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

NCT02550106 | Completed Phase 4 Results

• 1 other identifier: CIGE025EFR02
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 29

Brief Summary

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

Conditions

CHRONIC SPONTANEOUS URTICARIA

Keywords

CHRONIC SPONTANEOUS URTICARIA; OMALIZUMAB; URTICARIA CONTROL TEST; IGE025

Outcome Measures

Primary Outcomes (1)

• Percent of Participants With an Urticaria Control Test [UCT] Score of Greater Than or Equal to 12

  Number of participants with an Urticaria Control Test score of greater than or equal to 12 at Week 12 The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control.

  WEEK 12

Secondary Outcomes (11)

• Percent of Participants With UAS7≤6 (Patients Achieving Disease Control), in Adult Patients With CSU, With or Without the Presence of Angioedema

  WEEK 12

• CSU Disease Activity Using the Urticaria Activity Score (UAS7), With or Without the Presence of Angioedema

  baseline and week 12

• Urticaria Control Test (UCT) Score According to the Presence of Angioedema at Baseline and Week 12

  baseline and week 12

• 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

  week 16

• 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

  week 20

Study Arms (1)

OMALIZUMAB

EXPERIMENTAL

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

Drug: OMALIZUMAB

Interventions

OMALIZUMAB DRUG

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

OMALIZUMAB

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (29)

Novartis Investigative Site

Paris, Cedex 10, 75475, France

Location

Novartis Investigative Site

Limoges, Haute Vienne, 87000, France

Location

Novartis Investigative Site

Toulon, Val De Marne, 83800, France

Location

Novartis Investigative Site

Angers, 49933, France

Location

Novartis Investigative Site

Argenteuil, 95107, France

Location

Novartis Investigative Site

Besançon, 25030, France

Location

Novartis Investigative Site

Bobigny, 93009, France

Location

Novartis Investigative Site

Bordeaux, 33075, France

Location

Novartis Investigative Site

Châlons-en-Champagne, 51005, France

Location

Novartis Investigative Site

Clermont-Ferrand, 63003, France

Location

Novartis Investigative Site

Dijon, 21034, France

Location

Novartis Investigative Site

Grenoble, 38043, France

Location

Novartis Investigative Site

Lille, 59000, France

Location

Novartis Investigative Site

Lille, 59037, France

Location

Novartis Investigative Site

Lyon, 69317, France

Location

Novartis Investigative Site

Marseille, 13885, France

Location

Novartis Investigative Site

Montpellier, 34295, France

Location

Novartis Investigative Site

Nantes, 44035, France

Location

Novartis Investigative Site

Nice, 06202, France

Location

Novartis Investigative Site

Nîmes, 30029, France

Location

Novartis Investigative Site

Paris, 75014, France

Location

Novartis Investigative Site

Paris, 75877, France

Location

Novartis Investigative Site

Quimper, 29000, France

Location

Novartis Investigative Site

Reims, 51090, France

Location

Novartis Investigative Site

Rennes, 35033, France

Location

Novartis Investigative Site

Rouen, 76031, France

Location

Novartis Investigative Site

Saint-Etienne, 42055, France

Location

Novartis Investigative Site

Toulouse, 31400, France

Location

Novartis Investigative Site

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

Chronic Urticaria

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Limitations and Caveats

No placebo arm and limited duration of the study (3 months for the main period)

