Remibrutinib in Real-world Clinical Practice - a US Sub-study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Spontaneous Urticaria. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Remibrutinib in Real-world Clinical Practice: a Prospective, Multi-country, Non-interventional, Effectiveness and Safety Study - a US Sub-study
Overview
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.
Detailed description
This is a 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, covering a broader, real-world clinical practice population. This local US study is part of an umbrella design which brings the evidence needs from multiple countries under the REASSERT global program (CLOU064A2402).
Primary outcome measures
- UAS7 score [Time frame: 12 weeks after initiating remibrutinib treatment]
Secondary outcome measures (12)
- UCT7 score [Time frame: 12 weeks after initiating remibrutinib treatment]
- Number and proportion of participants with well-controlled disease and complete disease [Time frame: Up to 24 months]
- Change from baseline (CFB) in UCT score [Time frame: Up to 24 months]
- Change from Baseline in UAS7 score ≥ minimal important difference [Time frame: Up to 24 months]
- Change in angioedema activity score (AAS7) from baseline [Time frame: Up to 24 months]
- Number of weeks without angioedema [Time frame: Up to 24 months]
- Number of participants with rescue medication requirement [Time frame: Up to 24 months]
- Characterize CSU relapse [Time frame: Up to 24 months]
- UCT score [Time frame: Up to 24 months]
- UAS7 score [Time frame: Up to 24 months]
- Number of participants with administration of remibrutinib as monotherapy [Time frame: Up to 24 months]
- Monotherapy duration [Time frame: Up to 24 months]
Eligibility criteria
Inclusion criteria
- Patients with a confirmed diagnosis of primary CSU by the treating physician.
- Aged at least 18 years on the date of enrolment.
- Written informed consent of the patient to participate in the study (according to country specifications) and willingness to complete full follow-up period of 24 months.
- Cohort-specific observational inclusion criteria:
- Cohort 1: Inadequate control of CSU despite licensed dose of sgH1-AH (no other pre-treatments permitted) and decision (independent of study enrolment) to escalate sgH1-AH treatment.
- 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 (independent of study enrolment) to switch to remibrutinib treatment as per local label.
- Cohort 3: Any other treatment received in addition to H1-AH, any time during patients' CSU treatment history, with decision (independent of study enrolment) to switch to remibrutinib treatment as per local label. Note, occasional steroid rescue medication is out of scope for cohort definition. If a patient had been on continuous steroids for at least three weeks during treatment history, they will be included in cohort 3.
Note: Candidate patients must not have initiated the next escalated treatment step (i.e. up dosed AH for cohort 1, or remibrutinib for cohorts 2 and 3) prior to their enrolment to ensure the baseline visit captures their clinical status before treatment escalation.
Exclusion criteria
- Currently enrolled in a clinical trial or on any experimental treatment.
- Patients within the safety follow-up phase of a previous interventional or non-interventional study.
- Patients who received remibrutinib as an investigational medical product during a remibrutinib interventional study or MAP/PSDS at any time in the past.
- Patients not capable or willing to continuously provide ePRO/eDiary data via electronic means throughout the duration of the study.
- Patients who are treated with remibrutinib outside of the local label.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Cleaver Dermatology — Kirksville
Identifiers
NCT: NCT07358780 · CLOU064AUS04