Generated static export from Obsidian-friendly vault markdown
ClinPharm Vault

Remibrutinib real-world multi-country effectiveness study (NCT07358364)

Study Snapshot

  • Program: Remibrutinib
  • Study ID(s): NCT07358364
  • Phase: NR
  • Indication: Chronic Spontaneous Urticaria
  • Status: Recruiting
  • Sponsor: Novartis Pharmaceuticals
  • Study family: Real-world evidence program

Design

  • Study type: OBSERVATIONAL
  • Randomization / allocation: None
  • Intervention model: None
  • Masking: None
  • Primary purpose: None
  • Enrollment: 3280 (ESTIMATED)

Population

  • Conditions: Chronic Spontaneous Urticaria
  • Sex: ALL
  • Age range: 18 Years to None
  • Healthy volunteers: False
  • Summary: Prospective, multi-country, 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.

Operational design summary

  • Arms represented in current CT.gov export: 3
  • Active dose regimens represented in current local source layer: NR
  • Total study enrollment in CT.gov: 3280 (ESTIMATED)
  • Per-arm sample size summary: 3280 total across 3 listed arms; exact arm-specific counts are not explicitly stated in the current local source text.
  • Arm-size evidence source: ClinicalTrials.gov arm descriptions and summary text.

Arms

Arm Type Dose Frequency Route Description N Evidence status
Cohort 1 NR NR NR NR Inadequate control of CSU despite licensed dose of sgH1-AH (no other pre-treatments permitted) and decision to escalate sgH1-AH treatment NR Summary-level arm-size evidence exists, but exact N is not mapped to this CT.gov arm label in the current local layer
Cohort 2 NR NR NR NR 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 NR Summary-level arm-size evidence exists, but exact N is not mapped to this CT.gov arm label in the current local layer
Cohort 3 NR NR NR NR 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 NR Summary-level arm-size evidence exists, but exact N is not mapped to this CT.gov arm label in the current local layer

Key source-backed points

  • CT.gov lists an estimated enrollment of 3280 and three real-world cohorts defined by prior treatment pathway before remibrutinib use.
  • Primary outcomes include UCT7 and UAS7 at 12 weeks after initiating remibrutinib.

Endpoints

  • Primary outcomes:
  • UCT7 score (time frame: 12 weeks after initiating remibrutinib treatment)
  • UAS7 score (time frame: 12 weeks after initiating remibrutinib treatment)

Clinical Pharmacology Findings

  • PK: Not clearly summarized in the currently linked local source snippets.
  • PD: Not clearly summarized in the currently linked local source snippets.
  • Linked manuscripts: No trial-level primary publication is explicitly linked in the current registry.

Safety Findings

  • Safety detail is not strongly enriched beyond the current CT.gov/source-registry layer.

Linked Evidence

  • CT.gov page: https://clinicaltrials.gov/study/NCT07358364
  • Local CT.gov cache: raw/clinicaltrials/markdown/NCT07358364.md

Interpretation

  • Verified facts: this page reflects the current local registry and CT.gov inventory export without inferring unsupported arm sizes or endpoint results.
  • Interpretation: this trial is currently represented mainly by CT.gov and any linked sponsor-source artifacts; manual enrichment is still needed for a richer narrative page.
  • Open questions:
  • Some studies still lack exact arm-specific N in the current promoted evidence layer even when allocation schema or total enrollment is visible.
  • No explicit trial-level primary manuscript is currently linked in the registry.
  • No sponsor artifact is explicitly linked to this trial by identifier in the current registry.

Provenance

  • Source type: ClinicalTrials.gov inventory with linked sponsor/publication registry where available
  • Primary source(s):
  • NCT07358364
  • ../raw/clinicaltrials/markdown/NCT07358364.md
  • ../inventories/source_registry.json
  • Supporting source(s):
  • ../inventories/ctgov_priority_trials.json
  • Last verified: 2026-04-08
  • Verification status: Partial

Change Log

  • 2026-04-08: Generated or refreshed this study page from the v2 source registry and CT.gov inventory.