PRINCIPAL_INVESTIGATOR

HOPITAL BICHAT CLAUDE BERNARD - PARIS CEDEX 18

EMMANUEL MAHE

Role: PRINCIPAL_INVESTIGATOR

CH VICTOR DUPOUY - ARGENTEUIL CEDEX

LILIANE LAROCHE

Role: PRINCIPAL_INVESTIGATOR

HOPITAL AVICENNE - BOBIGNY CEDEX

GERMAINE GABISON

Role: PRINCIPAL_INVESTIGATOR

HOPITAL SAINT LOUIS - PARIS CEDEX 10

SELIM ARACTINGI

Role: PRINCIPAL_INVESTIGATOR

HOPITAL COCHIN - PARIS

LAURENCE BOUILLET

Role: PRINCIPAL_INVESTIGATOR

CHU DE GRENOBLE - LA TRONCHE

JEAN-JACQUES GROB

Role: PRINCIPAL_INVESTIGATOR

HOPITAL TIMONE - MARSEILLE CEDEX 05

FREDERIC CAMBAZARD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT ETIENNE - ST PRIEST EN JAREZ CEDEX

THIERRY BOYE

Role: PRINCIPAL_INVESTIGATOR

HIA SAINTE ANNE - TOULON CEDEX 9

JEAN-PHILIPPE LACOUR

Role: PRINCIPAL_INVESTIGATOR

HOPITAL DE L'ARCHET - NICE CEDEX 3

PHILIPPE BERBIS

Role: PRINCIPAL_INVESTIGATOR

HOPITAL NORD- MARSEILLE

LAURENT MEUNIER

Role: PRINCIPAL_INVESTIGATOR

HOPITAL CAREMEAU - NIMES CEDEX 9

FRANCOISE GIORDANO LABADIE

Role: PRINCIPAL_INVESTIGATOR

HOPITAL LARREY - TOULOUSE CEDEX 9

NADIA RAISON PEYRON

Role: PRINCIPAL_INVESTIGATOR

HOPITAL ST ELOI - MONTPELLIER CEDEX 5

MARIE CHRISTINE FERRIER LE BOUEDEC

Role: PRINCIPAL_INVESTIGATOR

CHU ESTAING - CLERMONT FERRAND

MARIE SYLVIE DOUTRE

Role: PRINCIPAL_INVESTIGATOR

HOPITAL DE HAUT LEVEQUE - PESSAC CEDEX

BRIGITTE MILPIED

Role: PRINCIPAL_INVESTIGATOR

HOPITAL ST ANDRE - BORDEAUX CEDEX

CHRISTOPHE BEDANE

Role: PRINCIPAL_INVESTIGATOR

HOPITAL DUPUYTREN - LIMOGES CEDEX 1

PHILIPPE MODIANO

Role: PRINCIPAL_INVESTIGATOR

HOPITAL ST VINCENT DE PAUL - LILLE CEDEX

Locations

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Novartis Investigative Site

Paris, Cedex 10, France

Site Status

Novartis Investigative Site

Limoges, Haute Vienne, France

Site Status

Novartis Investigative Site

Toulon, Val De Marne, France

Site Status

Novartis Investigative Site

Angers, , France

Site Status

Novartis Investigative Site

Argenteuil, , France

Site Status

Novartis Investigative Site

Besançon, , France

Site Status

Novartis Investigative Site

Bobigny, , France

Site Status

Novartis Investigative Site

Bordeaux, , France

Site Status

Novartis Investigative Site

Châlons-en-Champagne, , France

Site Status

Novartis Investigative Site

Clermont-Ferrand, , France

Site Status

Novartis Investigative Site

Dijon, , France

Site Status

Novartis Investigative Site

Grenoble, , France

Site Status

Novartis Investigative Site

Lille, , France

Site Status

Novartis Investigative Site

Lille, , France

Site Status

Novartis Investigative Site

Lyon, , France

Site Status

Novartis Investigative Site

Marseille, , France

Site Status

Novartis Investigative Site

Montpellier, , France

Site Status

Novartis Investigative Site

Nantes, , France

Site Status

Novartis Investigative Site

Nice, , France

Site Status

Novartis Investigative Site

Nîmes, , France

Site Status

Novartis Investigative Site

Paris, , France

Site Status

Novartis Investigative Site

Paris, , France

Site Status

Novartis Investigative Site

Quimper, , France

Site Status

Novartis Investigative Site

Reims, , France

Site Status

Novartis Investigative Site

Rennes, , France

Site Status

Novartis Investigative Site

Rouen, , France

Site Status

Novartis Investigative Site

Saint-Etienne, , France

Site Status

Novartis Investigative Site

Toulouse, , France

Site Status

Novartis Investigative Site

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

Other Identifiers

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CIGE025EFR02

Identifier Type: -

Identifier Source: org_study_id

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