Clinical trial NCT02550106: Omalizumab in Chronic Spontaneous Urticaria Patients Non Responding to Initial Standard antihistaminE Treatment
Official title: A Phase IV, Multicenter, Single-arm and Open-label Study With Omalizumab (Xolair®) in Chronic Spontaneous Urticaria (CSU) Patients Who Remain Symptomatic Despite Antihistamine (H1) Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: CHRONIC SPONTANEOUS URTICARIA
Keywords: CHRONIC SPONTANEOUS URTICARIA
OMALIZUMAB
URTICARIA CONTROL TEST
IGE025
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2015-09-15
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Percent of Participants With an Urticaria Control Test [UCT] Score of Greater Than or Equal to 12
timeFrame: WEEK 12
Secondary outcomes:
measure: Percent of Participants With UAS7≤6 (Patients Achieving Disease Control), in Adult Patients With CSU, With or Without the Presence of Angioedema
timeFrame: WEEK 12
measure: CSU Disease Activity Using the Urticaria Activity Score (UAS7), With or Without the Presence of Angioedema
timeFrame: baseline and week 12
measure: Urticaria Control Test (UCT) Score According to the Presence of Angioedema at Baseline and Week 12
timeFrame: baseline and week 12
measure: Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 16, With or Without the Presence of Angioedema
timeFrame: week 16
measure: Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 20, With or Without the Presence of Angioedema
timeFrame: week 20
measure: Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 24, With or Without the Presence of Angioedema
timeFrame: week 24
measure: Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 28, With or Without the Presence of Angioedema
timeFrame: week 28
measure: The Quality of Life Using the Chronic Urticaria Quality of Life (CU-QoL) Questionnaire
timeFrame: baseline and week 12
measure: The Angioedema Quality of Life (AE-QoL)
timeFrame: baseline and week 12
measure: The Dermatology Life Quality Index (DLQI)
timeFrame: baseline and week 12
measure: Angioedema Activity Using the Angioedema Activity Score (AAS)
timeFrame: baseline and week 12
Other outcomes:
Locations:
city: Paris Cedex 10
country: France
facility: Novartis Investigative Site
state: Cedex 10
city: Limoges cedex
country: France
facility: Novartis Investigative Site
state: Haute Vienne
city: Toulon Cedex 9
country: France
facility: Novartis Investigative Site
state: Val De Marne
city: Angers cedex 09
country: France
facility: Novartis Investigative Site
city: Argenteuil
country: France
facility: Novartis Investigative Site
city: Besancon Cedex
country: France
facility: Novartis Investigative Site
city: Bobigny Cedex
country: France
facility: Novartis Investigative Site
city: Bordeaux Cedex
country: France
facility: Novartis Investigative Site
city: Chalons-en-Champagne
country: France
facility: Novartis Investigative Site
city: Clermont Ferrand cedex 1
country: France
facility: Novartis Investigative Site
city: Dijon
country: France
facility: Novartis Investigative Site
city: Grenoble
country: France
facility: Novartis Investigative Site
city: Lille Cedex
country: France
facility: Novartis Investigative Site
city: Lille
country: France
facility: Novartis Investigative Site
city: Lyon cedex 04
country: France
facility: Novartis Investigative Site
city: Marseille Cedex 05
country: France
facility: Novartis Investigative Site
city: Montpellier cedex 5
country: France
facility: Novartis Investigative Site
city: Nantes
country: France
facility: Novartis Investigative Site
city: Nice
country: France
facility: Novartis Investigative Site
city: Nimes Cedex
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Quimper
country: France
facility: Novartis Investigative Site
city: Reims
country: France
facility: Novartis Investigative Site
