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Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab

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ClinicalTrials.gov Identifier: NCT04210843
Recruitment Status : Active, not recruiting
First Posted : December 26, 2019
Last Update Posted : July 28, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:

The purpose of this extension study is to establish efficacy and safety of ligelizumab. This will be assessed in adult and adolescent chronic spontaneous urticaria (CSU) patients who have completed a preceding ligelizumab study and have relapsed, following treatment in these preceding studies, despite standard of care H1-antihistamine (H1-AH) treatment. In a subset of subjects, the safety and efficacy of ligelizumab monotherapy will be assessed.

This study will also fulfill the Novartis commitment to provide post-trial access to patients who have completed studies CQGE031C2302, CGQE031C2303, CQGE031C2202 or CQGE031C1301


Condition or disease Intervention/treatment Phase
Chronic Spontaneous Urticaria Drug: Ligelizumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1038 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-center, Double-blinded and Open-label Extension Study to Evaluate the Efficacy and Safety of Ligelizumab as Retreatment, Self-administered Therapy and Monotherapy in Chronic Spontaneous Urticaria Patients Who Completed Studies CQGE031C2302, CQGE031C2303, CQGE031C2202 or CQGE031C1301
Actual Study Start Date : April 8, 2020
Estimated Primary Completion Date : August 30, 2022
Estimated Study Completion Date : August 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ligelizumab Dose 1 and 3
Liquid in vial 72 mg/mL followed by 120 mg/mL PFS
 Drug: Ligelizumab
liquid in vial 120 mg/mL Prefilled Syringe 120 mg/mL
Other Name: QGE031
Experimental: Ligelizumab Dose 2 and 3
Liquid in vial 120 mg/mL followed by 120 mg/mL PFS
 Drug: Ligelizumab
liquid in vial 120 mg/mL Prefilled Syringe 120 mg/mL
Other Name: QGE031


Outcome Measures
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Primary Outcome Measures :
  1. The proportion of subjects with well-controlled disease (UAS7 ≤ 6) at Week 12 [ Time Frame: Week 12 ]

    The Urticaria Activity Score (UAS) is the sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS).

    The HSS, defined by number of hives (wheals), will be recorded by the subject twice daily in their eDiary, on a scale of 0 (none) to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 preceding days. The possible range of the weekly score is therefore 0 - 21.

    The severity of the itch will be recorded by the subject twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). A weekly score (ISS7) is derived by adding up the average daily scores of the 7 preceding days. The possible range of the weekly score is therefore 0-21 (maximum itch).

    The UAS7 is the sum of the HSS7 score and the ISS7 score. The possible range of the weekly UAS7 score is 0 - 42 (highest activity).



Secondary Outcome Measures :
  1. Complete control of chronic spontaneous urticaria (CSU) at Week 12 [ Time Frame: Week 12 ]
    Assessed as the proportion of subjects with completely controlled disease (UAS7 =0) at Week 12

  2. A reduction from extension study baseline in the UAS7 at Week 12 [ Time Frame: Week 12 ]
    Assessed as absolute change from extension study baseline in the UAS7 at Week 12

  3. A reduction from extension study baseline in the ISS7 at Week 12 [ Time Frame: Week 12 ]
    Assessed as absolute change from extension study baseline in the ISS7 (weekly itch severity score) at Week 12

  4. A reduction from extension study baseline in the HSS7 at Week 12 [ Time Frame: Week 12 ]
    Assessed as absolute change from extension study baseline in the HSS7 (weekly hives severity score) at Week 12

  5. Achieving an angioedema-free period at Week 12 [ Time Frame: Week 12 ]
    Assessed as cumulative number of weeks that subjects achieve weekly angioedema activity score (AAS7) = 0 between extension study baseline and Week 12

  6. Achieving Dermatology Life Quality Index (DLQI) = 0-1 at Week 12 [ Time Frame: Week 12 ]
    Assessed as percentage of subjects achieving DLQI = 0-1 at Week 12

  7. Efficacy of ligelizumab in the treatment of CSU, 12 weeks after starting self-administration [ Time Frame: Week 12 ]
    Assessed as the proportion of subjects with well-controlled disease (UAS7 ≤ 6), 12 weeks after starting self-administration

  8. Safety and tolerability of ligelizumab 120 mg q4w in all subjects who self-administer [ Time Frame: from Week 24 to Week 104 ]
    Occurence of Adverse Events for patients who self-administer


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Written informed consent
  • Subjects who successfully completed all of the treatment period and the follow-up period in any of the following studies: CQGE031C2302, CQGE031C2303, CQGE031C2202 or CQGE031C1301
  • Male and female, adult and adolescent subjects ≥12 years of age
  • Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedule

Key Exclusion Criteria:

  • Use of investigational drugs, other than those in use in the preceding studies, at the time of enrollment
  • Use of omalizumab within 16 weeks of Screening
  • History of hypersensitivity to the study drug ligelizumab or its components, or to drugs of similar chemical classes
  • New onset or signs and symptoms of any form of chronic urticarias other than CSU during the preceding studies CQGE031C2302, CQGE031C2303 or CQGE031C2202.
  • Diseases with possible symptoms of urticaria or angioedema
  • Subjects with evidence of helminthic parasitic infection
  • Documented history of anaphylaxis
  • Pregnant or nursing (lactating) women
Contacts and Locations
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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): NCT04210843


Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04210843    
Other Study ID Numbers: CQGE031C2302E1
2019-001792-37 ( EudraCT Number )
First Posted: December 26, 2019    Key Record Dates
Last Update Posted: July 28, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Anti-IgE
chronic spontaneous urticaria
hives severity score
 itch severity score
urticaria activity score
CSU
Additional relevant MeSH terms:
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Urticaria
Chronic Urticaria
Skin Diseases, Vascular
Skin Diseases
 Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases