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

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ClinicalTrials.gov Identifier: NCT02550106
Recruitment Status : Completed
First Posted : September 15, 2015
Last Update Posted : March 22, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment Phase
CHRONIC SPONTANEOUS URTICARIA Drug: OMALIZUMAB Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: 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 Start Date : April 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Omalizumab

Arm Intervention/treatment
Experimental: OMALIZUMAB
sub cutaneous injections of 300 mg every 4 weeks until Week 8.
Drug: OMALIZUMAB
sub cutaneous injections of 300 mg every 4 weeks until Week 8.




Primary Outcome Measures :
  1. proportion of patients with an urticaria control test [UCT] score of greater than or equal to 12 [ Time Frame: WEEK 12 ]

Secondary Outcome Measures :
  1. proportion of patient with UAS7≤6 (patients achieving disease control), in adult patients with CSU, with or without the presence of angioedema [ Time Frame: WEEK 12 ]
  2. CSU disease activity using the urticaria activity score (UAS7), with or without the presence of angioedema [ Time Frame: WEEK 12 ]
  3. control of the CSU using the UCT score, with or without the presence of angioedema [ Time Frame: WEEK 12 ]
  4. The quality of life using the chronic urticaria quality of life (CU-QoL) questionnaire [ Time Frame: WEEK 12 ]
  5. angioedema activity using the angioedema activity score (AAS) [ Time Frame: WEEK 12 ]
  6. The angioedema quality of life (AE-QoL) [ Time Frame: WEEK 12 ]
  7. The dermatology life quality index (DLQI) [ Time Frame: WEEK 12 ]

Other Outcome Measures:
  1. correlation between CSU disease control (UCT) and disease activity (UAS7 and AAS) [ Time Frame: WEEK 12 ]
  2. evolution of D-Dimer concentration [ Time Frame: WEEK 4, 8, 12 ]
  3. D-Dimer concentration based on the presence or absence of angioedema [ Time Frame: WEEK 4, 8, 12 ]
  4. correlation between D-Dimer concentration and CSU disease control (UCT) [ Time Frame: WEEK 12 ]
  5. correlation between D-Dimer concentration and disease activity (UAS7) [ Time Frame: WEEK 12 ]
  6. correlation between CSU disease control (UCT) and QoL (CU-QoL, AE-QoL and DLQI) measures [ Time Frame: WEEK 12 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02550106


Locations
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France
Novartis Investigative Site
Paris, Cedex 10, France, 75475
Novartis Investigative Site
Angers, France, 49033
Novartis Investigative Site
Argenteuil, France, 95107
Novartis Investigative Site
Besancon Cedex, France, 25030
Novartis Investigative Site
Bobigny Cedex, France, 93009
Novartis Investigative Site
Bordeaux Cedex, France, 33075
Novartis Investigative Site
Bordeaux, France, 33076
Novartis Investigative Site
Chalons-en-Champagne, France, 51005
Novartis Investigative Site
Clermont Ferrand cedex 1, France, 63003
Novartis Investigative Site
Dijon, France, 21034
Novartis Investigative Site
Grenoble, France, 38043
Novartis Investigative Site
LILLE Cedex, France, 59037
Novartis Investigative Site
Lille, France, 59000
Novartis Investigative Site
Limoges cedex, France, 87042
Novartis Investigative Site
Lyon cedex 04, France, 69317
Novartis Investigative Site
Marseille Cedex 05, France, 13885
Novartis Investigative Site
Montpellier cedex 5, France, 34295
Novartis Investigative Site
Nantes, France, 44035
Novartis Investigative Site
Nice, France, 06202
Novartis Investigative Site
Nimes Cedex, France, 30029
Novartis Investigative Site
Paris, France, 75014
Novartis Investigative Site
Paris, France, 75877
Novartis Investigative Site
Quimper, France, 29000
Novartis Investigative Site
Reims, France, 51092
Novartis Investigative Site
Rennes Cedex 9, France, 35033
Novartis Investigative Site
Rouen, France, 76031
Novartis Investigative Site
Saint-Etienne, France, 42055
Novartis Investigative Site
Toulon Cedex 9, France, 83800
Novartis Investigative Site
Toulouse Cedex, France, 31400
Novartis Investigative Site
Vandoeuvre Les Nancy, France, 54511
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Principal Investigator: 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

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02550106     History of Changes
Other Study ID Numbers: CIGE025EFR02
First Posted: September 15, 2015    Key Record Dates
Last Update Posted: March 22, 2016
Last Verified: March 2016
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
CHRONIC SPONTANEOUS URTICARIA, OMALIZUMAB, URTICARIA CONTROL TEST
Additional relevant MeSH terms:
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Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Omalizumab
Histamine Antagonists
Histamine H1 Antagonists
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Physiological Effects of Drugs
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action