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

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

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

Study Overview

• Status: Completed
• Conditions: CHRONIC SPONTANEOUS URTICARIA
• Intervention / Treatment: Drug: OMALIZUMAB

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Angers cedex 09, France, 49933
    • 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
  • 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, France, 59000
    • Novartis Investigative Site
  • Lille Cedex, France, 59037
    • 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, 51090
    • Novartis Investigative Site
  • Rennes Cedex 9, France, 35033
    • Novartis Investigative Site
  • Rouen, France, 76031
    • Novartis Investigative Site
  • Saint-Etienne, France, 42055
    • Novartis Investigative Site
  • Toulouse Cedex, France, 31400
    • Novartis Investigative Site
  • Vandoeuvre Les Nancy, France, 54511
    • Novartis Investigative Site
  • Cedex 10
    • Paris Cedex 10, Cedex 10, France, 75475
      • Novartis Investigative Site
  • Haute Vienne
    • Limoges cedex, Haute Vienne, France, 87000
      • Novartis Investigative Site
  • Val De Marne
    • Toulon Cedex 9, Val De Marne, France, 83800
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Participants With UAS7≤6 (Patients Achieving Disease Control), in Adult Patients With CSU, With or Without the Presence of Angioedema	2 patients with angioedema status were missing at baseline and not included	WEEK 12
CSU Disease Activity Using the Urticaria Activity Score (UAS7), With or Without the Presence of Angioedema	A total score of UAS7 is calculated by adding for 7 days the daily UAS. The UAS7 is the sum of the daily UAS over 7 days before baseline and W12. The UAS7 score ranges from 0 to 42 with higher scores reflecting higher activity of the disease. Scores were categorized into five diseases states : urticaria-free (score =0), well-controlled (scores 1-6), mild (scores 7-15), moderate (scores 16-27) and severe urticaria (scores 28-42).	baseline and week 12
Urticaria Control Test (UCT) Score According to the Presence of Angioedema at Baseline and Week 12	The UCT is a questionnaire collecting retrospective information over the last 4 weeks before baseline and W12. The UCT score ranges from 0 to 16 with higher scores reflecting lower control of the disease. A score of ≥12 indicates well-controlled urticaria.	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	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 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	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 20
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	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 24
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	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 28
The Quality of Life Using the Chronic Urticaria Quality of Life (CU-QoL) Questionnaire	The Cu-QoL is a questionnaire collecting retrospective information over the last 2 weeks before baseline and W12. The CU-QoL total score is transformed to range from 0 to 100, with higher scores indicating worse Health Related Quality of life.	baseline and week 12
The Angioedema Quality of Life (AE-QoL)	The angioedema Quality of Life Questionnaire is a valuable tool to assess changes of QoL impairment in angioedema patients. The results of all the answered questions are summed up and transferred to a scale ranging from 0 to 100, with higher scores indicative of a higher QoL impairment	baseline and week 12
The Dermatology Life Quality Index (DLQI)	The Dermatology life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. It is designed for people aged 16 years and above. Each question is scored from 0 to 3, giving a possible score range form 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life).	baseline and week 12
Angioedema Activity Using the Angioedema Activity Score (AAS)	The Angioedema Activity Score (AAS) was completed by patients on a daily basis. The AAS is a validated questionnaire to determine the severity and impact of the angioedema episode. Te daily AAS values are added over 7 days before baseline and W12. Weekly AAS (AAS7) scores range from 0 to 105, with higher scores indicative of a higher disease activity.	baseline and week 12

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: 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, Hôpital Robert Debré - 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, Hôpital Henri Mondor - Créteil; 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

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2015
• Primary Completion (Actual): January 11, 2016
• Study Completion (Actual): January 11, 2016

Study Registration Dates

• First Submitted: March 9, 2015
• First Submitted That Met QC Criteria: September 11, 2015
• First Posted (Estimate): September 15, 2015

Study Record Updates

• Last Update Posted (Actual): February 25, 2020
• Last Update Submitted That Met QC Criteria: February 11, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: CHRONIC SPONTANEOUS URTICARIA; OMALIZUMAB; URTICARIA CONTROL TEST; IGE025
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Skin Diseases, Vascular; Hypersensitivity; Urticaria; Chronic Urticaria; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Omalizumab
• Other Study ID Numbers: CIGE025EFR02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No