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

Overview

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

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: January 11, 2016

Interventions

  • Drug: OMALIZUMAB
    • sub cutaneous injections of 300 mg every 4 weeks until Week 8.

Arms, Groups and Cohorts

  • Experimental: OMALIZUMAB
    • sub cutaneous injections of 300 mg every 4 weeks until Week 8.

Clinical Trial Outcome Measures

Primary Measures

  • Percent of Participants With an Urticaria Control Test [UCT] Score of Greater Than or Equal to 12
    • Time Frame: WEEK 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.

Secondary Measures

  • Percent of Participants With UAS7≤6 (Patients Achieving Disease Control), in Adult Patients With CSU, With or Without the Presence of Angioedema
    • Time Frame: WEEK 12
    • 2 patients with angioedema status were missing at baseline and not included
  • CSU Disease Activity Using the Urticaria Activity Score (UAS7), With or Without the Presence of Angioedema
    • Time Frame: baseline and week 12
    • 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).
  • Urticaria Control Test (UCT) Score According to the Presence of Angioedema at Baseline and Week 12
    • Time Frame: 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.
  • 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
    • Time Frame: week 16
    • 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.
  • 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
    • Time Frame: week 20
    • 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.
  • 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
    • Time Frame: week 24
    • 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
  • 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
    • Time Frame: week 28
    • 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.
  • The Quality of Life Using the Chronic Urticaria Quality of Life (CU-QoL) Questionnaire
    • Time Frame: baseline and week 12
    • 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.
  • The Angioedema Quality of Life (AE-QoL)
    • Time Frame: baseline and week 12
    • 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
  • The Dermatology Life Quality Index (DLQI)
    • Time Frame: baseline and week 12
    • 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).
  • Angioedema Activity Using the Angioedema Activity Score (AAS)
    • Time Frame: baseline and week 12
    • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novartis Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • CLAIRE BERNIER TAUGOURDEAU, Principal Investigator, HOPITAL HOTEL DIEU – NANTES CEDEX 1
    • PASCAL JOLY, Principal Investigator, HOPITAL CHARLES NICOLLE – ROUEN CEDEX
    • LUDOVIC MARTIN, Principal Investigator, HOTEL DIEU – ANGERS CEDEX 9
    • GERARD GUILLET, Principal Investigator, CHR LA MILETRIE – POITIERS CEDEX
    • PATRICE PLANTIN, Principal Investigator, CHI DE CORNOUAILLE – QUIMPER CEDEX
    • ALAIN DUPUY, Principal Investigator, HOPITAL PONTCHAILLOU – RENNES CEDEX 9
    • EVELYNE COLLET, Principal Investigator, CHU SITE DU BOCAGE – DIJON CEDEX
    • ANNICK BARBAUD, Principal Investigator, HOPITAUX DE BRABOIS – VANDOEUVRE LES NANCY CEDEX
    • ZIAD REGUIAI, Principal Investigator, HOPITAL ROBERT DEBRE – REIMS CEDEX
    • FABIEN PELLETIER, Principal Investigator, HOPITAL JEAN MINJOZ – BESANCON CEDEX
    • DELPHINE STAUMONT SALLE, Principal Investigator, HOPITAL CLAUDE HURIEZ- LILLE CEDEX
    • JULIETTE JEGOU, Principal Investigator, CH DE CHALONS EN CHAMPAGNE – CHALONS EN CHAMPAGNE CEDEX
    • EMMANUELLE AMSLER, Principal Investigator, HOPITAL TENON – PARIS CEDEX 20
    • OLIVIER CHOSIDOW, Principal Investigator, HOPITAL HENRI MONDOR – CRETEIL
    • VINCENT DESCAMPS, Principal Investigator, HOPITAL BICHAT CLAUDE BERNARD – PARIS CEDEX 18
    • EMMANUEL MAHE, Principal Investigator, CH VICTOR DUPOUY – ARGENTEUIL CEDEX
    • LILIANE LAROCHE, Principal Investigator, HOPITAL AVICENNE – BOBIGNY CEDEX
    • GERMAINE GABISON, Principal Investigator, HOPITAL SAINT LOUIS – PARIS CEDEX 10
    • SELIM ARACTINGI, Principal Investigator, HOPITAL COCHIN – PARIS
    • LAURENCE BOUILLET, Principal Investigator, CHU DE GRENOBLE – LA TRONCHE
    • JEAN-JACQUES GROB, Principal Investigator, HOPITAL TIMONE – MARSEILLE CEDEX 05
    • FREDERIC CAMBAZARD, Principal Investigator, CHU SAINT ETIENNE – ST PRIEST EN JAREZ CEDEX
    • THIERRY BOYE, Principal Investigator, HIA SAINTE ANNE – TOULON CEDEX 9
    • JEAN-PHILIPPE LACOUR, Principal Investigator, HOPITAL DE L’ARCHET – NICE CEDEX 3
    • PHILIPPE BERBIS, Principal Investigator, HOPITAL NORD- MARSEILLE
    • LAURENT MEUNIER, Principal Investigator, HOPITAL CAREMEAU – NIMES CEDEX 9
    • FRANCOISE GIORDANO LABADIE, Principal Investigator, HOPITAL LARREY – TOULOUSE CEDEX 9
    • NADIA RAISON PEYRON, Principal Investigator, HOPITAL ST ELOI – MONTPELLIER CEDEX 5
    • MARIE CHRISTINE FERRIER LE BOUEDEC, Principal Investigator, CHU ESTAING – CLERMONT FERRAND
    • MARIE SYLVIE DOUTRE, Principal Investigator, HOPITAL DE HAUT LEVEQUE – PESSAC CEDEX
    • BRIGITTE MILPIED, Principal Investigator, HOPITAL ST ANDRE – BORDEAUX CEDEX
    • CHRISTOPHE BEDANE, Principal Investigator, HOPITAL DUPUYTREN – LIMOGES CEDEX 1
    • PHILIPPE MODIANO, Principal Investigator, HOPITAL ST VINCENT DE PAUL – LILLE CEDEX

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