Remibrutinib in Real-world Clinical Practice - a US Sub-study

Part of paid clinical trials in Kirksville, Missouri.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07358780
Status
Recruiting
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Conditions

  • Chronic Spontaneous Urticaria

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Study Details

Prospective, non-interventional study in patients with CSU where the treatment decision prior enrolment has been made to either escalate current sgH1-AHs treatment or escalate/switch current treatment to remibrutinib. The primary aim of this study is to gather real-world effectiveness and safety data for remibrutinib, a new treatment option, covering a broader, real-world clinical practice population.

Key Dates

Start date
Feb 2, 2026
Status verified
Feb 2026
Primary completion
Sep 30, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
505 participants (estimated)

Arms

  • Arm: Cohort 1
    Inadequate control of CSU despite licensed dose of sgH1-AH (no other pre-treatments permitted) and decision to escalate sgH1-AH treatment
  • Arm: Cohort 2
    Inadequate control of CSU despite licensed dose or escalated sgH1-AH(s) (no other pre-treatment with exception of first generation H1-AH permitted) with decision to switch to remibrutinib treatment as per local label
  • Arm: Cohort 3
    Any other treatment received in addition to H1-AH, any time during patients' CSU treatment history, with decision to switch to remibrutinib treatment as per local label

Primary Outcome Measure

UAS7 score [ Time Frame: 12 weeks after initiating remibrutinib treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleaver DermatologyKirksvilleMissouri63501-

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Cleaver Dermatology· Kirksville, MO

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