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

Официальное название

Remibrutinib in Real-world Clinical Practice: a Prospective, Multi-country, Non-interventional, Effectiveness and Safety Study - a US Sub-study

Обзор

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.

Подробное описание

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).

Первичные конечные точки

• UAS7 score [Срок оценки: 12 weeks after initiating remibrutinib treatment]

Вторичные конечные точки (12)

• UCT7 score [Срок оценки: 12 weeks after initiating remibrutinib treatment]
• Number and proportion of participants with well-controlled disease and complete disease [Срок оценки: Up to 24 months]
• Change from baseline (CFB) in UCT score [Срок оценки: Up to 24 months]
• Change from Baseline in UAS7 score ≥ minimal important difference [Срок оценки: Up to 24 months]
• Change in angioedema activity score (AAS7) from baseline [Срок оценки: Up to 24 months]
• Number of weeks without angioedema [Срок оценки: Up to 24 months]
• Number of participants with rescue medication requirement [Срок оценки: Up to 24 months]
• Characterize CSU relapse [Срок оценки: Up to 24 months]
• UCT score [Срок оценки: Up to 24 months]
• UAS7 score [Срок оценки: Up to 24 months]
• Number of participants with administration of remibrutinib as monotherapy [Срок оценки: Up to 24 months]
• Monotherapy duration [Срок оценки: Up to 24 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Cleaver Dermatology — Kirksville

Идентификаторы

NCT: NCT07358780 · CLOU064AUS04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