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

(862) 778-8300

Study Officials

• CLAIRE BERNIER TAUGOURDEAU

  HOPITAL HOTEL DIEU - NANTES CEDEX 1

  PRINCIPAL INVESTIGATOR

• PASCAL JOLY

  HOPITAL CHARLES NICOLLE - ROUEN CEDEX

  PRINCIPAL INVESTIGATOR

• LUDOVIC MARTIN

  HOTEL DIEU - ANGERS CEDEX 9

  PRINCIPAL INVESTIGATOR

• GERARD GUILLET

  CHR LA MILETRIE - POITIERS CEDEX

  PRINCIPAL INVESTIGATOR

• PATRICE PLANTIN

  CHI DE CORNOUAILLE - QUIMPER CEDEX

  PRINCIPAL INVESTIGATOR

• ALAIN DUPUY

  HOPITAL PONTCHAILLOU - RENNES CEDEX 9

  PRINCIPAL INVESTIGATOR

• EVELYNE COLLET

  CHU SITE DU BOCAGE - DIJON CEDEX

  PRINCIPAL INVESTIGATOR

• ANNICK BARBAUD

  HOPITAUX DE BRABOIS - VANDOEUVRE LES NANCY CEDEX

  PRINCIPAL INVESTIGATOR

• ZIAD REGUIAI

  HOPITAL ROBERT DEBRE - REIMS CEDEX

  PRINCIPAL INVESTIGATOR

• FABIEN PELLETIER

  HOPITAL JEAN MINJOZ - BESANCON CEDEX

  PRINCIPAL INVESTIGATOR

• DELPHINE STAUMONT SALLE

  HOPITAL CLAUDE HURIEZ- LILLE CEDEX

  PRINCIPAL INVESTIGATOR

• JULIETTE JEGOU

  CH DE CHALONS EN CHAMPAGNE - CHALONS EN CHAMPAGNE CEDEX

  PRINCIPAL INVESTIGATOR

• EMMANUELLE AMSLER

  HOPITAL TENON - PARIS CEDEX 20

  PRINCIPAL INVESTIGATOR

• OLIVIER CHOSIDOW

  HOPITAL HENRI MONDOR - CRETEIL

  PRINCIPAL INVESTIGATOR

• VINCENT DESCAMPS

  HOPITAL BICHAT CLAUDE BERNARD - PARIS CEDEX 18

  PRINCIPAL INVESTIGATOR

• EMMANUEL MAHE

  CH VICTOR DUPOUY - ARGENTEUIL CEDEX

  PRINCIPAL INVESTIGATOR

• LILIANE LAROCHE

  HOPITAL AVICENNE - BOBIGNY CEDEX

  PRINCIPAL INVESTIGATOR

• GERMAINE GABISON

  HOPITAL SAINT LOUIS - PARIS CEDEX 10

  PRINCIPAL INVESTIGATOR

• SELIM ARACTINGI

  HOPITAL COCHIN - PARIS

  PRINCIPAL INVESTIGATOR

• LAURENCE BOUILLET

  CHU DE GRENOBLE - LA TRONCHE

  PRINCIPAL INVESTIGATOR

• JEAN-JACQUES GROB

  HOPITAL TIMONE - MARSEILLE CEDEX 05

  PRINCIPAL INVESTIGATOR

• FREDERIC CAMBAZARD

  CHU SAINT ETIENNE - ST PRIEST EN JAREZ CEDEX

  PRINCIPAL INVESTIGATOR

• THIERRY BOYE

  HIA SAINTE ANNE - TOULON CEDEX 9

  PRINCIPAL INVESTIGATOR

• JEAN-PHILIPPE LACOUR

  HOPITAL DE L'ARCHET - NICE CEDEX 3

  PRINCIPAL INVESTIGATOR

• PHILIPPE BERBIS

  HOPITAL NORD- MARSEILLE

  PRINCIPAL INVESTIGATOR

• LAURENT MEUNIER

  HOPITAL CAREMEAU - NIMES CEDEX 9

  PRINCIPAL INVESTIGATOR

• FRANCOISE GIORDANO LABADIE

  HOPITAL LARREY - TOULOUSE CEDEX 9

  PRINCIPAL INVESTIGATOR

• NADIA RAISON PEYRON

  HOPITAL ST ELOI - MONTPELLIER CEDEX 5

  PRINCIPAL INVESTIGATOR

• MARIE CHRISTINE FERRIER LE BOUEDEC

  CHU ESTAING - CLERMONT FERRAND

  PRINCIPAL INVESTIGATOR

• MARIE SYLVIE DOUTRE

  HOPITAL DE HAUT LEVEQUE - PESSAC CEDEX

  PRINCIPAL INVESTIGATOR

• BRIGITTE MILPIED

  HOPITAL ST ANDRE - BORDEAUX CEDEX

  PRINCIPAL INVESTIGATOR

• CHRISTOPHE BEDANE

  HOPITAL DUPUYTREN - LIMOGES CEDEX 1

  PRINCIPAL INVESTIGATOR

• PHILIPPE MODIANO

  HOPITAL ST VINCENT DE PAUL - LILLE CEDEX

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: September 15, 2015
• Study Start: April 22, 2015
• Primary Completion: January 11, 2016
• Study Completion: January 11, 2016
• Last Updated: February 25, 2020
• Results First Posted: February 25, 2020

Record last verified: 2020-02

Locations

FR (29)