Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab
Condition: Chronic Spontaneous Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Intervention: Ligelizumab
Intervention description: For the first 12 weeks of treatment: i) participants transitioning from CQGE031C2302 (NCT03580369) and CQGE031C2303 (NCT03580356) previously treated with ligelizumab 72 mg LIVI s.c. Q4W were treated with the same dose regimen in a double-blind manner; ii) all other participants transitioning from CQGE031C2302 (NCT03580369) and CQGE031C2303 (NCT03580356) were treated with ligelizumab 120 mg LIVI s.c. Q4W in a double-blind manner; iii) participants transitioning from CQGE031C1301 (NCT03907878) and CQGE031C2202 (NCT03437278) were treated with ligelizumab 120 mg LIVI s.c. Q4W in an open-label manner.
Thereafter, all participants were switched to ligelizumab 120 mg s.c. PFS Q4W in an open-label manner and they were offered an opportunity to self-administer ligelizumab.
The longest possible treatment was 104 weeks, however this treatment might not be continuous and might span over a period of 156 weeks due to the possibility of entering the intervening observation period.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Participants transitioning from CQGE031C2302 (NCT03580369) and CQGE031C2303 (NCT03580356) were treated in a double-blind manner for the first 12 weeks of treatment. Thereafter, they were treated in an open-label manner.
No blinding was required for participants transitioning from CQGE031C1301 (NCT03907878) and CQGE031C2202 (NCT03437278)
Enrollment: 1033.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Anti-IgE; chronic spontaneous urticaria; hives severity score; itch severity score; urticaria activity score; CSU

Summary:

      The purpose of this extension study was to establish efficacy and safety of ligelizumab. This
      was assessed in adult and adolescent chronic spontaneous urticaria (CSU) patients who had
      completed a preceding ligelizumab study and have relapsed, following treatment in these
      preceding studies, despite standard of care H1-antihistamine (H1-AH) treatment.

      This study also fulfilled the Novartis commitment to provide post-trial access to patients
      who had completed studies: CQGE031C2302 (NCT03580369), CQGE031C2303 (NCT03580356),
      CQGE031C2202 (NCT03437278) or CQGE031C1301 (NCT03907878).
    

Eligibility 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 (NCT03580369), CQGE031C2303
             (NCT03580356), CQGE031C2202 (NCT03437278) or CQGE031C1301 (NCT03907878)

          -  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 (NCT03580369), CQGE031C2303 (NCT03580356) or
             CQGE031C2202 (NCT03437278).

          -  Diseases with possible symptoms of urticaria or angioedema

          -  Subjects with evidence of helminthic parasitic infection

          -  Documented history of anaphylaxis

          -  Pregnant or nursing (lactating) women