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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04210843
Collaborator
(none)
1,038
Enrollment
256
Locations
2
Arms
28.7
Anticipated Duration (Months)
4.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 3

Study Design

Study Type:
Interventional
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 :
Apr 8, 2020
Anticipated Primary Completion Date :
Aug 30, 2022
Anticipated Study Completion Date :
Aug 30, 2022

Arms and Interventions

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 Names:
  • 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 Names:
  • QGE031

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The proportion of subjects with well-controlled disease (UAS7 ≤ 6) at Week 12 [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 [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 [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 [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 [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 [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 [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 [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 [from Week 24 to Week 104]

      Occurence of Adverse Events for patients who self-administer

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

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    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT04210843
    Other Study ID Numbers:
    • CQGE031C2302E1
    • 2019-001792-37
    First Posted:
    Dec 26, 2019
    Last Update Posted:
    Jul 28, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Novartis Pharmaceuticals
    Anti-IgE
    chronic spontaneous urticaria
    hives severity score
    itch severity score
    urticaria activity score
    CSU
    Additional relevant MeSH terms:
    Urticaria
    Chronic Urticaria

    Study Results

    No Results Posted as of Jul 28, 2022