city: Rennes Cedex 9
country: France
facility: Novartis Investigative Site
city: Rouen
country: France
facility: Novartis Investigative Site
city: Saint-Etienne
country: France
facility: Novartis Investigative Site
city: Toulouse Cedex
country: France
facility: Novartis Investigative Site
city: Vandoeuvre Les Nancy
country: France
facility: Novartis Investigative Site
Study officials:
affiliation: HOPITAL HOTEL DIEU - NANTES CEDEX 1
name: CLAIRE BERNIER TAUGOURDEAU
role: PRINCIPAL_INVESTIGATOR
affiliation: HOPITAL CHARLES NICOLLE - ROUEN CEDEX
name: PASCAL JOLY
role: PRINCIPAL_INVESTIGATOR
affiliation: HOTEL DIEU - ANGERS CEDEX 9
name: LUDOVIC MARTIN
role: PRINCIPAL_INVESTIGATOR
affiliation: CHR LA MILETRIE - POITIERS CEDEX
name: GERARD GUILLET
role: PRINCIPAL_INVESTIGATOR
affiliation: CHI DE CORNOUAILLE - QUIMPER CEDEX
name: PATRICE PLANTIN
role: PRINCIPAL_INVESTIGATOR
affiliation: HOPITAL PONTCHAILLOU - RENNES CEDEX 9
name: ALAIN DUPUY
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU SITE DU BOCAGE - DIJON CEDEX
name: EVELYNE COLLET
role: PRINCIPAL_INVESTIGATOR
affiliation: HOPITAUX DE BRABOIS - VANDOEUVRE LES NANCY CEDEX
name: ANNICK BARBAUD
role: PRINCIPAL_INVESTIGATOR
affiliation: HOPITAL ROBERT DEBRE - REIMS CEDEX
name: ZIAD REGUIAI
role: PRINCIPAL_INVESTIGATOR
affiliation: HOPITAL JEAN MINJOZ - BESANCON CEDEX
name: FABIEN PELLETIER
role: PRINCIPAL_INVESTIGATOR
affiliation: HOPITAL CLAUDE HURIEZ- LILLE CEDEX
name: DELPHINE STAUMONT SALLE
role: PRINCIPAL_INVESTIGATOR
affiliation: CH DE CHALONS EN CHAMPAGNE - CHALONS EN CHAMPAGNE CEDEX
name: JULIETTE JEGOU
role: PRINCIPAL_INVESTIGATOR
affiliation: HOPITAL TENON - PARIS CEDEX 20
name: EMMANUELLE AMSLER
role: PRINCIPAL_INVESTIGATOR
affiliation: HOPITAL HENRI MONDOR - CRETEIL
name: OLIVIER CHOSIDOW
role: PRINCIPAL_INVESTIGATOR
affiliation: HOPITAL BICHAT CLAUDE BERNARD - PARIS CEDEX 18
name: VINCENT DESCAMPS
role: PRINCIPAL_INVESTIGATOR
affiliation: CH VICTOR DUPOUY - ARGENTEUIL CEDEX
name: EMMANUEL MAHE
role: PRINCIPAL_INVESTIGATOR
affiliation: HOPITAL AVICENNE - BOBIGNY CEDEX
name: LILIANE LAROCHE
role: PRINCIPAL_INVESTIGATOR
affiliation: HOPITAL SAINT LOUIS - PARIS CEDEX 10
name: GERMAINE GABISON
role: PRINCIPAL_INVESTIGATOR
affiliation: HOPITAL COCHIN - PARIS
name: SELIM ARACTINGI
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU DE GRENOBLE - LA TRONCHE
name: LAURENCE BOUILLET
role: PRINCIPAL_INVESTIGATOR
affiliation: HOPITAL TIMONE - MARSEILLE CEDEX 05
name: JEAN-JACQUES GROB
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU SAINT ETIENNE - ST PRIEST EN JAREZ CEDEX
name: FREDERIC CAMBAZARD
role: PRINCIPAL_INVESTIGATOR
affiliation: HIA SAINTE ANNE - TOULON CEDEX 9
name: THIERRY BOYE
role: PRINCIPAL_INVESTIGATOR
affiliation: HOPITAL DE L'ARCHET - NICE CEDEX 3
name: JEAN-PHILIPPE LACOUR
role: PRINCIPAL_INVESTIGATOR
affiliation: HOPITAL NORD- MARSEILLE
name: PHILIPPE BERBIS
role: PRINCIPAL_INVESTIGATOR
affiliation: HOPITAL CAREMEAU - NIMES CEDEX 9
name: LAURENT MEUNIER
role: PRINCIPAL_INVESTIGATOR
affiliation: HOPITAL LARREY - TOULOUSE CEDEX 9
name: FRANCOISE GIORDANO LABADIE
role: PRINCIPAL_INVESTIGATOR
affiliation: HOPITAL ST ELOI - MONTPELLIER CEDEX 5
name: NADIA RAISON PEYRON
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU ESTAING - CLERMONT FERRAND
name: MARIE CHRISTINE FERRIER LE BOUEDEC
role: PRINCIPAL_INVESTIGATOR
affiliation: HOPITAL DE HAUT LEVEQUE - PESSAC CEDEX
name: MARIE SYLVIE DOUTRE
role: PRINCIPAL_INVESTIGATOR
affiliation: HOPITAL ST ANDRE - BORDEAUX CEDEX
name: BRIGITTE MILPIED
role: PRINCIPAL_INVESTIGATOR
affiliation: HOPITAL DUPUYTREN - LIMOGES CEDEX 1
name: CHRISTOPHE BEDANE
role: PRINCIPAL_INVESTIGATOR
affiliation: HOPITAL ST VINCENT DE PAUL - LILLE CEDEX
name: PHILIPPE MODIANO
role: PRINCIPAL_INVESTIGATOR
References: